Active — Not RecruitingNot Applicable

Exposure Therapy Study In Adults With Eating Disorders

United States30 participantsStarted 2024-05-02

Plain-language 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).

Who can participate

Age range17 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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:

What they're measuring

Structured Clinical Interview for DSM-5-Research Version (SCID-5-RV)

Timeframe: Admission-Baseline (Week 0)

Demographic Form

Timeframe: Admission-Baseline (Week 0)

Food Phobia Survey

Timeframe: Admission-Baseline (Week 0)

Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)

Timeframe: Admission-Baseline (Week 0)

Fear of Food Measure (FOFM)

Timeframe: Admission-Baseline (Week 0)

Body Shape Questionnaire (BSQ)

Timeframe: Admission-Baseline (Week 0)

Clinical Impairment Assessment (CIA)

Timeframe: Admission-Baseline (Week 0)

Eating Disorder Fear Questionnaire (EDFQ)

Timeframe: Admission-Baseline (Week 0)

Trial details

NCT IDNCT06171711

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Eating Disorders trials

Plain-language summary

Who can participate

Age range17 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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:

What they're measuring

Structured Clinical Interview for DSM-5-Research Version (SCID-5-RV)

Timeframe: Admission-Baseline (Week 0)

Demographic Form

Timeframe: Admission-Baseline (Week 0)

Food Phobia Survey

Timeframe: Admission-Baseline (Week 0)

Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)

Timeframe: Admission-Baseline (Week 0)

Fear of Food Measure (FOFM)

Timeframe: Admission-Baseline (Week 0)

Body Shape Questionnaire (BSQ)

Timeframe: Admission-Baseline (Week 0)

Clinical Impairment Assessment (CIA)

Timeframe: Admission-Baseline (Week 0)

Eating Disorder Fear Questionnaire (EDFQ)

Timeframe: Admission-Baseline (Week 0)