Study of Treatment for Adolescents With Bulimia Nervosa
Treatment of Bulimic Adolescents
2 other identifiers
interventional
130
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 7, 2009
CompletedFirst Posted
Study publicly available on registry
April 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMay 25, 2015
May 1, 2015
5.7 years
April 7, 2009
May 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Binge and purge frequency as assessed by the Eating Disorder Examination (EDE)
End of Treatment
Secondary Outcomes (1)
Changes in the subscale scores of the EDE
End of Treatment
Study Arms (1)
Psychotherapy
EXPERIMENTALPatients 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- University of Chicagocollaborator
Study Sites (2)
Stanford University School of Medicine
Stanford, California, 94305, United States
University of Chicago
Chicago, Illinois, 60637, United States
Related Publications (5)
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.
PMID: 30734406DERIVEDValenzuela 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.
PMID: 29446174DERIVEDLe 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.
PMID: 26506579DERIVEDDarcy 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.
PMID: 25146149DERIVEDDarcy 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.
PMID: 23001391DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James D Lock
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry and Behavioral Sciences
Study Record Dates
First Submitted
April 7, 2009
First Posted
April 9, 2009
Study Start
January 1, 2009
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
May 25, 2015
Record last verified: 2015-05