Affirmative Family and Individual Psychotherapy for Sexual and Gender Minority Adults and Their Nonaccepting Parents
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20+
SponsorYale University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
LGBTQ-affirmative CBT
Behavioral16-session LGBTQ-affirmative psychotherapy using cognitive behavioral techniques
ABFT-SGM
Behavioral16-session attachment-based family therapy for sexual and gender minority young adults and their nonaccepting parents
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: LGBTQ-affirmative CBTExperimental treatment 1 intervention
Group B: ABFT-SGMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Immediate Post-intervention, 5-month Post-intervention2
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.
Time frame
Baseline, Immediate Post-intervention, 5-month Post-interventionSecondary outcomes
1
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.
Time frame
Baseline, Immediate Post-intervention, 5-month Post-intervention2
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.
Time frame
Baseline, Immediate Post-intervention, 5-month Post-intervention3
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.
Time frame
Baseline, Immediate Post-intervention, 5-month Post-intervention4
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.
Time frame
Baseline, Immediate Post-intervention, 5-month Post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Ben-Gurion University of the Negev
Collaborator
Israel Science Foundation
Collaborator
Source ClinicalTrials.gov