Clinical trial NCT00610753: Comparison of Two Types of Family Therapy in the Treatment of Adolescent Anorexia Nervosa
Official title: Family Therapy in the Treatment of Adolescent Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
Adolescents
Family therapy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-02-08
Enrollment: 164
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percent Ideal Body Weight (%IBW)
timeFrame: 9-months and 21-months
Secondary outcomes:
measure: Eating Disorder Psychopathology
timeFrame: 9 months and 21 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Center for Eating Disorder Treatment & Research
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Baltimore
country: United States
facility: Sheppard-Pratt Health System
state: Maryland
city: St Louis
country: United States
facility: Washington University, Department of Psychiatry
state: Missouri
city: White Plains
country: United States
facility: Department of Psychiatry, Cornell University
state: New York
city: Tulsa
country: United States
facility: Laureate Psychiatric Clinic & Hospital
state: Oklahoma
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Stanford University
name: William Stewart Agras
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sadeh-Sharvit S, Arnow KD, Osipov L, Lock JD, Jo B, Pajarito S, Brandt H, Dodge E, Halmi KA, Johnson C, Kaye W, Wilfley D, Agras WS. Are parental self-efficacy and family flexibility mediators of treatment for anorexia nervosa? Int J Eat Disord. 2018 Mar;51(3):275-280. doi: 10.1002/eat.22826. Epub 2018 Jan 4.
citation: Agras WS, Lock J, Brandt H, Bryson SW, Dodge E, Halmi KA, Jo B, Johnson C, Kaye W, Wilfley D, Woodside B. Comparison of 2 family therapies for adolescent anorexia nervosa: a randomized parallel trial. JAMA Psychiatry. 2014 Nov;71(11):1279-86. doi: 10.1001/jamapsychiatry.2014.1025.