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 Endpoint Classification: Efficacy Study 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 Stanford University:
Primary Outcome Measures:
- Full remission from AN (%MBW>95) [ Time Frame: End of Treatment (6 months) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) |
| Genders Eligible for Study: | Both |
| 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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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: 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 |
| Study First Received: | April 5, 2012 |
| Last Updated: | April 12, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 September 26, 2016