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

Primary Purpose

Anorexia Nervosa, Subthreshold Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Primary Restriction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Parent Skills Training
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, Eating Disorder, Treatment, Acceptance and Commitment Therapy, Separated Family Treatment

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Outcomes

Primary Outcome Measures

Body Mass Index

Secondary Outcome Measures

Eating Disorder Examination (16.0D)
Measures eating disorder symptoms.

Full Information

First Posted
January 9, 2011
Last Updated
August 12, 2013
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT01274416
Brief Title
Acceptance-Based Separated Family Treatment for Adolescent Anorexia Nervosa
Acronym
ASFT
Official Title
Acceptance-Based Separated Family Treatment for Adolescent Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Subthreshold Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Primary Restriction
Keywords
Anorexia Nervosa, Eating Disorder, Treatment, Acceptance and Commitment Therapy, Separated Family Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
The stated goal of this intervention is to increase willingness to experience difficult thoughts, feelings, and bodily sensations in order to engage in flexible action.
Intervention Type
Behavioral
Intervention Name(s)
Parent Skills Training
Intervention Description
Skills Training for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation.
Primary Outcome Measure Information:
Title
Body Mass Index
Time Frame
9 months (6 months active treatment, 3 months follow-up)
Secondary Outcome Measure Information:
Title
Eating Disorder Examination (16.0D)
Description
Measures eating disorder symptoms.
Time Frame
1 year (6 months of treatment and 3 months follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhonda Merwin, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States

12. IPD Sharing Statement

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Acceptance-Based Separated Family Treatment for Adolescent Anorexia Nervosa

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