AzTrials
AzTrials

Anorexia NervosaNCT07188155

Adapting Exposure for Adolescent AN

A study testing Exposure Therapy for Anorexia (Exp-AN) in people with Anorexia Nervosa, run by Milton S. Hershey Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Anorexia Nervosa
What is being tested?
Exposure Therapy for Anorexia (Exp-AN)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
20 Feb 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Has a diagnosis of anorexia nervosa (AN)
  • English speaking
  • Mentally stable for an outpatient level of care
  • Living with at least one parent/caregiver
  • Experienced significant weight loss as determined by the local principal investigator at each enrolling local site

Who cannot join

  • Younger than 12 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Penn State College of Medicine

    Hershey, Pennsylvania, 17033

    Jamal H Essayli, PhD, 717-531-0003 ext. 320191, jessayli@pennstatehealth.psu.edu

    Jamal H Essayli, PhD

    Recruiting

Other trials in United States

About this study

Official title: Adapting Exposure Therapy to Target Anxiety About Weight Gain in Adolescents With Anorexia Nervosa

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.

Being tested
Exposure Therapy for Anorexia (Exp-AN)
Keywords
anorexia nervosa, exposure therapy, adolescents
Medical subject headings
Anorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exposure Therapy for Anorexia (Exp-AN)Behavioural

    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.

Study groups in NCT07188155
Study groupRoleWhat they receive
Exposure Therapy for AN (Exp-AN)ExperimentalExp-AN aims to target anxiety about weight gain by helping participants identify their specific feared consequences of weight gain (e.g., "I will permanently hate myself if I gain weight"), and combining in vivo (i.e., in real life) and imaginal (i.e., mental) exposure exercises to address these fears. Exp-AN consists of four core modules: (1) Treatment Rationale and Psychoeducation; (2) In-Session Weight Exposure; (3) Planning, Conducting, and Reviewing Exposures; and (4) Relapse Prevention.
Receives: Behavioral: Exposure Therapy for Anorexia (Exp-AN)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The Eating Disorder Examination Questionnaire (EDE-Q) is a 28-item self-report questionnaire. It was designed to assess the range, frequency, and severity of behaviors associated with a diagnosis of an eating disorder. A global score is obtained by summing the four subscales scores (ranging from 0-6) and dividing the total by the number of subscales (4). The score of items are calculated and range from 0 to 6. The higher score indicate greater ED symptoms.

    Measured: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up

  2. Fear of Food Measure (FOFM)

    The Fear of Food Measure (FORM) is a 23-item self-report questionnaire. It examines the participant's severity of behaviors associated with a diagnosis of an eating disorder. Each item is scored on a 1-7 scale. The questionnaire range from 23 to 161 meaning 23: no fear of food and 161 meaning severe fear of food.

    Measured: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up

  3. Body Shape Questionnaire (BSQ)

    The BSQ is a self-reported measurement of the body shape concerns typical of bulimia nervosa and anorexia nervosa. The questionnaire has 34 items scored from 0 to 6 points (least and most impaired, respectively), with the sum of the questions giving a range from 0 to 204. The higher score indicates greater concerns about body shape.

    Measured: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up

  4. Clinical Impairment Assessment (CIA)

    The Clinical Impairment Assessment Questionnaire (CIA) is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features and focuses on the past 28 days. The 16 items cover impairment in domains of life that are typically affected by eating disorder psychopathology: mood and self-perception, cognitive functioning, interpersonal functioning, and work performance. The responses are scored 0,1,2 and 3, with a higher rating indicating a higher level of impairment. The total range is between 0 and 48.

    Measured: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up

  5. Eating Disorder Fear Questionnaire (EDFQ)

    The Eating Disorder Fear Questionnaire (EDFQ) is a 20-item self-report questionnaire. It examines the participant's severity of behaviors associated with a diagnosis of an eating disorder. The response range between 1 to 7 with a total range of 20 to 140. The higher rating indicates a higher severe impairment.

    Measured: Baseline, Sessions 1-20, 3-Month-Follow-Up

  6. Weight Gain Anxiety Questionnaire

    The Weight Gain Anxiety Questionnaire is a 12-item self-report questionnaire that targets anxiety about weight gain. The scores are measured on a 0-100 scale, with the higher the score indicating more distress about weight gain, with the exception for question 2 which is reverse scored.

