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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LGBTQ-affirmative cognitive behavioral group therapy | Behavioral | 10 sessions of supportive, LGBTQ-affirmative psychotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Participant identifies as either a gender minority (e.g., transgender, nonbinary) or as a sexual minority (e.g., gay, bisexual)
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| Name | Affiliation | Role |
|---|---|---|
| John Pachankis, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Pachankis' Lab | New York | New York | 10010 | United States |
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available 12 months after study completion for three years.
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.
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The study was advertised to potential participants using social media (Facebook and Twitter). Study team also sent emails to LGBTQ organizations in the Tri-state area to promote the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. LGBTQ-affirmative cognitive behavioral group therapy: 10 sessions of supportive, LGBTQ-affirmative psychotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. LGBTQ-affirmative cognitive behavioral group therapy: 10 sessions of supportive, LGBTQ-affirmative psychotherapy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. 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) | Only 8 participants were analyzed, as 1 participant was dismissed after session 2 for not meeting eligibility criteria. | Posted | Mean | Standard Deviation | score on a scale | Immediate Post-treatment at Week 10 |
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From enrollment to completion of the final follow-up survey, up to 19 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. LGBTQ-affirmative cognitive behavioral group therapy: 10 sessions of supportive, LGBTQ-affirmative psychotherapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ilana Seager van Dyk | Massey University | +64 4 979 3625 | i.seagervandyk@massey.ac.nz |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2021 | Mar 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Open trial
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| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Grade in School | Count of Participants | Participants |
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| Sexual Orientation | Count of Participants | Participants |
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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. LGBTQ-affirmative cognitive behavioral group therapy: 10 sessions of supportive, LGBTQ-affirmative psychotherapy |
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| 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. | Posted | Mean | Standard Deviation | sessions | Immediate Post-treatment at Week 10 |
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