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

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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

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.

Condition or disease Intervention/treatment Phase
LGBTQ Sexual Behavior Behavioral: Online EQuIP Behavioral: Self-monitoring control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults
Actual Study Start Date : May 31, 2020
Actual Primary Completion Date : February 18, 2022
Actual Study Completion Date : February 18, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Online EQuIP
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Behavioral: Online EQuIP
This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.

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
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.)

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
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)
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408469


Locations
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United States, New York
Dr. Pachankis' Lab
New York, New York, United States, 10010
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: John Pachankis, PhD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04408469    
Other Study ID Numbers: 2000025803
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
on-line intervention
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms