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.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: Family Behavior Therapy; Behavioral: Systems 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.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Family Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: William Stewart Agras, Stanford University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 25, 2008
• First Submitted That Met QC Criteria: January 25, 2008
• First Posted (Estimate): February 8, 2008

Study Record Updates

• Last Update Posted (Estimate): February 11, 2013
• Last Update Submitted That Met QC Criteria: February 7, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Adolescents; Anorexia nervosa; Family therapy
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: SU-12132007-933; 5 U01 MH076290; SPO#33857