Testing an Alternative Therapy for Bulimia Nervosa
Primary Purpose
Eating Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ICAT
CBT
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorders focused on measuring Bulimia Nervosa, Treatment Efficacy, Integrative Cognitive Affective Therapy, Cognitive Behavior Therapy
Eligibility 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
Sites / Locations
- University of Minnesota Eating Disorders Research Program
- Neuropsychiatric Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Integrative cognitive affective therapy (ICAT)
Cognitive behavioral therapy (CBT)
Outcomes
Primary Outcome Measures
Percent reduction in binging or purging frequency as defined by symptom recall (SR)
Percent reduction in binging or purging frequency, as defined by the Eating Disorders Examination (EDE)
Secondary Outcome Measures
Reduction in depression, as defined by the Beck Depression Inventory (BDI)
Reduction in anxiety as defined by the State-Trait Anxiety Inventory (STAI)
Abstinence from binging and purging behavior, as defined by SR and EDE
Study retention rates
Patient and therapist satisfaction, as defined by the Treatment Acceptability, Feasibility and Satisfaction Scale (TAFSQ)
Self-esteem, as defined by the Rosenberg Self Esteem Questionnaire (RSEQ)
Self-discrepancy, as defined by the Selves Interview
Full Information
NCT ID
NCT00773617
First Posted
October 15, 2008
Last Updated
March 27, 2018
Sponsor
Neuropsychiatric Research Institute, Fargo, North Dakota
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00773617
Brief Title
Testing an Alternative Therapy for Bulimia Nervosa
Official Title
Integrative Cognitive Affective Therapy for Bulimia Nervosa (ICAT)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuropsychiatric Research Institute, Fargo, North Dakota
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Bulimia Nervosa, Treatment Efficacy, Integrative Cognitive Affective Therapy, Cognitive Behavior Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Integrative cognitive affective therapy (ICAT)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Cognitive behavioral therapy (CBT)
Intervention Type
Behavioral
Intervention Name(s)
ICAT
Intervention Description
ICAT is a new manual-based psychotherapy treatment for bulimia nervosa (BN) that focuses on emotions and bulimic behavior.
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
Study retention rates
Time Frame
Measured weekly throughout treatment
Title
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
Title
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
Title
Self-discrepancy, as defined by the Selves Interview
Time Frame
Measured at baseline, end of treatment, and at 32-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen A. Wonderlich, PhD
Organizational Affiliation
Neuropsychiatric Research Institute, University of North Dakota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Eating Disorders Research Program
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Neuropsychiatric Research Institute
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28117906
Citation
Peterson CB, Berg KC, Crosby RD, Lavender JM, Accurso EC, Ciao AC, Smith TL, Klein M, Mitchell JE, Crow SJ, Wonderlich SA. The effects of psychotherapy treatment on outcome in bulimia nervosa: Examining indirect effects through emotion regulation, self-directed behavior, and self-discrepancy within the mediation model. Int J Eat Disord. 2017 Jun;50(6):636-647. doi: 10.1002/eat.22669. Epub 2017 Jan 24.
Results Reference
derived
PubMed Identifier
27611235
Citation
Haynos AF, Pearson CM, Utzinger LM, Wonderlich SA, Crosby RD, Mitchell JE, Crow SJ, Peterson CB. Empirically derived personality subtyping for predicting clinical symptoms and treatment response in bulimia nervosa. Int J Eat Disord. 2017 May;50(5):506-514. doi: 10.1002/eat.22622. Epub 2016 Sep 9.
Results Reference
derived
PubMed Identifier
26689304
Citation
Accurso EC, Wonderlich SA, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ, Berg KC, Peterson CB. Predictors and moderators of treatment outcome in a randomized clinical trial for adults with symptoms of bulimia nervosa. J Consult Clin Psychol. 2016 Feb;84(2):178-84. doi: 10.1037/ccp0000073. Epub 2015 Dec 21.
Results Reference
derived
PubMed Identifier
25894667
Citation
Accurso EC, Fitzsimmons-Craft EE, Ciao A, Cao L, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ, Wonderlich SA, Peterson CB. Therapeutic alliance in a randomized clinical trial for bulimia nervosa. J Consult Clin Psychol. 2015 Jun;83(3):637-42. doi: 10.1037/ccp0000021. Epub 2015 Apr 20.
Results Reference
derived
PubMed Identifier
23701891
Citation
Wonderlich SA, Peterson CB, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ. A randomized controlled comparison of integrative cognitive-affective therapy (ICAT) and enhanced cognitive-behavioral therapy (CBT-E) for bulimia nervosa. Psychol Med. 2014 Feb;44(3):543-53. doi: 10.1017/S0033291713001098. Epub 2013 May 23. Erratum In: Psychol Med. 2014 Aug;44(11):2462-3.
Results Reference
derived
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Testing an Alternative Therapy for Bulimia Nervosa
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