Clinical trial NCT05408858: LGBTQ-affirmative CBT for Youth
Official title: LGBTQ-affirmative Cognitive Behavioral Group Therapy for Youth: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depression
LGBTQ
Keywords: minority stress
LGBTQ
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open trial
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Client Satisfaction With Treatment
timeFrame: Immediate Post-treatment at Week 10
Secondary outcomes:
measure: Session Attendance
timeFrame: Immediate Post-treatment at Week 10
Other outcomes:
Locations:
city: New York
country: United States
facility: Dr. Pachankis' Lab
state: New York
Study officials:
affiliation: Yale University
name: John Pachankis, PhD
role: PRINCIPAL_INVESTIGATOR
References: