Adapting Exposure for Adolescent AN
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exposure Therapy for Anorexia (Exp-AN).
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa. Basic parameters: 14 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adapting Exposure Therapy to Target Anxiety About Weight Gain in Adolescents With Anorexia Nervosa
Overview
This pilot study is evaluating Exposure Therapy (Exp-AN) as a virtual treatment for adolescents (ages 14 - 17 years) with anorexia nervosa (AN) recruited from eating disorder clinic waitlists and clinician referrals at the Penn State Milton S. Hershey Medical Center and the University of California, San Francisco (UCSF) (8 participants per site). Adolescents who agree to take part in this study will receive 20 free virtual 40-60 minute weekly Exp-AN sessions at an outpatient level of care. Exp-AN for adolescents will combine individual virtual session time (35-50 min) with parent involvement (10-25 min). Parents will serve as "collaborators," supporting skill development, exposure completion, and treatment goal achievement. Exp-AN sessions will focus on helping participants overcome anxiety about weight gain by encouraging them to do challenging things that increase anxiety in the short term but help them better tolerate anxiety over the long term. Participants will be asked to complete a clinical interview, questionnaires, and labs and vitals testing before they begin the study. Adolescents will also complete questionnaires and participate in 15-min semi-structured interviews, while parents/caregivers will complete separate parallel interviews, at: mid-treatment, end-of-treatment, and 3-month follow-up. To ensure that all participants are receiving the same type of therapy, they will not be able to have any concurrent psychotherapy while receiving this treatment (other forms of care including dieticians, nutritionists, and psychiatrists are allowed). Exp-AN is designed to target anxiety about weight gain. Exp-AN includes education about the effects of undereating; the importance of overcoming anxiety about weight gain; in-session weight exposures (e.g., stepping on a scale while reading a script describing fears about weight gain); creating a meal plan to help improve eating; reviewing eating behaviors over the past week; conducting in-session and between-session exposures that help participants face fears related to weight gain; and relapse prevention.
Interventions
- Behavioral Exposure Therapy for Anorexia (Exp-AN)
Exp-AN is specifically designed to target anxiety about weight gain. Exp-AN helps participants identify their specific feared consequences of weight gain (e.g., "I will permanently hate myself if I gain weight"), and combines in vivo (i.e., in real life) and imaginal (i.e., mental) exposure exercises to address these fears.
Primary outcome measures
- Eating Disorder Examination - Self-Report Questionnaire (EDE-Q) [Time frame: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up]
- Fear of Food Measure (FOFM) [Time frame: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up]
- Body Shape Questionnaire (BSQ) [Time frame: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up]
- Clinical Impairment Assessment (CIA) [Time frame: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up]
- Eating Disorder Fear Questionnaire (EDFQ) [Time frame: Baseline, Sessions 1-20, 3-Month-Follow-Up]
- Weight Gain Anxiety Questionnaire [Time frame: Baseline, Sessions 1-20, 3-Month-Follow-Up]
- Eating Anxiety Questionnaire [Time frame: Baseline, Sessions 1-20, 3-Month-Follow-Up]
- Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up]
- Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up]
- Eating Disorder Examination - Self-Report Questionnaire Parent Version 1.5 (PEDE-Q) [Time frame: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up]
Secondary outcome measures (5)
- Treatment Acceptability Questionnaire [Time frame: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up]
- Recruitment [Time frame: Through study completion, an average of 2 years]
- Retention [Time frame: Through study completion, an average of 2 years]
- Engagement [Time frame: Through study completion, an average of 2 years]
- Treatment Fidelity [Time frame: Through study completion, an average of 2 years]
Eligibility criteria
Inclusion criteria
- Has a diagnosis of anorexia nervosa (AN)
- English speaking
- Mentally stable for an outpatient level of care
- Living with at least one parent/caregiver
- Less than or equal to 90% of expected body weight
Exclusion criteria
- Younger than 14 years old or older than 17 years old
- Has a current psychotherapist and not open to pausing treatment for the duration of the study
- Has a diagnosis of bulimia nervosa or binge-eating disorder
- Acutely suicidal
- Pregnant
- Meets DSM-5 criteria for a psychotic disorder and/or has an intellectual disability
- Non-English speaking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Penn State College of Medicine — Hershey
Identifiers
NCT: NCT07188155 · 27028