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Sexual AbuseNCT03794986

Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors

A study testing Trauma-informed SGM affirmative care and Motivational Interviewing in people with Sexual Abuse, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Sexual Abuse
What is being tested?
Trauma-informed SGM affirmative care and Motivational Interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
356 participants
Where
1 siteUnited States
Study dates
1 Apr 2019to 30 Nov 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale University

    New Haven, Connecticut, 06511

Other trials in United States

About this study

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.

Read the 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).

Conditions
Sexual Abuse
Being tested
Trauma-informed SGM affirmative care, Motivational Interviewing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma-informed SGM affirmative careBehavioural

    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 InterviewingBehavioural

    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"

Study groups in NCT03794986
Study groupRoleWhat they receive
Motivational InterviewingExperimentalSexual and gender minority males who are sexual abuse survivors.
Receives: Behavioral: Motivational Interviewing
MI with trauma-informed SGM affirmative careActive comparatorMI w/trauma-informed SGM affirmative care
Receives: Behavioral: Trauma-informed SGM affirmative care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (4)

  1. 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.

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

  2. 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.

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

  3. Substance Abuse

    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.

    Measured: Baseline (immediately pre-intervention)

  4. Substance Abuse

    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.

    Measured: Post-intervention (immediately following last online group)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2019
  2. Study start1 Apr 2019
  3. Primary completion30 Nov 2021
  4. Study completion30 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized comparative
Masking
None (open label)
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03794986
Sponsor's protocol ID
2000024842
Other IDs
AD-2018C1-11098
Status last verified
Nov 2023
First submitted
12 Dec 2018
Last updated
22 Apr 2024
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40113455

  • 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.

    PubMed 37795783

Questions about this trial

What is this clinical trial studying?

A study testing Trauma-informed SGM affirmative care and Motivational Interviewing in people with Sexual Abuse, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03794986, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.

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