LGBTQ-Affirmative Therapy for Mental Health Issues
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.12345Why 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.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 16 weekly sessions of either LGBTQ-affirmative CBT or ABFT-SGM delivered via telehealth
Follow-up
Participants are monitored for changes in mental health symptoms and psychosocial mechanisms
What Are the Treatments Tested in This Trial?
Interventions
- ABFT-SGM
- LGBTQ-affirmative CBT
ABFT-SGM is already approved in United States for the following indications:
- Depressive symptoms in sexual and gender minority adults
- Anxiety symptoms in sexual and gender minority adults
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Ben-Gurion University of the Negev
Collaborator
Israel Science Foundation
Collaborator