Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors

Conditions
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Sexual Abuse

Intervention / Treatment
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* Behavioral: Trauma-informed SGM affirmative care
* Behavioral: Motivational Interviewing


Participation Criteria
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Eligibility Criteria
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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 3.0 or higher on emotional distress, using a 4-question symptom inventory. Exclusion Criteria: Individuals who endorse active psychosis Individuals who have a cognitive dysfunction SGM men who report that they are currently in formal mental health counseling

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized comparative
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing<br>Sexual and gender minority males who are sexual abuse survivors. | Behavioral: Motivational Interviewing<br>* 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<br>|
| Active Comparator: MI with trauma-informed SGM affirmative care<br>MI w/trauma-informed SGM affirmative care | Behavioral: Trauma-informed SGM affirmative care<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Engage in Mental Health Treatment | 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. | within 120 days of last online group | 
| Center for Epidemiological Studies Depression Scale | 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. | baseline | 
| Center for Epidemiological Studies Depression Scale | 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. | 14 days post intervention | 
| Center for Epidemiological Studies Depression Scale | 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. | 60 days post-intervention | 
| Center for Epidemiological Studies Depression Scale | 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. | 120 days post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Traumatic Stress Disorder | 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. | baseline | 
| Post Traumatic Stress Disorder | 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. | 14 days post intervention | 
| Post Traumatic Stress Disorder | 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. | 60 days post-intervention | 
| Post Traumatic Stress Disorder | 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. | 120 days post-intervention | 
| Substance abuse | ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test). The ASSIST is an 8-item measure of participants' use of alcohol, tobacco products, and other drugs across their lifetime and in the past three months. | baseline | 
| Substance abuse | ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test). The ASSIST is an 8-item measure of participants' use of alcohol, tobacco products, and other drugs across their lifetime and in the past three months. | 14 days post-intervention | 
| Substance abuse | ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test). The ASSIST is an 8-item measure of participants' use of alcohol, tobacco products, and other drugs across their lifetime and in the past three months. | 60 days post-intervention | 
| Substance abuse | ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test). The ASSIST is an 8-item measure of participants' use of alcohol, tobacco products, and other drugs across their lifetime and in the past three months. | 120 days post-intervention | 
| Psychosocial Functioning | 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. | baseline | 
| Psychosocial Functioning | 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. | 14 days post-intervention | 
| Psychosocial Functioning | 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. | 60 days post-intervention | 
| Psychosocial Functioning | 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. | 120 days post-intervention | 
| Service Utilization | The Service Use and Resource Form (SURF) is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days | screening | 
| Service Utilization | SURF is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days | baseline | 
| Service Utilization | SURF is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days | 14 days post intervention | 
| Service Utilization | SURF is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days | 60 days | 
| Service Utilization | SURF is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days | 120 days |