Comparison of Two Types of Family Therapy in the Treatment of Adolescent Anorexia Nervosa
|ClinicalTrials.gov Identifier: NCT00610753|
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : February 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Behavioral: Family Behavior Therapy Behavioral: Systems Family Therapy||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Family Therapy in the Treatment of Adolescent Anorexia Nervosa|
|Study Start Date :||July 2006|
|Primary Completion Date :||July 2012|
|Study Completion Date :||July 2012|
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
- Percent Ideal Body Weight (%IBW) [ Time Frame: 9-months and 21-months ]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.
- Eating Disorder Psychopathology [ Time Frame: 9 months and 21 months ]Eating Disorders Examination obtained in a standardized interview assessing: Binge eating, purging, weight and shape concerns. Assessed as the global measure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610753
|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|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2|
|Principal Investigator:||William Stewart Agras||Stanford University|