LGBTQ-affirmative CBT for Youth

NCT ID: NCT05408858

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-01-26

Brief Summary

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.

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.

Conditions

Anxiety Disorders; Depression; LGBTQ

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

LGBTQ-affirmative cognitive behavioral group therapy

Intervention Type: BEHAVIORAL

10 sessions of supportive, LGBTQ-affirmative psychotherapy

Interventions

LGBTQ-affirmative cognitive behavioral group therapy

10 sessions of supportive, LGBTQ-affirmative psychotherapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Pachankis, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Dr. Pachankis' Lab

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2000030664

Identifier Type: -

Identifier Source: org_study_id