Clinical trial NCT05766592: Affirmative Family and Individual Psychotherapy for Sexual and Gender Minority Adults and Their Nonaccepting Parents
Official title: Affirmative Family and Individual Psychotherapy for Sexual and Gender Minority Adults and Their Nonaccepting Parents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Mental Health Issue
Parent-Child Relations
Keywords: LGBTQ
Cognitive Behavioral Therapy
Attachment-Based Family Therapy
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
name: Israel Science Foundation
First posted: 2023-03-13
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

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 disorder (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 DIAMOND.
* exhibit active suicidality or active homicidality, as assessed by the SIDAS and DIAMOND
* 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

Primary outcomes:
measure: Change in depression symptoms
timeFrame: Baseline, Immediate Post-intervention, 5-month Post-intervention
measure: Change in anxiety symptoms
timeFrame: Baseline, Immediate Post-intervention, 5-month Post-intervention
Secondary outcomes:
measure: Change in suicidal ideation
timeFrame: Baseline, Immediate Post-intervention, 5-month Post-intervention
measure: Change in sexual orientation and gender modality concealment motivation, as relevant
timeFrame: Baseline, Immediate Post-intervention, 5-month Post-intervention
measure: Change in sexual orientation and gender modality acceptance concerns, as relevant
timeFrame: Baseline, Immediate Post-intervention, 5-month Post-intervention
measure: Change in explicit internalized stigma
timeFrame: Baseline, Immediate Post-intervention, 5-month Post-intervention
measure: Change in emotion dysregulation
timeFrame: Baseline, Immediate Post-intervention, 5-month Post-intervention
measure: Change in implicit sexual orientation bias
timeFrame: Baseline, Immediate Post-intervention
measure: Change in parental acceptance of sexual orientation or gender modality, as relevant
timeFrame: Baseline, Immediate Post-intervention, 5-month Post-intervention
measure: Change in parental rejection of sexual orientation or gender modality, as relevant
timeFrame: Baseline, Immediate Post-intervention, 5-month Post-intervention
measure: Change in quality of attachment relationship
timeFrame: Baseline, Immediate Post-intervention, 5-month Post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Yale LGBTQ Mental Health Initiative with the Yale School of Public Health Office
state: New York
city: Be'er Sheva
country: Israel
facility: Ben-Gurion University Psychotherapy Research Lab
Study officials:
affiliation: Yale University
name: John E Pachankis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ben-Gurion University of the Negev
name: Gary M Diamond, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.