Testing an Alternative Therapy for Bulimia Nervosa

NCT00773617 | Completed DMC

• 2 other identifiers: R34MH0775715R34MH077571-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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).

Conditions

Eating Disorders

Keywords

Bulimia Nervosa; Treatment Efficacy; Integrative Cognitive Affective Therapy; Cognitive Behavior Therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• 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

• 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

• Abstinence from binging and purging behavior, as defined by SR and EDE

  Measured at the end of treatment and 32-week follow-up

• Study retention rates

  Measured weekly throughout treatment

• 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

Study Arms (2)

1

EXPERIMENTAL

Integrative cognitive affective therapy (ICAT)

Behavioral: ICAT

2

ACTIVE COMPARATOR

Cognitive behavioral therapy (CBT)

Behavioral: CBT

Interventions

ICAT BEHAVIORAL

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

1

CBT BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuropsychiatric Research Institute, Fargo, North Dakota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Minnesota Eating Disorders Research Program

Minneapolis, Minnesota, 55454, United States

Location

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

Location

Related Publications (5)

• 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.

  PMID: 28117906 DERIVED

• 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.

  PMID: 27611235 DERIVED

• 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.

  PMID: 26689304 DERIVED

• 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.

  PMID: 25894667 DERIVED

• 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.

  PMID: 23701891 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Bulimia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Stephen A. Wonderlich, PhD

  Neuropsychiatric Research Institute, University of North Dakota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: March 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 29, 2018

Record last verified: 2013-04

Locations

US (2)