Testing an Alternative Therapy for Bulimia Nervosa

Status Completed

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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00773617
Study type	Interventional
Source	Neuropsychiatric Research Institute, Fargo, North Dakota
Contact
Status	Completed
Phase	N/A
Start date	March 2009
Completion date	April 2011

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05656859` - Prevalence of Eating Disorders Among Patients in the Department of Health Promotion
Completed	`NCT04085861` - Mental Health in Dancers; an Intervention Study	N/A
Recruiting	`NCT05651295` - A Precision Medicine Approach to Target Engagement for Emotion Regulation	N/A
Enrolling by invitation	`NCT04174703` - Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing	N/A
Terminated	`NCT04278755` - Binge Eating & Birth Control	Phase 2
Withdrawn	`NCT03050632` - Effects of Cognitive and Emotional Functioning on Treatment Outcomes	N/A
Completed	`NCT02567890` - Swedish Body Project for Prevention of Eating Disorders	N/A
Completed	`NCT02484794` - Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application	N/A
Completed	`NCT02252822` - Improving Treatment Engagement for Adolescents With Bulimia Nervosa	N/A
Completed	`NCT02021344` - Mental Health First Aid for College Students	N/A
Completed	`NCT00601354` - Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder	N/A
Completed	`NCT00418977` - Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents	N/A
Completed	`NCT00304187` - Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa	Phase 2
Completed	`NCT00733525` - Effectiveness of Stepped Care Versus Best Available Care for Bulimia Nervosa	N/A
Active, not recruiting	`NCT04779216` - Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa	Phase 3
Completed	`NCT04433663` - Eating Disorders, Self Regulation and Mentalization	N/A
Recruiting	`NCT05509257` - Naltrexone Neuroimaging in Teens With Eating Disorders	Early Phase 1
Completed	`NCT04509531` - Building Resilience in Cyberbullying Victims	N/A
Recruiting	`NCT05730348` - Mealtime Anxiety in Eating Disorders
Enrolling by invitation	`NCT05814653` - A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.