Adapting Exposure for Adolescent AN
ConditionAnorexia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-17
SponsorMilton S. Hershey Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has a diagnosis of anorexia nervosa (AN)
English speaking
Mentally stable for an outpatient level of care
Living with at least one parent/caregiver
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Exposure Therapy for Anorexia (Exp-AN)
BehavioralExp-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.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Exposure Therapy for AN (Exp-AN)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up2
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.
Time frame
Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up3
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.
Time frame
Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up4
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.
Time frame
Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-UpSecondary outcomes
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.
Time frame
Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up2
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.
Time frame
Through study completion, an average of 2 years3
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.
Time frame
Through study completion, an average of 2 years4
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.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov