<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/NCT04408469</url>
  </required_header>
  <id_info>
    <org_study_id>2000025803</org_study_id>
    <nct_id>NCT04408469</nct_id>
  </id_info>
  <brief_title>A Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults</brief_title>
  <official_title>A Randomized Controlled Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to test the efficacy of an online CBT intervention (EQuIP) that addresses the&#xD;
      pathways through which minority stress compromises LGBTQ young adults' co-occurring mental&#xD;
      (e.g., depression) and behavioral (e.g., substance use, condomless anal sex) health problems.&#xD;
      This purpose of this study is to determine if the treatment is efficacious when delivered&#xD;
      online and if its efficacy exceeds that of the self-monitoring control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the preliminary efficacy of an LGBTQ-affirmative online CBT treatment and whether&#xD;
      such an LGBTQ-affirmative focus adds benefit, a 2-arm RCT that would examine (1) whether&#xD;
      online EQuIP demonstrates significant mental health improvements compared to self-monitoring&#xD;
      of stress and mood, and (2) whether participant baseline LGBTQ-specific stress exposure&#xD;
      moderates treatment efficacy, such that participants with the most LGBTQ-specific stress&#xD;
      exposure benefit more from online EQuIP than self-monitoring of stress and mood.&#xD;
&#xD;
      The primary outcomes are depressive symptoms, anxiety symptoms, substance abuse, sexual risk&#xD;
      behavior, and suicidality, all of which disproportionally affect LGBTQ young adults.&#xD;
      Secondary outcomes include hypothesized cognitive, affective, and behavioral minority stress&#xD;
      mechanisms, such as internalized homophobia, rejection sensitivity, concealment, social&#xD;
      isolation, and emotional dysregulation.&#xD;
&#xD;
      Participants will be randomized to either self-monitoring control or Online EQuIP group.&#xD;
&#xD;
      Self-monitoring control: In this control condition, participants will be asked to indicate&#xD;
      their past 7-day mood; stress experiences; and mental and behavioral health on an online&#xD;
      survey. This type of self-monitoring has been shown to yield improvement in behavioral health&#xD;
      outcomes. Self-reporting LGBTQ stress experiences has also been shown to produce reductions&#xD;
      in depression symptoms over time. Participants will record these experiences once per week&#xD;
      for 10 weeks.&#xD;
&#xD;
      Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will&#xD;
      complete over the course of 10 weeks. Modules contain weekly psychoeducational text and&#xD;
      vignettes about minority stress and mental health; brief videos illustrating the CBT skills;&#xD;
      and homework exercises that therapists review and provide feedback on. Homework exercises&#xD;
      include weekly tracking of stressful situations and mood, practicing new skills (e.g.,&#xD;
      mindfulness, cognitive restructuring), and exercises related to considering the origins of&#xD;
      stress and negative emotions that participants may be experiencing. Therapists provide&#xD;
      feedback after each homework assignment, including reviewing each participant's treatment&#xD;
      goals as part of the first session's homework. Therapists who support this condition will be&#xD;
      instructed to incorporate LGBTQ-specific content and feedback into homework reviews.&#xD;
      Therapists will either be postdoctoral fellows in the Pachankis lab or clinical/counseling&#xD;
      psychology interns/externs in the Pachankis lab who possess an advanced degree in a mental&#xD;
      health field with significant prior experience treating LGBTQ young adults with mental health&#xD;
      concerns. Modules were adapted directly from the in-person materials (e.g., therapist manual,&#xD;
      participant handouts) used in our previously successful trials of this treatment. A team of&#xD;
      six therapists and supervisors of the original in-person treatment adapted the text for the&#xD;
      online modules, including realistic vignettes and easy-to-follow skills training. A video&#xD;
      production company created accompanying videos with our clinical team's close input.&#xD;
&#xD;
      In preparation for this RCT, the online EQuIP treatment was delivered to 14 LGBTQ young&#xD;
      adults who meet all eligibility criteria for the full trial. The purpose of this initial test&#xD;
      was to ensure acceptability of the treatment content and usability of the technical platform.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2020</start_date>
  <completion_date type="Actual">February 18, 2022</completion_date>
  <primary_completion_date type="Actual">February 18, 2022</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Distress</measure>
    <time_frame>Baseline, 4 months, 8 months</time_frame>
    <description>Distress will be measured using the Brief Symptom Inventory (BSI). The BSI is an 18 item measure that uses a 0-4 rating scale for each item. An overall score of 72 would be the highest possible score on the measure and would indicate an extreme level of overall distress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Depression</measure>
    <time_frame>Baseline, 4 months, 8 months</time_frame>
    <description>Depression will be measured using the Center for Epidemiological Studies -- Depression Scale (CESD). An overall depression score is computed as the sum of 20 items, with items 3, 11, 14, and 16 reversed. In cases with internally missing data (items not answered), the sums are computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A higher score indicates more depressive symptomatology during the past week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Depression Severity</measure>
