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Friendship Bench Adaptation to Improve Mental Health & HIV Care Engagement Outcomes Among PLWH and PWID in Vietnam (VITAL)

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ClinicalTrials.gov Identifier: NCT04790201
Recruitment Status : Not yet recruiting
First Posted : March 10, 2021
Last Update Posted : November 8, 2021
Sponsor:
Collaborators:
Hanoi Medical University
The Friendship Bench Trust
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
This project will adapt and pilot a feasible and effective problem-solving therapy designed for low-resource settings to address common mental disorders like depression and anxiety - the Friendship Bench- in a Vietnamese population of individuals living with HIV who also have opiate use disorder. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among people living with HIV (PLWH) with Opioid Use Disorder (OUD), a critical population driving the HIV epidemic in Vietnam and many Southeast Asian countries. This proposal will generate critical evidence for designing a fully powered clinical trial to test the investigation team's adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral Symptoms Depression Anxiety Opioid-use Disorder Virus Infection Immune System Diseases Opioid Dependence Behavioral: Friendship Bench Delivered by Professional Counselor Behavioral: Friendship Bench Delivered by Lay Counselor Behavioral: Enhanced Usual Care Not Applicable

Detailed Description:

Injection drug use is the primary driver of the HIV epidemic in Southeast Asia. In 2017, the HIV prevalence among people who inject drugs (PWID) in Southeast Asia was 15%. PWID, most of whom have OUD, who are living with HIV have low rates of retention in care, antiretroviral therapy (ART) initiation, and viral suppression. PWID also experience high rates of HIV-related and all-cause mortality. Common mental disorders (CMDs), including depressive, anxiety, and stress-related illnesses, occur in 40-50% of PLWH and OUD. Despite serious consequences of mental illness on health and HIV progression, mental illness remains under-diagnosed and under-treated in HIV populations, especially in low- and middle-income countries (LMICs), such as many countries in Southeast Asia.

To respond to the great need for mental health treatment in low- and middle-income countries, the global mental health field has focused on developing task-shifting and integration approaches that equip non-specialists to deliver evidence-based mental health interventions at scale. However, such task shifting interventions to address CMDs have received limited attention in Southeast Asia among OUD. Vietnam, with its high prevalence of PLWH and OUD, its integration of methadone maintenance therapy (MMT) with HIV care, and its priority for developing CMD care for this population, is an ideal setting to evaluate task-shifting mental health approaches to address CMDs and improve HIV care outcomes.

The Friendship Bench (FB) is a feasible and effective task-shifting mental health intervention designed for low-resource settings that is a strong candidate to address CMDs in this population. FB is a problem solving therapy-based intervention with demonstrated effectiveness in treating CMDs among primary care patients when delivered by lay counselors. Lay counselors may effectively deliver FB to PLWH with OUD, but CMD may prove more difficult to treat in patients with OUD and require professionally trained counselors to be effective.

The investigators' objective is to complete a pilot randomized trial of 75 patients from 4 MMT clinics in Hanoi. The investigators' specific aims are: 1) To adapt the Friendship Bench (FB) protocol to be optimized for PLWH and OUD in Vietnam; and 2) To evaluate the feasibility, fidelity, and acceptability of the adapted FB as well as preliminary indicators of its impact in improving CMDs and HIV care and drug use treatment outcomes. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among PLWH with OUD, a critical population driving the HIV epidemic in Vietnam and many Southeast Asian countries. This proposal will generate critical evidence for designing a fully powered clinical trial to test the adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three-arm individually randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adaptation of the Friendship Bench Counseling Intervention to Improve Mental Health and HIV Care Engagement Outcomes Among People Living With HIV Who Inject Drugs in Vietnam
Estimated Study Start Date : December 13, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Friendship Bench Delivered by Professional Counselor
25 participants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will initiate FB with a professional counselor. Individuals enrolled in this arm will receive 6 weekly counseling sessions per the adapted FB protocol (Aim 1).
Behavioral: Friendship Bench Delivered by Professional Counselor
Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.

Experimental: Friendship Bench Delivered by Lay Counselor
25 participants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will initiate FB with a trained lay counselor. Individuals enrolled in this arm arm will receive 6 weekly counselling sessions per the adapted FB protocol (Aim 1).
Behavioral: Friendship Bench Delivered by Lay Counselor
Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.

Active Comparator: Enhanced Usual Care
25 participants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Enhanced usual care will include general training of the HIV providers and clinics about CMD identification and management, and feedback to the HIV provider of the status of their enrolled patient to allow follow-up per the clinic's standard care.
Behavioral: Enhanced Usual Care
Enhanced usual care (EUC) will include general training of the HIV providers and clinics about CMD identification and management, and feedback to the HIV provider of the status of their enrolled patient to allow follow-up per the clinic's standard care. Information will be collected in follow-up interviews to characterize the care that patients receive. These activities will occur in all three arms, but they are the only activities in the EUC arm.




Primary Outcome Measures :
  1. Intervention Feasibility - Recruitment Rate [ Time Frame: 12th month of the intervention. ]
    This measure of feasibility will be measured as the ability to successfully enroll PLWH and OUD with CMDs in the pilot intervention. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).

  2. Intervention Feasibility - 3 Month Retention Rate [ Time Frame: 3rd month of intervention ]
    This measure of feasibility will be measured as the ability to retain PLWH and OUD with CMDs in the pilot intervention. Feasibility will be evaluated by measuring the retention rate (proportion of patients enrolled at baseline who are still enrolled in the trial).

  3. Intervention Feasibility - 6 Month Retention Rate [ Time Frame: 6th month of intervention ]
    This measure of feasibility will be measured as the ability to retain PLWH and OUD with CMDs in the pilot intervention. Feasibility will be evaluated by measuring the retention rate (proportion of patients enrolled at baseline who are still enrolled in the trial).

  4. Intervention Feasibility - 12 Month Retention Rate [ Time Frame: 12th month of intervention ]
    This measure of feasibility will be measured as the ability to retain PLWH and OUD with CMDs in the pilot intervention. Feasibility will be evaluated by measuring the retention rate (proportion of patients enrolled at baseline who are still enrolled in the trial).

  5. Intervention Feasibility - Proportion of FB Sessions Attended at 3 months [ Time Frame: Study baseline through 3rd month of follow-up. ]
    The proportion of FB sessions attended by participants out of total FB sessions offered.

  6. Intervention Feasibility - Proportion of FB Sessions Attended at 6 months [ Time Frame: Study baseline and through the 6th month of follow-up. ]
    The proportion of FB sessions attended by participants out of total FB sessions offered.

  7. Intervention Feasibility - Proportion of FB Sessions Attended at 12 months [ Time Frame: Study baseline and through the 12th month of follow-up. ]
    The proportion of FB sessions attended by participants out of total FB sessions offered.

  8. Intervention Feasibility - Cumulative Counselor Time Per Session [ Time Frame: At treatment exit (6 weeks) ]
    Mean duration of counselor time per session (in minutes) including preparation, documentation, and supervision.

  9. Intervention Feasibility - Cumulative Counselor Time Per Patient [ Time Frame: At treatment exit (6 weeks) ]
    Mean duration of counselor time per patient (in minutes) including preparation, documentation, and supervision.

  10. Intervention Acceptability - Percent Thematic Dominance across all Key Informant Interviews [ Time Frame: Assessed for patient participants when the participant completes the intervention (on average 12 months). Assessed for clinical and administrative participants at the end of the intervention at the participant's intervention site (on average 12 months). ]
    A qualitative, applied thematic approach will summarize and report intervention acceptability across key informant interviews (n=84). Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. Acceptability will be measured through brief exit interviews with all patient participants (n=75), HIV providers treating patients in the FB protocol, professional counselors (n=3), lay counselors (n=3), and supervising Master Trainers (n=1 per clinic, n=2 or 3 total). Exit interviews with patients will occur after the final FB session, while exit interviews with other groups will occur after the end of FB activities at each site. Exit interviews will include both closed and open-ended questions and will measure how easy the intervention was to participate in or deliver, the perceived usefulness of the intervention, and suggestions for improvement.

  11. Intervention Acceptability - Percent thematic dominance in patient participant key informant interviews [ Time Frame: Assessed for patient participants when the participant completes the intervention (on average 12 months). ]
    A qualitative, applied thematic approach will measure intervention acceptability. Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. Acceptability will be measured through brief exit interviews with all patient participants (n=75).

  12. Intervention Acceptability - Percent thematic dominance in HIV provider key informant interviews [ Time Frame: Assessed for clinical participants at the end of the intervention at the participant's intervention site (on average 12 months). ]
    A qualitative, applied thematic approach will measure intervention acceptability. Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. Acceptability will be measured through brief exit interviews with HIV providers treating patients in the FB protocol.

