Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565637
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Targeting Minority Stressors to Improve Eating Disorder Symptoms in Sexual Minority Individuals With Eating Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Targeting Minority Stressors to Improve Eating Disorder Symptoms in Sexual Minority Individuals With Eating Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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 eg prejudice victimization discrimination and subsequent SM stress reactions eg 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 ie internalized stigma SM-stress coping self-efficacy during the R61 phase in a sample of n 30 participants and is feasibleacceptable the investigators will move to the R33 phase
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 ie internalized stigma SM-stress coping self-efficacy during the R61 phase in a sample of n 30 participants and is feasibleacceptable the investigators will move to the R33 phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None