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Augmenting Mental Health Support Through a Supportive Text Messaging Program (Text4Support)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05411302
Recruitment Status : Not yet recruiting
First Posted : June 9, 2022
Last Update Posted : June 10, 2022
Sponsor:
Collaborators:
Dalhousie University
Nova Scotia Health Authority
Information provided by (Responsible Party):
Vincent Agyapong, Nova Scotia Health Authority

Brief Summary:
Patients seeking mental health care and those being discharged from psychiatric units frequently express psychological distress. A lack of routine follow-up and tailored support during these critical stages of a patient's journey can weaken the patient's connection to the health care system, resulting in low adherence and dissatisfaction with treatment, and the need for more intensive therapies. These unfavourable outcomes may result in deterioration of the patient's mental health, readmissions, recurrent emergency department (ED) visits, and extended length of stay (LOS). The investigators propose implementing an add-on supportive text messaging service (Text4Support), developed using cognitive-behavioural therapy (CBT) principles to augment mental health support for patients accessing different degrees of psychiatric care in Nova Scotia. The primary objective is to investigate the effectiveness of Text4Support, compared to usual care, in improving clinical mental health outcomes and overall mental wellbeing among participants. Secondary objective is to examine the impact of Text4Support on health services utilization and patient satisfaction. Lastly, investigators will explore Text4Support implementation outcomes. This will be a multicenter, mixed-methods, longitudinal, prospective, parallel, two-arm, rater-blinded randomized controlled trial. Participants will be randomized into two arms: the intervention arm will receive the usual care, plus daily automated supportive text messages from an online application, and the control arm will receive the usual care, which includes the freely accessible Health Authority approved e-mental health services. It is planned to enrol at least 1500 participants. Quantitative data will be analyzed using repeated measures mixed-effects modelling, effect size analysis, and correlational analysis between measures at each time point on an intention-to-treat basis. Qualitative data analysis will be guided by the six-phase thematic analysis framework. The analysis of the implementation outcomes will be guided by the RE-AIM framework. The results of the study will provide important information with respect to a comprehensive evaluation of outcomes of a supportive daily text message program; comparability of a supportive daily text message program compared with care as usual; and the impact of a supportive daily text message program on clinical outcomes, patient satisfaction and health services utilization.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Generalized Anxiety Disorder Mental Health Wellness 1 Other: Mental health supportive text messages Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Administrative data outcome assessors will be blinded to treatment group allocation by not involving them in discussions about study participants and not granting them access to the randomization code database.
Primary Purpose: Supportive Care
Official Title: Augmenting Mental Health Support for Patients Accessing Different Degrees of Formal Psychiatric Care Through a Supportive Text Messaging Program: A Randomized Controlled Trial
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Text4Support Arm
Patients in the intervention (Text4Support) arm of the study will receive the usual care (i.e. community care, follow-up appointments), plus daily automated supportive text messages from an online application.
Other: Mental health supportive text messages
Text4Support program was developed based on knowledge from randomized controlled trials conducted in Ireland and Alberta and from evaluations of the Text4Mood program. The diagnostic-specific approach is based on an analysis of service data, which suggested that diagnostic clusters for individuals accessing mental health services into 6 categories: mood disorders, anxiety disorders, schizophrenia and other psychotic disorders, substance use disorders, adjustment disorders and personality disorders. Thus, text message content will focus on 2 dimensions. General range includes messages of self-care, social support, hope, affirmation, and recovery. Specific content will focus on managing symptoms related to the conditions described above. As a component of scalability and inclusiveness, text message content can also be customized based on end-user characteristics. We will explore content that is sensitive to needs based on age group, cultural identity and gender identity.

No Intervention: Care as usual arm
Patients in the control arm of the study will receive the usual care, which includes the freely accessible Health Authority approved low-intensity e-mental health services. They will receive a single text message informing and encouraging them to utilize current MHAP resources on the NS Health website. They will not receive automated daily supportive text messages.



Primary Outcome Measures :
  1. Change in Well-being [ Time Frame: Baseline, 6 weeks, 3, 6 and 12 months ]
    Change from Baseline to 6 weeks, 3, 6 and 12 months for the mean scores for the quality life, assessed through the World Health Organization 5 Well-Being Index (WHO-5) in both groups. WHO-5-Well-Being Index is a short 5-item generic global rating scale measuring subjective well-being. The scale was derived from the WHO-10, which in turn was derived from a 28-item rating scale. The scale has adequate validity both as a screening tool for depression and as an outcome measure in clinical trials. The raw score is calculated by totaling the figures of the five answers. The raw score ranges from 0 (zero) to 25, 0 (zero) representing worst possible and 25 representing best possible quality of life.To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 (zero) represents worst possible, whereas a score of 100 represents best possible quality of life.

  2. Change in Recovery [ Time Frame: Baseline, 6 weeks, 3, 6 and 12 months ]
    Change from Baseline to 6 weeks, 3, 6 and 12 months for the mean scores for recovery, assessed through the Recovery Assessment Scale (RAS), in both groups. RAS is a 20-item measure developed based on a process model of recovery. The RAS evaluates various aspects of recovery with a special focus on hope and self-determination.

