Adaptive Family Treatment for Adolescent Anorexia Nervosa
This study is currently recruiting participants.
Verified October 2012 by Stanford University
Sponsor:
Stanford University
Collaborator:
University of Chicago
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01579682
First received: April 5, 2012
Last updated: October 24, 2012
Last verified: October 2012
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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 |
Resource links provided by NLM:
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.
| Estimated Enrollment: | 90 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2014 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579682
Contacts
| Contact: Kate Arnow, BA | 650-723-7885 | karnow@stanford.edu |
| Contact: Nandini Datta, BS | 650-723-9182 | nandinid@stanford.edu |
Locations
| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Kate Arnow, BA 650-723-7885 karnow@stanford.edu | |
| Contact: Nandini Datta, BA 650-723-9182 nandinid@stanford.edu | |
| Principal Investigator: James D Lock, MD, PhD | |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Maya Sztainer 773-702-0789 msztainer@yoda.bsd.uchicago.edu | |
| Contact: Catherine Byrnes (773) 702-0789 cbyrne@yoda.bsd.uchicago.edu | |
| Principal Investigator: Daniel LeGrange, PhD | |
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:
No publications provided
| Responsible Party: | 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: | October 24, 2012 |
| 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 Eating Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013