LGBTQ-affirmative CBT for Youth

NCT05408858 | Completed Results

• 1 other identifier: 2000030664
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depression; LGBTQ

Keywords

minority stress; LGBTQ

Outcome Measures

Primary Outcomes (1)

• 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. Total score is determined by summing the 8 items, yielding a score between 8 and 32. The CSQ-8 has demonstrated excellent internal consistency in prior studies (alpha = 0.93)

  Immediate Post-treatment at Week 10

Secondary Outcomes (1)

• Session Attendance

  Immediate Post-treatment at Week 10

Study Arms (1)

LGBTQ-affirmative cognitive behavioral group therapy

EXPERIMENTAL

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

Interventions

LGBTQ-affirmative cognitive behavioral group therapy BEHAVIORAL

10 sessions of supportive, LGBTQ-affirmative psychotherapy

LGBTQ-affirmative cognitive behavioral group therapy

Eligibility Criteria

• Age: 12 Years - 17 Years
• Gender Eligibility Details: Participant identifies as either a gender minority (e.g., transgender, nonbinary) or as a sexual minority (e.g., gay, bisexual)
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Dr. Pachankis' Lab

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Ilana Seager van Dyk
• Organization: Massey University

i.seagervandyk@massey.ac.nz

+64 4 979 3625

Study Officials

• John Pachankis, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open trial

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 7, 2022
• Study Start: August 31, 2021
• Primary Completion: January 11, 2022
• Study Completion: January 26, 2022
• Last Updated: May 31, 2024
• Results First Posted: May 31, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available 12 months after study completion for three years.
• 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.

Locations

US (1)