    <time_frame>Baseline, 4 months, 8 months</time_frame>
    <description>Depression severity will be measured using the Overall Depression Severity &amp; Impairment Scale (ODSIS). This 5 item measure uses a 0-4 rating scale and sums across the items for a maximum score of 20. The higher the score, the greater the severity of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Anxiety Symptoms</measure>
    <time_frame>Baseline, 4 months, 8 months</time_frame>
    <description>Anxiety symptoms will be measured by the Overall Anxiety Severity &amp; Impairment Scale (OASIS). This 5 item measure uses a 0-4 rating scale and sums across the items for a maximum score of 20. The higher the score, the greater the presence of anxiety symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Substance Abuse</measure>
    <time_frame>Baseline, 4 months, 8 months</time_frame>
    <description>Alcohol use in participants will be assessed using the Alcohol Use Disorders Identification (AUDIT) instrument. The AUDIT consists of 10 items. Each of the questions has a set of responses to choose from, and each response has a score ranging from 0 to 4. All response scores should be added and recorded as &quot;Total&quot;. Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence. (A cut-off score of 10 will provide greater specificity but at the expense of sensitivity.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sexual Risk Behavior</measure>
    <time_frame>Baseline, 4 months, 8 months</time_frame>
    <description>Sexual risk behavior is defined as: condomless anal or vaginal/frontal sex [not counting the sole use of prosthetics] in the absence of PrEP, with any HIV+ partner [except primary HIV+ partners with a known undetectable viral load] or status-unknown partner.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Suicidality</measure>
    <time_frame>Baseline, 4 months, 8 months</time_frame>
    <description>Suicidal ideation will be measured using the Suicidal Ideation Attributes Scale (SIDAS) . Total SIDAS scores are calculated as the sum of the five items, with controllability reverse scored (10=0, 9=1, …, 0=10). Total scores range from 0 to 50.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>LGBTQ</condition>
  <condition>Sexual Behavior</condition>
  <arm_group>
    <arm_group_label>Online EQuIP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-Monitoring</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online EQuIP</intervention_name>
    <description>This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.</description>
    <arm_group_label>Online EQuIP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-monitoring control</intervention_name>
    <description>Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks</description>
    <arm_group_label>Self-Monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  identify as lesbian, bisexual, gay, or another sexual minority identity (e.g.,&#xD;
             pansexual, demisexual)&#xD;
&#xD;
          -  past-week symptoms of depression or anxiety using the Brief Symptom Inventory-4 cutoff&#xD;
             of 2.5 on either the depression subscale or anxiety subscale&#xD;
&#xD;
          -  weekly access to internet on a laptop, desktop, or tablet device&#xD;
&#xD;
          -  ability to read, write, and speak in English&#xD;
&#xD;
          -  provision of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current active suicidality or homicidality (defined as active intent or concrete plan,&#xD;
             as opposed to passive suicidal ideation)&#xD;
&#xD;
          -  evidence of active untreated mania, psychosis, or gross cognitive impairment - current&#xD;
             enrollment in an intervention study&#xD;
&#xD;
          -  current enrollment in intensive mental health treatment (i.e., receiving mental health&#xD;
             treatment more than once per month or 8 or more sessions of CBT within the past year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participant identifies as lesbian, bisexual, gay, or another sexual minority identity (e.g., pansexual, demisexual)</gender_description>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Pachankis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Pachankis' Lab</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>June 21, 2022</last_update_submitted>
  <last_update_submitted_qc>June 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>on-line intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>January 19, 2023</submitted>
  </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/NCT04408469
org study id: 2000025803
nct id: NCT04408469
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is to test the efficacy of an online CBT intervention (EQuIP) that addresses the
      pathways through which minority stress compromises LGBTQ young adults' co-occurring mental
      (e.g., depression) and behavioral (e.g., substance use, condomless anal sex) health problems.
      This purpose of this study is to determine if the treatment is efficacious when delivered
      online and if its efficacy exceeds that of the self-monitoring control.
To evaluate the preliminary efficacy of an LGBTQ-affirmative online CBT treatment and whether
      such an LGBTQ-affirmative focus adds benefit, a 2-arm RCT that would examine (1) whether
      online EQuIP demonstrates significant mental health improvements compared to self-monitoring
      of stress and mood, and (2) whether participant baseline LGBTQ-specific stress exposure
      moderates treatment efficacy, such that participants with the most LGBTQ-specific stress
      exposure benefit more from online EQuIP than self-monitoring of stress and mood.

