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

NCT ID: NCT06565637

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2026-07-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Eating Disorders Sexual Minorities

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Promoting Resilience to Improve Disordered Eating

Intervention Type BEHAVIORAL

See description under "Arms"

Interventions

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Promoting Resilience to Improve Disordered Eating

See description under "Arms"

Intervention Type BEHAVIORAL

Other Intervention Names

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PRIDE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Diego State University

OTHER

Sponsor Role collaborator

Auburn University

OTHER

Sponsor Role lead

Responsible Party

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Tiffany Brown

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tiffany Brown, PhD

Role: PRINCIPAL_INVESTIGATOR

Auburn University

Aaron Blashill, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

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Auburn University

Auburn, Alabama, United States

Site Status RECRUITING

San Diego State University

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tiffany Brown, PhD

Role: CONTACT

334-844-6687

Kennedi Burton, B.A.

Role: CONTACT

Facility Contacts

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Tiffany A Brown, PhD

Role: primary

334-844-6687

Kennedi Burton, BA

Role: backup

Aaron Blashill, PhD

Role: primary

619-594-2245

Nathaniel Holmes, B.A.

Role: backup

Other Identifiers

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1R61MH133710-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R61MH133710-01A

Identifier Type: -

Identifier Source: org_study_id

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