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Testing an Alternative Therapy for Bulimia Nervosa

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier:
NCT00773617
First received: October 15, 2008
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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 Intervention
Eating Disorders
Behavioral: ICAT
Behavioral: CBT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrative Cognitive Affective Therapy for Bulimia Nervosa (ICAT)

Resource links provided by NLM:


Further study details as provided by Neuropsychiatric Research Institute, Fargo, North Dakota:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Study retention rates [ Time Frame: Measured weekly throughout treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Self-discrepancy, as defined by the Selves Interview [ Time Frame: Measured at baseline, end of treatment, and at 32-week follow-up ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: March 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: ICAT
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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773617

Locations
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
Investigators
Principal Investigator: Stephen A. Wonderlich, PhD Neuropsychiatric Research Institute, University of North Dakota
  More Information

No publications provided by Neuropsychiatric Research Institute, Fargo, North Dakota

Additional 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: R34 MH077571, R34MH077571, 5 R34 MH077571-02, DATR A2-AIM
Study First Received: October 15, 2008
Last Updated: April 22, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 20, 2014