      The primary outcomes are depressive symptoms, anxiety symptoms, substance abuse, sexual risk
      behavior, and suicidality, all of which disproportionally affect LGBTQ young adults.
      Secondary outcomes include hypothesized cognitive, affective, and behavioral minority stress
      mechanisms, such as internalized homophobia, rejection sensitivity, concealment, social
      isolation, and emotional dysregulation.

      Participants will be randomized to either self-monitoring control or Online EQuIP group.

      Self-monitoring control: In this control condition, participants will be asked to indicate
      their past 7-day mood; stress experiences; and mental and behavioral health on an online
      survey. This type of self-monitoring has been shown to yield improvement in behavioral health
      outcomes. Self-reporting LGBTQ stress experiences has also been shown to produce reductions
      in depression symptoms over time. Participants will record these experiences once per week
      for 10 weeks.

      Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will
      complete over the course of 10 weeks. Modules contain weekly psychoeducational text and
      vignettes about minority stress and mental health; brief videos illustrating the CBT skills;
      and homework exercises that therapists review and provide feedback on. Homework exercises
      include weekly tracking of stressful situations and mood, practicing new skills (e.g.,
      mindfulness, cognitive restructuring), and exercises related to considering the origins of
      stress and negative emotions that participants may be experiencing. Therapists provide
      feedback after each homework assignment, including reviewing each participant's treatment
      goals as part of the first session's homework. Therapists who support this condition will be
      instructed to incorporate LGBTQ-specific content and feedback into homework reviews.
      Therapists will either be postdoctoral fellows in the Pachankis lab or clinical/counseling
      psychology interns/externs in the Pachankis lab who possess an advanced degree in a mental
      health field with significant prior experience treating LGBTQ young adults with mental health
      concerns. Modules were adapted directly from the in-person materials (e.g., therapist manual,
      participant handouts) used in our previously successful trials of this treatment. A team of
      six therapists and supervisors of the original in-person treatment adapted the text for the
      online modules, including realistic vignettes and easy-to-follow skills training. A video
      production company created accompanying videos with our clinical team's close input.

      In preparation for this RCT, the online EQuIP treatment was delivered to 14 LGBTQ young
      adults who meet all eligibility criteria for the full trial. The purpose of this initial test
      was to ensure acceptability of the treatment content and usability of the technical platform.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Change in Distress
time frame: Baseline, 4 months, 8 months
description: Distress will be measured using the Brief Symptom Inventory (BSI). The BSI is an 18 item measure that uses a 0-4 rating scale for each item. An overall score of 72 would be the highest possible score on the measure and would indicate an extreme level of overall distress.
measure: Change in Depression
time frame: Baseline, 4 months, 8 months
description: Depression will be measured using the Center for Epidemiological Studies -- Depression Scale (CESD). An overall depression score is computed as the sum of 20 items, with items 3, 11, 14, and 16 reversed. In cases with internally missing data (items not answered), the sums are computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A higher score indicates more depressive symptomatology during the past week.
measure: Change in Depression Severity
time frame: Baseline, 4 months, 8 months
description: Depression severity will be measured using the Overall Depression Severity & Impairment Scale (ODSIS). This 5 item measure uses a 0-4 rating scale and sums across the items for a maximum score of 20. The higher the score, the greater the severity of depression.
measure: Change in Anxiety Symptoms
time frame: Baseline, 4 months, 8 months
description: Anxiety symptoms will be measured by the Overall Anxiety Severity & Impairment Scale (OASIS). This 5 item measure uses a 0-4 rating scale and sums across the items for a maximum score of 20. The higher the score, the greater the presence of anxiety symptoms.
measure: Change in Substance Abuse
time frame: Baseline, 4 months, 8 months
description: Alcohol use in participants will be assessed using the Alcohol Use Disorders Identification (AUDIT) instrument. The AUDIT consists of 10 items. Each of the questions has a set of responses to choose from, and each response has a score ranging from 0 to 4. All response scores should be added and recorded as "Total". Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence. (A cut-off score of 10 will provide greater specificity but at the expense of sensitivity.)
measure: Sexual Risk Behavior
time frame: Baseline, 4 months, 8 months
description: Sexual risk behavior is defined as: condomless anal or vaginal/frontal sex [not counting the sole use of prosthetics] in the absence of PrEP, with any HIV+ partner [except primary HIV+ partners with a known undetectable viral load] or status-unknown partner.
measure: Change in Suicidality
time frame: Baseline, 4 months, 8 months
description: Suicidal ideation will be measured using the Suicidal Ideation Attributes Scale (SIDAS) . Total SIDAS scores are calculated as the sum of the five items, with controllability reverse scored (10=0, 9=1, …, 0=10). Total scores range from 0 to 50.
arm group label: Online EQuIP
arm group type: Experimental
description: The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
arm group label: Self-Monitoring
arm group type: Placebo Comparator
description: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
intervention type: Behavioral
intervention name: Online EQuIP
description: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
arm group label: Online EQuIP
intervention type: Behavioral
intervention name: Self-monitoring control
description: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
arm group label: Self-Monitoring
criteria: 
gender: All
gender based: Yes
gender description: Participant identifies as lesbian, bisexual, gay, or another sexual minority identity (e.g., pansexual, demisexual)
minimum age: 16 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John Pachankis, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
submitted: January 19, 2023