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

NCT05766592 | Recruiting Phase 3 DMC

• 1 other identifier: 2000034163
• Study Type: interventional
• Target: 124
• Locations: 2 countries
• Sites: 2

Brief Summary

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).

Conditions

Mental Health Issue; Parent-Child Relations

Keywords

LGBTQ; Cognitive Behavioral Therapy; Attachment-Based Family Therapy

Outcome Measures

Primary Outcomes (2)

• Change in depression symptoms

  Depressive symptoms will be measured using the 21-item Beck Depression Inventory-II (BDI). Items are rated on a scale from 0-3 where higher scores indicate greater depression symptoms, with a maximum score of 63.

  Baseline, Immediate Post-intervention, 5-month Post-intervention

• Change in anxiety symptoms

  Anxiety symptoms will be measured using the 21-item Beck Anxiety Inventory (BAI). Items are rated on a scale from 0-3 where higher scores indicate greater anxiety symptoms, with a maximum score of 63.

  Baseline, Immediate Post-intervention, 5-month Post-intervention

Secondary Outcomes (9)

• Change in suicidal ideation

  Baseline, Immediate Post-intervention, 5-month Post-intervention

• Change in sexual orientation and gender modality concealment motivation, as relevant

  Baseline, Immediate Post-intervention, 5-month Post-intervention

• Change in sexual orientation and gender modality acceptance concerns, as relevant

  Baseline, Immediate Post-intervention, 5-month Post-intervention

• Change in explicit internalized stigma

  Baseline, Immediate Post-intervention, 5-month Post-intervention

• Change in emotion dysregulation

  Baseline, Immediate Post-intervention, 5-month Post-intervention

Study Arms (2)

LGBTQ-affirmative CBT

EXPERIMENTAL

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.

Behavioral: LGBTQ-affirmative CBT

ABFT-SGM

EXPERIMENTAL

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.

Behavioral: ABFT-SGM

Interventions

ABFT-SGM BEHAVIORAL

16-session attachment-based family therapy for sexual and gender minority young adults and their nonaccepting parents

ABFT-SGM

LGBTQ-affirmative CBT BEHAVIORAL

16-session LGBTQ-affirmative psychotherapy using cognitive behavioral techniques

LGBTQ-affirmative CBT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Ben-Gurion University of the Negev: collaborator
• Israel Science Foundation: collaborator

Study Sites (2)

Yale LGBTQ Mental Health Initiative with the Yale School of Public Health Office

New York, New York, 10001, United States

NOT YET RECRUITING

Ben-Gurion University Psychotherapy Research Lab

Beersheba, 84105, Israel

RECRUITING

Related Publications (12)

• Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.

  PMID: 24402217 BACKGROUND

• Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.

  PMID: 3204199 BACKGROUND

• Mohr JJ, Kendra MS. Revision and extension of a multidimensional measure of sexual minority identity: the Lesbian, Gay, and Bisexual Identity Scale. J Couns Psychol. 2011 Apr;58(2):234-245. doi: 10.1037/a0022858.

  PMID: 21319899 BACKGROUND

• Gouveia P, Ramos C, Brito J, Almeida TC, Cardoso J. The Difficulties in Emotion Regulation Scale - Short Form (DERS-SF): psychometric properties and invariance between genders. Psicol Reflex Crit. 2022 May 6;35(1):11. doi: 10.1186/s41155-022-00214-2.

  PMID: 35522349 BACKGROUND

• Kibrik EL, Cohen N, Stolowicz-Melman D, Levy A, Boruchovitz-Zamir R, Diamond GM. Measuring Adult Children's Perceptions of Their Parents' Acceptance and Rejection of Their Sexual Orientation: Initial Development of the Parental Acceptance and Rejection of Sexual Orientation Scale (PARSOS). J Homosex. 2019;66(11):1513-1534. doi: 10.1080/00918369.2018.1503460. Epub 2018 Aug 24.

  PMID: 30142289 BACKGROUND

• Kasch KL, Klein DN, Lara ME. A construct validation study of the Response Styles Questionnaire Rumination Scale in participants with a recent-onset major depressive episode. Psychol Assess. 2001 Sep;13(3):375-83. doi: 10.1037//1040-3590.13.3.375.

  PMID: 11556274 BACKGROUND

• Steffens MC, Buchner A. Implicit Association Test: separating transsituationally stable and variable components of attitudes toward gay men. Exp Psychol. 2003;50(1):33-48. doi: 10.1027//1618-3169.50.1.33.

  PMID: 12629959 BACKGROUND

• Fraley RC, Heffernan ME, Vicary AM, Brumbaugh CC. The Experiences in Close Relationships-Relationship Structures questionnaire: a method for assessing attachment orientations across relationships. Psychol Assess. 2011 Sep;23(3):615-25. doi: 10.1037/a0022898.

  PMID: 21443364 BACKGROUND

• Tolin DF, Gilliam C, Wootton BM, Bowe W, Bragdon LB, Davis E, Hannan SE, Steinman SA, Worden B, Hallion LS. Psychometric Properties of a Structured Diagnostic Interview for DSM-5 Anxiety, Mood, and Obsessive-Compulsive and Related Disorders. Assessment. 2018 Jan;25(1):3-13. doi: 10.1177/1073191116638410. Epub 2016 Mar 17.

  PMID: 26988404 BACKGROUND

• Lang AJ, Norman SB, Means-Christensen A, Stein MB. Abbreviated brief symptom inventory for use as an anxiety and depression screening instrument in primary care. Depress Anxiety. 2009;26(6):537-43. doi: 10.1002/da.20471.

  PMID: 19016462 BACKGROUND

• Cook SE, Marsiske M, McCoy KJ. The use of the Modified Telephone Interview for Cognitive Status (TICS-M) in the detection of amnestic mild cognitive impairment. J Geriatr Psychiatry Neurol. 2009 Jun;22(2):103-9. doi: 10.1177/0891988708328214.

  PMID: 19417219 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

Study Officials

• John E Pachankis, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Gary M Diamond, PhD

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John E Pachankis, PhD

CONTACT

646-429-9407; john.pachankis@yale.edu

Danielle M Chiaramonte, PhD

CONTACT

708-334-8331; danielle.chiaramonte@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be immediately assigned to either condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: August 13, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available 12 months after study completion for three years.
• Access Criteria: Data access requests from qualified academic investigators for non-commercial research interests will be reviewed by study investigators. Requestors will be required to sign a data access agreement.

Locations

US (1); IL (1)