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Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors

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ClinicalTrials.gov Identifier: NCT03794986
Recruitment Status : Enrolling by invitation
First Posted : January 7, 2019
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Yale University

Brief Summary:
The study will conduct a randomized comparative effectiveness trial of peer-facilitated, online, 6-week group Motivational Interviewing (MI) vs. Motivational Interviewing (MI) with a trauma-informed Sexual and Gender Minority (SGM) affirmative care approach.

Condition or disease Intervention/treatment Phase
Sexual Abuse Behavioral: Trauma-informed SGM affirmative care Behavioral: Motivational Interviewing Not Applicable

Detailed Description:
Through workshops and ongoing supervision/consultation, researchers will train MaleSurvivor peer leaders to competently deliver both versions of MI and conduct a randomized controlled trial comparing the two versions of MI to enhance treatment engagement in SGM male survivors with mental health problems. All SGM male survivors who meet inclusion criteria, including significant emotional distress, will complete pre-test measures and be randomized to 6-week MI delivered by peers in online groups or 6-week MI with trauma-informed, SGM affirmative care delivered by peers in online groups. Randomization will be counterbalanced by treatment status: treatment naive versus treatment-experienced (prior treatment but not within the past 60 days).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized comparative
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Motivational Interviewing
Sexual and gender minority males who are sexual abuse survivors.
Behavioral: Motivational Interviewing
Major principles and tenets of Motivational Interviewing (MI) group include: Non-confrontational nature of group; environment is one of respect, safety, and encouragement of all group members; purpose is to learn about members' personal thoughts and choices and not to push an "agenda"

Active Comparator: MI with trauma-informed SGM affirmative care
MI w/trauma-informed SGM affirmative care
Behavioral: Trauma-informed SGM affirmative care

All SGM male survivors who meet inclusion criteria, including significant emotional distress, will complete pre-test measures and be randomized to 6-week Motivational Interviewing (MI) delivered by peers in online groups or 6-week MI with trauma-informed, SGM affirmative care delivered by peers in online groups.

Participants will complete pre-intervention (baseline), end of the 6-week intervention, 60- and 120-days follow-up assessments via an online survey platform, to determine if there was an increase in formal treatment engagement, and any significant changes in mental health symptomology (i.e., PTSD, depression, high-risk drinking, and illicit substance use).





Primary Outcome Measures :
  1. Number of Participants Who Engage in Mental Health Treatment [ Time Frame: within 120 days of last online group ]
    The number of participants who initiated mental health treatment/reinitiated mental health treatment versus those who did not. Mental health treatment engagement will be operationally defined as having ≥1 visit(s) or scheduled appointments to any mental health services within 120 days of the last online group.

  2. Center for Epidemiological Studies Depression Scale [ Time Frame: baseline ]
    This is a 20-item questionnaire that asks about experience and frequency of depressive symptoms over the past week. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. A score of 16 or higher identifies those individuals who are at risk for major depression (which is equivalent to endorsing at least 6 out of 20 symptoms for depression. Researchers will be looking for scores to reduce to below 16, indicating a lack of criteria being met for major depressive disorder.

  3. Center for Epidemiological Studies Depression Scale [ Time Frame: 7 days post intervention ]
    This is a 20-item questionnaire that asks about experience and frequency of depressive symptoms over the past week. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. A score of 16 or higher identifies those individuals who are at risk for major depression (which is equivalent to endorsing at least 6 out of 20 symptoms for depression. Researchers will be looking for scores to reduce to below 16, indicating a lack of criteria being met for major depressive disorder.

  4. Center for Epidemiological Studies Depression Scale [ Time Frame: 60 days post-intervention ]
    This is a 20-item questionnaire that asks about experience and frequency of depressive symptoms over the past week. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. A score of 16 or higher identifies those individuals who are at risk for major depression (which is equivalent to endorsing at least 6 out of 20 symptoms for depression. Researchers will be looking for scores to reduce to below 16, indicating a lack of criteria being met for major depressive disorder.

  5. Center for Epidemiological Studies Depression Scale [ Time Frame: 120 days post-intervention ]
    This is a 20-item questionnaire that asks about experience and frequency of depressive symptoms over the past week. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. A score of 16 or higher identifies those individuals who are at risk for major depression (which is equivalent to endorsing at least 6 out of 20 symptoms for depression. Researchers will be looking for scores to reduce to below 16, indicating a lack of criteria being met for major depressive disorder.


