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Dialectical Behavior Therapy Guided Self-Help for Binge Eating Disorder (DBT-GSH-BED)

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ClinicalTrials.gov Identifier: NCT02834299
Recruitment Status : Completed
First Posted : July 15, 2016
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Jacqueline Carter-Major, Memorial University of Newfoundland

Brief Summary:
This study will compare unguided and guided dialectical behavior therapy (DBT) self-help to an attention-placebo self-help control condition. Participants with binge eating disorder will be randomly assigned to one of the three self-help conditions for 12 weeks. Six guided self-help sessions will take place via secure video-calling. Assessments will take place before, mid-way through, and after the self-help program as well as at 3-month follow-up. Six guided self-help sessions will take place via secure video-calling.

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Behavioral: DBT Guided Self-Help Behavioral: DBT Unguided Self-Help Behavioral: Self-Esteem-Focused Unguided Self-Help Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of a Dialectical Behavior Therapy Guided Self-Help Intervention for Binge Eating Disorder
Actual Study Start Date : September 20, 2016
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : March 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: DBT Guided Self-Help
Participants will be provided with the DBT self-help manual "Dialectical Behavior Therapy for Binge Eating: A Self-Help Program" by Safer, Adler & Masson (2016) and receive six brief therapy sessions via video-calling.
Behavioral: DBT Guided Self-Help
DBT self-help manual plus six 30-minute therapy sessions for 12 weeks

Experimental: DBT Unguided Self-Help
Participants will be provided with the DBT self-help manual "Dialectical Behavior Therapy for Binge Eating: A Self-Help Program" by Safer, Adler & Masson (2016) and asked to follow the manual on their own.
Behavioral: DBT Unguided Self-Help
DBT self-help manual without any therapy sessions for 12 weeks

Active Comparator: Self-Esteem-Focused Unguided Self-Help
Participants will be provided with the self-help manual "Self-Esteem" by McKay & Fanning (2016) as asked to follow the manual on their own.
Behavioral: Self-Esteem-Focused Unguided Self-Help
Self-esteem focused self-help manual without any therapy sessions for 12 weeks




Primary Outcome Measures :
  1. Eating Disorder Examination Questionnaire [ Time Frame: Change from baseline at Week 12 ]
    measures core eating disorder psychopathology and binge eating


Secondary Outcome Measures :
  1. Difficulties in Emotion Regulation Scale [ Time Frame: Change from baseline at Week 12 ]
    Measures deficits in emotion management skills

  2. Brief Symptom Inventory [ Time Frame: Change from baseline at Week 12 ]
    measures general psychological distress



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • meets DSM 5 criteria for binge eating disorder (BED)

Exclusion Criteria:

  • receiving specialized psychological treatment for BED,
  • BMI under 18.5,
  • substance use disorder, major medical illness, psychotic symptoms

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): NCT02834299


Locations
Canada, Newfoundland & Labrador
Memorial University of Newfoundland
St. John's, Newfoundland & Labrador, Canada, A1B 0X9
Sponsors and Collaborators
Memorial University of Newfoundland
Investigators
Principal Investigator: Jacqueline Carter, D.Phil. Memorial University

Responsible Party: Jacqueline Carter-Major, Associate Professor, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT02834299     History of Changes
Other Study ID Numbers: 3379
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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