Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
ConditionAnorexia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorIcahn School of Medicine at Mount Sinai
About this trial
This project includes a parallel group randomized controlled trial comparing two psychological treatments: 1) Exposure-based Family Therapy (IE) vs. 2) Family Based Therapy (FBT) for low weight eating disorders with 12 month follow-up. Primary outcomes are expected body weight and clinical impairment. Three mechanisms of change (Autonomous Eating, Non-Judgmental Body Awareness, and Extinction Learning) will be examined in a process mediation models of change.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 12-18
Speak English
Permission from pediatrician or equivalent to receive outpatient care
Clinically significant restriction of food intake by EDA-5 or evidence of persistent food avoidance from patient or guardians
Disqualifiers
Comorbid psychotic or bipolar disorder
Active suicidal ideation
Current substance dependence
Psychiatric medication initiated or dosage changes <2 weeks from baseline
Trial design
Design model
Parallel
Treatments tested in this trial
Interoceptive Exposure Treatment (IE)
BehavioralInteroceptive Exposure Therapy (IE) targets food avoidance in Anorexia Nervosa. Each session the therapist weighs the patient, checks-in, and reviews weekly homework. Sessions occur weekly for 20 weeks, with the first session lasting 1.5 hours and the remaining sessions one hour. Early sessions include using exposure to foods and counterconditioning to pair a positive stimulus with a food that would typically produce food avoidance. Parents are trained to model this at home. Sessions mid-way through address the use of non-judgmental description of appearance during mirror exposure. Sessions at the end of the 20 weeks are focused on recognizing change, planning for future obstacles, and developing a relapse prevention plan to continue practicing distress tolerance, counter-conditioning, and food/body exposure.
Family-Based Treatment (FBT)
BehavioralFamily-Based Therapy (FBT) includes parent-enforced contingencies to increase value of eating and decrease the value of food avoidance. Each session the therapist weighs the patient, checks-in, and reviews weekly homework. Sessions occur weekly for 20 weeks, with the first session lasting 1.5 hours and the remaining sessions one hour. Sessions consist of checking in with the patient, discussion of the week's implementation of refeeding, and helping parents separate the illness from their child. In session 2, a family meal provides the therapist with an opportunity for direct observation of the familial interaction patterns around eating. The therapist makes careful and persistent requests for united parental action toward re-feeding and/or regulating eating habits, the primary concern at this point of the treatment, and the therapist tries to create and reinforce a strong parental alliance around efforts at feeding the child.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Interoceptive Exposure Treatment (IE)Experimental treatment 1 intervention
Group B: Family-Based Treatment (FBT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Expected Body Weight Percentage
Expected body weight percentage will be calculated at baseline and end of treatment (6-months) to calculate difference.
Time frame
Baseline and 6-months2
Change in Expected Body Weight Percentage
Expected body weight percentage will be calculated at baseline and 1 year after treatment (18-months) to calculate difference.
Time frame
Baseline and 18-months3
Change in Impairment
Impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and end of treatment (6-months) scores from CIA.
Time frame
Baseline and 6-months4
Change in Impairment
Impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and 1 year after treatment (18-months) scores from CIA.
Time frame
Baseline and 18-monthsSecondary outcomes
1
Change in Autonomous Eating
Autonomous eating will be measured in total calories consumed during a single-item meal. Change in total calories consumed will be calculated between baseline and end of treatment (6-months).
Time frame
Baseline and 6-months2
Change in Autonomous Eating
Autonomous eating will be measured in total calories consumed during a single-item meal. Change in total calories consumed will be calculated between baseline and 1 year after treatment (18-months).
Time frame
Baseline and 18-months3
Change in Food Cue Learning
Food cue learning is a task completed on a computer that tests associations between food and level of disgust. Pictures of food are shown including fresh and rotten versions of each and participants then rate on a scale from yucky to yummy for each. These ratings produce an extinction rate. There is no set range for scoring, however lower rates indicate more impairment and higher rates indicate less impairment. Extinction rate will be calculated between baseline and end of treatment (6-months).
Time frame
Baseline and 6-months4
Change in Food Cue Learning
Food cue learning is a task completed on a computer that tests associations between food and level of disgust. Pictures of food are shown including fresh and rotten versions of each and participants then rate on a scale from yucky to yummy for each. These ratings produce an extinction rate. There is no set range for scoring, however lower rates indicate more impairment and higher rates indicate less impairment. Extinction rate will be calculated between baseline and 1 year after treatment (18-months).
Time frame
Baseline and 18-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov