Affirmative Family and Individual Psychotherapy for Sexual and Gender Minority Adults and Their Nonaccepting Parents

Yale University

Status and phase: Enrolling; Phase 3

Conditions: Mental Health Issue; Parent-Child Relations

Treatments: Behavioral: LGBTQ-affirmative CBT; Behavioral: ABFT-SGM

Study type: Interventional

Funder types: Other

Identifiers

NCT05766592

2000034163

Details and patient eligibility

About

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).

Full description

The purpose of this study is to assess the efficacy and purported change mechanisms in 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 in New York, Pennsylvania, Connecticut, and Israel. In this 2-arm randomized clinical trial (RCT), participants will receive 16 weekly sessions of either LGBTQ-affirmative CBT or ABFT-SGM. Investigators will assess whether both treatments are associated with significant decreases in depressive and anxiety symptoms. Investigators will also assess whether psychosocial mechanisms (e.g., rejection sensitivity, internalized stigma, emotion dysregulation, parental rejection and acceptance) mediate reductions in psychological symptoms, and whether such mediators differ between the two treatments. Finally, investigators will assess whether participants who begin treatment with higher levels of parental rejection benefit more from ABFT-SGM than from LGBTQ-affirmative CBT, and whether participants with higher initial levels of maladaptive stress responses benefit more from LGBTQ-affirmative CBT.

Enrollment: 124 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• be 20 and older
• be fluent in English
• self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity
• currently experience elevated depressive or anxiety symptoms (screened initially using a cutoff of ≥ 2.5 on the Brief Symptom Inventory-4 and further confirmed by the BDI and BAI).
• 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, Pennsylvania, Connecticut, or Israel.

Exclusion criteria

• report current mental health treatment ≥1 day/month (except for medication management ≤1 day/week)
• report beginning a new medication within the past 30 days
• exhibit active psychosis or active mania, as assessed by the SCID-Psych Screen.
• exhibit active suicidality or active homicidality, as assessed by the SIDAS
• be currently legally mandated to attend treatment
• demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status
• do not have a parent willing to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

LGBTQ-affirmative CBT

Experimental group

Description:

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.

Treatment:

Behavioral: LGBTQ-affirmative CBT

ABFT-SGM

Experimental group

Description:

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.

Treatment:

Behavioral: ABFT-SGM