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

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: Recruiting
• Conditions: Eating Disorders; Sexual Minorities
• Intervention / Treatment: Behavioral: Promoting Resilience to Improve Disordered Eating

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: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Tiffany Brown, PhD; Phone Number: 334-844-6687; Email: tiffanybrown@auburn.edu
• Study Contact Backup: Name: Kennedi Burton, B.A.; Email: krb0136@auburn.edu

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849-9027
      • Recruiting
      • Auburn University
      • Contact: Tiffany A Brown, PhD; Phone Number: 334-844-6687; Email: tab0110@auburn.edu
      • Contact: Kennedi Burton, BA; Email: krb0136@auburn.edu
  • California
    • San Diego, California, United States, 92182
      • Recruiting
      • San Diego State University
      • Contact: Nathaniel Holmes, B.A.; Email: nholmes@sdsu.edu
      • Contact: Aaron Blashill, PhD; Phone Number: 619-594-2245; Email: ajblashill@sdsu.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Auburn University
• Collaborators: San Diego State University
• Investigators: Principal Investigator: Tiffany Brown, PhD, Auburn University; Principal Investigator: Aaron Blashill, PhD, San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Feeding and Eating Disorders
• Other Study ID 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