Integrative Cognitive-Affective Therapy for Binge Eating Disorder

Binge Eating Disorder Clinical Trial

Official title:

Integrative Cognitive-Affective Therapy for Binge Eating Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043496
• Other study ID #: PSYCH-2016-22310
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: August 2017

Study information

• Verified date: July 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Disease
• Feeding and Eating Disorders

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Neuropsychiatric Research Institute	Fargo	North Dakota
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Neuropsychiatric Research Institute, Fargo, North Dakota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binge Eating Episode Frequency (Eating Disorder Examination)	Frequency of binge eating as measured by the Eating Disorder Examination	17 Weeks and 6-month Follow-up
Secondary	Global Eating Disorder Symptoms (EDE)	Global Eating Disorder Symptoms as measured by the Eating Disorder Examination	17 Weeks and 6-month follow-up
Secondary	Symptoms of Depression (BDI)	Symptoms of Depression as measured by the Beck Depression Inventory	17 Weeks and 6-month follow-up
Secondary	Symptoms of Anxiety (STAI)	Symptoms of Anxiety as measured by the State-Trait Anxiety Inventory	17 Weeks and 6-month Follow-up
Secondary	Self-Esteem (RSEQ)	Self-esteem as measured by the Rosenberg Self-Esteem Questionnaire	17 Weeks and 6-month Follow-up