LGBTQ-Affirmative Therapy for Mental Health Issues

Recruiting at 1 trial location

Overseen By Danielle M Chiaramonte, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Yale University

Disqualifiers: Active psychosis, Active mania, Active suicidality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

Duration: 16 weeks

124 Participants Needed

Trial Summary

What is the purpose of this trial?

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, Pennsylvania, 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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have started a new medication in the past 30 days.

What data supports the effectiveness of the treatment ABFT-SGM for mental health issues in LGBTQ+ young adults?

Research shows that Attachment-Based Family Therapy (ABFT) has been adapted for LGBTQ+ youth and has shown promise in reducing suicidal thoughts and improving family communication. Additionally, cognitive behavioral therapy (CBT) tailored for sexual and gender minority youth has been effective in improving mood and coping skills. ^{1 2 3 4 5}

Is LGBTQ-Affirmative Therapy safe for humans?

Research on LGBTQ-Affirmative Therapy, including Attachment-Based Family Therapy (ABFT) and cognitive behavioral therapy (CBT) adapted for sexual and gender minority youth, suggests it is generally safe. Studies show that these therapies are feasible and acceptable, with participants completing treatment and reporting positive experiences. ^{1 2 3 4 5}

How does the treatment ABFT-SGM differ from other treatments for mental health issues in LGBTQ+ youth?

ABFT-SGM is unique because it combines attachment-based family therapy with LGBTQ-affirmative cognitive behavioral therapy, specifically tailored to address the unique challenges faced by sexual and gender minority youth, such as family rejection and societal exclusion, which are not typically addressed in standard treatments. ^{1 2 3 5 6}

Research Team

John E Pachankis, PhD

Principal Investigator

Yale University

Gary M Diamond, PhD

Principal Investigator

Ben-Gurion University of the Negev

Eligibility Criteria

This trial is for sexual and gender minority adults over 20 in New York or Connecticut with nonaccepting parents willing to join therapy. Participants must have elevated depression or anxiety, not be on new meds within the last month, and can't be under legal treatment mandates or exhibit active suicidality/homicidality, psychosis, mania, or severe cognitive impairment.

Inclusion Criteria

Live in New York State, Connecticut, or Israel

Be fluent in English

I am over 20 years old.

Exclusion Criteria

I started a new medication within the last 30 days.

Demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status

Do not have a parent willing to participate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 16 weekly sessions of either LGBTQ-affirmative CBT or ABFT-SGM delivered via telehealth

16 weeks

16 visits (virtual)

Follow-up

Participants are monitored for changes in mental health symptoms and psychosocial mechanisms

5 months

Immediate Post-intervention, 5-month Post-intervention assessments

Treatment Details

Interventions

• ABFT-SGM
• LGBTQ-affirmative CBT

Trial Overview The study tests LGBTQ-affirmative individual CBT and family therapy (ABFT-SGM) via telehealth for reducing depressive and anxiety symptoms among sexual and gender minority adults facing parental rejection. It aims to understand how these therapies improve mental health by addressing factors like stigma.

Participant Groups

Group I: LGBTQ-affirmative CBT Experimental Treatment 1 Intervention

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.

Group II: ABFT-SGM Experimental Treatment 1 Intervention

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.

ABFT-SGM is already approved in United States for the following indications:

Approved in United States as ABFT-SGM for:

• Depressive symptoms in sexual and gender minority adults
• Anxiety symptoms in sexual and gender minority adults

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Ben-Gurion University of the Negev

Collaborator

Trials

64

Recruited

2,446,000+

Israel Science Foundation

Collaborator

Trials

16

Recruited

3,200+

Findings from Research

Attachment-based family therapy (ABFT) was found to be feasible and acceptable for LGBTQ+ adolescents and young adults, with all 10 participants completing the 16-week treatment without dropouts.

