Acceptance-Based Separated Family Treatment for Adolescent Anorexia Nervosa (ASFT)

The investigators are trying to learn the most effective way to treat an adolescent's eating disorder and how best to involve the parents or caregivers in this process.

Typically, parents and their child are seen together in therapy. However, this can sometimes be difficult for both the parents and the adolescent. Both parents and adolescents have different concerns and are struggling with different aspects of the eating disorder. Therefore, the treatment in this study involves the parents in treatment, but does not have therapy sessions with the parents and child together.

The purpose of this study is to develop this investigational type of treatment (separated family treatment), and see what works best for adolescents and their families.

Participants meet with a therapist for 20 sessions over the course of 24 weeks. For the first 16 weeks families separate therapy sessions weekly. For the last 8 weeks families meet with the therapist bi-weekly. These bi-weekly sessions are conjoint - that is, adolescents and parents will meet with the therapist together. This is to help parents and adolescents come together as a family to continue to aid the adolescent in the treatment of his/her eating disorder.

The investigators hypothesize that adolescents who receive ASFT will demonstrate improvement in eating disorder symptoms and body-mass index, that caregivers who participate in ASFT will demonstrate decreased distress and caregiver burden, that increases in psychological acceptance will be seen for both adolescents and caregivers post-treatment, and that treatment will be viewed as both credible and acceptable to both caregiver and adolescent

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa; Subthreshold Anorexia Nervosa; Eating Disorder Not Otherwise Specified, Primary Restriction
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy; Behavioral: Parent Skills Training

Detailed Description

The purpose of this study is to develop and gather preliminary data on an acceptance-based behavioral treatment for adolescents with anorexia nervosa (AN) that is delivered in a separated family format. The treatment will combine a parent's skills curriculum that has demonstrated preliminary effectiveness in the treatment of AN, with a novel adolescent component based on Acceptance and Commitment Therapy (ACT). ACT has been found to be useful in the treatment of an array of psychological difficulties, and may be particularly well-suited for the cognitive and behavioral avoidance and rigidity that characterizes individuals with AN and their caregivers.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adolescent is between 12-18 years of age and living in home with caregivers
• Parent or primary caregiver willing to attend therapy sessions
• Adolescent meets diagnostic criteria of anorexia nervosa (either restricting or binge/purge subtype) or subthreshold AN (relaxation of weight criterion to 90% of ideal body weight as determined by weight history and CDC growth curves) or eating disorder not otherwise specified (with restricting as the primary symptom) according to the DSM-IV TR
• Adolescent is appropriate for outpatient care and receives medical clearance from a primary care physician

Exclusion Criteria:

• Caregiver or adolescent with a co-morbid diagnosis of psychotic disorder, bi-polar disorder, or substance dependence
• Caregiver or adolescent with diagnosis of mental retardation or a pervasive developmental disorder
• Adolescent with a diagnosis of eating disorder not otherwise specified with the primary symptoms of bingeing and purging, binging without compensatory behaviors or spitting food or with restricting patterns but a BMI greater than 90% ideal weight (as determined by weight history and CDC growth curves)
• Adolescent with extreme malnutrition or other medical complications/diagnoses that require a higher level of care
• Acute suicide risk

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body Mass Index	9 months (6 months active treatment, 3 months follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Disorder Examination (16.0D)	Measures eating disorder symptoms.	1 year (6 months of treatment and 3 months follow-up)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Rhonda Merwin, PhD, Assistant Professor

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: January 9, 2011
• First Submitted That Met QC Criteria: January 10, 2011
• First Posted (Estimate): January 11, 2011

Study Record Updates

• Last Update Posted (Estimate): August 14, 2013
• Last Update Submitted That Met QC Criteria: August 12, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Treatment; Acceptance and Commitment Therapy; Anorexia Nervosa; Eating Disorder; Separated Family Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Anorexia; Anorexia Nervosa; Feeding and Eating Disorders
• Other Study ID Numbers: Pro00016058