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Testing an Alternative Therapy for Bulimia Nervosa

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ClinicalTrials.gov Identifier: NCT00773617
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : April 23, 2013
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment
Eating Disorders Behavioral: ICAT Behavioral: 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrative Cognitive Affective Therapy for Bulimia Nervosa (ICAT)
Study Start Date : March 2009
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Integrative cognitive affective therapy (ICAT)
Behavioral: ICAT
ICAT is a new manual-based psychotherapy treatment for bulimia nervosa (BN) that focuses on emotions and bulimic behavior.
Active Comparator: 2
Cognitive behavioral therapy (CBT)
Behavioral: CBT
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.

Outcome Measures

Primary Outcome Measures :
  1. Percent reduction in binging or purging frequency as defined by symptom recall (SR) [ Time Frame: Measured at baseline, weekly intervals throughout the duration of therapy, end of treatment, and 32-week follow-up ]
  2. Percent reduction in binging or purging frequency, as defined by the Eating Disorders Examination (EDE) [ Time Frame: Measured at baseline, end of treatment, and 32-week follow-up ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773617

United States, Minnesota
University of Minnesota Eating Disorders Research Program
Minneapolis, Minnesota, United States, 55454
United States, North Dakota
Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
Neuropsychiatric Research Institute, Fargo, North Dakota
National Institute of Mental Health (NIMH)
Principal Investigator: Stephen A. Wonderlich, PhD Neuropsychiatric Research Institute, University of North Dakota
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier: NCT00773617     History of Changes
Other Study ID Numbers: R34MH077571 ( U.S. NIH Grant/Contract )
5R34MH077571-02 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

Keywords provided by Neuropsychiatric Research Institute, Fargo, North Dakota:
Bulimia Nervosa
Treatment Efficacy
Integrative Cognitive Affective Therapy
Cognitive Behavior Therapy

Additional relevant MeSH terms:
Feeding and Eating Disorders
Bulimia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms