Testing an Alternative Therapy for Bulimia Nervosa
Condition: Eating Disorders
MeSH terms: Bulimia; Feeding and Eating Disorders; Bulimia Nervosa
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): ICAT; CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): ICAT is a new manual-based psychotherapy treatment for bulimia nervosa (BN) that focuses on emotions and bulimic behavior.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bulimia Nervosa; Treatment Efficacy; Integrative Cognitive Affective Therapy; Cognitive Behavior Therapy