LGBTQ-affirmative CBT for Youth

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408858
• Other study ID #: 2000030664
• Status: Completed
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: January 26, 2022

Study information

• Verified date: June 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 26, 2022
• Est. primary completion date: January 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• LGBTQ

Intervention

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

Locations

Country	Name	City	State
United States	Dr. Pachankis' Lab	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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