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A Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04408469
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE May 26, 2020
First Posted Date  ICMJE May 29, 2020
Last Update Posted Date June 27, 2022
Actual Study Start Date  ICMJE May 31, 2020
Actual Primary Completion Date February 18, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2022)
  • Change in Distress [ Time Frame: Baseline, 4 months, 8 months ]
    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.
  • Change in Depression [ Time Frame: Baseline, 4 months, 8 months ]
    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.
  • Change in Depression Severity [ Time Frame: Baseline, 4 months, 8 months ]
    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.
  • Change in Anxiety Symptoms [ Time Frame: Baseline, 4 months, 8 months ]
    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.
  • Change in Substance Abuse [ Time Frame: Baseline, 4 months, 8 months ]
    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.)
  • Sexual Risk Behavior [ Time Frame: Baseline, 4 months, 8 months ]
    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.
  • Change in Suicidality [ Time Frame: Baseline, 4 months, 8 months ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
  • Change in Distress [ Time Frame: Baseline, 3 months, 6 months ]
    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.
  • Change in Depression [ Time Frame: Baseline, 3 months, 6 months ]
    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.
  • Change in Depression Severity [ Time Frame: Baseline, 3 months, 6 months ]
    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.
  • Change in Anxiety Symptoms [ Time Frame: Baseline, 3 months, 6 months ]
    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.
  • Change in Substance Abuse [ Time Frame: Baseline, 3 months, 6 months ]
    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.)
  • Sexual Risk Behavior [ Time Frame: Baseline, 3 months, 6 months ]
    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.
  • Change in Suicidality [ Time Frame: Baseline, 3 months, 6 months ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults
Official Title  ICMJE A Randomized Controlled Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE
  • LGBTQ
  • Sexual Behavior
Intervention  ICMJE
  • Behavioral: Online EQuIP
    This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
  • Behavioral: Self-monitoring control
    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
Study Arms  ICMJE
  • Experimental: Online EQuIP
    The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
    Intervention: Behavioral: Online EQuIP
  • Placebo Comparator: Self-Monitoring
    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: Behavioral: Self-monitoring control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 18, 2022
Actual Primary Completion Date February 18, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • identify as lesbian, bisexual, gay, or another sexual minority identity (e.g., pansexual, demisexual)
  • past-week symptoms of depression or anxiety using the Brief Symptom Inventory-4 cutoff of 2.5 on either the depression subscale or anxiety subscale
  • weekly access to internet on a laptop, desktop, or tablet device
  • ability to read, write, and speak in English
  • provision of informed consent.

Exclusion Criteria:

  • current active suicidality or homicidality (defined as active intent or concrete plan, as opposed to passive suicidal ideation)
  • evidence of active untreated mania, psychosis, or gross cognitive impairment - current enrollment in an intervention study
  • current enrollment in intensive mental health treatment (i.e., receiving mental health treatment more than once per month or 8 or more sessions of CBT within the past year.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Participant identifies as lesbian, bisexual, gay, or another sexual minority identity (e.g., pansexual, demisexual)
Ages  ICMJE 16 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04408469
Other Study ID Numbers  ICMJE 2000025803
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yale University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Yale University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Pachankis, PhD Yale University
PRS Account Yale University
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP