Acceptance-Based Separated Family Treatment for Adolescent Anorexia Nervosa

NCT01274416 | Completed DMC

• 1 other identifier: Pro00016058
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Body Mass Index

  9 months (6 months active treatment, 3 months follow-up)

Secondary Outcomes (1)

• Eating Disorder Examination (16.0D)

  1 year (6 months of treatment and 3 months follow-up)

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

Parent Skills Training BEHAVIORAL

Skills Training for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rhonda Merwin, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2011
• First Posted: January 11, 2011
• Study Start: May 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2012
• Last Updated: August 14, 2013

Record last verified: 2013-08

Locations

US (1)