LGBTQ-affirmative CBT for Youth

LGBTQ-affirmative Cognitive Behavioral Group Therapy for Youth: A Pilot Study

This study will adapt LGBTQ-affirmative cognitive behavior therapy (CBT) - previously only used with adults - for youth aged 12-17 years. This intervention addresses the pathways through which minority stress compromises lesbian, gay, bisexual, transgender, and queer (LGBTQ) young peoples' mental health. The purpose of this study is to determine if the intervention is acceptable and feasible for LGBTQ youth.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety Disorders; LGBTQ
• Intervention / Treatment: Behavioral: LGBTQ-affirmative cognitive behavioral group therapy

Detailed Description

Lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth experience more mental health problems than their heterosexual and cisgender peers. The purpose of the proposed mixed-methods study is to assess the feasibility, acceptability, and need for refinement of LGBTQ-affirmative cognitive behavior therapy for youth aged 12-17 years in New York, New Jersey, and Connecticut. This study will be the first to adapt the randomized controlled trial tested LGBTQ-affirmative CBT intervention for youth, and the first to deliver it in a virtual group format. Qualitatively, investigators will conduct structured post-treatment interviews to assess the feasibility, acceptability, and refinement of the intervention in this population. Quantitatively, investigators will assess the feasibility and acceptability of the intervention through analysis of indices like number of sessions attended, number of homework assignments completed, weekly treatment satisfaction ratings, and a post-treatment feedback survey. Investigators will also examine changes from pre- to post-treatment in youth's mental health symptoms, minority stress reactions, and emotional regulation and coping difficulties. These pilot data will be used to estimate the sample sizes needed for a future, larger trial of this treatment, as well as areas in which the treatment could be refined.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Dr. Pachankis' Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 12-17 years old
• Self-identify as LGBTQ (any diverse sexual orientation and/or gender identity)
• Live in New York, New Jersey, or Connecticut
• Fluent in English
• Meet diagnostic criteria for a DSM-5 internalizing disorder (any depressive, anxiety, obsessive-compulsive, or adjustment disorder)
• Have consistent, weekly access to an Internet-enabled electronic device that allows for video-conferencing
• Availability to attend 10 weekly 90 minute intervention sessions in summer 2021
• Access to a quiet, private place for intervention sessions
• Provision of informed consent from parent/guardian and assent from the youth

Exclusion Criteria:

• Evidence of any psychotic or bipolar spectrum diagnosis
• Active suicidality and/or homicidality (defined as active intent or concrete plan, as opposed to passive ideation) or psychiatric hospitalization within the past 6 months
• Significant cognitive impairment (as determined by an intellectual disability screener) or significant developmental disorder (if impairing youth's ability to participate in group therapy)
• Significant behavior disorder (e.g., oppositional defiant disorder, conduct disorder) if impairing youth's ability to participate in group therapy
• Currently in mental health treatment exceeding one day per month
• Received any cognitive-behavioral therapy treatment in the past 12 months
• Unstable psychotropic medications (defined as changes to antidepressant dosage in the past 3 months, or changes to a benzodiazepine dosage in the past month)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: LGBTQ-affirmative cognitive behavioral group therapy; LGBTQ-affirmative cognitive behavioral group therapy consists of 10 weekly, 90-minute group therapy sessions, delivered remotely via Zoom. Intervention sessions and associated home practice will cover the following topics: Building and keeping motivation; Introduction to LGBTQ-related stress; Getting to know your emotions; Introduction to emotional behaviors and behavioral experiments; Awareness of physical sensations and introduction to flexible thinking; Being flexible in your thinking; Awareness of emotional experiences; Assertiveness; Situational exposures; Reviewing accomplishments and looking ahead. Participants will be taught intervention content through a range of teaching modalities including use of the Zoom whiteboard feature, videos, interactive activities, worksheets, and group discussion.

Behavioral: LGBTQ-affirmative cognitive behavioral group therapy; 10 sessions of supportive, LGBTQ-affirmative psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction with Treatment	Client satisfaction with treatment will be measured through the Client Satisfaction Questionnaire-8 (CSQ-8; Larsen et al., 1979), a well-validated, 8-item self-report questionnaire designed to assess patient/client satisfaction with services received. Both the adolescent self-report and the parent report of child services versions of the CSQ-8 will be used in this study. Items are scored on a 4-point scale, where higher scores indicate more satisfaction. The CSQ-8 has demonstrated excellent internal consistency in prior studies (alpha = 0.93)	Immediate Post-treatment at Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Session Attendance	Participant session attendance will be tracked by the study therapist each week to examine the feasibility of weekly sessions. Attendance will be scored as an average of summed weekly attendance counts per participant.	Immediate Post-treatment at Week 10

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 31, 2021
• Primary Completion (ACTUAL): January 11, 2022
• Study Completion (ACTUAL): January 26, 2022

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (ACTUAL): June 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: LGBTQ; minority stress
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2000030664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available 12 months after study completion for three years.
• IPD Sharing Access Criteria: Data access requests from qualified academic investigators for non-commercial research interests will be reviewed by study investigators. Requestors will be required to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No