NCT02043496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

3.7 years

First QC Date

January 14, 2014

Last Update Submit

July 15, 2020

Conditions

Binge Eating Disorder

Keywords

Binge Eating DisorderBinge EatingEating DisordersObesityPsychotherapyCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Global Eating Disorder Symptoms (EDE)

    17 Weeks and 6-month follow-up

  • Symptoms of Depression (BDI)

    17 Weeks and 6-month follow-up

  • Symptoms of Anxiety (STAI)

    17 Weeks and 6-month Follow-up

  • Self-Esteem (RSEQ)

    17 Weeks and 6-month Follow-up

Study Arms (2)

CBT-Guided Self Help

EXPERIMENTAL

Integrative Cognitive-Affective Therapy CBT-Guided Self Help

Behavioral: CBT-Guided Self Help

Integrative Cognitive-Affective Therapy

EXPERIMENTAL

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

Interventions

Integrative Cognitive-Affective TherapyBEHAVIORAL

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

Integrative Cognitive-Affective Therapy
CBT-Guided Self HelpBEHAVIORAL

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

CBT-Guided Self Help

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Binge eating disorder (DSM-5)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Neuropsychiatric Research Institute

Fargo, North Dakota, 58107, United States

Location

Related Publications (1)

  • 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.

    PMID: 32583478DERIVED

MeSH Terms

Conditions

Binge-Eating DisorderBulimiaFeeding and Eating DisordersObesity

Condition Hierarchy (Ancestors)

Mental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Carol B Peterson, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Stephen A Wonderlich, PhD

    Neuropsychiatric Research Institute/University of North Dakota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 23, 2014

Study Start

December 1, 2013

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

US(2)