Eating DisordersPhase 1NCT06565637
Targeting Minority Stressors to Improve Eating Disorder Symptoms in Sexual Minority Individuals With Eating Disorders
A Phase 1 study testing Promoting Resilience to Improve Disordered Eating in people with Eating Disorders and Sexual Minorities, run by Auburn University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders, Sexual Minorities
- What is being tested?
- Promoting Resilience to Improve Disordered Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Feb 2025to 30 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Auburn University
Auburn, Alabama, 36849-9027
San Diego State University
San Diego, California, 92182
About this study
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
Read the 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.
- Conditions
- Eating Disorders, Sexual Minorities
- Being tested
- Promoting Resilience to Improve Disordered Eating
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Resilience to Improve Disordered EatingBehavioural
Also called PRIDE
See description under "Arms"
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Promoting Resilience to Improve Disordered Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internalized Homophobia Scale (IHP)
Assesses internalized stigma (9 items, 5-point scale, higher scores indicate greater internalized stigma).
Measured: 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.
Measured: 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).
Measured: Change from Baseline through 3- and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start28 Feb 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University
- Responsible party
- Principal investigator, Tiffany Brown, Auburn University
- Investigators
- Tiffany Brown, PhD, Principal investigator, Auburn UniversityAaron Blashill, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565637
- Sponsor's protocol ID
- 1R61MH133710-01A
- Other IDs
- 1R61MH133710-01
- Status last verified
- Jul 2026
- First submitted
- 20 Aug 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Minority Stressors to Improve Eating Disorder Symptoms in Sexual Minority Individuals With Eating Disorders
- ClinicalTrials.gov ID
- NCT06565637
- Acronym / sponsor ID
- 1R61MH133710-01A
- Conditions
- Eating Disorders, Sexual Minorities
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- San Diego State University
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Experimental | Behavioral: Promoting Resilience to Improve Disordered EatingParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promoting Resilience to Improve Disordered EatingAlso: PRIDESee description under "Arms" | Behavioural | Psychotherapy |
Primary outcome
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).
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Brown, PhD principal investigator
Auburn University
Aaron Blashill, PhD principal investigator
San Diego State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Promoting Resilience to Improve Disordered Eating in people with Eating Disorders and Sexual Minorities, run by Auburn University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internalized Homophobia Scale (IHP) (time frame: Change from Baseline through 3- and 6-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.