← Back to Search

LGBTQ-Affirmative Therapy for Mental Health Issues

Phase 3

Recruiting

Led By Gary Diamond, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediate post-intervention, 5-month post-intervention

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will assess if LGBTQ-affirmative CBT and family therapy can reduce depression & anxiety in SGM adults with nonaccepting parents. Investigating how the treatments work to reduce mental health symptoms.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While traditional side effects are not applicable as this is a psychotherapy intervention rather than medication, participants may experience emotional discomfort discussing sensitive topics during sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediate post-intervention, 5-month post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediate post-intervention, 5-month post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediate post-intervention, 5-month post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in anxiety symptoms

Change in depression symptoms

Secondary study objectives

Change in emotion dysregulation

Change in explicit internalized stigma

Change in implicit sexual orientation bias

+6 more

Other study objectives

Change in parental acceptance of sexual orientation or gender identity

Change in parental rejection of sexual orientation or gender identity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: LGBTQ-affirmative CBTExperimental Treatment1 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-SGMExperimental Treatment1 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.

Do I qualify?Apply below to find out