Eating DisordersNCT02503098
Optimizing a Smartphone Application for Individuals With Eating Disorders
A study testing Recovery Record adaptive smartphone application and Recovery Record standard smartphone application in people with Eating Disorders and Binge Eating Disorder, run by Recovery Record Research at 2 sites in United States.
Trial summary
This study will augment an existing mobile application for individuals with eating disorders by developing adaptive, tailored content targeting remediation of cognitive distortions. The adaptive application will be deployed and assessed for efficacy relative to the standard product in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Eating Disorders, Binge Eating Disorder, Bulimia Nervosa
- What is being tested?
- Recovery Record adaptive smartphone application and Recovery Record standard smartphone application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,340 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Nov 2016to 13 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meets criteria for clinically significant symptoms of eating disorder using self-report measures
- Has an Android or iPhone and is willing to use phone for the study
- Is able to speak and read English
- Lives within the United States of America
- Is at least 16 years of age
Who cannot join
- Has visual, hearing, voice, or motor impairment that would prevent completion of study and treatment procedures
- Has any psychiatric condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders, bipolar disorders, severe post traumatic stress disorder, etc.).
- Exhibits severe suicidality, including ideation, plan, and intent.
- Currently receiving weekly psychotherapy or planning to receive weekly psychotherapy for eating disorder during the 12 weeks of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Recovery Record Research
San Francisco, California, 94107
Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences
Stanford, California, 94304
About this study
This study will augment an existing mobile application for individuals with eating disorders by developing adaptive, tailored content targeting remediation of cognitive distortions. The adaptive application will be deployed and assessed for efficacy relative to the standard product in a randomized controlled trial.
Read the detailed description
Eating Disorders (ED) are common and serious psychological disorders. Anorexia Nervosa (AN) has a prevalence estimated at between 0.48% and 0.70% among young females. Bulimia Nervosa (BN) is a serious mental health problem, with a prevalence of between 1-2% of young women while clinically significant bulimic behaviors occur in an additional 2-3%. There are significant barriers to access of evidence-based treatments and current models of individual psychotherapy will likely never meet the enormous need for psychological services for ED. Unfortunately, even with treatment, rates of recovery are modest with the best performing treatments achieving remission in only about 50% of cases while relapse rates are high, especially if the ED becomes chronic. It is widely acknowledged that a major shift in intervention practice is needed and that smartphone apps will almost certainly play a role due to their reach and breadth of functionality.
As the first commercially available smartphone app for EDs, Recovery Record (RR) has established wide reach and user acceptability. The app provides users with meal and ED symptom self-monitoring and coping skill strategies in an evidence-based CBT format. Preliminary pilot data suggest that for a proportion of RR users, using RR is associated with clinically significant symptom reduction. However, a limitation of the current app is that it is a "one-size-fits-all" product that does not account for the heterogeneity of ED symptoms. Genetic, personality and neurocognitive data support distinct clusters of ED presentations that also differ according to response to treatment, course and outcome. Pilot data confirm that clinical response to RR is not homogenous across groups and that extent of cognitive distortions is the most potent factor to predict outcome. There is considerable opportunity to increase RR's effectiveness across a range of ED symptoms and behaviors by creating adaptive and tailored content focused on remediation of cognitive distortions.
During Phase 1 of this study screening algorithm will be validated against an unseen, prospective test dataset of approximately 2,000 users. All candidate predictor variables will be entered into a Signal Detection Analysis to confirm the sensitivity and specificity of the screen. Informed by the resultant algorithms, adaptive content will be developed that targets ED-specific cognitive distortions. To evaluate acceptability, adapted content will be piloted with approximately 200 individuals for a period of one month. Participant feedback and utilization data will inform content acceptability and feasibility. By the end of the first phase tailored content that is acceptable to individuals with specific symptom presentations will be developed.
Phase 2 will focus on an evaluation of whether an adaptive app offering tailored content addressing eating related cognitive distortions in a stepped way can outperform the current standard app. The adaptive content will be integrated into a new, dynamic version of the app (RR-A) that will then be evaluated against the current app (RR-S). Approximately 5,000 registered users of RR will be randomized to receive either RR augmented with targeted content (RR-A), or RR in its current standard format (RR-S) over a two-month period. Outcome data will be measured at baseline, one month, end of treatment, and at six-month follow-up. At the end of the study period it is predicted that the resultant evidence-based product will have demonstrated ability to bring about clinically significant reduction in symptoms in more users than the current app, and thus will have potential to make a substantial public health impact.
