NCT06565637

Brief Summary

The goal of this clinical trial is to learn if a new intervention (Promoting Resilience to Improve Disordered Eating; PRIDE) can decrease internalized stigma and increase the ability to cope effectively with stressors in sexual minority populations diagnosed with eating disorders. The main question it aims to answer is: Will an eating disorders treatment focused on decreasing internalized stigma and increasing sexual minority stress coping self efficacy in sexual minority populations? Participants Will

  • Complete a telephone screen with study staff to determine preliminary eligibility for the study
  • Undergo a behavioral eligibility screening that includes structured clinical interviewing in order to determine proper diagnosis of an eating disorder along with ensuring absence of non-eating disorder diagnoses
  • Complete self-report measures to determine study eligibility
  • Attend up to 14 weekly therapy sessions as part of the PRIDE intervention, where participants will work with qualified clinicians to address eating pathology and disordered body image along with developing effective strategies for coping with sexual minority stressors
  • Complete surveys upon completion of the intervention 3 and 6 months post follow-up

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
2mo left

Started Feb 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2025Jul 2026

First Submitted

Initial submission to the registry

August 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

October 6, 2025

Status Verified

October 1, 2025

Enrollment Period

1.3 years

First QC Date

August 20, 2024

Last Update Submit

October 1, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Internalized Homophobia Scale (IHP)

    Assesses internalized stigma (9 items, 5-point scale, higher scores indicate greater internalized stigma).

    Change from Baseline through 3- and 6-month follow-up

  • Sexual Orientation Implicit Association Test

    Assesses internalized stigma via computerized behavioral task involving categorizing positive/negative words with sexual minority and heterosexual people.

    Change from Baseline through 3- and 6-month follow-up

  • Coping Self Efficacy Scale (CSES)

    Assesses sexual minority(SM)-stress coping self efficacy, as adapted for address SM stress in prior research (13 items, 11-point scale, higher scores indicate greater SM-stress coping self-efficacy).

    Change from Baseline through 3- and 6-month follow-up

Study Arms (1)

Psychotherapy

EXPERIMENTAL

Participants in this arm will experience the PRIDE intervention. PRIDE is a 14-session treatment that incorporates aspects of cognitive behavioral therapy for eating disorders (CBT-E) and SM-affirmative therapy. CBT-E aspects of treatment include in-session weighing, self-monitoring (food logs), regular eating, and techniques to address overvaluation of weight and shape. SM-affirmative therapy techniques include discussing the impact of minority stress on health, resilience, and strength within the SM community, specific manifestations of minority stress on eating and body image, current coping strategies, emotion regulation skills, and developing mindful, present-focused reactions to minority stress.

Behavioral: Promoting Resilience to Improve Disordered Eating

Interventions

See description under "Arms"

Also known as: PRIDE
Psychotherapy

Eligibility Criteria

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

You may qualify if:

  • age 18 to 65 years
  • identify as lesbian, gay, bisexual, other non-heterosexual identities
  • meet criteria for a Diagnostic and Statistical Manual - 5 (DSM-5) eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder, other specified feeding or eating disorder)
  • reports current (past 12 months) experience with discrimination due to sexual orientation;
  • speaks English
  • has internet access and a working webcam
  • reside (and plan to continue to reside for the study duration) in California or one of the Psychology Interjurisdictional Compact (PSYPACT) states
  • able to provide informed consent

You may not qualify if:

  • inability to speak/read English
  • active suicidal plans or intent
  • other major untreated psychiatric diagnoses (e.g., untreated bipolar disorder, untreated psychosis)
  • body mass index below 17.0, a standard clinical cutoff used to denote moderate-severe underweight that may be indicated for a higher level of medical care than standard outpatient treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Auburn University

Auburn, Alabama, 36849-9027, United States

RECRUITING

San Diego State University

San Diego, California, 92182, United States

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Tiffany Brown, PhD

    Auburn University

    PRINCIPAL INVESTIGATOR
  • Aaron Blashill, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Brown, PhD

CONTACT

Kennedi Burton, B.A.

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 22, 2024

Study Start

February 28, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

October 6, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Data will be available via NDA in compliance with the National Institute of Mental Health (NIMH) grant funding. Researchers will be able to use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable. As an alternative, instructions for contacting investigators (MPIs) will be placed on their lab websites so that researchers interested in using the data can contact them directly to obtain the de-identified data. The research team will require that any recipients of the data execute a data sharing agreement with Auburn University that will obligate recipients to 1) use data only for research; 2) not identify an individual participant; 3) commit to securing data using appropriate computer technology; and 4) commit to destroying or returning data after analyses are completed or three years have passed.

Locations