Comparison of Two Types of Family Therapy in the Treatment of Adolescent Anorexia Nervosa - Tabular View

Tracking Information

First Received Date ^ICMJE

January 25, 2008

Last Updated Date

March 3, 2009

Start Date ^ICMJE

July 2006

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Body Mass Index

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00610753 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Eating Disorder Psychopathology

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Comparison of Two Types of Family Therapy in the Treatment of Adolescent Anorexia Nervosa

Official Title ^ICMJE

Family Therapy in the Treatment of Adolescent Anorexia Nervosa

Brief Summary

This study will compare the effectiveness of two different family treatments for the treatment of adolescent anorexia nervosa.

Detailed Description

The long-term objective of this study is to enhance the treatment and outcome of anorexia nervosa (AN). Research on the treatment of AN has lagged that of other conditions, even other eating disorders such as bulimia nervosa. The focus of this study is on adolescent AN. Successful early treatment is likely to reduce the prevalence of chronic AN with its high rates of morbidity and mortality and high health care costs. The most promising treatment for adolescent AN is a specific form of family therapy called behavioral family therapy (BFT). This treatment is focused on the disordered eating behavior that characterizes AN and enables parents to refeed their child. Although there have been several small scale studies of BFT there has been no controlled comparison with another form of family therapy. Therefore we propose to use systems family therapy (SFT) which has been developed to represent the type of family therapy practiced in the community.

One hundred and sixty adolescents of both genders aged 12-18 years meeting DSM-IV criteria for anorexia nervosa will be entered to the study. Recruitment is projected to extend for 2 years. Participants will be randomly allocated to one of the two types of family therapy. Family therapy will be given for 36-weeks. For the purpose of the present study, patients will be followed for 12-months after the end of family treatment. Hence, each family will participate for approximately 2-years, with a total participation time of some 40-hours. In a sub-study blood will be drawn from those volunteering for genetic analysis focusing on the subset of non-responders to treatments.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Anorexia Nervosa

Intervention ^ICMJE

Behavioral: Family therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

April 2011

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:Diagnosis of anorexia nervosa with Ideal Body Weight >75%

Exclusion Criteria:Current psychotic illness or mental retardation that would prohibit the use of psychotherapy Medically unstable for outpatient treatment

Gender

Both

Ages

12 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: James D Lock, MD

(650) 723-5473

jimlock@stanford.edu

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00610753

Responsible Party

James D Lock, MD, Stanford University School of Medicine

Study ID Numbers ^ICMJE

SU-12132007-933, 5 U01 MH076290; SPO#33857

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Katherine Halmi, MD
Craig Johnson, PhD
Harry Brandt, MD
Walter Kaye MD
Blake Woodside MD
Denise Wilfley, PhD
James D Lock, MD

Investigators ^ICMJE

Principal Investigator:	Blake Woodside	Toronto General Hospital
Principal Investigator:	Denise Wilfley	Washington University, Department of Psychiatry
Principal Investigator:	Harry ABrandt	Sheppard Pratt Health System
Sub-Investigator:	James DLock	Stanford University
Principal Investigator:	Katherine Halmi	Department of Psychiatry, Cornell University
Principal Investigator:	Walter HKaye	UCSD Center for Eating Disorder Treatment & Research

Information Provided By

Stanford University

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP