Trial Outcomes & Findings for Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors (NCT NCT03794986)

Last Updated: 2024-04-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

356 participants

Primary outcome timeframe

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

Results posted on

2024-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	Motivational Interviewing Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: 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"	MI With Trauma-informed SGM Affirmative Care MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: 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).
Overall Study STARTED	178	178
Overall Study Partial Completion	35	31
Overall Study Completed Intervention	104	104
Overall Study COMPLETED	139	135
Overall Study NOT COMPLETED	39	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Motivational Interviewing Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: 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"	MI With Trauma-informed SGM Affirmative Care MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: 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).
Overall Study 0 Sessions Attended	34	37
Overall Study Withdrawal by Subject	4	6
Overall Study Protocol Violation	1	0

Baseline Characteristics

356 were randomized and analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Motivational Interviewing n=178 Participants Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: 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"	MI With Trauma-informed SGM Affirmative Care n=178 Participants MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: 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).	Total n=356 Participants Total of all reporting groups
Age, Continuous	34.7 years STANDARD_DEVIATION 12.2 • n=93 Participants • 356 were randomized and analyzed.	35 years STANDARD_DEVIATION 11.3 • n=4 Participants • 356 were randomized and analyzed.	34.9 years STANDARD_DEVIATION 11.8 • n=27 Participants • 356 were randomized and analyzed.
Sex/Gender, Customized Gender Identity · Male	146 Participants n=93 Participants	153 Participants n=4 Participants	299 Participants n=27 Participants
Sex/Gender, Customized Gender Identity · Trans male/Trans man	26 Participants n=93 Participants	18 Participants n=4 Participants	44 Participants n=27 Participants
Sex/Gender, Customized Gender Identity · Other	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Asian	17 Participants n=93 Participants	11 Participants n=4 Participants	28 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Black or African American	17 Participants n=93 Participants	16 Participants n=4 Participants	33 Participants n=27 Participants
Race (NIH/OMB) White	129 Participants n=93 Participants	134 Participants n=4 Participants	263 Participants n=27 Participants
Race (NIH/OMB) More than one race	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Mental Health Treatment History Treatment naive	21 Participants n=93 Participants	19 Participants n=4 Participants	40 Participants n=27 Participants
Mental Health Treatment History Not treatment naive	157 Participants n=93 Participants	159 Participants n=4 Participants	316 Participants n=27 Participants
Depression (CES-D)	30.61 units on a scale STANDARD_DEVIATION 10.85 • n=93 Participants	31.24 units on a scale STANDARD_DEVIATION 10.81 • n=4 Participants	30.92 units on a scale STANDARD_DEVIATION 10.82 • n=27 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Motivational Interviewing n=178 Participants Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: 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"	MI With Trauma-informed SGM Affirmative Care n=178 Participants MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: 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).
Number of Participants Who Engage in Mental Health Treatment Post-Intervention	23 Participants	18 Participants
Number of Participants Who Engage in Mental Health Treatment 60-day follow-up	31 Participants	26 Participants
Number of Participants Who Engage in Mental Health Treatment 120-day follow-up	28 Participants	31 Participants

PRIMARY outcome

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

Population: For outcome analyses, linear mixed models (LMM) of mental health symptoms were modeled as a repeated measures outcome variable, nested within participants, and nested within cohorts. Baseline values of the dependent variable, along with any baseline characteristics that differentiated the two groups, were included as time-invariant covariates (between participants), as was treatment group.

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.

Outcome measures

Outcome measures
Measure	Motivational Interviewing n=178 Participants Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: 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"	MI With Trauma-informed SGM Affirmative Care n=178 Participants MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: 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).
Center for Epidemiological Studies Depression Scale 60-day follow-up	27.33 score on a scale Standard Error .77	25.46 score on a scale Standard Error .75
Center for Epidemiological Studies Depression Scale 120-day follow-up	24.01 score on a scale Standard Error .79	23.74 score on a scale Standard Error .77
Center for Epidemiological Studies Depression Scale Post-intervention	24.04 score on a scale Standard Error .75	22.87 score on a scale Standard Error .73
Center for Epidemiological Studies Depression Scale Baseline	30.50 score on a scale Standard Error .67	30.70 score on a scale Standard Error .67

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Motivational Interviewing n=178 Participants Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: 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"	MI With Trauma-informed SGM Affirmative Care n=178 Participants MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: 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).
Post Traumatic Stress Disorder Post-intervention	29.30 score on a scale Standard Error 1.10	27.84 score on a scale Standard Error 1.06
Post Traumatic Stress Disorder 120-day follow-up	27.47 score on a scale Standard Error 1.14	25.57 score on a scale Standard Error 1.12
Post Traumatic Stress Disorder Baseline	36.26 score on a scale Standard Error .97	36.45 score on a scale Standard Error .97
Post Traumatic Stress Disorder 60-day follow-up	32.22 score on a scale Standard Error 1.12	29.21 score on a scale Standard Error 1.10

