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

Mental Health Issue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766592
• Other study ID #: 2000034163
• Status: Recruiting
• Phase: Phase 3
• Start date: June 9, 2024
• Est. completion date: September 15, 2027

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: John E Pachankis, PhD
• Phone: 646-429-9407
• Email: john.pachankis[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: September 15, 2027
• Est. primary completion date: September 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Issue
• Parent-Child Relations

Intervention

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

Locations

Country	Name	City	State
Israel	Ben-Gurion University Psychotherapy Research Lab	Be'er Sheva
United States	Yale LGBTQ Mental Health Initiative with the Yale School of Public Health Office	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Ben-Gurion University of the Negev, Israel Science Foundation

Countries where clinical trial is conducted

United States,  Israel, 

References & Publications (12)

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. — View 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. — View 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. — View 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. Erratum In: Psicol Reflex Crit. 2022 Jul 4;35(1):19. doi: 10.1186/s41155-022-00225-z. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in suicidal ideation	Suicidal ideation will be measured using a single item from the Patient Health Questionnaire-9. This item is rated from 0-3, where a higher score indicates higher suicidal ideation.	Baseline, Immediate Post-intervention, 5-month Post-intervention
Secondary	Change in sexual orientation and gender modality concealment motivation, as relevant	Motivation to conceal sexual orientation and gender modality will be assessed using the Concealment Motivation subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher concealment motivation.	Baseline, Immediate Post-intervention, 5-month Post-intervention
Secondary	Change in sexual orientation and gender modality acceptance concerns, as relevant	Acceptance concerns of sexual minority identity and gender identity will be assessed using the Acceptance Concerns subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher acceptance concerns.	Baseline, Immediate Post-intervention, 5-month Post-intervention
Secondary	Change in explicit internalized stigma	Change in explicit internalized stigma will be assessed using the Internalized Homonegativity subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher acceptance concerns.	Baseline, Immediate Post-intervention, 5-month Post-intervention
Secondary	Change in emotion dysregulation	Emotion dysregulation will be assessed using the 18-item Difficulties in Emotion Regulation Scale-Short Form (DERS-SF). Items are rated on a 5-point scale from 1-5; items 1, 4, and 6 are reverse coded. Items are averaged for a total maximum score of 5, where higher scores indicate higher emotion dysregulation.	Baseline, Immediate Post-intervention, 5-month Post-intervention
Secondary	Change in implicit sexual orientation bias	Implicit bias related to sexual orientation will be measured using the sexual orientation Implicit Association Test. Scores range from -2 to 2, where higher scores indicate higher implicit preference towards heterosexuality.	Baseline, Immediate Post-intervention
Secondary	Change in parental acceptance of sexual orientation or gender modality, as relevant	Parental acceptance will be measured by the Parental Acceptance subscale of the Parental Acceptance and Rejection of Sexual Orientation and Gender Identity Scale (PARSOS). 15 items are rated on a 5-point scale from 1-5. Items are averaged for a maximum total score of 5, indicating higher parental acceptance.	Baseline, Immediate Post-intervention, 5-month Post-intervention
Secondary	Change in parental rejection of sexual orientation or gender modality, as relevant	Parental rejection will be measured by the Parental Rejection subscale of the Parental Acceptance and Rejection of Sexual Orientation and Gender Identity Scale (PARSOS). 13 items are rated on a 5-point scale from 1-5. Items are averaged for a maximum total score of 5, indicating higher parental rejection.	Baseline, Immediate Post-intervention, 5-month Post-intervention
Secondary	Change in quality of attachment relationship	Quality of attachment relationship will be assessed using the Experience in Close Relationships-Relationship Structures Questionnaire (ECR-RS). 9 items are rated on a scale from 1-7 and averaged for a total maximum score of 7, indicating a higher quality of attachment relationship.	Baseline, Immediate Post-intervention, 5-month Post-intervention