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Completed

NCT Number: NCT02043496

Integrative Cognitive-Affective Therapy for Binge Eating Disorder

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.

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Key information

Conditions

Binge Eating Disorder Binge-Eating Disorder Body Weight Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrative Cognitive-Affective Therapy

Behavioral

Integrative Cognitive-Affective Therapy is a psychotherapy treatment for binge eating that focuses on changing behaviors, feelings, thoughts, and relationships

CBT-Guided Self Help

Behavioral

CBT-Guided Self Help focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Symptoms of Depression (BDI)

    Time frame: 17 Weeks and 6-month follow-up

    Symptoms of Depression as measured by the Beck Depression Inventory

  3. Symptoms of Anxiety (STAI)

    Time frame: 17 Weeks and 6-month Follow-up

    Symptoms of Anxiety as measured by the State-Trait Anxiety Inventory

  4. Self-Esteem (RSEQ)

    Time frame: 17 Weeks and 6-month Follow-up

    Self-esteem as measured by the Rosenberg Self-Esteem Questionnaire

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Neuropsychiatric Research Institute, Fargo, North Dakota

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2014
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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