Clinical trial NCT03794986: Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors
Official title: Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Abuse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2019-01-07
Enrollment: 356
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized comparative
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility 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 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

Primary outcomes:
measure: Number of Participants Who Engage in Mental Health Treatment
timeFrame: Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.
measure: Center for Epidemiological Studies Depression Scale
timeFrame: Baseline (pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.
Secondary outcomes:
measure: Post Traumatic Stress Disorder
timeFrame: Baseline (immediately pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.
measure: Psychosocial Functioning
timeFrame: Baseline (immediately pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day
measure: Substance Abuse
timeFrame: Baseline (immediately pre-intervention)
measure: Substance Abuse
timeFrame: Post-intervention (immediately following last online group)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale School of Medicine Department of Psychiatry
name: Joan Cook, Phd
role: PRINCIPAL_INVESTIGATOR
References: