Status:
RECRUITING
Exposure Therapy Study In Adults With Eating Disorders
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Eating Disorders
Anorexia Nervosa
Eligibility:
All Genders
17-65 years
Phase:
NA
Brief Summary
The current proposal will evaluate the feasibility, acceptability, and preliminary efficacy of Exposure Therapy for anorexia nervosa (AN) spectrum disorders (Exp-AN), an innovative treatment rooted in...
Detailed Description
The current proposal will evaluate the feasibility, acceptability, and preliminary efficacy of Exposure Therapy for anorexia nervosa (AN) Spectrum Disorders (Exp-AN), an innovative treatment rooted in...
Eligibility Criteria
Inclusion
- Participants will be English speakers, ages 17 - 65 years, of all genders, with AN-spectrum disorders, defined as a diagnosis of AN, atypical AN, or AN in partial remission.
- Participants with AN, atypical AN, and AN in partial remission share the same DSM-5 criteria, with the exception of criterion A: "Significantly low body weight."
- Individuals with atypical AN are weight suppressed, but not "objectively" underweight (e.g., someone who experiences rapid weight loss from a BMI of 27 to 21). Those with AN in partial remission are partially or fully weight restored (e.g., after stepping down from an inpatient setting), but continue to experience significant AN behaviors (e.g., food avoidance) and/or cognitions (e.g., fear of weight gain).
- Diagnoses will be determined using the Structured Clinical Interview for DSM-5 - Research Version (SCID-5-RV).93 All participants in this study will be monitored by a Penn State Health medical provider.
- All individuals who are deemed to be, or become, unsafe by their supervising medical provider will be admitted to our hospital or another facility for medical stabilization.
Exclusion
- Participants will be excluded if they are below 18 years of age.
- Those identified as non-English speakers will be excluded due to lack of funding to translate the measures to other languages.
- Individuals with other EDs (e.g., bulimia nervosa) will be excluded.
- Participants will be excluded if they are:
- a.at high risk for suicide i.Suicide risk will be determined using the Columbia Suicide Severity Rating Scale (CSSRS) screen. The CSSRS will be administered by the study coordinator when they initially meet with the participant for Session 0 (see section 7 of this protocol), and at the start of every weekly session with the study therapist. The study coordinator and study therapists will be trained by the PI to adhere to a Suicide Assessment Protocol. This protocol will state that all participants who report high suicide risk should be sent by an ambulance to our institution's emergency department.
- b.pregnant determined by verbal verification (the study coordinator will ask participants if they are pregnant when completing the eligibility checklist and/or during the informed consent process).
- c. Meet DSM-5 criteria for a psychotic disorder and/or have an intellectual disability.
Key Trial Info
Start Date :
May 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06171711
Start Date
May 2 2024
End Date
September 30 2026
Last Update
November 17 2025
Active Locations (1)
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1
905 W Govener Rd
Hershey, Pennsylvania, United States, 17033