Back to resultsLGBTQ-affirmative CBT for Youth
Primary Purpose
Anxiety Disorders, Depression, LGBTQ
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LGBTQ-affirmative cognitive behavioral group therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety Disorders focused on measuring minority stress, LGBTQ
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)
Sites / Locations
- Dr. Pachankis' Lab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LGBTQ-affirmative cognitive behavioral group therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05408858
Brief Title
LGBTQ-affirmative CBT for Youth
Official Title
LGBTQ-affirmative Cognitive Behavioral Group Therapy for Youth: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
January 11, 2022 (Actual)
Study Completion Date
January 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression, LGBTQ
Keywords
minority stress, LGBTQ
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LGBTQ-affirmative cognitive behavioral group therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LGBTQ-affirmative cognitive behavioral group therapy
Intervention Description
10 sessions of supportive, LGBTQ-affirmative psychotherapy
Primary Outcome Measure Information:
Title
Client Satisfaction with Treatment
Description
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)
Time Frame
Immediate Post-treatment at Week 10
Secondary Outcome Measure Information:
Title
Session Attendance
Description
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.
Time Frame
Immediate Post-treatment at Week 10
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Participant identifies as either a gender minority (e.g., transgender, nonbinary) or as a sexual minority (e.g., gay, bisexual)
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Pachankis, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Pachankis' Lab
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
LGBTQ-affirmative CBT for Youth
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