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Mental Health IssuePhase 3NCT05766592

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

A Phase 3 study testing LGBTQ-affirmative CBT and ABFT-SGM in people with Mental Health Issue and Parent-Child Relations, run by Yale University at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Mental Health Issue, Parent-Child Relations
What is being tested?
LGBTQ-affirmative CBT and ABFT-SGM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
2 sitesin 2 countries
Study dates
13 Aug 2024to 30 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

John E Pachankis, PhD contact

646-429-9407

john.pachankis@yale.edu

Danielle M Chiaramonte, PhD contact

708-334-8331

danielle.chiaramonte@yale.edu

2 sites in 2 countries

United States1 site, 1 recruiting

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

    New York, New York, 10001

    Danielle M Chiaramonte, PhD, 708-334-8331, danielle.chiaramonte@yale.edu

    Benjamin E Eisenstadt, BA, 347-633-0610, ben.eisenstadt@yale.edu

    Not yet recruiting

Other trials in United States

Israel1 site, 1 recruiting

  • Ben-Gurion University Psychotherapy Research Lab

    Beersheba, 84105

    Gary M Diamond, PhD, 267-388-9393, gdiamond@bgu.ac.il

    Noam Aiziczon, noamaizi@post.bgu.ac.il

    Recruiting

Other trials in Israel

About this study

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).

Read the 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.

Being tested
LGBTQ-affirmative CBT, ABFT-SGM
Keywords
LGBTQ, Cognitive Behavioral Therapy, Attachment-Based Family Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LGBTQ-affirmative CBTBehavioural

    16-session LGBTQ-affirmative psychotherapy using cognitive behavioral techniques

  • ABFT-SGMBehavioural

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

Study groups in NCT05766592
Study groupRoleWhat they receive
LGBTQ-affirmative CBTExperimentalIndividuals assigned to LGBTQ-affirmative cognitive behavioral therapy will receive 16 weekly individually-delivered sessions, directly after baseline assessment, delivered via telehealth. Based on the Unified Protocol, sessions will address minority stress mechanisms underlying sexual and gender minority mental health disparities.
Receives: Behavioral: LGBTQ-affirmative CBT
ABFT-SGMExperimentalIndividuals assigned to attachment-based family therapy for sexual and gender minorities will receive a 16-session sequence of family-based therapy delivered via telehealth. This sequence will include sessions with sexual and/or gender minority adult children alone, adult children and parent(s), and parent(s) alone. Sessions will address the quality parent-child relationship in relation to child sexual orientation and gender identity to target mental health disparities.
Receives: Behavioral: ABFT-SGM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Immediate Post-intervention, 5-month Post-intervention

  2. 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.

    Measured: Baseline, Immediate Post-intervention, 5-month Post-intervention

Secondary outcomes (9)

  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.

    Measured: Baseline, Immediate Post-intervention, 5-month Post-intervention

  2. 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.

    Measured: Baseline, Immediate Post-intervention, 5-month Post-intervention

  3. 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.

    Measured: Baseline, Immediate Post-intervention, 5-month Post-intervention

  4. 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.

    Measured: Baseline, Immediate Post-intervention, 5-month Post-intervention

  5. 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.

    Measured: Baseline, Immediate Post-intervention, 5-month Post-intervention

  6. 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.

    Measured: Baseline, Immediate Post-intervention

  7. 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.

    Measured: Baseline, Immediate Post-intervention, 5-month Post-intervention

  8. 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.

    Measured: Baseline, Immediate Post-intervention, 5-month Post-intervention

  9. 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.

    Measured: Baseline, Immediate Post-intervention, 5-month Post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start13 Aug 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05766592
Sponsor's protocol ID
2000034163
Status last verified
Jan 2026
First submitted
1 Mar 2023
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data will be made available to qualified researchers upon request to the PIs following study conclusion.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 21443364

  • 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.

    PubMed 26988404

  • 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.

    PubMed 19016462

  • 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.

    PubMed 19417219

  • 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.

    PubMed 11556941

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LGBTQ-affirmative CBT and ABFT-SGM in people with Mental Health Issue and Parent-Child Relations, run by Yale University at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact John E Pachankis, PhD (646-429-9407, john.pachankis@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in depression symptoms (time frame: Baseline, Immediate Post-intervention, 5-month Post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05766592, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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