Exposure therapy for adults with anorexia nervosa

Exposure Therapy for Anorexia Nervosa Pilot Trial

This study is testing a new type of therapy for adults with anorexia nervosa to see if facing their fears about eating and weight gain can help them feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Milton S. Hershey Medical Center (Academic / other)
• Locations: 1 site (Hershey, Pennsylvania)
• Trial ID: NCT06171711 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility, acceptability, and preliminary efficacy of an innovative Exposure Therapy designed for adults with anorexia nervosa and related disorders. The therapy combines in vivo and imaginal exposure techniques to address anxiety surrounding eating and weight gain. Participants will engage in five treatment modules, which include real-life exposure to feared foods while processing associated fears. The study aims to assess both the effectiveness of the therapy and the mechanisms that contribute to positive treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are English-speaking adults aged 18 to 65 with a diagnosis of anorexia nervosa, atypical anorexia, or anorexia in partial remission.

Not a fit: Patients who do not meet the diagnostic criteria for anorexia spectrum disorders or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve treatment outcomes for individuals suffering from anorexia nervosa by reducing anxiety and increasing healthy weight gain.

How similar studies have performed: While exposure therapy has been explored in various contexts, this specific approach for anorexia nervosa is innovative and has not been widely tested in previous studies.

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.

Where this trial is running

Hershey, Pennsylvania

• 905 W Govener Rd — Hershey, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Jamal Essayli — Penn State University
• Study coordinator: Jamal Essayli, Ph.D

Conditions Eating Disorders; Anorexia Nervosa