  13. Intervention Acceptability - Percent thematic dominance in professional counselor key informant interviews [ Time Frame: Assessed for clinical participants at the end of the intervention at the participant's intervention site (on average 12 months). ]
    A qualitative, applied thematic approach will measure intervention acceptability. Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. Acceptability will be measured through brief exit interviews with professional counselors (n=3).

  14. Intervention Acceptability - Percent thematic dominance in lay counselor key informant interviews [ Time Frame: Assessed for clinical participants at the end of the intervention at the participant's intervention site (on average 12 months). ]
    A qualitative, applied thematic approach will measure intervention acceptability. Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. Acceptability will be measured through brief exit interviews with lay counselors (n=3).

  15. Intervention Acceptability - Percent thematic dominance across Master Trainer key informant interviews [ Time Frame: Assessed for clinical and administrative participants at the end of the intervention at the participant's intervention site (on average 12 months). ]
    A qualitative, applied thematic approach will measure intervention acceptability. Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. Acceptability will be measured through brief exit interviews with supervising Master Trainers (n=1 per clinic, n=2 or 3 total).

  16. Intervention Fidelity - Mean Percent of Intervention Checklist Items Followed [ Time Frame: 12 months ]
    This measure of fidelity will be measured as a single mean value: the mean percent of intervention checklist items followed during counseling sessions. Covering at least 80% of checklist items during each session will be considered fidelity to the intervention protocol, as measured by a Master Trainer by using a checklist of counseling session elements either during direct monitoring or using audio recording.

  17. Intervention Fidelity - Mean Percent of Sessions Achieving 80% or greater than 80% Fidelity [ Time Frame: 12 months ]
    This measure of fidelity will be measured as a single mean value: the mean percent of intervention checklist items followed during counseling sessions. Covering at least 80% of checklist items during each session will be considered fidelity to the intervention protocol, as measured by a Master Trainer by using a checklist of counseling session elements either during direct monitoring or using audio recording.


Secondary Outcome Measures :
  1. Proportion of Participants Achieving HIV Viral Suppression [ Time Frame: Study baseline through 6 months ]
    HIV viral load will be measured from clinical records, or measured and ordered by the study if no viral load is collected in the appropriate window.

  2. Proportion of Participants Achieving HIV Viral Suppression [ Time Frame: Study baseline through 12 months ]
    HIV viral load will be measured from clinical records, or measured and ordered by the study if no viral load is collected in the appropriate window.

  3. Proportion of Participants with Consistent ART Use over 12 Months [ Time Frame: Assessed during entire study period (Study baseline through 12 months follow-up) ]
    Consistent ART use over 12 months as confirmed by clinical records.

  4. Proportion of Scheduled HIV Visits Attended vs. Unattended in the 12-Month Follow-Up period. [ Time Frame: Study baseline and each study follow-up through 12 months of follow-up. ]
    The proportion of scheduled visits in the 12-month follow-up period that are attended vs. no-shows (the "kept visit proportion"). HIV appointment data will be abstracted from clinic records at the end of the study period.

  5. Proportion of Participants with Depression Anxiety Stress-Scale (DASS-21) Total Score Indicating Any CMD Symptoms [ Time Frame: Study entrance/baseline. ]
    The DASS-21 measures self-reported depression, anxiety, and stress with 3 subscales. Responses are ranked on a Likert scale: 0 "Does not apply to me at all (Never)", 1 "Applied to me to some degree, or some of the time (Sometimes)", 2 "Applied to me to a considerable degree, or a good part of time (Often)", and 3 "Applied to me very much, or most of the time (Always)". The sub-scale scores are added ranging 0-126. Higher scores indicate higher emotional stress. A depression sub-scale score ≥14 indicates depressive disorders, anxiety sub-scale score ≥10 indicates anxiety disorders, and stress sub-scale score ≥19 indicates stress disorders. The depression sub-scale is measured as: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The anxiety sub-scale is: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The stress sub-scale is: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42.

  6. Proportion of Participants with Depression Anxiety Stress-Scale (DASS-21) Total Score Indicating Any CMD Symptoms [ Time Frame: 6 weeks after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress with 3 subscales. Responses are ranked on a Likert scale: 0 "Does not apply to me at all (Never)", 1 "Applied to me to some degree, or some of the time (Sometimes)", 2 "Applied to me to a considerable degree, or a good part of time (Often)", and 3 "Applied to me very much, or most of the time (Always)". The sub-scale scores are added ranging 0-126. Higher scores indicate higher emotional stress. A depression sub-scale score ≥14 indicates depressive disorders, anxiety sub-scale score ≥10 indicates anxiety disorders, and stress sub-scale score ≥19 indicates stress disorders. The depression sub-scale is measured as: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The anxiety sub-scale is: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The stress sub-scale is: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42.

