Eating DisorderNCT02978742
Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder
A study testing Adaptive Recovery Record App and Standardized Coaching in people with Eating Disorder and Bulimia Nervosa, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Eating Disorder, Bulimia Nervosa, Binge Eating Disorder
- What is being tested?
- Adaptive Recovery Record App and Standardized Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2017to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Capital Health District Health Authority
Halifax, Nova Scotia, B3H2E2
About this study
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.
Read the 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.
- Conditions
- Eating Disorder, Bulimia Nervosa, Binge Eating Disorder
- Being tested
- Adaptive Recovery Record App, Standardized Coaching
- Keywords
- Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, App, Smartphone, Self-Help, Coaching, Recovery Record, Mobile Phone, Cognitive Behavioral Therapy
- Medical subject headings
- Feeding and Eating Disorders, Bulimia Nervosa, Binge-Eating Disorder, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Recovery Record AppBehavioural
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.
Standardized CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Adaptive Recovery Record App; Behavioral: 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). Receives: Behavioral: Adaptive Recovery Record App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eating Disorder Symptom Severity
Self-reported symptom severity will be assessed with the Eating Disorder Examination Questionnaire (EDE-Q).
Measured: 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
Binge/purge frequency for the month prior will be gathered from self-reported EDE-Q responses.
Measured: Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up
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: Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up
Treatment Satisfaction
Likert-scale and open-ended questions specific to the intervention will be used to assess participant satisfaction with treatment.
Measured: Measured at end of treatment (up to 8 weeks)
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: Measured from start of treatment to the end of treatment (up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startSep 2017 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Why it stopped: Study not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Keshen, Nova Scotia Health Authority
- Investigators
- Aaron Keshen, MD, FRCPC, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978742
- Sponsor's protocol ID
- 59093009
- Status last verified
- Jan 2018
- First submitted
- 29 Nov 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26213130
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT02978742
- Acronym / sponsor ID
- 59093009
- Conditions
- Eating Disorder, Bulimia Nervosa, Binge Eating Disorder
- Keywords
- Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, App, Smartphone, Self-Help, Coaching, Recovery Record
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coached Recovery Record App | Experimental | Behavioral: Adaptive Recovery Record App, Behavioral: Standardized CoachingParticipants 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. |
| Uncoached Recovery Record App | Active comparator | Behavioral: Adaptive Recovery Record AppParticipants will complete the 8-week adaptive Recovery Record app program on their own (i.e., without a coach providing feedback and support). |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Recovery Record AppParticipants 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. | Behavioural | Coached Recovery Record App, Uncoached Recovery Record App |
| Standardized CoachingCoaches (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. | Behavioural | Coached Recovery Record App |
Primary outcome
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).
4 secondary outcomes
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
Change in Clinical Impairment
Time frame: Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up
Treatment Satisfaction
Time frame: Measured at end of treatment (up to 8 weeks)
Treatment Adherence
Time frame: Measured from start of treatment to the end of treatment (up to 8 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Background: PubMed 26213130Tregarthen 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.
- Recovery Record Smartphone Application WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Keshen, MD, FRCPC principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Recovery Record App and Standardized Coaching in people with Eating Disorder and Bulimia Nervosa, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02978742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.