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Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors

Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03794986
Enrollment
356
Registered
2019-01-07
Start date
2019-04-01
Completion date
2021-11-30
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Abuse

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).

Interventions

BEHAVIORALTrauma-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).

BEHAVIORALMotivational 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

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

randomized comparative

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Engage in Mental Health TreatmentPost-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.
Center for Epidemiological Studies Depression ScaleBaseline (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.

Secondary

MeasureTime frameDescription
Post Traumatic Stress DisorderBaseline (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.
Psychosocial FunctioningBaseline (immediately pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-dayInventory 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.
Substance AbuseBaseline (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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
178
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).
178
Total356

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Study0 Sessions Attended3437
Overall StudyProtocol Violation10
Overall StudyWithdrawal by Subject46

Baseline characteristics

CharacteristicMotivational InterviewingMI With Trauma-informed SGM Affirmative CareTotal
Age, Continuous34.7 years
STANDARD_DEVIATION 12.2
35 years
STANDARD_DEVIATION 11.3
34.9 years
STANDARD_DEVIATION 11.8
Depression (CES-D)30.61 units on a scale
STANDARD_DEVIATION 10.85
31.24 units on a scale
STANDARD_DEVIATION 10.81
30.92 units on a scale
STANDARD_DEVIATION 10.82
Mental Health Treatment History
Not treatment naive
157 Participants159 Participants316 Participants
Mental Health Treatment History
Treatment naive
21 Participants19 Participants40 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants2 Participants4 Participants
Race (NIH/OMB)
Asian
17 Participants11 Participants28 Participants
Race (NIH/OMB)
Black or African American
17 Participants16 Participants33 Participants
Race (NIH/OMB)
More than one race
12 Participants12 Participants24 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants
Race (NIH/OMB)
White
129 Participants134 Participants263 Participants
Sex/Gender, Customized
Gender Identity
Male
146 Participants153 Participants299 Participants
Sex/Gender, Customized
Gender Identity
Other
6 Participants7 Participants13 Participants
Sex/Gender, Customized
Gender Identity
Trans male/Trans man
26 Participants18 Participants44 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1780 / 178
other
Total, other adverse events
5 / 17812 / 178
serious
Total, serious adverse events
2 / 1780 / 178

Outcome results

Primary

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Motivational InterviewingCenter for Epidemiological Studies Depression ScaleBaseline30.50 score on a scaleStandard Error 0.67
Motivational InterviewingCenter for Epidemiological Studies Depression ScalePost-intervention24.04 score on a scaleStandard Error 0.75
Motivational InterviewingCenter for Epidemiological Studies Depression Scale60-day follow-up27.33 score on a scaleStandard Error 0.77
Motivational InterviewingCenter for Epidemiological Studies Depression Scale120-day follow-up24.01 score on a scaleStandard Error 0.79
MI With Trauma-informed SGM Affirmative CareCenter for Epidemiological Studies Depression Scale120-day follow-up23.74 score on a scaleStandard Error 0.77
MI With Trauma-informed SGM Affirmative CareCenter for Epidemiological Studies Depression ScaleBaseline30.70 score on a scaleStandard Error 0.67
MI With Trauma-informed SGM Affirmative CareCenter for Epidemiological Studies Depression Scale60-day follow-up25.46 score on a scaleStandard Error 0.75
MI With Trauma-informed SGM Affirmative CareCenter for Epidemiological Studies Depression ScalePost-intervention22.87 score on a scaleStandard Error 0.73
Primary

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.

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Motivational InterviewingNumber of Participants Who Engage in Mental Health TreatmentPost-Intervention23 Participants
Motivational InterviewingNumber of Participants Who Engage in Mental Health Treatment60-day follow-up31 Participants
Motivational InterviewingNumber of Participants Who Engage in Mental Health Treatment120-day follow-up28 Participants
MI With Trauma-informed SGM Affirmative CareNumber of Participants Who Engage in Mental Health TreatmentPost-Intervention18 Participants
MI With Trauma-informed SGM Affirmative CareNumber of Participants Who Engage in Mental Health Treatment60-day follow-up26 Participants
MI With Trauma-informed SGM Affirmative CareNumber of Participants Who Engage in Mental Health Treatment120-day follow-up31 Participants
Secondary

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.

