Study of Treatment for Adolescents With Bulimia Nervosa

Bulimia Clinical Trial

Official title:

Treatment of Bulimic Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879151
• Other study ID #: SU-02272009-1878
• Secondary ID: eProtocol Number
• Status: Completed
• Phase: N/A
• First received: April 7, 2009
• Last updated: May 21, 2015
• Start date: January 2009
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

1. 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).

2. 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%.

3. 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:

1. psychotic illness or other mental illness requiring hospitalization; bipolar I disorder, depression with active suicidal thoughts and behavior;

2. associated physical illness that necessitates hospitalization;

3. current dependence on drugs or alcohol;

4. current diagnosis of anorexia nervosa or weight less that 85% IBW;

5. physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight;

6. currently taking medication for co-morbid conditions for less than 2-months;

7. 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;

8. currently taking medications for symptoms of BN and unwilling to discontinue these prior to initiating treatment in the study

9. previous CBT or FBT treatment for BN

10. married subjects

11. emancipated minors

12. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bulimia

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Adolescents
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.
• Supportive Psychotherapy
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.
• Family Based Therapy for Bulimia Nervosa
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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binge and purge frequency as assessed by the Eating Disorder Examination (EDE)		End of Treatment	No
Secondary	Changes in the subscale scores of the EDE		End of Treatment	No