The therapy significantly reduced suicidal ideation among participants, indicating its potential effectiveness in addressing suicide risk in this population, although changes in depression levels were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Attachment-Based Family Therapy for Depressed and Suicidal Adolescents and Young Adults in LGBTQ+ Services. Russon, J., Morrissey, J., Dellinger, J., et al.[2022]

Transgender and gender diverse (TGD) youth are at a higher risk for suicidal thoughts and behaviors compared to their cisgender peers, highlighting the urgent need for effective treatments.

A case study of a self-identified gender nonconforming adolescent showed that modifications to attachment-based family therapy (ABFT) led to significant reductions in suicidal symptoms and improved family communication over 24 weeks, suggesting that ABFT may be a promising intervention for TGD youth at risk for suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demonstrating Attachment-Based Family Therapy for Transgender and Gender Diverse Youth with Suicidal Thoughts and Behavior: A Case Study. Russon, J., Smithee, L., Simpson, S., et al.[2022]

In a study of 129 adolescents (31% LGBQ) receiving either Attachment-Based Family Therapy (ABFT) or Family Enhanced Nondirective Supportive Therapy (FE-NST) over 16 weeks, LGBQ adolescents showed a significantly greater reduction in depressive symptoms with ABFT compared to those receiving FE-NST.

While both LGBQ and heterosexual adolescents experienced reductions in depressive symptoms, LGBQ adolescents benefited more from ABFT, indicating that this therapy may be particularly effective for this at-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attachment-based family therapy versus nondirective supportive therapy for lesbian, gay, bisexual and questioning adolescents with depression, and suicidal ideation: An exploratory study. Russon, J., Abbott, CH., Jin, B., et al.[2023]

Adapting empirically supported treatments (ESTs) like cognitive behavioral therapy (CBT) for diverse sexual and gender minority youth (SGMY) can enhance their effectiveness by addressing the unique challenges these youths face.

The development of an affirmative CBT intervention was informed by focus groups with culturally diverse SGMY, highlighting the importance of cultural norms, the role of religious communities, and family dynamics in shaping their experiences and identities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empirically Supported Interventions for Sexual and Gender Minority Youth. Austin, A., Craig, SL.[2021]

The AFFIRM intervention is an 8-session cognitive behavioral therapy (CBT)-informed group program designed to improve coping skills and reduce sexual risk behaviors among sexual and gender minority youth (SGMY), with a target sample size of 300 participants.

This pragmatic trial aims to assess the effectiveness of AFFIRM in enhancing sexual health self-efficacy and mental health while addressing issues like internalized homophobia, potentially providing a scalable solution for the unique challenges faced by SGMY.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Affirmative Coping Skills Intervention to Improve the Mental and Sexual Health of Sexual and Gender Minority Youth (Project Youth AFFIRM): Protocol for an Implementation Study. Craig, SL., McInroy, LB., Eaton, AD., et al.[2020]

LGBQ+ affirmative psychotherapies are essential for addressing the unique needs of sexual minority clients, but there is a lack of empirical research on their effectiveness and specific practices.

The authors propose that these therapies should not be limited to sexual orientation-specific approaches but can be beneficial for all clients, emphasizing the need for further research and diverse therapeutic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging in LGBQ+ affirmative psychotherapies with all clients: Defining themes and practices. Moradi, B., Budge, SL.[2019]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Implementing Attachment-Based Family Therapy for Depressed and Suicidal Adolescents and Young Adults in LGBTQ+ Services. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Demonstrating Attachment-Based Family Therapy for Transgender and Gender Diverse Youth with Suicidal Thoughts and Behavior: A Case Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Attachment-based family therapy versus nondirective supportive therapy for lesbian, gay, bisexual and questioning adolescents with depression, and suicidal ideation: An exploratory study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Empirically Supported Interventions for Sexual and Gender Minority Youth. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

An Affirmative Coping Skills Intervention to Improve the Mental and Sexual Health of Sexual and Gender Minority Youth (Project Youth AFFIRM): Protocol for an Implementation Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Engaging in LGBQ+ affirmative psychotherapies with all clients: Defining themes and practices. [2019]