  7. Proportion of Participants with Depression Anxiety Stress-Scale (DASS-21) Total Score Indicating Any CMD Symptoms [ Time Frame: 3 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress with 3 subscales. Responses are ranked on a Likert scale: 0 "Does not apply to me at all (Never)", 1 "Applied to me to some degree, or some of the time (Sometimes)", 2 "Applied to me to a considerable degree, or a good part of time (Often)", and 3 "Applied to me very much, or most of the time (Always)". The sub-scale scores are added ranging 0-126. Higher scores indicate higher emotional stress. A depression sub-scale score ≥14 indicates depressive disorders, anxiety sub-scale score ≥10 indicates anxiety disorders, and stress sub-scale score ≥19 indicates stress disorders. The depression sub-scale is measured as: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The anxiety sub-scale is: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The stress sub-scale is: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42.

  8. Proportion of Participants with Depression Anxiety Stress-Scale (DASS-21) Total Score Indicating Any CMD Symptoms [ Time Frame: 6 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress with 3 subscales. Responses are ranked on a Likert scale: 0 "Does not apply to me at all (Never)", 1 "Applied to me to some degree, or some of the time (Sometimes)", 2 "Applied to me to a considerable degree, or a good part of time (Often)", and 3 "Applied to me very much, or most of the time (Always)". The sub-scale scores are added ranging 0-126. Higher scores indicate higher emotional stress. A depression sub-scale score ≥14 indicates depressive disorders, anxiety sub-scale score ≥10 indicates anxiety disorders, and stress sub-scale score ≥19 indicates stress disorders. The depression sub-scale is measured as: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The anxiety sub-scale is: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The stress sub-scale is: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42.

  9. Proportion of Participants with Depression Anxiety Stress-Scale (DASS-21) Total Score Indicating Any CMD Symptoms [ Time Frame: 12 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress with 3 subscales. Responses are ranked on a Likert scale: 0 "Does not apply to me at all (Never)", 1 "Applied to me to some degree, or some of the time (Sometimes)", 2 "Applied to me to a considerable degree, or a good part of time (Often)", and 3 "Applied to me very much, or most of the time (Always)". The sub-scale scores are added ranging 0-126. Higher scores indicate higher emotional stress. A depression sub-scale score ≥14 indicates depressive disorders, anxiety sub-scale score ≥10 indicates anxiety disorders, and stress sub-scale score ≥19 indicates stress disorders. The depression sub-scale is measured as: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The anxiety sub-scale is: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The stress sub-scale is: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42.

  10. Proportion of Participants with DASS-21 depression subscale score ≥14 indicating a depressive disorder [ Time Frame: Study entrance/baseline. ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a DASS-21 score indicating a depressive disorder (a depression sub-scale score ≥ 14) will be measured.

  11. Proportion of Participants with DASS-21 depression subscale score ≥14 indicating a depressive disorder [ Time Frame: 6 weeks after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a DASS-21 score indicating a depressive disorder (a depression sub-scale score ≥ 14) will be measured.

  12. Proportion of Participants with DASS-21 depression subscale score ≥14 indicating a depressive disorder [ Time Frame: 3 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a DASS-21 score indicating a depressive disorder (a depression sub-scale score ≥ 14) will be measured.

  13. Proportion of Participants with DASS-21 depression subscale score ≥14 indicating a depressive disorder [ Time Frame: 6 months ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a DASS-21 score indicating a depressive disorder (a depression sub-scale score ≥ 14) will be measured.

  14. Proportion of Participants with DASS-21 depression subscale score ≥14 indicating a depressive disorder [ Time Frame: 12 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a DASS-21 score indicating a depressive disorder (a depression sub-scale score ≥ 14) will be measured.

  15. Proportion of participants with a 50 percent decrease in depressive symptom severity as measured using the DASS-21 depression sub-scale [ Time Frame: 6 weeks after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

  16. Proportion of participants with a 50 percent decrease in depressive symptom severity as measured using the DASS-21 depression sub-scale [ Time Frame: 3 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

  17. Proportion of participants with a 50 percent decrease in depressive symptom severity as measured using the DASS-21 depression sub-scale [ Time Frame: 6 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

  18. Proportion of participants with a 50 percent decrease in depressive symptom severity as measured using the DASS-21 depression sub-scale [ Time Frame: 12 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

  19. Probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up as indicated by a DASS-21 depression sub-scale score ≤ 9 [ Time Frame: 6 weeks after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up is measured by having a score of 0-9 on the DASS-21 depression sub-scale.

