NCT03794986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 22, 2024

Completed
Last Updated

April 22, 2024

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

December 12, 2018

Results QC Date

October 31, 2022

Last Update Submit

November 6, 2023

Conditions

Sexual Abuse

Outcome Measures

Primary Outcomes (2)

  • 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.

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

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

Secondary Outcomes (4)

  • Post Traumatic Stress Disorder

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

  • Psychosocial Functioning

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

  • Substance Abuse

    Baseline (immediately pre-intervention)

  • Substance Abuse

    Post-intervention (immediately following last online group)

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

Sexual and gender minority males who are sexual abuse survivors.

Behavioral: Motivational Interviewing

MI with trauma-informed SGM affirmative care

ACTIVE COMPARATOR

MI w/trauma-informed SGM affirmative care

Behavioral: Trauma-informed SGM affirmative care

Interventions

Trauma-informed SGM affirmative careBEHAVIORAL

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).

MI with trauma-informed SGM affirmative care
Motivational InterviewingBEHAVIORAL

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"

Motivational Interviewing

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen who have sex with men or individuals identifying as sexual gender minority (SGM) males who report a history of sexual abuse.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals who endorse active psychosis
  • Individuals who have a cognitive dysfunction
  • SGM men who report that they are currently in formal mental health counseling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (2)

  • Mandavia AD, Banducci AN, Simpson TL, Marx BP, Hawn SE, Hyde J, Ameral VE, Sistad Hall RE, Roth CE, Sarpong AA, Davenport M, Meng F, Stein MD, Livingston NA. Sex Differences in Suicide, Lethal Means, and Years of Potential Life Lost Among Veterans With Substance Use Disorder. Womens Health Issues. 2025 May-Jun;35(3):196-204. doi: 10.1016/j.whi.2025.02.002. Epub 2025 Mar 19.

    PMID: 40113455DERIVED

  • O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

    PMID: 37795783DERIVED

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Joan Cook
Organization
Yale University, School of Medicine
joan.cook@yale.edu
203-856-2782

Study Officials

  • Joan Cook, Phd

    Yale School of Medicine Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized comparative
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2018

First Posted

January 7, 2019

Study Start

April 1, 2019

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

April 22, 2024

Results First Posted

April 22, 2024

Record last verified: 2023-11

Locations

US(1)