Family Treatment for Adolescents With Anorexia Nervosa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01280799|
Recruitment Status : Completed
First Posted : January 21, 2011
Last Update Posted : May 19, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa Subthreshold Anorexia Nervosa Eating Disorder Not Otherwise Specified, Primarily Restriction||Behavioral: Acceptance-based separated family treatment||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acceptance Based Separated Family Treatment for Adolescents With Anorexia Nervosa|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||May 2012|
|Experimental: Active Treatment||
Behavioral: Acceptance-based separated family treatment
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.
- Body Mass Index (BMI [ Time Frame: 9 months (6 months active treatment, 3 months follow-up) ]
- Eating Disorder Examination (16.0D) [ Time Frame: 9 months (6 months of treatment and 3 month follow-up) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280799
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27713|
|United States, Pennsylvania|
|University of the Sciences|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Alix Timko, PhD||Towson University/University of the Sciences|