  3. Change in Major Depressive Disorder [ Time Frame: Baseline, 6 weeks, 3, 6 and 12 months ]
    Change from Baseline to 6 weeks, 3, 6 and 12 months for the mean scores for moderate to high depression (likely Major Depressive Disorder) assessed through the Patient Health Questionnaire (PHQ-9), in both groups. The PHQ-9 is a 9-item validated instrument used to diagnose and measure the severity of depression in general medical and mental health settings. PHQ-9 scores are: 0 - 4 None-minimal (patient may not need depression treatment); 5 - 9 Mild (use clinical judgment about treatment, based on patient's duration of symptoms and functional impairment); 10 - 14 Moderate (use clinical judgment about treatment, based on patient's duration of symptoms and functional impairment); 15 - 19 Moderately severe (treat using antidepressants, psychotherapy or a combination of treatment); 20 - 27 Severe (treat using antidepressants with or without psychotherapy).

  4. Change in Generalized Anxiety Disorder [ Time Frame: Baseline, 6 weeks, 3, 6 and 12 months ]
    Change from Baseline to 6 weeks, 3, 6 and 12 months in prevalence for moderate to high anxiety (likely Generalized Anxiety Disorder), assessed through the Generalized Anxiety Disorder (GAD-7) scale, in both groups. GAD-7 is a validated 7-item questionnaire used to assess the self-reported levels of anxiety in respondents. This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety.


Secondary Outcome Measures :
  1. Health services utilization (crisis calls) [ Time Frame: 12 months ]
    Differences in health services utilization data (crisis calls), between groups.

  2. Health services utilization (Emergency Department visits) [ Time Frame: 12 months ]
    Differences in health services utilization data (ED visits) between groups

  3. Health services utilization (hospital admissions) [ Time Frame: 12 months ]
    Differences in health services utilization data (hospital admissions) between groups.

  4. Health services utilization (hospital readmissions - i.e. admissions before 30 days os the last admission) [ Time Frame: 12 months ]
    Differences in health services utilization data (readmissions) between groups.

  5. Health services utilization (lenght of stay - LOS) [ Time Frame: 12 months ]
    Differences in health services utilization data (LOS following inpatient hospitalization) between groups

  6. Patient retention [ Time Frame: 12 months ]
    Differences between groups of self-reported retention rates assessed through a 5-point Likert scale on the frequency of reading messages and returning to messages, and actions taken.

  7. Patient satisfaction [ Time Frame: 12 months ]
    Differences between groups of overall patient satisfaction using a 5-point self-designed Likert scale.


Other Outcome Measures:
  1. Implementation (reach) [ Time Frame: 6 weeks, 3, 6 and 12 months after enrollment ]
    Reach of the interventions will be assessed in the intervention group only, through administrative data about the proportion of target population who receive the daily supportive text messages across Nova Scotia.

  2. Implementation (acceptability) [ Time Frame: 12 months after enrollment ]
    Acceptability of the intervention will be assessed in the intervention group only, through instrument developed and pilot tested, and published by the authors.

  3. Implementation (appropriateness) [ Time Frame: 6 months after enrollment ]
    Appropriateness of the intervention will be assessed through qualitative in-depth individual interview.

  4. Implementation (fidelity) [ Time Frame: 6 weeks, 3, 6 and 12 months. ]
    Fidelity of the intervention will be assessed through administrative data about Percentage of participants who received text messages as planned (no technical issues).

  5. Implementation (cost-effectiveness) [ Time Frame: 6 weeks, 3, 6 and 12 months. ]
    Cost-effectiveness of the intervention, evaluated through adminstrative data about the incremental cost-effectiveness ratio (ICER) is the ratio between the difference in costs and the difference in benefits of the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being a new patient (i.e. first-time user) of the TMHP, DH, RASP or MHCC, OR being a patient discharged from the ED or PIU (i.e. within a week period before discharge date).
  • Ownership of a mobile device capable of receiving text messages.
  • Able to read English text messages.
  • Can provide informed written consent.

Exclusion Criteria:

  • Patients who are not capable of reading text messages in English.
  • Patients who are not own a mobile phone capable of receiving text messages.
  • Patients who are not able/willing to provide consent to take part in the study.

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): NCT05411302


Contacts
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Contact: Vincent Agyapong 780-215-7771 vincent.agyapong@nshealth.ca
Contact: Raquel Luz Dias raquelL.dias@nshealth.ca

Locations
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Canada, Nova Scotia
Nova Scotia Health - Abbie J. Lane Memorial Building QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2E2
Contact: Vincent Agyapong    780-215-7771    vincent.agyapong@nshealth.ca   
Contact: Raquel Luz Dias       raquelL.dias@nshealth.ca   
Sponsors and Collaborators
Vincent Agyapong
Dalhousie University
Nova Scotia Health Authority
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Responsible Party: Vincent Agyapong, Psychiatrist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT05411302    
Other Study ID Numbers: Text4Support-NS47476
First Posted: June 9, 2022    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vincent Agyapong, Nova Scotia Health Authority:
Mental Health
Text messages
e-health
Text4Support
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depressive Disorder, Major
Anxiety Disorders
Pathologic Processes
Mood Disorders
Mental Disorders