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Motivational Interviewing n=178 Participants Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: 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"	MI With Trauma-informed SGM Affirmative Care n=178 Participants MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: 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).
Psychosocial Functioning Post-intervention	39.88 score on a scale Standard Error 1.56	38.51 score on a scale Standard Error 1.52
Psychosocial Functioning 60-day follow-up	39.97 score on a scale Standard Error 1.58	34.05 score on a scale Standard Error 1.56
Psychosocial Functioning 120-day follow-up	39.69 score on a scale Standard Error 1.62	38.72 score on a scale Standard Error 1.60
Psychosocial Functioning Baseline	45.64 score on a scale Standard Error 1.36	44.71 score on a scale Standard Error 1.37

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Motivational Interviewing n=178 Participants Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: 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"	MI With Trauma-informed SGM Affirmative Care n=178 Participants MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: 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).
Substance Abuse Hallucinogens	.98 score on a scale Standard Error .15	.98 score on a scale Standard Error .15
Substance Abuse Tobacco	5.77 score on a scale Standard Error .28	5.83 score on a scale Standard Error .28
Substance Abuse Alcohol	8.83 score on a scale Standard Error .35	8.93 score on a scale Standard Error .35
Substance Abuse Marijuana	6.44 score on a scale Standard Error .33	6.53 score on a scale Standard Error .33
Substance Abuse Cocaine	1.58 score on a scale Standard Error .17	1.69 score on a scale Standard Error .17
Substance Abuse Amphetamine/ Stimulant	2.51 score on a scale Standard Error .23	2.55 score on a scale Standard Error .23
Substance Abuse Inhalants	.96 score on a scale Standard Error .15	1.06 score on a scale Standard Error .15
Substance Abuse Sedatives	2.00 score on a scale Standard Error .23	1.84 score on a scale Standard Error .23
Substance Abuse Opioids	1.02 score on a scale Standard Error .17	1.03 score on a scale Standard Error .17
Substance Abuse Other	8.83 score on a scale Standard Error .35	8.93 score on a scale Standard Error .35
Substance Abuse Medical Marijuana	1.68 score on a scale Standard Error .30	1.65 score on a scale Standard Error .30

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Motivational Interviewing n=178 Participants Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: 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"	MI With Trauma-informed SGM Affirmative Care n=178 Participants MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: 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).
Substance Abuse Tobacco	4.92 score on a scale Standard Error .32	4.75 score on a scale Standard Error .31
Substance Abuse Marijuana	5.89 score on a scale Standard Error .38	5.69 score on a scale Standard Error .36
Substance Abuse Cocaine	1.39 score on a scale Standard Error .20	1.04 score on a scale Standard Error .19
Substance Abuse Alcohol	7.71 score on a scale Standard Error .40	8.26 score on a scale Standard Error .39
Substance Abuse Amphetamine/ Stimulant	2.16 score on a scale Standard Error .26	2.11 score on a scale Standard Error .27
Substance Abuse Inhalants	1.06 score on a scale Standard Error .16	.90 score on a scale Standard Error .17
Substance Abuse Sedatives	1.67 score on a scale Standard Error .26	2.21 score on a scale Standard Error .25
Substance Abuse Hallucinogens	.88 score on a scale Standard Error .17	.98 score on a scale Standard Error .17
Substance Abuse Opioids	.83 score on a scale Standard Error .19	.99 score on a scale Standard Error .19
Substance Abuse Other	4.92 score on a scale Standard Error .32	4.75 score on a scale Standard Error .31
Substance Abuse Medical Marijuana	1.55 score on a scale Standard Error .39	2.74 score on a scale Standard Error .36

Adverse Events

Motivational Interviewing

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

MI With Trauma-informed SGM Affirmative Care

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Motivational Interviewing n=178 participants at risk Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: 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"	MI With Trauma-informed SGM Affirmative Care n=178 participants at risk MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: 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).
Psychiatric disorders Psychiatric hospitalization	0.56% 1/178 • Number of events 1 • From baseline to 120-day follow-up, approximately 170 days.	0.00% 0/178 • From baseline to 120-day follow-up, approximately 170 days.
Psychiatric disorders Sexual Assault	0.56% 1/178 • Number of events 1 • From baseline to 120-day follow-up, approximately 170 days.	0.00% 0/178 • From baseline to 120-day follow-up, approximately 170 days.

Other adverse events

Other adverse events
Measure	Motivational Interviewing n=178 participants at risk Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: 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"	MI With Trauma-informed SGM Affirmative Care n=178 participants at risk MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: 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).
Psychiatric disorders High Suicidality	2.8% 5/178 • Number of events 5 • From baseline to 120-day follow-up, approximately 170 days.	6.7% 12/178 • Number of events 12 • From baseline to 120-day follow-up, approximately 170 days.

Additional Information

Dr. Joan Cook

Yale University, School of Medicine

Phone: 203-856-2782

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place