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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01274416
First received: January 9, 2011
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Anorexia Nervosa
Subthreshold Anorexia Nervosa
Eating Disorder Not Otherwise Specified, Primary Restriction
Behavioral: Acceptance and Commitment Therapy
Behavioral: Parent Skills Training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acceptance-Based Separated Family Treatment for Adolescent Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Body Mass Index [ Time Frame: 9 months (6 months active treatment, 3 months follow-up) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Eating Disorder Examination (16.0D) [ Time Frame: 1 year (6 months of treatment and 3 months follow-up) ] [ Designated as safety issue: No ]
    Measures eating disorder symptoms.


Enrollment: 75
Study Start Date: May 2009
Study Completion Date: May 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Acceptance and Commitment Therapy
    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.
    Behavioral: Parent Skills Training
    Skills Training for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation.
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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274416

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27713
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Rhonda Merwin, PhD Assistant Professor
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01274416     History of Changes
Other Study ID Numbers: Pro00016058
Study First Received: January 9, 2011
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Anorexia Nervosa
Eating Disorder
Treatment
Acceptance and Commitment Therapy
Separated Family Treatment

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Eating Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014