Secondary Outcome Measures :
  1. Post Traumatic Stress Disorder [ Time Frame: baseline ]
    PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) , DSM-5 (PCL-5; Weathers et al., 2013) is a 20-item instrument that corresponds to the current psychiatric diagnostic criteria for PTSD. Participants respond on a Likert scale ranging from 0 (not at all) to 4 (extremely). A provisional PTSD diagnosis can be made by treating each item rated as 2 (moderately) or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (Intrusion symptoms; questions 1-5), 1 Criterion C item (Avoidance symptoms; questions 6-7), 2 Criterion D items (Alternations in cognitions and mood; questions 8-14), 2 Criterion E items (Alterations in arousal and reactivity; questions 15-20). A PCL-5 cut-point of 33 appears to be a reasonable value to use for provisional PTSD diagnosis. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80.

  2. Post Traumatic Stress Disorder [ Time Frame: 7 days post intervention ]
    PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013) is a 20-item instrument that corresponds to the current psychiatric diagnostic criteria for PTSD. Participants respond on a Likert scale ranging from 0 (not at all) to 4 (extremely). A provisional PTSD diagnosis can be made by treating each item rated as 2 (moderately) or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (Intrusion symptoms; questions 1-5), 1 Criterion C item (Avoidance symptoms; questions 6-7), 2 Criterion D items (Alternations in cognitions and mood; questions 8-14), 2 Criterion E items (Alterations in arousal and reactivity; questions 15-20). A PCL-5 cut-point of 33 appears to be a reasonable value to use for provisional PTSD diagnosis. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80.

  3. Post Traumatic Stress Disorder [ Time Frame: 60 days post-intervention ]
    PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013) is a 20-item instrument that corresponds to the current psychiatric diagnostic criteria for PTSD. Participants respond on a Likert scale ranging from 0 (not at all) to 4 (extremely). A provisional PTSD diagnosis can be made by treating each item rated as 2 (moderately) or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (Intrusion symptoms; questions 1-5), 1 Criterion C item (Avoidance symptoms; questions 6-7), 2 Criterion D items (Alternations in cognitions and mood; questions 8-14), 2 Criterion E items (Alterations in arousal and reactivity; questions 15-20). A PCL-5 cut-point of 33 appears to be a reasonable value to use for provisional PTSD diagnosis. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80.

  4. Post Traumatic Stress Disorder [ Time Frame: 120 days post-intervention ]
    PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013) is a 20-item instrument that corresponds to the current psychiatric diagnostic criteria for PTSD. Participants respond on a Likert scale ranging from 0 (not at all) to 4 (extremely). A provisional PTSD diagnosis can be made by treating each item rated as 2 (moderately) or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (Intrusion symptoms; questions 1-5), 1 Criterion C item (Avoidance symptoms; questions 6-7), 2 Criterion D items (Alternations in cognitions and mood; questions 8-14), 2 Criterion E items (Alterations in arousal and reactivity; questions 15-20). A PCL-5 cut-point of 33 appears to be a reasonable value to use for provisional PTSD diagnosis. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80.

  5. Substance abuse [ Time Frame: baseline ]
    Addiction Severity Index (ASI; McLellan, Luborsky, O'Brien, & Woody, 1980; Butler et al., 2001) is a measure of recent (past 30 days) and lifetime problems related to substance abuse including: medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status. A composite score is used to compare pre- and post-treatment evaluation points. It is not used as a measure of clinical cutoff or for diagnostic purposes. Composite scores are determined by summing the responses to questions ascertaining which substances were used, how often, how troubled participants are by their substance use, and how important treatment for their substance use is to them. No range of scores can be presented as it varies by person and days of use. A computerized scoring program will be utilized to calculate the composite scores.

  6. Substance abuse [ Time Frame: 7 days post-intervention ]
    Addiction Severity Index (ASI; McLellan, Luborsky, O'Brien, & Woody, 1980; Butler et al., 2001) is a measure of recent (past 30 days) and lifetime problems related to substance abuse including: medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status. A composite score is used to compare pre- and post-treatment evaluation points. It is not used as a measure of clinical cutoff or for diagnostic purposes. Composite scores are determined by summing the responses to questions ascertaining which substances were used, how often, how troubled participants are by their substance use, and how important treatment for their substance use is to them. No range of scores can be presented as it varies by person and days of use. A computerized scoring program will be utilized to calculate the composite scores.

  7. Substance abuse [ Time Frame: 60 days post-intervention ]
    Addiction Severity Index (ASI; McLellan, Luborsky, O'Brien, & Woody, 1980; Butler et al., 2001) is a measure of recent (past 30 days) and lifetime problems related to substance abuse including: medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status. A composite score is used to compare pre- and post-treatment evaluation points. It is not used as a measure of clinical cutoff or for diagnostic purposes. Composite scores are determined by summing the responses to questions ascertaining which substances were used, how often, how troubled participants are by their substance use, and how important treatment for their substance use is to them. No range of scores can be presented as it varies by person and days of use. A computerized scoring program will be utilized to calculate the composite scores.

  8. Substance abuse [ Time Frame: 120 days post-intervention ]
    Addiction Severity Index (ASI; McLellan, Luborsky, O'Brien, & Woody, 1980; Butler et al., 2001) is a measure of recent (past 30 days) and lifetime problems related to substance abuse including: medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status. A composite score is used to compare pre- and post-treatment evaluation points. It is not used as a measure of clinical cutoff or for diagnostic purposes. Composite scores are determined by summing the responses to questions ascertaining which substances were used, how often, how troubled participants are by their substance use, and how important treatment for their substance use is to them. No range of scores can be presented as it varies by person and days of use. A computerized scoring program will be utilized to calculate the composite scores.

  9. Psychosocial Functioning [ Time Frame: baseline ]
    Inventory of Psychosocial Functioning (IPF-B; Rodriguez, Holowka, & Marx, 2012) is a brief 7-item scale that assesses functional impairment or quality of life related to trauma and PTSD. Questions assess for impairment in romantic relationships, family relationships, work, friendships and socializing, parenting, academic pursuits, and self-care. Higher scores indicate greater functional impairment. Respondents answer each item by using a 7-point scale ranging from 1 ("never") to 7 ("always"). The IPF yields an overall functional impairment score.

  10. Psychosocial Functioning [ Time Frame: 7 days post-intervention ]
    Inventory of Psychosocial Functioning (IPF-B; Rodriguez, Holowka, & Marx, 2012) is a brief 7-item scale that assesses functional impairment or quality of life related to trauma and PTSD. Questions assess for impairment in romantic relationships, family relationships, work, friendships and socializing, parenting, academic pursuits, and self-care. Higher scores indicate greater functional impairment. Respondents answer each item by using a 7-point scale ranging from 1 ("never") to 7 ("always"). The IPF yields an overall functional impairment score.

  11. Psychosocial Functioning [ Time Frame: 60 days post-intervention ]
    Inventory of Psychosocial Functioning (IPF-B; Rodriguez, Holowka, & Marx, 2012) is a brief 7-item scale that assesses functional impairment or quality of life related to trauma and PTSD. Questions assess for impairment in romantic relationships, family relationships, work, friendships and socializing, parenting, academic pursuits, and self-care. Higher scores indicate greater functional impairment. Respondents answer each item by using a 7-point scale ranging from 1 ("never") to 7 ("always"). The IPF yields an overall functional impairment score.

  12. Psychosocial Functioning [ Time Frame: 120 days post-intervention ]
    Inventory of Psychosocial Functioning (IPF-B; Rodriguez, Holowka, & Marx, 2012) is a brief 7-item scale that assesses functional impairment or quality of life related to trauma and PTSD. Questions assess for impairment in romantic relationships, family relationships, work, friendships and socializing, parenting, academic pursuits, and self-care. Higher scores indicate greater functional impairment. Respondents answer each item by using a 7-point scale ranging from 1 ("never") to 7 ("always"). The IPF yields an overall functional impairment score.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men who have sex with men or individuals identifying as sexual gender minority (SGM) males who report a history of sexual abuse.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or older
  • English-speaking; men who have sex with men or individuals identifying as SGM males
  • Individuals who report a history of sexual abuse and individuals who self-report a minimum cut-off score of 2.5 or higher on emotional distress, using a 4-question symptom inventory.

Exclusion Criteria:

  • Individuals who endorse active psychosis
  • Individuals who have a cognitive dysfunction
  • Individuals who have amnestic disorder per the Mini-International Neuropsychiatric Interview (MINI)
  • SGM men who report that they are currently in formal mental health counseling

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): NCT03794986


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Joan Cook, Phd Yale School of Medicine Department of Psychiatry

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03794986     History of Changes
Other Study ID Numbers: Cook.12.10.18
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No