  20. Probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up as indicated by a DASS-21 depression sub-scale score ≤ 9 [ Time Frame: 3 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up is measured by having a score of 0-9 on the DASS-21 depression sub-scale.

  21. Probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up as indicated by a DASS-21 depression sub-scale score ≤ 9 [ Time Frame: 6 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up is measured by having a score of 0-9 on the DASS-21 depression sub-scale.

  22. Probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up as indicated by a DASS-21 depression sub-scale score ≤ 9 [ Time Frame: 12 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up is measured by having a score of 0-9 on the DASS-21 depression sub-scale.

  23. Proportion of participants with a DASS-21 anxiety subscale score ≥10 indicating an anxiety disorder [ Time Frame: Study entrance/baseline. ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) anxiety sub-scale score indicating an anxiety disorder (a score ≥ 10) will be measured.

  24. Proportion of participants with a DASS-21 anxiety subscale score ≥10 indicating an anxiety disorder [ Time Frame: 6 weeks after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) anxiety sub-scale score indicating an anxiety disorder (a score ≥ 10) will be measured.

  25. Proportion of participants with a DASS-21 anxiety subscale score ≥10 indicating an anxiety disorder [ Time Frame: 3 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) anxiety sub-scale score indicating an anxiety disorder (a score ≥ 10) will be measured.

  26. Proportion of participants with a DASS-21 anxiety subscale score ≥10 indicating an anxiety disorder [ Time Frame: 6 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) anxiety sub-scale score indicating an anxiety disorder (a score ≥ 10) will be measured.

  27. Proportion of participants with a DASS-21 anxiety subscale score ≥10 indicating an anxiety disorder [ Time Frame: 12 months ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) anxiety sub-scale score indicating an anxiety disorder (a score ≥ 10) will be measured.

  28. Proportion of participants with a 50 percent decrease in anxiety symptom severity as measured using the DASS-21 anxiety sub-scale [ Time Frame: 6 weeks ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥10 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

  29. Proportion of participants with a 50 percent decrease in anxiety symptom severity as measured using the DASS-21 anxiety sub-scale [ Time Frame: 3 months ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥10 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

  30. Proportion of participants with a 50 percent decrease in anxiety symptom severity as measured using the DASS-21 anxiety sub-scale [ Time Frame: 6 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥10 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

  31. Proportion of participants with a 50 percent decrease in anxiety symptom severity as measured using the DASS-21 anxiety sub-scale [ Time Frame: 12 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥10 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

  32. Probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up as indicated by a DASS-21 anxiety sub-scale score ≤6. [ Time Frame: 6 weeks after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up will be measured by a DASS-21 anxiety sub-scale score of 0-6.

  33. Probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up as indicated by a DASS-21 anxiety sub-scale score ≤6. [ Time Frame: 3 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up will be measured by a DASS-21 anxiety sub-scale score of 0-6.

  34. Probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up as indicated by a DASS-21 anxiety sub-scale score ≤6. [ Time Frame: 6 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up will be measured by a DASS-21 anxiety sub-scale score of 0-6.

  35. Probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up as indicated by a DASS-21 anxiety sub-scale score ≤6. [ Time Frame: 12 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up will be measured by a DASS-21 anxiety sub-scale score of 0-6.

  36. Proportion of participants with a DASS-21 stress sub-scale score ≥19 indicating a stress disorder [ Time Frame: Study entrance/baseline. ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score indicating a stress disorder (a score ≥ 19) will be measured.

  37. Proportion of participants with a DASS-21 stress sub-scale score ≥19 indicating a stress disorder [ Time Frame: 6 weeks after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score indicating a stress disorder (a score ≥ 19) will be measured.

  38. Proportion of participants with a DASS-21 stress sub-scale score ≥19 indicating a stress disorder [ Time Frame: 3 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score indicating a stress disorder (a score ≥ 19) will be measured.

  39. Proportion of participants with a DASS-21 stress sub-scale score ≥19 indicating a stress disorder [ Time Frame: 6 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score indicating a stress disorder (a score ≥ 19) will be measured.

  40. Proportion of participants with a DASS-21 stress sub-scale score ≥19 indicating a stress disorder [ Time Frame: 12 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score indicating a stress disorder (a score ≥ 19) will be measured.

