Integrative Cognitive-Affective Therapy for Binge Eating Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Neuropsychiatric Research Institute, Fargo, North Dakota
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT02043496
First received: January 14, 2014
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

The purpose of the study is to test a newly developed individual psychotherapy treatment for binge eating disorder in adults. This treatment is a type of individual psychotherapy called Integrative Cognitive-Affective Therapy (ICAT) that focuses on helping people change their behaviors, feelings, thoughts about themselves, and relationships. This new treatment is being compared to an existing treatment called Cognitive-Behavior Therapy-Guided Self Help (CBTgsh), which focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist. The primary hypothesis of this investigation is that ICAT will be associated with greater reductions in binge eating at end of treatment and follow-up compared to CBTgsh.


Condition Intervention
Binge Eating Disorder
Behavioral: Integrative Cognitive-Affective Therapy
Behavioral: CBT-Guided Self Help

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrative Cognitive-Affective Therapy for Binge Eating Disorder

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Binge Eating Episode Frequency (Eating Disorder Examination) [ Time Frame: 17 Weeks and 6-month Follow-up ] [ Designated as safety issue: No ]
    Frequency of binge eating as measured by the Eating Disorder Examination


Secondary Outcome Measures:
  • Global Eating Disorder Symptoms (EDE) [ Time Frame: 17 Weeks and 6-month follow-up ] [ Designated as safety issue: No ]
    Global Eating Disorder Symptoms as measured by the Eating Disorder Examination

  • Symptoms of Depression (BDI) [ Time Frame: 17 Weeks and 6-month follow-up ] [ Designated as safety issue: No ]
    Symptoms of Depression as measured by the Beck Depression Inventory

  • Symptoms of Anxiety (STAI) [ Time Frame: 17 Weeks and 6-month Follow-up ] [ Designated as safety issue: No ]
    Symptoms of Anxiety as measured by the State-Trait Anxiety Inventory

  • Self-Esteem (RSEQ) [ Time Frame: 17 Weeks and 6-month Follow-up ] [ Designated as safety issue: No ]
    Self-esteem as measured by the Rosenberg Self-Esteem Questionnaire


Estimated Enrollment: 112
Study Start Date: December 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Binge Eating Disorder Treatment
Integrative Cognitive-Affective Therapy CBT-Guided Self Help
Behavioral: Integrative Cognitive-Affective Therapy
Integrative Cognitive-Affective Therapy is a psychotherapy treatment for binge eating that focuses on changing behaviors, feelings, thoughts, and relationships
Behavioral: CBT-Guided Self Help
CBT-Guided Self Help focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Binge eating disorder (DSM-5)

Exclusion Criteria:

  • History of gastric bypass surgery
  • Medical condition acutely affecting eating and/or weight
  • Current medical and/or psychiatric instability (e.g., acute suicidality)
  • Psychosis and/or bipolar disorder
  • Severe cognitive impairment or developmental disability
  • Inability to read English
  • Current substance use disorder
  • Current participation in psychotherapy and/or commercial weight loss program
  • Change in dosage and/or frequency of psychotropic medication in the past 6 weeks
  • Pregnant or breast feeding
  • BMI < 21
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043496

Contacts
Contact: Carol B Peterson, PhD 612-273-9811 peter161@umn.edu
Contact: Stephen A Wonderlich, PhD 701-365-4910 swonderlich@nrifargo.com

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Carol B Peterson, PhD    612-273-9811    peter161@umn.edu   
Principal Investigator: Carol B Peterson, PhD         
United States, North Dakota
Neuropsychiatric Research Institute Recruiting
Fargo, North Dakota, United States, 58107
Contact: Stephen A Wonderlich, PhD    701-365-4910    swonderlich@nrifargo.com   
Principal Investigator: Stephen A Wonderlich, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Neuropsychiatric Research Institute, Fargo, North Dakota
Investigators
Principal Investigator: Carol B Peterson, PhD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Stephen A Wonderlich, PhD Neuropsychiatric Research Institute/University of North Dakota
  More Information

Additional Information:
No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02043496     History of Changes
Other Study ID Numbers: 1R34MH099040-01A1
Study First Received: January 14, 2014
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Binge Eating Disorder
Binge Eating
Eating Disorders
Obesity
Psychotherapy
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014