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Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder

Primary Purpose

Eating Disorder, Bulimia Nervosa, Binge Eating Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Adaptive Recovery Record App
Standardized Coaching
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorder focused on measuring Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, App, Smartphone, Self-Help, Coaching, Recovery Record, Mobile Phone, Cognitive Behavioral Therapy

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Capital Health District Health Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coached Recovery Record App

Uncoached Recovery Record App

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Binge Eating and Purging Frequency
Binge/purge frequency for the month prior will be gathered from self-reported EDE-Q responses.
Change in Clinical Impairment
The Clinical Impairment Assessment (CIA) will be used to identify changes in psychosocial impairment related to the participant's eating disorder.
Treatment Satisfaction
Likert-scale and open-ended questions specific to the intervention will be used to assess participant satisfaction with treatment.
Treatment Adherence
Treatment completion will be defined as completing more than 75% of the 8-week treatment program and treatment dropout will be defined as completing any less than 75% of the program.

Full Information

First Posted
November 29, 2016
Last Updated
January 24, 2018
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT02978742
Brief Title
Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder
Official Title
Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study not funded.
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The prevalence of bulimia nervosa (BN) is approximately 1.0-1.5% among women. With consistently higher prevalence rates, binge eating disorder (BED) affects up to 3.5% of women and 1.5% of men. These eating disorders represent a public health concern due to the high comorbidity of BN and BED with other psychiatric disorders and the association with poor physical health outcomes. Given this public health impact, it is concerning that less than half of BN and BED patients seek treatment for their eating disorder. This is especially concerning since a greater duration of untreated illness is associated with a poorer prognosis. Individuals' reluctance to seek treatment is likely due to factors such as an avoidance of disclosing symptoms to family members or clinicians. For example, one study reported that 27% of adolescents with BN declined participation because they did not want their families involved. Even for those who do wish to engage, treatment is often inaccessible due to the geographic centralization of eating disorder specialists and a low ratio of specialists to patients. Given the ubiquity of smartphone devices among adults and adolescents, one possible way to improve treatment accessibility and privacy is to offer it through a smartphone app. In recent development, an evidence-based smartphone app called Recovery Record (RR) has been conceived for use by people suffering from eating disorders as an adjunct to clinical treatment. This tool allows patients to self-monitor eating behaviours, connect with their clinician directly through the app, and provides other therapeutic features (e.g. cues coping skill use). Preliminary findings suggest that the app is feasible, with 67% of users continuing to log meals at 30 days. As well, RR is currently the most downloaded, most rated, and highest rated app of its kind, which suggests it is highly acceptable among users. In support of these findings, one study demonstrated that 26% of app users in a clinically severe range at baseline demonstrated clinically significant reductions in eating disorder symptoms at least 28 days later, which is consistent with other forms of self-help for BN. Moreover, 89% of users reported that using Recovery Record helped their condition from getting worse and a majority reported improvements to the frequency of disordered behaviours, reported urges, and mood. App developers have outfitted the app with an adaptive 8-week program that automatically uses patient data to tailor treatment for individual users (i.e. an automated pure self-help course of treatment). Although pure self-help is efficacious for BN and BED, self-help augmented by coaching (from a health care profession) has been associated with even better outcomes (with a moderate effect size). Given the support for this smartphone app and this potential avenue for providing private and accessible care to Nova Scotians, the aim of this study is to assess the efficacy of this adaptive smartphone app program, both coached and uncoached, for BN and BED patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder, Bulimia Nervosa, Binge Eating Disorder
Keywords
Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, App, Smartphone, Self-Help, Coaching, Recovery Record, Mobile Phone, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coached Recovery Record App
Arm Type
Experimental
Arm Description
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.
Arm Title
Uncoached Recovery Record App
Arm Type
Active Comparator
Arm Description
Participants will complete the 8-week adaptive Recovery Record app program on their own (i.e., without a coach providing feedback and support).
Intervention Type
Behavioral
Intervention Name(s)
Adaptive Recovery Record App
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardized Coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Eating Disorder Symptom Severity
Description
Self-reported symptom severity will be assessed with the Eating Disorder Examination Questionnaire (EDE-Q).
Time Frame
Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up
Secondary Outcome Measure Information:
Title
Change in Binge Eating and Purging Frequency
Description
Binge/purge frequency for the month prior will be gathered from self-reported EDE-Q responses.
Time Frame
Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up
Title
Change in Clinical Impairment
Description
The Clinical Impairment Assessment (CIA) will be used to identify changes in psychosocial impairment related to the participant's eating disorder.
Time Frame
Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up
Title
Treatment Satisfaction
Description
Likert-scale and open-ended questions specific to the intervention will be used to assess participant satisfaction with treatment.
Time Frame
Measured at end of treatment (up to 8 weeks)
Title
Treatment Adherence
Description
Treatment completion will be defined as completing more than 75% of the 8-week treatment program and treatment dropout will be defined as completing any less than 75% of the program.
Time Frame
Measured from start of treatment to the end of treatment (up to 8 weeks)
Other Pre-specified Outcome Measures:
Title
Diagnosis of Bulimia Nervosa or Binge Eating Disorder
Description
A DSM-V diagnosis of bulimia nervosa or binge eating disorder will be determined with the Eating Disorder Diagnostic Scale (EDDS).
Time Frame
Pre-Screening
Title
Suicidality
Description
Risk of suicide will be determined with the Columbia - Suicide Severity Rating Scale, Self-Report Screening Version (C-SSRS).
Time Frame
Pre-Screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Keshen, MD, FRCPC
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital Health District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26213130
Citation
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.
Results Reference
background
Links:
URL
http://www.recoveryrecord.com
Description
Recovery Record Smartphone Application Website

Learn more about this trial

Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder

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