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NCT Number: NCT05766592

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

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).

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Key information

Conditions

Mental Health Issue Parent-Child Relations

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ben-Gurion University Psychotherapy Research Lab, Beersheba, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LGBTQ-affirmative CBT

Behavioral

16-session LGBTQ-affirmative psychotherapy using cognitive behavioral techniques

ABFT-SGM

Behavioral

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

Primary outcomes

  1. Change in depression symptoms

    Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention

    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.

  2. Change in anxiety symptoms

    Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention

    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.

Secondary outcomes

  1. Change in suicidal ideation

    Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention

    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.

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

    Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention

    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.

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

    Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention

    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.

  4. Change in explicit internalized stigma

    Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention

    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.

  5. Change in emotion dysregulation

    Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention

    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.

  6. Change in implicit sexual orientation bias

    Time frame: Baseline, Immediate Post-intervention

    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.

  7. Change in parental acceptance of sexual orientation or gender modality, as relevant

    Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention

    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.

  8. Change in parental rejection of sexual orientation or gender modality, as relevant

    Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention

    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.

  9. Change in quality of attachment relationship

    Time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle M Chiaramonte, PhD

CONTACT

[email protected]

708-334-8331

John E Pachankis, PhD

CONTACT

[email protected]

646-429-9407

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Ben-Gurion University of the Negev
  • Israel Science Foundation

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2023
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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