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

Purpose

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

Condition	Intervention	Phase
Anorexia Nervosa	Behavioral: Family Behavior Therapy Behavioral: Systems Family Therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Family Therapy in the Treatment of Adolescent Anorexia Nervosa

Resource links provided by NLM:

MedlinePlus related topics: Eating Disorders

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Percent Ideal Body Weight (%IBW) [ Time Frame: 9-months and 21-months ] [ Designated as safety issue: Yes ]
Patients weighed in gowns on calibrated balance beam machines and height assessed with a stadiometer. Percent Ideal Body Weight calculated on a study designed calculator.

Secondary Outcome Measures:

Eating Disorder Psychopathology [ Time Frame: 9 months and 21 months ] [ Designated as safety issue: No ]
Eating Disorders Examination obtained in a standardized interview assessing: Binge eating, purging, weight and shape concerns. Assessed as the global measure.

Enrollment:	164
Study Start Date:	July 2006
Study Completion Date:	July 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Family Behavioral Therapy This intervention focuses on counseling the parents (and other family members) on refeeding their child. When weight is being steadily regained the focus of therapy shifts to allow the child more independence.	Behavioral: Family Behavior Therapy This treatment is usually delivered in two phases: In the first phase there is an initial investigation of family behavior around feeding using a family meal followed by family therapy focused on enhancing feeding of the anorexic child in order to promote weight gain. In the second phase, once weight gain is well established the adolescent is given greater autonomy over feeding and in later sessions over other issues. Other Name: Maudsley Family Therapy
Active Comparator: Systems Family Therapy This therapy focuses primarily on clarifying psychological processes within the family.	Behavioral: Systems Family Therapy This therapy is applied in three phases. 1. In the first 2 or 3-sessions the treatment is explained to the family and an initial examination of family issues begins. 2. In the second phase family interactions and psychological processes are explored with clarification for family members. 3. In the third phase knowledge of family patterns is refined aiming for behavior change. Other Name: Family Therapy

Arms

Assigned Interventions

Experimental: Family Behavioral Therapy

This intervention focuses on counseling the parents (and other family members) on refeeding their child. When weight is being steadily regained the focus of therapy shifts to allow the child more independence.

Behavioral: Family Behavior Therapy

This treatment is usually delivered in two phases: In the first phase there is an initial investigation of family behavior around feeding using a family meal followed by family therapy focused on enhancing feeding of the anorexic child in order to promote weight gain. In the second phase, once weight gain is well established the adolescent is given greater autonomy over feeding and in later sessions over other issues.

Other Name: Maudsley Family Therapy

Active Comparator: Systems Family Therapy

This therapy focuses primarily on clarifying psychological processes within the family.

Behavioral: Systems Family Therapy

This therapy is applied in three phases. 1. In the first 2 or 3-sessions the treatment is explained to the family and an initial examination of family issues begins. 2. In the second phase family interactions and psychological processes are explored with clarification for family members. 3. In the third phase knowledge of family patterns is refined aiming for behavior change.

Other Name: Family Therapy

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.

Eligibility

Ages Eligible for Study:	12 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610753

Locations

United States, California
UCSD Center for Eating Disorder Treatment & Research
San Diego, California, United States, 92037
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Maryland
Sheppard-Pratt Health System
Baltimore, Maryland, United States, 21204
United States, Missouri
Washington University, Department of Psychiatry
St Louis, Missouri, United States, 63110
United States, New York
Department of Psychiatry, Cornell University
White Plains, New York, United States, 10605
United States, Oklahoma
Laureate Psychiatric Clinic & Hospital
Tulsa, Oklahoma, United States, 74136
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2

Sponsors and Collaborators

Stanford University

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

William Stewart Agras

Stanford University

More Information

Additional Information:

Study description and password protected study documents This link exits the ClinicalTrials.gov site

Publications:

Lock J, Brandt H, Woodside B, Agras S, Halmi WK, Johnson C, Kaye W, Wilfley D. Challenges in conducting a multi-site randomized clinical trial comparing treatments for adolescent anorexia nervosa. Int J Eat Disord. 2012 Mar;45(2):202-13. doi: 10.1002/eat.20923. Epub 2011 Apr 14.

Responsible Party:	William Stewart Agras, Professor Emeritus, Stanford University
ClinicalTrials.gov Identifier:	NCT00610753 History of Changes
Other Study ID Numbers:	SU-12132007-933, 5 U01 MH076290; SPO#33857
Study First Received:	January 25, 2008
Last Updated:	February 7, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Stanford University:

Anorexia nervosa
Adolescents
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 23, 2013