Bulimia Nervosa Clinical Trial
Official title:
Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder
Verified date | January 2018 |
Source | Nova Scotia Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Canada | Capital Health District Health Authority | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Nova Scotia Health Authority |
Canada,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Diagnosis of Bulimia Nervosa or Binge Eating Disorder | A DSM-V diagnosis of bulimia nervosa or binge eating disorder will be determined with the Eating Disorder Diagnostic Scale (EDDS). | Pre-Screening | |
Other | Suicidality | Risk of suicide will be determined with the Columbia - Suicide Severity Rating Scale, Self-Report Screening Version (C-SSRS). | Pre-Screening | |
Primary | 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 | Change in Binge Eating and Purging Frequency | Binge/purge frequency for the month prior will be gathered from self-reported EDE-Q responses. | Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up | |
Secondary | 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. | Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up | |
Secondary | Treatment Satisfaction | Likert-scale and open-ended questions specific to the intervention will be used to assess participant satisfaction with treatment. | Measured at end of treatment (up to 8 weeks) | |
Secondary | 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. | Measured from start of treatment to the end of treatment (up to 8 weeks) |
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