NCT02978742

Brief Summary

Bulimia nervosa and binge eating disorder pose a public health concern due to their high co-occurrence with other psychiatric disorders and poor physical health outcomes. It is therefore concerning that less than half of these patients seek treatment for their condition. People may be reluctant to seek treatment due to not wanting to disclose symptoms to family members. Even for those who do wish to seek help, treatment is often inaccessible due to the geographic centralization of eating disorder specialists and a low ratio of specialists to patients. Therefore, the aim of this study is to test a potential solution to these problems and make eating disorder care more private and accessible. One possible way to improve the accessibility of treatment is through smartphone applications (or "apps"). We are testing an app called Recovery Record, which is primarily a tool used to self-monitor eating habits, where patients record their meals and related thoughts, feelings, emotions, and behaviours (e.g., binge eating/purging). The app also offers additional features such as discrete reminders to log meals, positive reinforcement, social support, coping strategy suggestions, and linking users with clinicians for real-time feedback and suggestions. The application is scientifically supported and has been tested with positive results. Recently, app developers have created a computer-automated 8-week treatment program that uses the patient's data to provide a tailored and individualized treatment program. This program aims to mimic the process of therapy by checking in with users, reminding them of their reasons for wanting to recover, and working towards goals. We will be testing this automated app treatment program, comparing it both with and without input from a trained coach providing individualized feedback to users.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

November 29, 2016

Last Update Submit

January 24, 2018

Conditions

Eating DisorderBulimia NervosaBinge Eating Disorder

Keywords

Eating DisordersBulimia NervosaBinge Eating DisorderAppSmartphoneSelf-HelpCoachingRecovery RecordMobile PhoneCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Eating Disorder Symptom Severity

    Self-reported symptom severity will be assessed with the Eating Disorder Examination Questionnaire (EDE-Q).

    Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up

Secondary Outcomes (4)

  • Change in Binge Eating and Purging Frequency

    Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up

  • Change in Clinical Impairment

    Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up

  • Treatment Satisfaction

    Measured at end of treatment (up to 8 weeks)

  • Treatment Adherence

    Measured from start of treatment to the end of treatment (up to 8 weeks)

Other Outcomes (2)

  • Diagnosis of Bulimia Nervosa or Binge Eating Disorder

    Pre-Screening

  • Suicidality

    Pre-Screening

Study Arms (2)

Coached Recovery Record App

EXPERIMENTAL

Participants will complete the 8-week adaptive Recovery Record app program and will be linked with a healthcare professional who will provide standardized coaching, in the way of feedback and support to participants for the duration of the program.

Behavioral: Adaptive Recovery Record AppBehavioral: Standardized Coaching

Uncoached Recovery Record App

ACTIVE COMPARATOR

Participants will complete the 8-week adaptive Recovery Record app program on their own (i.e., without a coach providing feedback and support).

Behavioral: Adaptive Recovery Record App

Interventions

Adaptive Recovery Record AppBEHAVIORAL

Participants will use the Recovery Record smartphone app, which is a meal monitoring tool, that incorporates discrete reminders, motivational tools, social support, summative feedback, and coping skill suggestions. Participants will also receive tailored, algorithm-generated content in a structured manner that mimics the progression of psychotherapy (e.g., checking in with users, reminding them of their reasons for wanting to recover, and working towards goals) over the course of 8 weeks.

Coached Recovery Record AppUncoached Recovery Record App
Standardized CoachingBEHAVIORAL

Coaches (dietitians or mental health clinicians) will review patients' logs daily and participants will receive one communication of standardized feedback each day through the app based on their food records. A standardized feedback manual to be used by coaches has been developed by co-investigators (two PhD psychologists and one psychiatrist), and all feedback will be monitored for consistency and quality by co-investigators.

Coached Recovery Record App

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-V diagnosis of bulimia nervosa or binge eating disorder
  • Ages 16-65 years
  • Has an Apple or Android smartphone with a data plan or daily access to Wi-Fi
  • Is able to download smartphone applications from the Apple App Store or Google Play Store to their smartphone
  • Lives in Canada
  • Provides consent to participate

You may not qualify if:

  • Actively engaged in psychological treatment, specifically for bulimia nervosa or binge eating disorder
  • Lacks English fluency
  • High risk for suicide, as determined by the Columbia Suicide Severity Rating Scale (Self-Report Screening Version)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Health District Health Authority

Halifax, Nova Scotia, B3H2E2, Canada

Location

Related Publications (1)

  • Tregarthen JP, Lock J, Darcy AM. Development of a smartphone application for eating disorder self-monitoring. Int J Eat Disord. 2015 Nov;48(7):972-82. doi: 10.1002/eat.22386. Epub 2015 Jul 27.

    PMID: 26213130BACKGROUND

Related Links

MeSH Terms

Conditions

Feeding and Eating DisordersBulimia NervosaBinge-Eating DisorderAlzheimer Disease

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive Disorders

Study Officials

  • Aaron Keshen, MD, FRCPC

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 1, 2016

Study Start

September 1, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

January 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)