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

NCT ID: NCT00610753

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2012-07-31

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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Family Behavior Therapy

Intervention Type: BEHAVIORAL

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 focuses primarily on clarifying psychological processes within the family.

Group Type: ACTIVE_COMPARATOR

Systems Family Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Maudsley Family Therapy; Family Therapy

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

William Stewart Agras

Professor Emeritus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Stewart Agras

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

UCSD Center for Eating Disorder Treatment & Research

San Diego, California, United States

Stanford University School of Medicine

Stanford, California, United States

Sheppard-Pratt Health System

Baltimore, Maryland, United States

Washington University, Department of Psychiatry

St Louis, Missouri, United States

Department of Psychiatry, Cornell University

White Plains, New York, United States

Laureate Psychiatric Clinic & Hospital

Tulsa, Oklahoma, United States

Toronto General Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 21495052 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29314160 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25250660 (View on PubMed)

Other Identifiers

5 U01 MH076290; SPO#33857

Identifier Type: -

Identifier Source: secondary_id

5U01MH076290

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SU-12132007-933

Identifier Type: -

Identifier Source: org_study_id