Testing an Alternative Therapy for Bulimia Nervosa

Study Overview
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Brief Summary
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This study will compare a new method of treatment for bulimia nervosa (ICAT), integrative cognitive-affective therapy, to the current standard method of treatment, cognitive behavioral therapy (CBT).

Detailed Description
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Bulimia nervosa (BN) is a disorder characterized by binge eating and compensatory behaviors, such as self-induced vomiting or laxative abuse. It affects 1% to 2% of adolescents and young women, and occurs more rarely in men. People who suffer from BN are also more likely to suffer from other psychiatric disorders, such as anxiety disorders, mood disorders, substance abuse disorders, and personality disorders-those categorized as Axis II in the DSM IV. Integrative cognitive-affective therapy (ICAT) is a new treatment developed as an alternative to cognitive behavioral therapy (CBT) for treating people with BN. CBT is the standard treatment for BN. ICAT uses some elements from CBT and some elements from therapies used to treat other disorders. Some elements of ICAT are also used to treat substance abuse disorders, depression, and personality disorders. This study will compare the effectiveness of ICAT and CBT in treating BN. Participants in this study, who must have BN symptoms, will be randomly assigned to receive either CBT or ICAT treatment. Participation in this study will last 18 weeks for participants assigned to receive CBT and 16 weeks for participants assigned to receive ICAT. Both treatments will consist of 20 individual therapy sessions lasting 50 minutes. Additionally, participants receiving ICAT will receive personal digital assistant (PDA) devices installed with therapeutic modules. Use of these modules will be unlimited during the period of ICAT treatment and will be recorded at study visits. Over the course of 2 screening visits, participants will complete questionnaires, undergo clinical interviews, and go through a medical screening that involves a blood test of electrolytes and a urine test for pregnancy. Each screening visit will take 2 to 3 hours. At the end of treatment and 4 months after treatment completion, participants will undergo 2 assessments, both of which will include 2 hours of interviews and questionnaires. During these assessments researchers will evaluate weight; eating behavior; and associated problems with mood, anxiety, obsessive-compulsive symptoms, self-concept, social adjustment, and other areas of psychosocial functioning.

Official Title
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Integrative Cognitive Affective Therapy for Bulimia Nervosa (ICAT)

Conditions
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Eating Disorders

Intervention / Treatment
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* Behavioral: ICAT
* Behavioral: CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bulimia nervosa, as defined by DSM-IV, or bulimic symptoms, as defined as purging episodes (with objective or subjective binge eating) that occur at least once per week for the past 3 months Exclusion Criteria: Past or current diagnosis of psychosis or bipolar disorder Inability to read English Medical instability, including electrolyte abnormalities Psychotherapy or pharmacotherapy initiated within 6 weeks of study entry Pregnant or lactating Drug or alcohol dependence in the past 6 months or drug or alcohol abuse in the past 6 weeks Severe cognitive impairment or mental retardation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Integrative cognitive affective therapy (ICAT) | Behavioral: ICAT<br>* ICAT is a new manual-based psychotherapy treatment for bulimia nervosa (BN) that focuses on emotions and bulimic behavior.<br>|
| Active Comparator: 2<br>Cognitive behavioral therapy (CBT) | Behavioral: CBT<br>* CBT is a highly structured, manual-based psychotherapy that has been shown to be effective in the treatment of BN. CBT focuses on cognitions and bulimic behavior.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in binging or purging frequency as defined by symptom recall (SR) |  | Measured at baseline, weekly intervals throughout the duration of therapy, end of treatment, and 32-week follow-up | 
| Percent reduction in binging or purging frequency, as defined by the Eating Disorders Examination (EDE) |  | Measured at baseline, end of treatment, and 32-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in depression, as defined by the Beck Depression Inventory (BDI) |  | Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up | 
| Reduction in anxiety as defined by the State-Trait Anxiety Inventory (STAI) |  | Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up | 
| Abstinence from binging and purging behavior, as defined by SR and EDE |  | Measured at the end of treatment and 32-week follow-up | 
| Study retention rates |  | Measured weekly throughout treatment | 
| Patient and therapist satisfaction, as defined by the Treatment Acceptability, Feasibility and Satisfaction Scale (TAFSQ) |  | Measured at therapy session two, therapy session eight, end of treatment, and 32-week follow-up | 
| Self-esteem, as defined by the Rosenberg Self Esteem Questionnaire (RSEQ) |  | Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up | 
| Self-discrepancy, as defined by the Selves Interview |  | Measured at baseline, end of treatment, and at 32-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bulimia Nervosa, Treatment Efficacy, Integrative Cognitive Affective Therapy, Cognitive Behavior Therapy