Testing an Alternative Therapy for Bulimia Nervosa

Neuropsychiatric Research Institute, Fargo, North Dakota

Status

Completed

Conditions

Eating Disorders

Treatments

Behavioral: CBT

Behavioral: ICAT

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00773617

R34MH077571 (U.S. NIH Grant/Contract)

5R34MH077571-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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