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

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ClinicalTrials.gov Identifier: NCT02978742
Recruitment Status : Withdrawn (Study not funded.)
First Posted : December 1, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Aaron Keshen, Nova Scotia Health Authority

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.


Condition or disease Intervention/treatment Phase
Eating Disorder Bulimia Nervosa Binge Eating Disorder Behavioral: Adaptive Recovery Record App Behavioral: Standardized Coaching Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Coached Recovery Record App
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 App
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.

Behavioral: Standardized Coaching
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.

Active Comparator: Uncoached Recovery Record App
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
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.




Primary Outcome Measures :
  1. Change in Eating Disorder Symptom Severity [ Time Frame: Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up ]
    Self-reported symptom severity will be assessed with the Eating Disorder Examination Questionnaire (EDE-Q).


Secondary Outcome Measures :
  1. Change in Binge Eating and Purging Frequency [ Time Frame: Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up ]
    Binge/purge frequency for the month prior will be gathered from self-reported EDE-Q responses.

  2. Change in Clinical Impairment [ Time Frame: Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up ]
    The Clinical Impairment Assessment (CIA) will be used to identify changes in psychosocial impairment related to the participant's eating disorder.

  3. Treatment Satisfaction [ Time Frame: Measured at end of treatment (up to 8 weeks) ]
    Likert-scale and open-ended questions specific to the intervention will be used to assess participant satisfaction with treatment.

  4. Treatment Adherence [ Time Frame: Measured from start of treatment to the end of treatment (up to 8 weeks) ]
    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.


Other Outcome Measures:
  1. Diagnosis of Bulimia Nervosa or Binge Eating Disorder [ Time Frame: Pre-Screening ]
    A DSM-V diagnosis of bulimia nervosa or binge eating disorder will be determined with the Eating Disorder Diagnostic Scale (EDDS).

  2. Suicidality [ Time Frame: Pre-Screening ]
    Risk of suicide will be determined with the Columbia - Suicide Severity Rating Scale, Self-Report Screening Version (C-SSRS).



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT02978742


Locations
Canada, Nova Scotia
Capital Health District Health Authority
Halifax, Nova Scotia, Canada, B3H2E2
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
Principal Investigator: Aaron Keshen, MD, FRCPC Nova Scotia Health Authority

Additional Information:
Publications:
Responsible Party: Aaron Keshen, Psychiatrist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02978742     History of Changes
Other Study ID Numbers: 59093009
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aaron Keshen, Nova Scotia Health Authority:
Eating Disorders
Bulimia Nervosa
Binge Eating Disorder
App
Smartphone
Self-Help
Coaching
Recovery Record
Mobile Phone
Cognitive Behavioral Therapy

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