18 and older, male only, with Sexual Abuse. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Engage in Mental Health TreatmentPrimary· 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.
Post-Intervention
Group
Value
95% CI
Motivational Interviewing
23
MI With Trauma-informed SGM Affirmative Care
18
60-day follow-up
Group
Value
95% CI
Motivational Interviewing
31
MI With Trauma-informed SGM Affirmative Care
26
120-day follow-up
Group
Value
95% CI
Motivational Interviewing
28
MI With Trauma-informed SGM Affirmative Care
31
Center for Epidemiological Studies Depression ScalePrimary· 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.
Baseline
Group
Value
95% CI
Motivational Interviewing
30.50
± .67
MI With Trauma-informed SGM Affirmative Care
30.70
± .67
Post-intervention
Group
Value
95% CI
Motivational Interviewing
24.04
± .75
MI With Trauma-informed SGM Affirmative Care
22.87
± .73
60-day follow-up
Group
Value
95% CI
Motivational Interviewing
27.33
± .77
MI With Trauma-informed SGM Affirmative Care
25.46
± .75
120-day follow-up
Group
Value
95% CI
Motivational Interviewing
24.01
± .79
MI With Trauma-informed SGM Affirmative Care
23.74
± .77
Post Traumatic Stress DisorderSecondary· 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;
Baseline
Group
Value
95% CI
Motivational Interviewing
36.26
± .97
MI With Trauma-informed SGM Affirmative Care
36.45
± .97
Post-intervention
Group
Value
95% CI
Motivational Interviewing
29.30
± 1.10
MI With Trauma-informed SGM Affirmative Care
27.84
± 1.06
60-day follow-up
Group
Value
95% CI
Motivational Interviewing
32.22
± 1.12
MI With Trauma-informed SGM Affirmative Care
29.21
± 1.10
120-day follow-up
Group
Value
95% CI
Motivational Interviewing
27.47
± 1.14
MI With Trauma-informed SGM Affirmative Care
25.57
± 1.12
Psychosocial FunctioningSecondary· 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.
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
Tobacco
Group
Value
95% CI
Motivational Interviewing
5.77
± .28
MI With Trauma-informed SGM Affirmative Care
5.83
± .28
Alcohol
Group
Value
95% CI
Motivational Interviewing
8.83
± .35
MI With Trauma-informed SGM Affirmative Care
8.93
± .35
Marijuana
Group
Value
95% CI
Motivational Interviewing
6.44
± .33
MI With Trauma-informed SGM Affirmative Care
6.53
± .33
Cocaine
Group
Value
95% CI
Motivational Interviewing
1.58
± .17
MI With Trauma-informed SGM Affirmative Care
1.69
± .17
Amphetamine/ Stimulant
Group
Value
95% CI
Motivational Interviewing
2.51
± .23
MI With Trauma-informed SGM Affirmative Care
2.55
± .23
Inhalants
Group
Value
95% CI
Motivational Interviewing
.96
± .15
MI With Trauma-informed SGM Affirmative Care
1.06
± .15
Sedatives
Group
Value
95% CI
Motivational Interviewing
2.00
± .23
MI With Trauma-informed SGM Affirmative Care
1.84
± .23
Hallucinogens
Group
Value
95% CI
Motivational Interviewing
.98
± .15
MI With Trauma-informed SGM Affirmative Care
.98
± .15
Substance AbuseSecondary· 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
Tobacco
Group
Value
95% CI
Motivational Interviewing
4.92
± .32
MI With Trauma-informed SGM Affirmative Care
4.75
± .31
Alcohol
Group
Value
95% CI
Motivational Interviewing
7.71
± .40
MI With Trauma-informed SGM Affirmative Care
8.26
± .39
Marijuana
Group
Value
95% CI
Motivational Interviewing
5.89
± .38
MI With Trauma-informed SGM Affirmative Care
5.69
± .36
Cocaine
Group
Value
95% CI
Motivational Interviewing
1.39
± .20
MI With Trauma-informed SGM Affirmative Care
1.04
± .19
Amphetamine/ Stimulant
Group
Value
95% CI
Motivational Interviewing
2.16
± .26
MI With Trauma-informed SGM Affirmative Care
2.11
± .27
Inhalants
Group
Value
95% CI
Motivational Interviewing
1.06
± .16
MI With Trauma-informed SGM Affirmative Care
.90
± .17
Sedatives
Group
Value
95% CI
Motivational Interviewing
1.67
± .26
MI With Trauma-informed SGM Affirmative Care
2.21
± .25
Hallucinogens
Group
Value
95% CI
Motivational Interviewing
.88
± .17
MI With Trauma-informed SGM Affirmative Care
.98
± .17
Adverse events — posted to ClinicalTrials.gov
Time frame: From baseline to 120-day follow-up, approximately 170 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 22 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03794986.