    Measured: Baseline, Sessions 1-20, 3-Month-Follow-Up

  7. Eating Anxiety Questionnaire

    The Eating Gain Anxiety Questionnaire is a 14-item self-report questionnaire that targets anxiety about eating fear foods. The scores are measured on a 0-100 scale, with the higher the score indicating more distress about eating fear foods, with the exception for question 2 which is reverse scored.

    Measured: Baseline, Sessions 1-20, 3-Month-Follow-Up

  8. Patient Health Questionnaire-9 (PHQ-9)

    The Patient Health Questionnaire-9 is a 9-item self-report questionnaire that targets depressive symptoms. The scores range from 0-27, with higher scores indicating a higher level of depression.

    Measured: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up

  9. Generalized Anxiety Disorder-7 (GAD-7)

    The Generalized Anxiety Disorder-7 is a 7-item self-report questionnaire that targets anxiety symptoms. The scores range from 0 to 21, with higher scores indicating higher levels of anxiety.

    Measured: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up

  10. Eating Disorder Examination - Self-Report Questionnaire Parent Version 1.5 (PEDE-Q)

    Eating Disorder Examination - Self-Report Questionnaire Parent Version 1.5 (PEDE-Q) is a 29-item self-report questionnaire. It is intended to be completed by the parent of a child with an eating disorder targeting the parent's perspective of their child's eating disorder. It was designed to assess the range, frequency, and severity of behaviors associated with a diagnosis of an eating disorder. A global score is obtained by summing the four subscales scores (ranging from 0-6) and dividing the total by the number of subscales (4). The score of items are calculated and range from 0 to 6. The higher scores indicate greater perceived child's ED symptoms.

    Measured: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up

  11. Parent vs Eating Disorder Scale (PVED)

    The Parent vs Eating Disorder Scale (PVED) is a 7-item self-report questionnaire that examines parents' opinions on parent involvement in the treatment of their child's eating disorder. Higher scores indicate higher agreement with the statements, and lower scores indicate lower agreement with the statements. Scores range from 1 (strongly disagree) - 5 (strongly agree).

    Measured: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up

  12. Percent of Expected Body Weight (EBW)

    We will measure the participants' weight using a wireless smart scale.

    Measured: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up

Secondary outcomes (5)
  1. Treatment Acceptability Questionnaire

    The Treatment Acceptability Questionnaire is a 10-item self-report questionnaire. It examines the participants' perspective on the modules in the exposure therapy. The response range between 1 to 7, with a total range of 10 to 70. The higher rating indicates a higher rating of treatment acceptability.

    Measured: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up

  2. Recruitment

    We will measure recruitment by calculating the percentage of eligible participants approached who consent to the study. The higher the percentage, the more successful we were with recruiting for the study.

    Measured: Through study completion, an average of 2 years

  3. Retention

    We will measure the percent of participants who complete the study by calculating the percentage of participants that complete the three-month follow-up. The higher the percentage, the more participants completed the study.

    Measured: Through study completion, an average of 2 years

  4. Engagement

    We will measure participant engagement by calculating the number of sessions participants attend out of 20 total sessions. The higher the number of sessions attended, the more participant engagement in the study.

    Measured: Through study completion, an average of 2 years

  5. Treatment Fidelity

    We will measure the therapists' adherence to the protocol by completing a treatment adherence measure that measures the study interventionists' adherence to the protocol. The higher the treatment adherence measure, the more the study interventionists adhered to the protocol.

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2025
  2. Study start20 Feb 2026
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07188155
Sponsor's protocol ID
27028
Status last verified
Oct 2026
First submitted
13 Sep 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Exposure Therapy for Anorexia (Exp-AN) in people with Anorexia Nervosa, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jamal Essayli, PhD ((717) 531-0003 ext. 320191, jessayli@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eating Disorder Examination - Self-Report Questionnaire (EDE-Q) (time frame: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Adapting Exposure for Adolescent AN (NCT07188155) | AzTrials