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Adaptive Family Treatment for Adolescent Anorexia Nervosa
This study has been completed.
Sponsor:
Stanford University
Collaborator:
University of Chicago
Information provided by (Responsible Party):
James Dale Lock, Stanford University
ClinicalTrials.gov Identifier:
NCT01579682
First received: April 5, 2012
Last updated: April 12, 2016
Last verified: April 2016
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Purpose
Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up. Consequently, providing an alternative therapy early in the treatment course for those not responding to FBT may enhance overall outcome. This study aims to develop a new treatment - Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to FBT.
| Condition | Intervention |
|---|---|
| Anorexia Nervosa | Behavioral: Family-Based Therapy (FBT) Behavioral: Family-Based Therapy with Intensive Family-Focused treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Adaptive Family Treatment for Adolescent Anorexia Nervosa |
Further study details as provided by James Dale Lock, Stanford University:
Primary Outcome Measures:
- Full remission from AN (%MBW>95) [ Time Frame: End of Treatment (6 months) ]Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)
Secondary Outcome Measures:
- Changes in subscale scores of the EDE [ Time Frame: End of Treatment (6 months) ]Eating Disorder Examination subscale measures (weight concern, shape concern, dietary restraint) within 1 standard deviation of normative scores.
| Enrollment: | 90 |
| Study Start Date: | September 2011 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Psychotherapy
Family-Based Therapy (12 sessions)
|
Behavioral: Family-Based Therapy (FBT)
12 sessions of FBT over the course of 6 months.
|
|
Experimental: Family-Based Therapy with Intensive Family-Focused Treatment
The patient will receive 4 sessions of Family-Based therapy, and if the participant does not make adequate weight gain within this time period, will be assigned to Intensive Family-Focused Therapy (IFT).
|
Behavioral: Family-Based Therapy with Intensive Family-Focused treatment
FBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame.
|
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Meets DSM-IV criteria for anorexia nervosa
- Lives with at least one English-speaking parent who is willing to participate
- Medically Stable
- Adequate transportation to clinic
- Proficient at speaking, reading, and writing English
Exclusion Criteria:
- Previous FBT for AN
- Medical condition that may affect eating or weight
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01579682
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579682
Locations
| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
Sponsors and Collaborators
Stanford University
University of Chicago
Investigators
| Principal Investigator: | James D Lock, MD, PhD | Stanford University |
| Principal Investigator: | Daniel LeGrange, PhD | University of Chicago |
More Information
Additional Information:
| Responsible Party: | James Dale Lock, Principal Investigator, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01579682 History of Changes |
| Other Study ID Numbers: |
SPO 49694 SPO 49798 ( Other Grant/Funding Number: NIMH ) |
| Study First Received: | April 5, 2012 |
| Last Updated: | April 12, 2016 |
Keywords provided by James Dale Lock, Stanford University:
|
Eating Disorder Anorexia Nervosa Eating Disorder Not Otherwise Specified Maudsley |
Family-Based Therapy FBT Family Therapy |
Additional relevant MeSH terms:
|
Anorexia Anorexia Nervosa Signs and Symptoms, Digestive |
Signs and Symptoms Feeding and Eating Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 23, 2017