Targeting Minority Stressors to Improve Eating Disorder Symptoms in Sexual Minority Individuals With Eating Disorders

October 1, 2025 updated by: Tiffany Brown, Auburn University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eating disorders are one of the deadliest psychiatric disorders and are associated with high economic burden (over $65 billion annually in the United States), and numerous physical health consequences. One of the most at-risk groups for developing eating disorders are sexual minority (SM; e.g., gay, lesbian, bisexual, pansexual, queer, non-heterosexual) individuals. Indeed, existing research finds that SM individuals have a 2-3 fold risk for developing an eating disorder compared to their non-SM peers and the these disparities have persisted during the past decade, with no signs of attenuating. This increased risk is due, in part, to chronic stressors (e.g., prejudice, victimization, discrimination) and subsequent SM stress reactions (e.g., internalized stigma) due to being part of a marginalized group. SM individuals experiencing perceived discrimination for their SM identity are 5-times more likely to develop an eating disorder. Data, including those from a large sample across the United States support that, in particular, internalized stigma is associated with increased eating disorder symptom severity in SM men and women. Prior research also supports in the face of SM stressors, SM individuals may be more likely to use maladaptive coping strategies, leading to low SM-stress coping self-efficacy, which has subsequently been shown to lead to disordered eating.

Despite this inequity, there are no known eating disorder treatments developed specifically for SM individuals to address the distinct processes that increase and maintain eating disorder risk. Further, existing treatments for eating disorders are only effective for ~50% of patients, calling for more targeted approaches. SM adults have been accessing eating disorder treatment at increasing rates over the last decade. However, pilot data from our group also suggests that SM individuals are also more likely to drop out of eating disorder treatment compared to their non-SM peers, suggesting that culturally sensitive treatments to address the unique needs of SM individuals with eating disorders are needed. To address this gap, and consistent with a mechanism-informed experimental therapeutics approach, the proposed study will test an innovative, virtually-delivered, treatment (Promoting Resilience to Improve Disordered Eating; PRIDE) integrating current evidence-based treatment for eating disorders with techniques and principles of SM-affirmative treatment to address SM stressors that are posited to maintain eating disorder symptoms. If PRIDE exerts a clinically meaningful effect on the posited targets (i.e., internalized stigma, SM-stress coping self-efficacy) during the R61 phase in a sample of n = 30 participants and is feasible/acceptable, the investigators will move to the R33 phase.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36849-9027
    • California
      • San Diego, California, United States, 92182
        • Recruiting
        • San Diego State University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Psychotherapy
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
See description under "Arms"
Other Names:
  • PRIDE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Internalized Homophobia Scale (IHP)
Time Frame: Change from Baseline through 3- and 6-month follow-up
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
Time Frame: Change from Baseline through 3- and 6-month follow-up
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)
Time Frame: Change from Baseline through 3- and 6-month follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Auburn University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
San Diego State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tiffany Brown, PhD, Auburn University
  • Principal Investigator: Aaron Blashill, PhD, San Diego State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R61MH133710-01A
  • 1R61MH133710-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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