LGBTQ-Affirmative Therapy for Mental Health Issues

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of LGBTQ-affirmative therapy delivered online to reduce anxiety and depression in LGBTQ+ adults with unsupportive parents. It aims to determine if individual cognitive behavioral therapy (CBT) or family therapy (Attachment-Based Family Therapy for Sexual and Gender Minority Young Adults, ABFT-SGM) can effectively lower mental health symptoms. The trial focuses on how these therapies might address issues like feeling rejected, internalized stigma, and emotional challenges. Individuals who identify as lesbian, bisexual, queer, pansexual, or another non-heterosexual identity, and who have experienced parental rejection, may be suitable if they live in New York, Pennsylvania, Connecticut, or Israel. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both treatments in this study are safe. Earlier trials with LGBTQ young adults found ABFT-SGM to be well-tolerated, with no major side effects reported. Participants and their families generally completed the treatment without significant problems.

Studies on LGBTQ-affirmative CBT also indicate it is safe and well-received. Earlier participants found the therapy acceptable and manageable, with few negative effects. These findings suggest that both therapies used in the trial are considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they specifically focus on the unique experiences of LGBTQ individuals, which traditional therapy options often overlook. ABFT-SGM (Attachment-Based Family Therapy for Sexual and Gender Minorities) uses a family-based approach to improve the parent-child relationship, addressing issues related to sexual orientation and gender identity. Meanwhile, LGBTQ-affirmative CBT (Cognitive Behavioral Therapy) integrates strategies to manage minority stress, targeting the stressors that disproportionately affect LGBTQ mental health. Both treatments are delivered via telehealth, making them more accessible and convenient for participants.

What evidence suggests that this trial's treatments could be effective for mental health issues?

This trial will compare two treatments: attachment-based family therapy for sexual and gender minorities (ABFT-SGM) and LGBTQ-affirmative cognitive behavioral therapy (CBT). Research has shown that ABFT can improve mental health in young adults who identify as sexual and gender minorities by strengthening family relationships and reducing issues like sensitivity to rejection and emotional regulation difficulties. Meanwhile, LGBTQ-affirmative CBT has successfully lowered depression and anxiety in LGBTQ+ individuals. Clinical trials indicate that this therapy helps by addressing the stress of being part of a marginalized group. Both treatments in this trial have shown promise in improving mental health by focusing on the unique challenges faced by sexual and gender minorities. ^{1 2 3 6 7}

Who Is on the Research Team?

John E Pachankis, PhD

Principal Investigator

Yale University

Gary M Diamond, PhD

Principal Investigator

Ben-Gurion University of the Negev

Are You a Good Fit for This Trial?

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

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Diamond and Boruchovitz-Zamir's book is a hands-on clinical guide that walks therapists through the theory, structure, and mechanics of attachment-based family.

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Attachment‐Based Family Therapy for LGBTQ Youth in a ...

This community-participatory, mixed-method study piloted the use of ABFT with LGBTQ youth. Fourteen families completed treatment with adolescent ...