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Integrative Cognitive-Affective Therapy for Binge Eating Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02043496
First Posted: January 23, 2014
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Neuropsychiatric Research Institute, Fargo, North Dakota
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (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 ]
    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 ]
    Global Eating Disorder Symptoms as measured by the Eating Disorder Examination

  • Symptoms of Depression (BDI) [ Time Frame: 17 Weeks and 6-month follow-up ]
    Symptoms of Depression as measured by the Beck Depression Inventory

  • Symptoms of Anxiety (STAI) [ Time Frame: 17 Weeks and 6-month Follow-up ]
    Symptoms of Anxiety as measured by the State-Trait Anxiety Inventory

  • Self-Esteem (RSEQ) [ Time Frame: 17 Weeks and 6-month Follow-up ]
    Self-esteem as measured by the Rosenberg Self-Esteem Questionnaire


Estimated Enrollment: 112
Study Start Date: December 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT-Guided Self Help
Integrative Cognitive-Affective Therapy CBT-Guided Self Help
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.
Experimental: 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: Integrative Cognitive-Affective Therapy
Integrative Cognitive-Affective Therapy is a psychotherapy treatment for binge eating that focuses on changing behaviors, feelings, thoughts, and relationships

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043496


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
United States, North Dakota
Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58107
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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02043496     History of Changes
Other Study ID Numbers: 1R34MH099040-01A1 ( U.S. NIH Grant/Contract )
First Submitted: January 14, 2014
First Posted: January 23, 2014
Last Update Posted: August 3, 2017
Last Verified: August 2017

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:
Disease
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms