Exposure Therapy Study In Adults With Eating Disorders

Launched by MILTON S. HERSHEY MEDICAL CENTER · Dec 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Exposure Therapy for adults with anorexia nervosa and related eating disorders. The goal is to see if this therapy, which helps people face their fears about eating and gaining weight, is safe and effective. The therapy combines real-life experiences, like eating foods that make participants anxious, with mental exercises, such as listening to recordings discussing their fears. The trial is currently looking for participants aged 18 to 65 who have been diagnosed with anorexia nervosa or similar conditions.

To be eligible, participants must be English speakers and able to commit to the study's requirements. They will receive support from medical professionals throughout the trial to ensure their safety. Participants can expect to engage in both therapy sessions and monitoring from healthcare providers, who will check in on their well-being regularly. It's important to note that individuals with other eating disorders, high suicide risk, pregnancy, or certain mental health conditions won't be included in the study. This trial aims to provide new ways to help those struggling with anorexia nervosa feel better and gain control over their fears.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants will be English speakers, ages 18 - 65 years, of all genders, with AN-spectrum disorders, defined as a diagnosis of AN, atypical AN, or AN in partial remission.
• • 1. 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."
• • 2. 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).
• • 3. 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.
• • 2. 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 Criteria:
• • 1. Participants will be excluded if they are below 18 years of age.
• • 2. Those identified as non-English speakers will be excluded due to lack of funding to translate the measures to other languages.
• • 3. Individuals with other EDs (e.g., bulimia nervosa) will be excluded.
• 4. 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.