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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William Stewart Agras, Stanford University
ClinicalTrials.gov Identifier:
NCT00610753
First received: January 25, 2008
Last updated: February 7, 2013
Last verified: February 2013

January 25, 2008
February 7, 2013
July 2006
July 2012   (final data collection date for primary outcome measure)
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.
Body Mass Index
Complete list of historical versions of study NCT00610753 on ClinicalTrials.gov Archive Site
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.
Eating Disorder Psychopathology
Not Provided
Not Provided
 
Comparison of Two Types of Family Therapy in the Treatment of Adolescent Anorexia Nervosa
Family Therapy in the Treatment of Adolescent Anorexia Nervosa

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Anorexia Nervosa
  • 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
  • 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
  • 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.
    Intervention: Behavioral: Family Behavior Therapy
  • Active Comparator: Systems Family Therapy
    This therapy focuses primarily on clarifying psychological processes within the family.
    Intervention: Behavioral: Systems Family Therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
164
July 2012
July 2012   (final data collection date for primary outcome measure)

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

Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00610753
SU-12132007-933, 5 U01 MH076290; SPO#33857
Yes
William Stewart Agras, Stanford University
Stanford University
National Institute of Mental Health (NIMH)
Principal Investigator: William Stewart Agras Stanford University
Stanford University
February 2013

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