Adaptive Family Treatment for Adolescent 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: NCT01579682|
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : April 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Behavioral: Family-Based Therapy (FBT) Behavioral: Family-Based Therapy with Intensive Family-Focused treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adaptive Family Treatment for Adolescent Anorexia Nervosa|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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.
- 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)
- 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.
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): NCT01579682
|United States, California|
|Stanford, California, United States, 94305|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||James D Lock, MD, PhD||Stanford University|
|Principal Investigator:||Daniel LeGrange, PhD||University of Chicago|