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

Overview

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).

Detailed 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.

Interventions

• Behavioral LGBTQ-affirmative CBT
  16-session LGBTQ-affirmative psychotherapy using cognitive behavioral techniques
• Behavioral ABFT-SGM
  16-session attachment-based family therapy for sexual and gender minority young adults and their nonaccepting parents

Primary outcome measures

• Change in depression symptoms [Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention]
• Change in anxiety symptoms [Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention]

Secondary outcome measures (9)

• Change in suicidal ideation [Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention]
• Change in sexual orientation and gender modality concealment motivation, as relevant [Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention]
• Change in sexual orientation and gender modality acceptance concerns, as relevant [Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention]
• Change in explicit internalized stigma [Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention]
• Change in emotion dysregulation [Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention]
• Change in implicit sexual orientation bias [Time frame: Baseline, Immediate Post-intervention]
• Change in parental acceptance of sexual orientation or gender modality, as relevant [Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention]
• Change in parental rejection of sexual orientation or gender modality, as relevant [Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention]
• Change in quality of attachment relationship [Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Yale LGBTQ Mental Health Initiative with the Yale School of Public Health Office — New York

Israel · 1 center

• Ben-Gurion University Psychotherapy Research Lab — Beersheba

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT05766592 · 2000034163

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