Testing an Alternative Therapy for Bulimia Nervosa

Eating Disorders Clinical Trial

Official title:

Integrative Cognitive Affective Therapy for Bulimia Nervosa (ICAT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773617
• Other study ID #: R34MH077571
• Secondary ID: R34MH0775715R34M
• Status: Completed
• Phase: N/A
• First received: October 15, 2008
• Last updated: March 27, 2018
• Start date: March 2009
• Est. completion date: April 2011

Study information

• Verified date: April 2013
• Source: Neuropsychiatric Research Institute, Fargo, North Dakota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• ICAT
ICAT is a new manual-based psychotherapy treatment for bulimia nervosa (BN) that focuses on emotions and bulimic behavior.
• 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.

Locations

Country	Name	City	State
United States	Neuropsychiatric Research Institute	Fargo	North Dakota
United States	University of Minnesota Eating Disorders Research Program	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Neuropsychiatric Research Institute, Fargo, North Dakota	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Abstinence from binging and purging behavior, as defined by SR and EDE		Measured at the end of treatment and 32-week follow-up
Secondary	Study retention rates		Measured weekly throughout treatment
Secondary	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
Secondary	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
Secondary	Self-discrepancy, as defined by the Selves Interview		Measured at baseline, end of treatment, and at 32-week follow-up