Time frame: Baseline (immediately 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.

ArmMeasureGroupValue (MEAN)Dispersion
Motivational InterviewingPost Traumatic Stress DisorderBaseline36.26 score on a scaleStandard Error 0.97
Motivational InterviewingPost Traumatic Stress DisorderPost-intervention29.30 score on a scaleStandard Error 1.1
Motivational InterviewingPost Traumatic Stress Disorder60-day follow-up32.22 score on a scaleStandard Error 1.12
Motivational InterviewingPost Traumatic Stress Disorder120-day follow-up27.47 score on a scaleStandard Error 1.14
MI With Trauma-informed SGM Affirmative CarePost Traumatic Stress Disorder120-day follow-up25.57 score on a scaleStandard Error 1.12
MI With Trauma-informed SGM Affirmative CarePost Traumatic Stress DisorderBaseline36.45 score on a scaleStandard Error 0.97
MI With Trauma-informed SGM Affirmative CarePost Traumatic Stress Disorder60-day follow-up29.21 score on a scaleStandard Error 1.1
MI With Trauma-informed SGM Affirmative CarePost Traumatic Stress DisorderPost-intervention27.84 score on a scaleStandard Error 1.06
Secondary

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.

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

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.

ArmMeasureGroupValue (MEAN)Dispersion
Motivational InterviewingPsychosocial FunctioningBaseline45.64 score on a scaleStandard Error 1.36
Motivational InterviewingPsychosocial FunctioningPost-intervention39.88 score on a scaleStandard Error 1.56
Motivational InterviewingPsychosocial Functioning60-day follow-up39.97 score on a scaleStandard Error 1.58
Motivational InterviewingPsychosocial Functioning120-day follow-up39.69 score on a scaleStandard Error 1.62
MI With Trauma-informed SGM Affirmative CarePsychosocial Functioning120-day follow-up38.72 score on a scaleStandard Error 1.6
MI With Trauma-informed SGM Affirmative CarePsychosocial FunctioningBaseline44.71 score on a scaleStandard Error 1.37
MI With Trauma-informed SGM Affirmative CarePsychosocial Functioning60-day follow-up34.05 score on a scaleStandard Error 1.56
MI With Trauma-informed SGM Affirmative CarePsychosocial FunctioningPost-intervention38.51 score on a scaleStandard Error 1.52
Secondary

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.

Time frame: Baseline (immediately pre-intervention)

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.

ArmMeasureGroupValue (MEAN)Dispersion
Motivational InterviewingSubstance AbuseCocaine1.58 score on a scaleStandard Error 0.17
Motivational InterviewingSubstance AbuseSedatives2.00 score on a scaleStandard Error 0.23
Motivational InterviewingSubstance AbuseMarijuana6.44 score on a scaleStandard Error 0.33
Motivational InterviewingSubstance AbuseHallucinogens.98 score on a scaleStandard Error 0.15
Motivational InterviewingSubstance AbuseAmphetamine/ Stimulant2.51 score on a scaleStandard Error 0.23
Motivational InterviewingSubstance AbuseOpioids1.02 score on a scaleStandard Error 0.17
Motivational InterviewingSubstance AbuseAlcohol8.83 score on a scaleStandard Error 0.35
Motivational InterviewingSubstance AbuseOther8.83 score on a scaleStandard Error 0.35
Motivational InterviewingSubstance AbuseInhalants.96 score on a scaleStandard Error 0.15
Motivational InterviewingSubstance AbuseMedical Marijuana1.68 score on a scaleStandard Error 0.3
Motivational InterviewingSubstance AbuseTobacco5.77 score on a scaleStandard Error 0.28
MI With Trauma-informed SGM Affirmative CareSubstance AbuseMedical Marijuana1.65 score on a scaleStandard Error 0.3
MI With Trauma-informed SGM Affirmative CareSubstance AbuseTobacco5.83 score on a scaleStandard Error 0.28
MI With Trauma-informed SGM Affirmative CareSubstance AbuseAlcohol8.93 score on a scaleStandard Error 0.35
MI With Trauma-informed SGM Affirmative CareSubstance AbuseMarijuana6.53 score on a scaleStandard Error 0.33
MI With Trauma-informed SGM Affirmative CareSubstance AbuseCocaine1.69 score on a scaleStandard Error 0.17
MI With Trauma-informed SGM Affirmative CareSubstance AbuseAmphetamine/ Stimulant2.55 score on a scaleStandard Error 0.23
MI With Trauma-informed SGM Affirmative CareSubstance AbuseInhalants1.06 score on a scaleStandard Error 0.15
MI With Trauma-informed SGM Affirmative CareSubstance AbuseSedatives1.84 score on a scaleStandard Error 0.23
MI With Trauma-informed SGM Affirmative CareSubstance AbuseHallucinogens.98 score on a scaleStandard Error 0.15
MI With Trauma-informed SGM Affirmative CareSubstance AbuseOpioids1.03 score on a scaleStandard Error 0.17
MI With Trauma-informed SGM Affirmative CareSubstance AbuseOther8.93 score on a scaleStandard Error 0.35
Secondary

