<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03794986</url>
  </required_header>
  <id_info>
    <org_study_id>2000024842</org_study_id>
    <nct_id>NCT03794986</nct_id>
  </id_info>
  <brief_title>Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors</brief_title>
  <official_title>Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will conduct a randomized comparative effectiveness trial of peer-facilitated,&#xD;
      online, 6-week group Motivational Interviewing (MI) vs. Motivational Interviewing (MI) with a&#xD;
      trauma-informed Sexual and Gender Minority (SGM) affirmative care approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Through workshops and ongoing supervision/consultation, researchers will train MaleSurvivor&#xD;
      peer leaders to competently deliver both versions of MI and conduct a randomized controlled&#xD;
      trial comparing the two versions of MI to enhance treatment engagement in SGM male survivors&#xD;
      with mental health problems. All SGM male survivors who meet inclusion criteria, including&#xD;
      significant emotional distress, will complete pre-test measures and be randomized to 6-week&#xD;
      MI delivered by peers in online groups or 6-week MI with trauma-informed, SGM affirmative&#xD;
      care delivered by peers in online groups. Randomization will be counterbalanced by treatment&#xD;
      status: treatment naive versus treatment-experienced (prior treatment but not within the past&#xD;
      60 days).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized comparative</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Engage in Mental Health Treatment</measure>
    <time_frame>within 120 days of last online group</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Center for Epidemiological Studies Depression Scale</measure>
    <time_frame>baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Center for Epidemiological Studies Depression Scale</measure>
    <time_frame>14 days post intervention</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Center for Epidemiological Studies Depression Scale</measure>
    <time_frame>60 days post-intervention</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Center for Epidemiological Studies Depression Scale</measure>
    <time_frame>120 days post-intervention</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post Traumatic Stress Disorder</measure>
    <time_frame>baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Traumatic Stress Disorder</measure>
    <time_frame>14 days post intervention</time_frame>
    <description>PTSD Checklist for 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Traumatic Stress Disorder</measure>
    <time_frame>60 days post-intervention</time_frame>
    <description>PTSD Checklist for 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Traumatic Stress Disorder</measure>
    <time_frame>120 days post-intervention</time_frame>
    <description>PTSD Checklist for 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substance abuse</measure>
    <time_frame>baseline</time_frame>
    <description>ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test). The ASSIST is an 8-item measure of participants' use of alcohol, tobacco products, and other drugs across their lifetime and in the past three months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substance abuse</measure>
    <time_frame>14 days post-intervention</time_frame>
    <description>ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test). The ASSIST is an 8-item measure of participants' use of alcohol, tobacco products, and other drugs across their lifetime and in the past three months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substance abuse</measure>
    <time_frame>60 days post-intervention</time_frame>
    <description>ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test). The ASSIST is an 8-item measure of participants' use of alcohol, tobacco products, and other drugs across their lifetime and in the past three months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substance abuse</measure>
    <time_frame>120 days post-intervention</time_frame>
    <description>ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test). The ASSIST is an 8-item measure of participants' use of alcohol, tobacco products, and other drugs across their lifetime and in the past three months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Functioning</measure>
    <time_frame>baseline</time_frame>
    <description>Inventory of Psychosocial Functioning (IPF-B; Rodriguez, Holowka, &amp; 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 (&quot;never&quot;) to 7 (&quot;always&quot;). The IPF yields an overall functional impairment score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Functioning</measure>
    <time_frame>14 days post-intervention</time_frame>
    <description>Inventory of Psychosocial Functioning (IPF-B; Rodriguez, Holowka, &amp; 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 (&quot;never&quot;) to 7 (&quot;always&quot;). The IPF yields an overall functional impairment score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Functioning</measure>
    <time_frame>60 days post-intervention</time_frame>
    <description>Inventory of Psychosocial Functioning (IPF-B; Rodriguez, Holowka, &amp; 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 (&quot;never&quot;) to 7 (&quot;always&quot;). The IPF yields an overall functional impairment score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Functioning</measure>
    <time_frame>120 days post-intervention</time_frame>
    <description>Inventory of Psychosocial Functioning (IPF-B; Rodriguez, Holowka, &amp; 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 (&quot;never&quot;) to 7 (&quot;always&quot;). The IPF yields an overall functional impairment score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Service Utilization</measure>
    <time_frame>screening</time_frame>
    <description>The Service Use and Resource Form (SURF) is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Service Utilization</measure>
    <time_frame>baseline</time_frame>
    <description>SURF is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Service Utilization</measure>
    <time_frame>14 days post intervention</time_frame>
    <description>SURF is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Service Utilization</measure>
    <time_frame>60 days</time_frame>
    <description>SURF is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Service Utilization</measure>
    <time_frame>120 days</time_frame>
    <description>SURF is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">356</enrollment>
  <condition>Sexual Abuse</condition>
  <arm_group>
    <arm_group_label>Motivational Interviewing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sexual and gender minority males who are sexual abuse survivors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MI with trauma-informed SGM affirmative care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MI w/trauma-informed SGM affirmative care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Trauma-informed SGM affirmative care</intervention_name>
    <description>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.&#xD;
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).</description>
    <arm_group_label>MI with trauma-informed SGM affirmative care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing</intervention_name>
    <description>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 &quot;agenda&quot;</description>
    <arm_group_label>Motivational Interviewing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  English-speaking; men who have sex with men or individuals identifying as SGM males&#xD;
&#xD;
          -  Individuals who report a history of sexual abuse and individuals who self-report a&#xD;
             minimum cut-off score of 3.0 or higher on emotional distress, using a 4-question&#xD;
             symptom inventory.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who endorse active psychosis&#xD;
&#xD;
          -  Individuals who have a cognitive dysfunction&#xD;
&#xD;
          -  SGM men who report that they are currently in formal mental health counseling&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Men who have sex with men or individuals identifying as sexual gender minority (SGM) males who report a history of sexual abuse.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joan Cook, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale School of Medicine Department of Psychiatry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>February 1, 2022</last_update_submitted>
  <last_update_submitted_qc>February 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <pending_results>
    <submitted>October 31, 2022</submitted>
    <returned>September 7, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03794986
org study id: 2000024842
nct id: NCT03794986
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized comparative
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Participants Who Engage in Mental Health Treatment
time frame: within 120 days of last online group
description: 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.
