NCT02834299

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2018

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

July 6, 2016

Last Update Submit

March 28, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Eating Disorder Examination Questionnaire

    measures core eating disorder psychopathology and binge eating

    Change from baseline at Week 12

Secondary Outcomes (2)

  • Difficulties in Emotion Regulation Scale

    Change from baseline at Week 12

  • Brief Symptom Inventory

    Change from baseline at Week 12

Study Arms (3)

DBT Guided Self-Help

EXPERIMENTAL

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 Unguided Self-Help

EXPERIMENTAL

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

Self-Esteem-Focused Unguided Self-Help

ACTIVE COMPARATOR

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

Interventions

DBT self-help manual plus six 30-minute therapy sessions for 12 weeks

DBT Guided Self-Help

DBT self-help manual without any therapy sessions for 12 weeks

DBT Unguided Self-Help

Self-esteem focused self-help manual without any therapy sessions for 12 weeks

Self-Esteem-Focused Unguided Self-Help

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1B 0X9, Canada

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Jacqueline Carter, D.Phil.

    Memorial University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 15, 2016

Study Start

September 20, 2016

Primary Completion

March 20, 2018

Study Completion

March 20, 2018

Last Updated

March 30, 2018

Record last verified: 2018-03

Locations