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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Family Behavior Therapy
Systems Family Therapy
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia nervosa, Adolescents, Family therapy

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers
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

Sites / Locations

  • UCSD Center for Eating Disorder Treatment & Research
  • Stanford University School of Medicine
  • Sheppard-Pratt Health System
  • Washington University, Department of Psychiatry
  • Department of Psychiatry, Cornell University
  • Laureate Psychiatric Clinic & Hospital
  • Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family Behavioral Therapy

Systems Family Therapy

Arm Description

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.

This therapy focuses primarily on clarifying psychological processes within the family.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Eating Disorder Psychopathology
Eating Disorders Examination obtained in a standardized interview assessing: Binge eating, purging, weight and shape concerns. Assessed as the global measure.

Full Information

First Posted
January 25, 2008
Last Updated
February 7, 2013
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00610753
Brief Title
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

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Anorexia nervosa, Adolescents, Family therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Behavioral Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Systems Family Therapy
Arm Type
Active Comparator
Arm Description
This therapy focuses primarily on clarifying psychological processes within the family.
Intervention Type
Behavioral
Intervention Name(s)
Family Behavior Therapy
Other Intervention Name(s)
Maudsley Family Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Systems Family Therapy
Other Intervention Name(s)
Family Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Ideal Body Weight (%IBW)
Description
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.
Time Frame
9-months and 21-months
Secondary Outcome Measure Information:
Title
Eating Disorder Psychopathology
Description
Eating Disorders Examination obtained in a standardized interview assessing: Binge eating, purging, weight and shape concerns. Assessed as the global measure.
Time Frame
9 months and 21 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Stewart Agras
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Center for Eating Disorder Treatment & Research
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Sheppard-Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Washington University, Department of Psychiatry
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Department of Psychiatry, Cornell University
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
Laureate Psychiatric Clinic & Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21495052
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.
Results Reference
background
PubMed Identifier
29314160
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.
Results Reference
derived
PubMed Identifier
25250660
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.
Results Reference
derived

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

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