Family Treatment for Adolescents With Anorexia Nervosa
Primary Purpose
Anorexia Nervosa, Subthreshold Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Primarily Restriction
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acceptance-based separated family treatment
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, Adolescents, Family Treatment, Eating Disorder, Acceptance and Commitment Therapy
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
Sites / Locations
- Duke University Medical Center
- University of the Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active Treatment
Arm Description
Outcomes
Primary Outcome Measures
Body Mass Index (BMI
Secondary Outcome Measures
Eating Disorder Examination (16.0D)
Full Information
NCT ID
NCT01280799
First Posted
January 19, 2011
Last Updated
May 16, 2014
Sponsor
Towson University
Collaborators
University of the Sciences in Philadelphia, Duke University
1. Study Identification
Unique Protocol Identification Number
NCT01280799
Brief Title
Family Treatment for Adolescents With Anorexia Nervosa
Official Title
Acceptance Based Separated Family Treatment for Adolescents With Anorexia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Towson University
Collaborators
University of the Sciences in Philadelphia, Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This treatment development study seeks to investigate 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 the majority of therapy sessions are conducted with the parent(s) and adolescent separately.
Participants meet with a therapist for 20 sessions over the course of 24 weeks. For the first 16 weeks parents and the adolescent meet individually with the therapist. For the last 8 weeks families meet with the therapist every other week. These last four 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 this treatment will demonstrate improvement in eating disorder symptoms and body-mass index and that caregivers who participate will demonstrate decreased distress and caregiver burden. Furthermore, the investigators hypothesize 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, Primarily Restriction
Keywords
Anorexia Nervosa, Adolescents, Family Treatment, Eating Disorder, Acceptance and Commitment Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Acceptance-based separated family treatment
Intervention Description
Family treatment that combines Acceptance and Commitment Therapy (ACT) for the adolescent with Parent Skills Training for caregivers. The treatment package is designed to increase willingness to experience difficult thoughts, feelings, and bodily sensations in order to engage in effective behavior. To facilitate this, caregivers are provided with psychoeducation on eating disorders and skills in behavior management, self-regulation, and emotion regulation.
Primary Outcome Measure Information:
Title
Body Mass Index (BMI
Time Frame
9 months (6 months active treatment, 3 months follow-up)
Secondary Outcome Measure Information:
Title
Eating Disorder Examination (16.0D)
Time Frame
9 months (6 months of treatment and 3 month 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
Alix Timko, PhD
Organizational Affiliation
Towson University/University of the Sciences
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
Facility Name
University of the Sciences
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25898341
Citation
Timko CA, Zucker NL, Herbert JD, Rodriguez D, Merwin RM. An open trial of Acceptance-based Separated Family Treatment (ASFT) for adolescents with anorexia nervosa. Behav Res Ther. 2015 Jun;69:63-74. doi: 10.1016/j.brat.2015.03.011. Epub 2015 Mar 28.
Results Reference
derived
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Family Treatment for Adolescents With Anorexia Nervosa
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