NCT06614868

Brief Summary

Lesbian, gay, bisexual, transgender, and queer+ (LGBTQ+) individuals experience a breadth of mental health disparities. Reducing these disparities is an area of key psychological research. Minority stress is theorized to be an underlying source of the disparities (Meyer, 2003). Minority stress can be conceptualized as the internalized stigma that results from experiences of social marginalization. By reducing minority stress, it is hypothesized that generalized mental illness indicators might be reduced and indicators of wellbeing increased.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jan 2025Aug 2026

First Submitted

Initial submission to the registry

September 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

September 24, 2024

Last Update Submit

June 6, 2025

Conditions

Keywords

Minority StressAcceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (6)

  • Depression

    Patient Health Questionnaire-9

    12 weeks

  • Anxiety

    Generalized Anxiety Disorder-7

    12 Weeks

  • Post Traumatic Stress

    Patient Checklist-5

    12 Weeks

  • Internalized Heterosexism

    Internalized Homophobia Scale

    12 Weeks

  • Discrimination

    Daily Heterosexist Questionnaire

    12 Weeks

  • Alcohol Problems

    Alcohol Use Disorders Identification Test

    16 Weeks

Secondary Outcomes (3)

  • Experiential Avoidance

    16 Weeks

  • Affect

    16 Weeks

  • Problematic Pornography Use

    12 Weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

Participants receiving acceptance and commitment therapy

Behavioral: Acceptance and Commitment Therapy

Treatment as usual

ACTIVE COMPARATOR

Unstructured counseling intervention

Behavioral: Treatment as Usual (TAU)

Interventions

Up to 16 session of unstructured counseling therapy informed by Acceptance and Commitment Therapy tradition.

Treatment Group

Unstructured counseling

Treatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must identify as non-heterosexual

You may not qualify if:

  • Suicide attempt within the past 12 months.
  • Current eating disorder.
  • Narcotics use within the past 3 months
  • Non-suicidal self-injury within the past 6 months.
  • Current/History of psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Interventions

Acceptance and Commitment TherapyTherapeutics

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Nicholas Borgogna (Assistant Professor), PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 24, 2024

First Posted

September 26, 2024

Study Start

January 15, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

deidentified data will be shared upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
More information

Locations