NCT06171711

Exposure Therapy Study In Adults With Eating Disorders

Exposure Therapy for Anorexia Nervosa Pilot Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 17 Years – 65 Years
• Healthy volunteers: Not accepted

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).

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 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.

Conditions

• Eating Disorders
• Anorexia Nervosa

Interventions

Type	Name	Description
BEHAVIORAL	Exposure Therapy	The proposed study will explore whether Exp-AN works via inhibitory learning (i.e., decreasing anxious beliefs and increasing anxiety tolerance) and/or between-session habituation (i.e., decreasing anxiety levels across therapy sessions), and the importance of targeting anxiety about eating versus weight gain. Results will provide information about the degree to which all three mechanisms of action (i.e., changes in anxiety ratings, anxious beliefs, and tolerance of anxiety) predict improved AN symptomatology across both treatments. Research that discovers whether specific treatments (e.g., Exp-AN) work in the way the investigators think they do (e.g., by increasing tolerance of anxiety), and whether modifying intervention targets (e.g., tolerance of anxiety) helps people get better (e.g., reduced AN symptomatology), will ultimately lead to more personalized, mechanism-based, and effective treatments (Insel 2014; Insel et al., 2010).

Timeline

• Start date: 2024-05-02
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2023-12-15
• Last updated: 2025-11-17

Locations

1 site across 1 country: United States