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

Anorexia Nervosa Clinical Trial

Official title:

Family Therapy in the Treatment of Adolescent Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610753
• Other study ID #: SU-12132007-933
• Secondary ID: 5 U01 MH076290
• Status: Completed
• Phase: Phase 3
• First received: January 25, 2008
• Last updated: February 7, 2013
• Start date: July 2006
• Est. completion date: July 2012

Study information

• Verified date: February 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
United States	Sheppard-Pratt Health System	Baltimore	Maryland
United States	UCSD Center for Eating Disorder Treatment & Research	San Diego	California
United States	Washington University, Department of Psychiatry	St Louis	Missouri
United States	Stanford University School of Medicine	Stanford	California
United States	Laureate Psychiatric Clinic & Hospital	Tulsa	Oklahoma
United States	Department of Psychiatry, Cornell University	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Ideal Body Weight (%IBW)	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.	9-months and 21-months	Yes
Secondary	Eating Disorder Psychopathology	Eating Disorders Examination obtained in a standardized interview assessing: Binge eating, purging, weight and shape concerns. Assessed as the global measure.	9 months and 21 months	No