  41. Proportion of participants with a 50% decrease in stress symptom severity as measured using the DASS-21 stress sub-scale [ Time Frame: 6 weeks after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥19 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a 50% decrease in stress symptom severity as indicated by Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score will be measured.

  42. Proportion of participants with a 50 decrease in stress symptom severity as measured using the DASS-21 stress sub-scale [ Time Frame: 3 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥19 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a 50% decrease in stress symptom severity as indicated by Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score will be measured.

  43. Proportion of participants with a 50 percent decrease in stress symptom severity as measured using the DASS-21 stress sub-scale [ Time Frame: 6 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥19 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a 50% decrease in stress symptom severity as indicated by Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score will be measured.

  44. Proportion of participants with a 50 percent decrease in stress symptom severity as measured using the DASS-21 stress sub-scale [ Time Frame: 12 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥19 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a 50% decrease in stress symptom severity as indicated by Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score will be measured.

  45. Probability of no longer meeting DASS-21 stress related diagnosis diagnostic criteria at follow-up as indicated by a DASS-21 stress sub-scale score ≤ 10. [ Time Frame: 6 weeks after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The probability of no longer meeting DASS-21 stress diagnostic criteria at follow-up will be measured by a DASS-21 stress sub-scale score of ≤ 10.

  46. Probability of no longer meeting DASS-21 stress related diagnosis diagnostic criteria at follow-up as indicated by a DASS-21 stress sub-scale score ≤ 10. [ Time Frame: 3 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The probability of no longer meeting DASS-21 stress diagnostic criteria at follow-up will be measured by a DASS-21 stress sub-scale score of ≤ 10.

  47. Probability of no longer meeting DASS-21 stress related diagnosis diagnostic criteria at follow-up as indicated by a DASS-21 stress sub-scale score ≤ 10. [ Time Frame: 6 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The probability of no longer meeting DASS-21 stress diagnostic criteria at follow-up will be measured by a DASS-21 stress sub-scale score of ≤ 10.

  48. Probability of no longer meeting DASS-21 stress related diagnosis diagnostic criteria at follow-up as indicated by a DASS-21 stress sub-scale score ≤ 10. [ Time Frame: 12 months after enrollment ]
    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The probability of no longer meeting DASS-21 stress diagnostic criteria at follow-up will be measured by a DASS-21 stress sub-scale score of ≤ 10.

  49. Proportion of Participants with Methadone Maintenance Engagement [ Time Frame: Study baseline and each study follow-up through 12 months of follow-up. ]
    The proportion of participants engaged in Methadone Maintenance Therapy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible individuals will meet the following criteria:

  • Adult patients (18 years and older) being treated at the Methadone Maintenance Treatment (MMT) clinic
  • Medical record indicates infection with HIV
  • Have been screened with the DASS-21 which has been translated, standardized and validated in the Vietnamese population with a positive result indicating a CMD (Henry & Crawford 2005; Le et al. 2017; Tran et al. 2013). The investigators will consider as eligible all patients with a depression subscale score ≥ 7, an anxiety subscale score ≥ 6, and/or a stress subscale score ≥ 10. Elevated depressive symptoms be present for ≥2 weeks and elevated anxiety or post-traumatic stress-related symptoms be present for ≥1 month. The investigators will consider a positive screen for any of the three categories as indicating a CMD.

Exclusion Criteria:

• Those with evidence of psychosis or bipolar disorder per the Mini International Neuropsychiatric Interview (MINI) will be excluded.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04790201


Contacts
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Contact: Ha Viet Tran, MD, MSc 84-24-3211-5839 vietha@live.unc.edu
Contact: Thi Thuy Ha Nong thuyha@unc.edu.vn

Locations
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Vietnam
CDC Hanoi
Hanoi, Hanoi City, Vietnam
Contact: Ha Viet Tran, MD, MSc    84-24-3211-5839    vietha@live.unc.edu   
Contact: Thuy Ha Nong    84-24-3211-5839 ext 206    thuyha@unc.edu.vn   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Hanoi Medical University
The Friendship Bench Trust
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Bradley Gaynes, MD, MPH University of North Carolina, Chapel Hill
Publications:
WHO Secretariat. HIV/AIDS and mental health. World Health Institution; 2008.

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04790201    
Other Study ID Numbers: 20-1689
R34DA051933 ( U.S. NIH Grant/Contract )
IGHID 12028 ( Other Identifier: UNC-CH )
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
Time Frame: 9 to 36 months following publication
Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Immune System Diseases
Opioid-Related Disorders
Behavioral Symptoms
Disease Attributes
Pathologic Processes
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders