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Completed

NCT Number: NCT03794986

Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06511, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma-informed SGM affirmative care

Behavioral

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).

Motivational Interviewing

Behavioral

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"

Primary outcomes

  1. Number of Participants Who Engage in Mental Health Treatment

    Time frame: Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.

    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 (pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.

    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 outcomes

  1. Post Traumatic Stress Disorder

    Time frame: Baseline (immediately pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.

    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. Psychosocial Functioning

    Time frame: Baseline (immediately pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day

    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.

  3. Substance Abuse

    Time frame: Baseline (immediately pre-intervention)

    The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is an 8-item measure of use of alcohol, tobacco products, and other drugs across the lifespan and in the past 3 months. The test has been shown to be a valid indicator of active substance use with adequate construct validity. Scores are summed across for each drug category separately with a maximum score for tobacco = 31 and a maximum score for each of the other drug categories = 39. A Global Continuum of Risk Score can also be calculated by summing all items for all drug classes together with a maximum score of 414. Scores are categorized into Low (0 - 3), Moderate (4 - 26), and High (27+) risk.

  4. Substance Abuse

    Time frame: Post-intervention (immediately following last online group)

    The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is an 8-item measure of use of alcohol, tobacco products, and other drugs across the lifespan and in the past 3 months. The test has been shown to be a valid indicator of active substance use with adequate construct validity. Scores are summed across for each drug category separately with a maximum score for tobacco = 31 and a maximum score for each of the other drug categories = 39. A Global Continuum of Risk Score can also be calculated by summing all items for all drug classes together with a maximum score of 414. Scores are categorized into Low (0 - 3), Moderate (4 - 26), and High (27+) risk.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2019
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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