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Study of Treatment for Adolescents With Bulimia Nervosa

Primary Purpose

Bulimia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy for Adolescents

Supportive Psychotherapy

Family Based Therapy for Bulimia Nervosa

About this trial

This is an interventional treatment trial for Bulimia

Eligibility Criteria

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

Inclusion Criteria:

Participants will be adolescents living with at least one of their parents and between the ages of 12 and 18 years of age with a DSM IV diagnosis of BN or partial BN (binge eating and purging at least one time per week over a six month period).
Males meeting inclusion criteria will also be entered into the study. They must have age-adjusted BMI greater than 17.5, or ideal body weight (IBW) > 85%.
Family, for the purposes of this study, includes members of the subject's household, including at least one parent or adult guardian. Single parent families, divorced families, step-parents, and other types of families will be allowed to enter the study.

Exclusion Criteria:

psychotic illness or other mental illness requiring hospitalization; bipolar I disorder, depression with active suicidal thoughts and behavior;
associated physical illness that necessitates hospitalization;
current dependence on drugs or alcohol;
current diagnosis of anorexia nervosa or weight less that 85% IBW;
physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight;
currently taking medication for co-morbid conditions for less than 2-months;
currently taking medications that may induce weight loss, e.g., appetite suppressants such as sibutramine, phentermine, and xenical, unless the participant is willing to withdraw from such medications;
currently taking medications for symptoms of BN and unwilling to discontinue these prior to initiating treatment in the study
previous CBT or FBT treatment for BN
married subjects
emancipated minors
family members will be excluded from engaging in treatment for the following reasons:
- Current or history of sexual or physical abuse of the patient by family members. Perpetrators of the abuse will be excluded from treatment. Should sexual or physical abuse by a family member occur during the course of treatment, perpetrators will be excluded from ongoing treatment.
- Substance dependence, psychosis, or severe medical illness that would limit full participation in therapy, or that might put the family member at risk for worsening of their condition during treatment. The decision whether or not to allow these individuals to continue to participate in treatment will be made by the therapist in consultation with the treatment supervisor.

Sites / Locations

Stanford University School of Medicine
University of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychotherapy

Arm Description

Patients are randomized to one of three different types of psychotherapy: Cognitive-Behavioral Therapy for adolescents, Family-Based Therapy for Bulimia Nervosa, and Supportive Psychotherapy. All treatments consist of 18 sessions over a period of approximately 6 months.

Outcomes

Primary Outcome Measures

Binge and purge frequency as assessed by the Eating Disorder Examination (EDE)

Secondary Outcome Measures

Changes in the subscale scores of the EDE

Full Information

NCT ID

NCT00879151

First Posted

April 7, 2009

Last Updated

May 21, 2015

Sponsor

Stanford University

Collaborators

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT00879151

Brief Title

Study of Treatment for Adolescents With Bulimia Nervosa

Official Title

Treatment of Bulimic Adolescents

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

University of Chicago

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In the face of scant literature on the subject, the investigators aim to more clearly identify effective treatments for adolescent bulimia nervosa (BN) through a treatment study comparing two current treatments (Cognitive Behavioral Therapy for Adolescents, CBT-A and Family Based Therapy for Bulimia Nervosa, FBT-BN) for the disorder in comparison with a non-specific therapy, Supportive Psychotherapy for Adolescent Bulimia (SPT). Additionally, the investigators hope to provide clinicians with information on treatment efficacy, variables that might influence outcome, and processes that may affect treatment efficacy that will guide them in their efforts to treat adolescent BN.

Detailed Description

BN is a serious disorder that is characterized by extreme concerns about body weight and shape, dieting, and the disinhibited eating behaviors of binging and purging. There are no published randomized clinical trials of psychotherapy treatment for Bulimia Nervosa in adolescents although it often onsets in this age group. There is evidence that some treatments are effective, but none has been empirically tested. Because Bulimia Nervosa is a serious medical and psychiatric illness it is important to learn efficacious ways to treat this disorder, especially in its early stages. Treatments used in this study are the best known treatments for adults with Bulimia Nervosa. The investigators hope to learn which of two previously studied treatments might be superior to the other, in an effort to guide clinicians in treatment choices. Successfully treating the disorder early on (even in those adolescents with partial BN, characterized by binge eating and purging at least one time per week over a 6 month period) may reduce the number of cases requiring treatment during adulthood, leading to possible reduction in severity of associated psychopathology and lower costs, as well as enable individuals to lead more productive lives. Given the neglect of adolescent BN in the research literature and the need for information to guide the clinical treatment of this disorder, this study's primary aim is to compare the efficacy of CBT-A to FBT-BN in decreasing binge eating and purging episodes in adolescents with BN and partial BN (defined as binge eating and purging at least one time per week for the past six months). Participation in this study will last 1 and a half years and will consist of 6 months of treatment and a follow-up session at 6 and 12 months post-treatment. All participants will first undergo baseline assessments, which include interviews and questionnaires about psychological history and BN symptoms, and an Eating Disorder Examination (EDE) interview. All treatment assignments consist of 18 sessions of therapy over the course of 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bulimia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Psychotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy for Adolescents

Intervention Description

The therapist will work with the adolescent to understand triggers to binge eating and purging, such as thoughts, feelings, and interpersonal difficulties. Also, establishing regular eating patterns and eliminating medically harmful behaviors associated with the eating disorder is a primary goal.