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.

Time frame: Post-intervention (immediately following last online group)

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.

ArmMeasureGroupValue (MEAN)Dispersion
Motivational InterviewingSubstance AbuseCocaine1.39 score on a scaleStandard Error 0.2
Motivational InterviewingSubstance AbuseSedatives1.67 score on a scaleStandard Error 0.26
Motivational InterviewingSubstance AbuseMarijuana5.89 score on a scaleStandard Error 0.38
Motivational InterviewingSubstance AbuseHallucinogens.88 score on a scaleStandard Error 0.17
Motivational InterviewingSubstance AbuseAmphetamine/ Stimulant2.16 score on a scaleStandard Error 0.26
Motivational InterviewingSubstance AbuseOpioids.83 score on a scaleStandard Error 0.19
Motivational InterviewingSubstance AbuseAlcohol7.71 score on a scaleStandard Error 0.4
Motivational InterviewingSubstance AbuseOther4.92 score on a scaleStandard Error 0.32
Motivational InterviewingSubstance AbuseInhalants1.06 score on a scaleStandard Error 0.16
Motivational InterviewingSubstance AbuseMedical Marijuana1.55 score on a scaleStandard Error 0.39
Motivational InterviewingSubstance AbuseTobacco4.92 score on a scaleStandard Error 0.32
MI With Trauma-informed SGM Affirmative CareSubstance AbuseMedical Marijuana2.74 score on a scaleStandard Error 0.36
MI With Trauma-informed SGM Affirmative CareSubstance AbuseTobacco4.75 score on a scaleStandard Error 0.31
MI With Trauma-informed SGM Affirmative CareSubstance AbuseAlcohol8.26 score on a scaleStandard Error 0.39
MI With Trauma-informed SGM Affirmative CareSubstance AbuseMarijuana5.69 score on a scaleStandard Error 0.36
MI With Trauma-informed SGM Affirmative CareSubstance AbuseCocaine1.04 score on a scaleStandard Error 0.19
MI With Trauma-informed SGM Affirmative CareSubstance AbuseAmphetamine/ Stimulant2.11 score on a scaleStandard Error 0.27
MI With Trauma-informed SGM Affirmative CareSubstance AbuseInhalants.90 score on a scaleStandard Error 0.17
MI With Trauma-informed SGM Affirmative CareSubstance AbuseSedatives2.21 score on a scaleStandard Error 0.25
MI With Trauma-informed SGM Affirmative CareSubstance AbuseHallucinogens.98 score on a scaleStandard Error 0.17
MI With Trauma-informed SGM Affirmative CareSubstance AbuseOpioids.99 score on a scaleStandard Error 0.19
MI With Trauma-informed SGM Affirmative CareSubstance AbuseOther4.75 score on a scaleStandard Error 0.31

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026