measure: Center for Epidemiological Studies Depression Scale
time frame: baseline
description: 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.
measure: Center for Epidemiological Studies Depression Scale
time frame: 14 days post intervention
description: 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.
measure: Center for Epidemiological Studies Depression Scale
time frame: 60 days post-intervention
description: 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.
measure: Center for Epidemiological Studies Depression Scale
time frame: 120 days post-intervention
description: 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.
measure: Post Traumatic Stress Disorder
time frame: baseline
description: 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.
measure: Post Traumatic Stress Disorder
time frame: 14 days post intervention
description: PTSD Checklist for 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.
measure: Post Traumatic Stress Disorder
time frame: 60 days post-intervention
description: PTSD Checklist for 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.
measure: Post Traumatic Stress Disorder
time frame: 120 days post-intervention
description: PTSD Checklist for 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.
measure: Substance abuse
time frame: baseline
description: ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test). The ASSIST is an 8-item measure of participants' use of alcohol, tobacco products, and other drugs across their lifetime and in the past three months.
measure: Substance abuse
time frame: 14 days post-intervention
description: ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test). The ASSIST is an 8-item measure of participants' use of alcohol, tobacco products, and other drugs across their lifetime and in the past three months.
measure: Substance abuse
time frame: 60 days post-intervention
description: ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test). The ASSIST is an 8-item measure of participants' use of alcohol, tobacco products, and other drugs across their lifetime and in the past three months.
measure: Substance abuse
time frame: 120 days post-intervention
description: ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test). The ASSIST is an 8-item measure of participants' use of alcohol, tobacco products, and other drugs across their lifetime and in the past three months.
measure: Psychosocial Functioning
time frame: baseline
description: 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.
measure: Psychosocial Functioning
time frame: 14 days post-intervention
description: 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.
measure: Psychosocial Functioning
time frame: 60 days post-intervention
description: 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.
measure: Psychosocial Functioning
time frame: 120 days post-intervention
description: 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.
measure: Service Utilization
time frame: screening
description: The Service Use and Resource Form (SURF) is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days
measure: Service Utilization
time frame: baseline
description: SURF is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days
measure: Service Utilization
time frame: 14 days post intervention
description: SURF is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days
measure: Service Utilization
time frame: 60 days
description: SURF is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days
measure: Service Utilization
time frame: 120 days
description: SURF is a questionnaire that documents inpatient and outpatient mental health and alcohol or drug service use, psychotropic medication use, and use of other support services and will be used to determine whether participants are currently receiving mental health services or have received mental health services in the past 60 days
arm group label: Motivational Interviewing
arm group type: Experimental
description: Sexual and gender minority males who are sexual abuse survivors.
arm group label: MI with trauma-informed SGM affirmative care
arm group type: Active Comparator
description: MI w/trauma-informed SGM affirmative care
intervention type: Behavioral
intervention name: Trauma-informed SGM affirmative care
description: 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).
arm group label: MI with trauma-informed SGM affirmative care
intervention type: Behavioral
intervention name: Motivational Interviewing
description: 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"
arm group label: Motivational Interviewing
criteria: 
gender: Male
gender based: Yes
gender description: Men who have sex with men or individuals identifying as sexual gender minority (SGM) males who report a history of sexual abuse.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joan Cook, Phd
role: Principal Investigator
affiliation: Yale School of Medicine Department of Psychiatry
facility: 
country: United States
responsible party type: Sponsor
submitted: October 31, 2022
returned: September 7, 2023