Intervention Type

Behavioral

Intervention Name(s)

Supportive Psychotherapy

Intervention Description

SPT focuses on having the patient build a relationship with the therapist and explore their unique individual needs within the context of their life and the experience of having an eating disorder.

Intervention Type

Behavioral

Intervention Name(s)

Family Based Therapy for Bulimia Nervosa

Intervention Description

FBT helps parents to take an active role in guiding their child through eating disorder treatment. In this therapy, the parents are supported in helping their child stop bingeing, purging and engaging in other harmful weight-control behaviors. The way in which the eating disorder has impacted the family and the adolescent's development is also explored.

Primary Outcome Measure Information:

Title

Binge and purge frequency as assessed by the Eating Disorder Examination (EDE)

Time Frame

End of Treatment

Secondary Outcome Measure Information:

Title

Changes in the subscale scores of the EDE

Time Frame

End of Treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants will be adolescents living with at least one of their parents and between the ages of 12 and 18 years of age with a DSM IV diagnosis of BN or partial BN (binge eating and purging at least one time per week over a six month period). Males meeting inclusion criteria will also be entered into the study. They must have age-adjusted BMI greater than 17.5, or ideal body weight (IBW) > 85%. Family, for the purposes of this study, includes members of the subject's household, including at least one parent or adult guardian. Single parent families, divorced families, step-parents, and other types of families will be allowed to enter the study. Exclusion Criteria: psychotic illness or other mental illness requiring hospitalization; bipolar I disorder, depression with active suicidal thoughts and behavior; associated physical illness that necessitates hospitalization; current dependence on drugs or alcohol; current diagnosis of anorexia nervosa or weight less that 85% IBW; physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight; currently taking medication for co-morbid conditions for less than 2-months; currently taking medications that may induce weight loss, e.g., appetite suppressants such as sibutramine, phentermine, and xenical, unless the participant is willing to withdraw from such medications; currently taking medications for symptoms of BN and unwilling to discontinue these prior to initiating treatment in the study previous CBT or FBT treatment for BN married subjects emancipated minors family members will be excluded from engaging in treatment for the following reasons: Current or history of sexual or physical abuse of the patient by family members. Perpetrators of the abuse will be excluded from treatment. Should sexual or physical abuse by a family member occur during the course of treatment, perpetrators will be excluded from ongoing treatment. Substance dependence, psychosis, or severe medical illness that would limit full participation in therapy, or that might put the family member at risk for worsening of their condition during treatment. The decision whether or not to allow these individuals to continue to participate in treatment will be made by the therapist in consultation with the treatment supervisor.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James D Lock

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30734406

Citation

Gorrell S, Kinasz K, Hail L, Bruett L, Forsberg S, Lock J, Le Grange D. Rituals and preoccupations associated with bulimia nervosa in adolescents: Does motivation to change matter? Eur Eat Disord Rev. 2019 May;27(3):323-328. doi: 10.1002/erv.2664. Epub 2019 Feb 7.

Results Reference

derived

PubMed Identifier

29446174

Citation

Valenzuela F, Lock J, Le Grange D, Bohon C. Comorbid depressive symptoms and self-esteem improve after either cognitive-behavioural therapy or family-based treatment for adolescent bulimia nervosa. Eur Eat Disord Rev. 2018 May;26(3):253-258. doi: 10.1002/erv.2582. Epub 2018 Feb 15.

Results Reference

derived

PubMed Identifier

26506579

Citation

Le Grange D, Lock J, Agras WS, Bryson SW, Jo B. Randomized Clinical Trial of Family-Based Treatment and Cognitive-Behavioral Therapy for Adolescent Bulimia Nervosa. J Am Acad Child Adolesc Psychiatry. 2015 Nov;54(11):886-94.e2. doi: 10.1016/j.jaac.2015.08.008. Epub 2015 Sep 2.

Results Reference

derived

PubMed Identifier

25146149

Citation

Darcy AM, Fitzpatrick KK, Manasse SM, Datta N, Klabunde M, Colborn D, Aspen V, Stiles-Shields C, Labuschagne Z, Le Grange D, Lock J. Central coherence in adolescents with bulimia nervosa spectrum eating disorders. Int J Eat Disord. 2015 Jul;48(5):487-93. doi: 10.1002/eat.22340. Epub 2014 Aug 22.

Results Reference

derived

PubMed Identifier

23001391

Citation

Darcy AM, Fitzpatrick KK, Colborn D, Manasse S, Datta N, Aspen V, Shields CS, Le Grange D, Lock J. Set-shifting among adolescents with bulimic spectrum eating disorders. Psychosom Med. 2012 Oct;74(8):869-72. doi: 10.1097/PSY.0b013e31826af636. Epub 2012 Sep 21.

Results Reference

derived

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Study of Treatment for Adolescents With Bulimia Nervosa

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