Clinical trial NCT00773617: Testing an Alternative Therapy for Bulimia Nervosa
Official title: Integrative Cognitive Affective Therapy for Bulimia Nervosa (ICAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Keywords: Bulimia Nervosa
Treatment Efficacy
Integrative Cognitive Affective Therapy
Cognitive Behavior Therapy
Lead sponsor: Neuropsychiatric Research Institute, Fargo, North Dakota
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-10-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent reduction in binging or purging frequency as defined by symptom recall (SR)
timeFrame: Measured at baseline, weekly intervals throughout the duration of therapy, end of treatment, and 32-week follow-up
measure: Percent reduction in binging or purging frequency, as defined by the Eating Disorders Examination (EDE)
timeFrame: Measured at baseline, end of treatment, and 32-week follow-up
Secondary outcomes:
measure: Reduction in depression, as defined by the Beck Depression Inventory (BDI)
timeFrame: Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up
measure: Reduction in anxiety as defined by the State-Trait Anxiety Inventory (STAI)
timeFrame: Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up
measure: Abstinence from binging and purging behavior, as defined by SR and EDE
timeFrame: Measured at the end of treatment and 32-week follow-up
measure: Study retention rates
timeFrame: Measured weekly throughout treatment
measure: Patient and therapist satisfaction, as defined by the Treatment Acceptability, Feasibility and Satisfaction Scale (TAFSQ)
timeFrame: Measured at therapy session two, therapy session eight, end of treatment, and 32-week follow-up
measure: Self-esteem, as defined by the Rosenberg Self Esteem Questionnaire (RSEQ)
timeFrame: Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up
measure: Self-discrepancy, as defined by the Selves Interview
timeFrame: Measured at baseline, end of treatment, and at 32-week follow-up
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Eating Disorders Research Program
state: Minnesota
city: Fargo
country: United States
facility: Neuropsychiatric Research Institute
state: North Dakota
Study officials:
affiliation: Neuropsychiatric Research Institute, University of North Dakota
name: Stephen A. Wonderlich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.