Affirmative Family and Individual Psychotherapy for Sexual and Gender Minority Adults and Their Nonaccepting Parents

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of an LGBTQ-affirmative individual cognitive behavioral psychotherapy (CBT) and LGBTQ-affirmative family therapy (attachment-based family therapy for sexual and gender minority young adults; ABFT-SGM) delivered via telehealth to a sample of sexual and gender minority adults with nonaccepting parent(s) in New York, Connecticut, and Israel. The investigators will assess whether both treatments are associated with significant decreases in depressive and anxiety symptoms. The investigators will also assess whether and how each treatment achieves reductions in mental health symptoms through specific mechanisms (e.g., rejection sensitivity, internalized stigma, emotion dysregulation, parental rejection and acceptance).

Detailed Description
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The purpose of this study is to assess the efficacy and purported change mechanisms in an LGBTQ-affirmative individual cognitive behavioral psychotherapy (CBT) and LGBTQ-affirmative family therapy (attachment-based family therapy for sexual and gender minority young adults; ABFT-SGM) delivered via telehealth to a sample of sexual and gender minority adults in New York, Connecticut, and Israel. In this 2-arm randomized clinical trial (RCT), participants will receive 16 weekly sessions of either LGBTQ-affirmative CBT or ABFT-SGM. Investigators will assess whether both treatments are associated with significant decreases in depressive and anxiety symptoms. Investigators will also assess whether psychosocial mechanisms (e.g., rejection sensitivity, internalized stigma, emotion dysregulation, parental rejection and acceptance) mediate reductions in psychological symptoms, and whether such mediators differ between the two treatments. Finally, investigators will assess whether participants who begin treatment with higher levels of parental rejection benefit more from ABFT-SGM than from LGBTQ-affirmative CBT, and whether participants with higher initial levels of maladaptive stress responses benefit more from LGBTQ-affirmative CBT.

Official Title
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Affirmative Family and Individual Psychotherapy for Sexual and Gender Minority Adults and Their Nonaccepting Parents

Conditions
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Mental Health Issue, Parent-Child Relations

Intervention / Treatment
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* Behavioral: LGBTQ-affirmative CBT
* Behavioral: ABFT-SGM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be over the age of 20 be fluent in English self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity currently experience elevated depressive or anxiety disorder (screened initially using a cutoff of ≥ 2.5 on the Brief Symptom Inventory-4 and further confirmed by the BDI and BAI). report at least moderate levels of parental rejection or low levels of parental acceptance, as measured using the PARSOS. have at least one rejecting/nonaccepting parent that agrees to participate in the therapy. live in New York State, Connecticut, or Israel. Exclusion Criteria: report current mental health treatment ≥1 day/month (except for medication management ≤1 day/week) report beginning a new medication within the past 30 days exhibit active psychosis or active mania, as assessed by the DIAMOND. exhibit active suicidality or active homicidality, as assessed by the SIDAS and DIAMOND be currently legally mandated to attend treatment demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status do not have a parent willing to participate

