Exposure Therapy Study In Adults With Eating Disorders

Last updated: April 25, 2025
Sponsor: Milton S. Hershey Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anorexia

Vomiting

Mood Disorders

Treatment

Exposure Therapy

Clinical Study ID

NCT06171711
23573
  • Ages 18-65
  • All Genders

Study 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 principles of inhibitory learning. Exp-AN will target anxiety about both eating and weight gain by combining in vivo (i.e., in real life) and imaginal (i.e., mental) exposure in novel ways (e.g., eating a feared food while listening to a recording describing fears about weight gain).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants will be English speakers, ages 18 - 65 years, of all genders, withAN-spectrum disorders, defined as a diagnosis of AN, atypical AN, or AN in partialremission.

  2. Participants with AN, atypical AN, and AN in partial remission share the sameDSM-5 criteria, with the exception of criterion A: "Significantly low bodyweight."

  3. Individuals with atypical AN are weight suppressed, but not "objectively"underweight (e.g., someone who experiences rapid weight loss from a BMI of 27to 21). Those with AN in partial remission are partially or fully weightrestored (e.g., after stepping down from an inpatient setting), but continue toexperience significant AN behaviors (e.g., food avoidance) and/or cognitions (e.g., fear of weight gain).

  4. Diagnoses will be determined using the Structured Clinical Interview for DSM-5

  • Research Version (SCID-5-RV).93 All participants in this study will bemonitored by a Penn State Health medical provider.
  1. All individuals who are deemed to be, or become, unsafe by their supervising medicalprovider will be admitted to our hospital or another facility for medicalstabilization.

Exclusion

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 totranslate 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 ColumbiaSuicide Severity Rating Scale (CSSRS) screen. The CSSRS will be administered by thestudy coordinator when they initially meet with the participant for Session 0 (seesection 7 of this protocol), and at the start of every weekly session with the studytherapist. The study coordinator and study therapists will be trained by the PI toadhere to a Suicide Assessment Protocol. This protocol will state that allparticipants who report high suicide risk should be sent by an ambulance to ourinstitution's emergency department. b.pregnant determined by verbal verification (the study coordinator will askparticipants if they are pregnant when completing the eligibility checklist and/orduring the informed consent process). c. Meet DSM-5 criteria for a psychotic disorder and/or have an intellectualdisability.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Exposure Therapy
Phase:
Study Start date:
May 02, 2024
Estimated Completion Date:
June 30, 2026

Study 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 principles of inhibitory learning. Exp-AN will target anxiety about both eating and weight gain by combining in vivo (i.e., in real life) and imaginal (i.e., mental) exposure in novel ways (e.g., eating a feared food while listening to a recording describing fears about weight gain).

The central hypothesis is that Exp-AN will effectively target anxiety related to eating and weight gain via inhibitory learning, and improve treatment outcomes. The investigator will test two aims:

Aim 1. Evaluate the feasibility, acceptability, and preliminary efficacy of Exp-AN.

Hypothesis 1.1: Exp-AN will be feasible, with satisfactory levels of recruitment (≥50%) and retention (≥75%).

Hypothesis 1.2: Participants will engage in Exp-AN, as measured by completion of the five treatment modules (≥80%) and therapy homework (≥60%).

Hypothesis 1.3: Participants will rate all five Exp-AN modules as acceptable.

Hypothesis 1.4: Exp-AN will result in increases in BMI and decreases in AN symptomatology.

Aim 2. Investigate Exp-AN's mechanisms of action, and if mechanisms are associated with positive outcomes.

Hypothesis 2.1: Exp-AN will result in decreases in anxiety between sessions, decreases in anxious beliefs, and increases in anxiety tolerance.

Hypothesis 2.2: Changes in anxiety ratings, anxious beliefs, and tolerance of anxiety will be associated with weight gain and reduced AN symptomatology.

Connect with a study center

  • 905 W Govener Rd

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

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