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Integrative Cognitive-Affective Therapy for Binge Eating Disorder

Primary Purpose

Binge Eating Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Integrative Cognitive-Affective Therapy

CBT-Guided Self Help

About this trial

This is an interventional treatment trial for Binge Eating Disorder focused on measuring Binge Eating Disorder, Binge Eating, Eating Disorders, Obesity, Psychotherapy, Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Minnesota
Neuropsychiatric Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CBT-Guided Self Help

Integrative Cognitive-Affective Therapy

Arm Description

Integrative Cognitive-Affective Therapy CBT-Guided Self Help

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

Outcomes

Primary Outcome Measures

Binge Eating Episode Frequency (Eating Disorder Examination)

Frequency of binge eating as measured by the Eating Disorder Examination

Secondary Outcome Measures

Global Eating Disorder Symptoms (EDE)

Global Eating Disorder Symptoms as measured by the Eating Disorder Examination

Symptoms of Depression (BDI)

Symptoms of Depression as measured by the Beck Depression Inventory

Symptoms of Anxiety (STAI)

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

Self-Esteem (RSEQ)

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

Full Information

NCT ID

NCT02043496

First Posted

January 14, 2014

Last Updated

July 15, 2020

Sponsor

University of Minnesota

Collaborators

Neuropsychiatric Research Institute, Fargo, North Dakota

1. Study Identification

Unique Protocol Identification Number

NCT02043496

Brief Title

Integrative Cognitive-Affective Therapy for Binge Eating Disorder

Official Title

Integrative Cognitive-Affective Therapy for Binge Eating Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

December 2013 (Actual)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

Collaborators

Neuropsychiatric Research Institute, Fargo, North Dakota

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Binge Eating Disorder

Keywords

Binge Eating Disorder, Binge Eating, Eating Disorders, Obesity, Psychotherapy, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT-Guided Self Help

Arm Type

Experimental

Arm Description

Integrative Cognitive-Affective Therapy CBT-Guided Self Help

Arm Title

Integrative Cognitive-Affective Therapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Integrative Cognitive-Affective Therapy

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

CBT-Guided Self Help

Intervention Description

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

Primary Outcome Measure Information:

Title

Binge Eating Episode Frequency (Eating Disorder Examination)

Description

Frequency of binge eating as measured by the Eating Disorder Examination

Time Frame

17 Weeks and 6-month Follow-up

Secondary Outcome Measure Information:

Title

Global Eating Disorder Symptoms (EDE)

Description

Global Eating Disorder Symptoms as measured by the Eating Disorder Examination

Time Frame

17 Weeks and 6-month follow-up

Title

Symptoms of Depression (BDI)

Description

Symptoms of Depression as measured by the Beck Depression Inventory

Time Frame

17 Weeks and 6-month follow-up

Title

Symptoms of Anxiety (STAI)

Description

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

Time Frame

17 Weeks and 6-month Follow-up

Title

Self-Esteem (RSEQ)

Description

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

Time Frame

17 Weeks and 6-month Follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol B Peterson, PhD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stephen A Wonderlich, PhD

Organizational Affiliation

Neuropsychiatric Research Institute/University of North Dakota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55454

Country

United States

Facility Name

Neuropsychiatric Research Institute

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58107

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32583478

Citation

Peterson CB, Engel SG, Crosby RD, Strauman T, Smith TL, Klein M, Crow SJ, Mitchell JE, Erickson A, Cao L, Bjorlie K, Wonderlich SA. Comparing integrative cognitive-affective therapy and guided self-help cognitive-behavioral therapy to treat binge-eating disorder using standard and naturalistic momentary outcome measures: A randomized controlled trial. Int J Eat Disord. 2020 Sep;53(9):1418-1427. doi: 10.1002/eat.23324. Epub 2020 Jun 25.

Results Reference

derived

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Integrative Cognitive-Affective Therapy for Binge Eating Disorder

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