Acceptance-Based Separated Family Treatment for Adolescent Anorexia Nervosa

NCT ID: NCT01274416

Last Updated: 2013-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Anorexia Nervosa Eating Disorder Treatment Acceptance and Commitment Therapy Separated Family Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Parent Skills Training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rhonda Merwin, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00016058

Identifier Type: -

Identifier Source: org_study_id