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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 over the age of 20
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediate post-intervention, 5-month post-intervention
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 20 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in anxiety symptoms
Change in depression symptoms
Secondary outcome measures
Change in emotion dysregulation
Change in gender identity acceptance concerns
Change in gender identity affirmation
+17 more
Other outcome measures
Change in parental acceptance of sexual orientation or gender identity
Change in parental rejection of sexual orientation or gender identity
Change in quality of attachment relationship

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.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,841 Previous Clinical Trials
2,734,403 Total Patients Enrolled
Ben-Gurion University of the NegevOTHER
57 Previous Clinical Trials
2,444,635 Total Patients Enrolled
Israel Science FoundationOTHER
15 Previous Clinical Trials
3,076 Total Patients Enrolled

Media Library

ABFT-SGM Clinical Trial Eligibility Overview. Trial Name: NCT05766592 — Phase 3
Parent-Child Relationship Research Study Groups: ABFT-SGM, LGBTQ-affirmative CBT
Parent-Child Relationship Clinical Trial 2023: ABFT-SGM Highlights & Side Effects. Trial Name: NCT05766592 — Phase 3
ABFT-SGM 2023 Treatment Timeline for Medical Study. Trial Name: NCT05766592 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What possible risks could be associated with the utilization of LGBTQ-affirmative cognitive behavioral therapy?

"Our in-house experts have assigned a rating of 3 to the safety profile of LGBTQ-affirmative CBT, which is currently undergoing Phase 3 trials with many instances confirming both its efficacy and security."

Answered by AI

Are enrollments available for this clinical experiment at the moment?

"The clinicaltrials.gov database implies that this medical study is no longer accepting patients, as it was last updated on March 10th 2023 after its initial posting on 15th of March the same year. Nonetheless, 105 other studies are currently recruiting candidates for their trials."

Answered by AI

What are the main aims of this investigation?

"This clinical trial's primary end-point, evaluated at Baseline, Immediate Post-intervention and 5 Month Post Intervention is the transformation in anxiety symptoms. Secondary objectives include a shift in gay/lesbian concealment motivation as assessed with an adapted version of the Lesbian, Gay & Bisexual Identity Scale (LGBIS), alteration in gender minority identity concealment motivation using LGBIS scoring system and change in sexual orientation acceptance concerns measured by the Acceptance Concerns subscale of the LGBIS."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Yale LGBTQ Mental Health Initiative with the Yale School of Public Health Office
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~83 spots leftby Sep 2027