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LGBTQ-affirmative CBT<br>Individuals assigned to LGBTQ-affirmative cognitive behavioral therapy will receive 16 weekly individually-delivered sessions, directly after baseline assessment, delivered via telehealth. Based on the Unified Protocol, sessions will address minority stress mechanisms underlying sexual and gender minority mental health disparities. | Behavioral: LGBTQ-affirmative CBT<br>* 16-session LGBTQ-affirmative psychotherapy using cognitive behavioral techniques<br>|
| Experimental: ABFT-SGM<br>Individuals assigned to attachment-based family therapy for sexual and gender minorities will receive a 16-session sequence of family-based therapy delivered via telehealth. This sequence will include sessions with sexual and/or gender minority adult children alone, adult children and parent(s), and parent(s) alone. Sessions will address the quality parent-child relationship in relation to child sexual orientation and gender identity to target mental health disparities. | Behavioral: ABFT-SGM<br>* 16-session attachment-based family therapy for sexual and gender minority young adults and their nonaccepting parents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression symptoms | Depressive symptoms will be measured using the 21-item Beck Depression Inventory-II (BDI). Items are rated on a scale from 0-3 where higher scores indicate greater depression symptoms, with a maximum score of 63. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in anxiety symptoms | Anxiety symptoms will be measured using the 21-item Beck Anxiety Inventory (BAI). Items are rated on a scale from 0-3 where higher scores indicate greater anxiety symptoms, with a maximum score of 63. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in suicidal ideation | Suicidal ideation will be measured using a single item from the Patient Health Questionnaire-9. This item is rated from 0-3, where a higher score indicates higher suicidal ideation. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in sexual orientation concealment motivation | Motivation to conceal sexual minority identity will be assessed using the Concealment Motivation subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher concealment motivation. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in gender identity concealment motivation | Motivation to conceal gender minority identity will be assessed using an adapted version of the Concealment Motivation subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher concealment motivation. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in sexual orientation acceptance concerns | Acceptance concerns of sexual minority identity will be assessed using the Acceptance Concerns subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher acceptance concerns. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in gender identity acceptance concerns | Acceptance concerns of gender minority identity will be assessed using an adapted version of the Acceptance Concerns subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher acceptance concerns. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in internalized heterosexism | Internalized heterosexism will be assessed using the Internalized Homophobia subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher internalized heterosexism. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in internalized cissexism | Internalized cissexism will be assessed using an adapted version of the Internalized Homophobia subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher internalized cissexism. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in sexual orientation identity uncertainty | Identity uncertainty of sexual minority identity will be assessed using the Identity Uncertainty subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher identity uncertainty. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in gender identity uncertainty | Identity uncertainty of gender minority identity will be assessed using an adapted version of the Identity Uncertainty subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher identity uncertainty. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in sexual orientation processing difficulty | Difficulty in processing sexual minority identity will be assessed using the Difficult Process subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate a more difficult process. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in gender identity processing difficulty | Difficulty in processing gender minority identity will be assessed using an adapted version of the Difficult Process subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate a more difficult process. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in sexual orientation identity affirmation | Identity affirmation of sexual minority identity will be assessed using the Identity Affirmation subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher identity affirmation. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in gender identity affirmation | Identity affirmation of gender minority identity will be assessed using an adapted version of the Identity Affirmation subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher identity affirmation. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in sexual orientation identity superiority | Identity superiority of sexual minority identity will be assessed using the Identity Superiority subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher identity superiority. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in gender identity superiority | Identity superiority of gender minority identity will be assessed using an adapted version of the Identity Superiority subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher identity superiority. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in sexual orientation identity centrality | Identity centrality of sexual minority identity will be assessed using the Identity Centrality subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher identity centrality. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in gender identity centrality | Identity centrality of gender minority identity will be assessed using an adapted version of the Identity Centrality subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher identity centrality. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in emotion dysregulation | Emotion dysregulation will be assessed using the 18-item Difficulties in Emotion Regulation Scale-Short Form (DERS-SF). Items are rated on a 5-point scale from 1-5; items 1, 4, and 6 are reverse coded. Items are averaged for a total maximum score of 5, where higher scores indicate higher emotion dysregulation. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in rumination | Rumination will be measured using the 22-item Response Styles Questionnaire Rumination Scale (RSQ). Items are rated on a 4 point scale from 1-4. Items are summed for a total maximum score of 88, where higher scores indicate higher rumination. | Baseline, Immediate Post-intervention, 5-month Post-intervention | 
| Change in implicit sexual orientation bias | Implicit bias related to sexual orientation will be measured using the sexual orientation Implicit Association Test. Scores range from -2 to 2, where higher scores indicate higher implicit preference towards heterosexuality. | Baseline, Immediate Post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LGBTQ, Cognitive Behavioral Therapy, Attachment-Based Family Therapy