View Clinical Trial (Medical Research Study)
Treatment of Bulimic Adolescents
| City: |
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Stanford |
| State: |
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California |
| Zip Code: |
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94305 |
| Conditions: |
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Bulimia |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00879151 |
| Primary Contact: |
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Principal Investigator
James D Lock
Stanford University
James Lock, MD, PhD
Phone: (650) 723-5473
Email: jimlock@stanford.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Stanford, California 94305
United States
James Lock, MD, PhD
Phone: 650-723-5473
Email: jimlock@stanford.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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