- Conditions
- Eating Disorders, Binge Eating Disorder, Bulimia Nervosa
- Being tested
- Recovery Record adaptive smartphone application, Recovery Record standard smartphone application
- Keywords
- Eating Disorders, Cognitive Behavioral Therapy, Mobile Phone, Smartphone, App, Binge Eating Disorder, Bulimia Nervosa, Signal Detection Analysis
- Medical subject headings
- Feeding and Eating Disorders, Binge-Eating Disorder, Bulimia Nervosa, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Record adaptive smartphone applicationBehavioural
Recovery Record standard smartphone applicationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Recovery Record adaptive smartphone application (RR-A) | Experimental | Participants will have access to all Recovery Record standard functions and will additionally receive tailored, algorithm-generated content targeting cognitive distortions. Receives: Behavioral: Recovery Record adaptive smartphone application |
| Recovery Record standard smartphone application (RR-S) | Active comparator | Participants will have access to all Recovery Record standard functions, including meal monitoring, motivational enhancement, social support, and coping skill strategies. Receives: Behavioral: Recovery Record standard smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Eating Disorder Severity
Self-reported eating disorder symptom severity. To measure changes in eating disorder severity over time, the Eating Disorder Evaluation Questionnaire (EDE-Q) will be used.
Measured: Measured at the start of treatment (baseline), week 4, week 8 and 6 months follow-up
Secondary outcomes (5)
Binge eating and purging episode frequency
Self-reported disordered behavior frequency will be assessed via behaviors self-monitored in the application in addition to symptom frequency questions in the Eating Disorder Evaluation Questionnaire.
Measured: Measured at the start of treatment (baseline), week 4, week 8 and 6 months follow-up
Changes in Clinical Impairment Severity
To measure changes in eating disorder related clinical impairment over time, the self-reported Clinical Impairment Assessment (CIA) will be used.
Measured: Measured at the start of treatment (baseline), week 4, week 8 and 6 months follow-up
Participant Satisfaction
Self-reported satisfaction
Measured: Participants will be followed for the duration of the 8-week trial
Adherence to the mobile application intervention
Adherence will be measured via dichotomous outcome of drop-out (an individual will be considered a system drop-out if they fail to login to the app at all for a period of 14 consecutive days). Adherence will be assessed through application usage data.
Measured: Measured from the start of application utilization (baseline) to 8-weeks
Adherence to self-monitoring tasks
Frequency of self-monitoring entries will be tracked automatically through the program server.
Measured: Measured from the start of application utilization (baseline) 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 posted20 Jul 2015 (estimated)
- Study start23 Nov 2016
- Primary completion13 Jul 2018
- Study completion13 Sep 2018
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 DisordersStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recovery Record Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503098
- Sponsor's protocol ID
- RRR-023
- Status last verified
- Oct 2020
- First submitted
- 15 Jul 2015
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tregarthen J, Paik Kim J, Sadeh-Sharvit S, Neri E, Welch H, Lock J. Comparing a Tailored Self-Help Mobile App With a Standard Self-Monitoring App for the Treatment of Eating Disorder Symptoms: Randomized Controlled Trial. JMIR Ment Health. 2019 Nov 21;6(11):e14972. doi: 10.2196/14972.
PubMed 31750837
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Smartphone Application for Individuals With Eating Disorders
- ClinicalTrials.gov ID
- NCT02503098
- Acronym / sponsor ID
- RRR-023
- Conditions
- Eating Disorders, Binge Eating Disorder, Bulimia Nervosa
- Keywords
- Eating Disorders, Cognitive Behavioral Therapy, Mobile Phone, Smartphone, App, Binge Eating Disorder, Bulimia Nervosa, Signal Detection Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,340 participants (actual)
- Lead sponsor
- Recovery Record ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 23 Nov 2016 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 20 Jul 2015 (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.
This study will augment an existing mobile application for individuals with eating disorders by developing adaptive, tailored content targeting remediation of cognitive distortions. The adaptive application will be deployed and assessed for efficacy relative to the standard product in a randomized controlled trial.
Detailed description
Eating Disorders (ED) are common and serious psychological disorders. Anorexia Nervosa (AN) has a prevalence estimated at between 0.48% and 0.70% among young females. Bulimia Nervosa (BN) is a serious mental health problem, with a prevalence of between 1-2% of young women while clinically significant bulimic behaviors occur in an additional 2-3%. There are significant barriers to access of evidence-based treatments and current models of individual psychotherapy will likely never meet the enormous need for psychological services for ED. Unfortunately, even with treatment, rates of recovery are modest with the best performing treatments achieving remission in only about 50% of cases while relapse rates are high, especially if the ED becomes chronic. It is widely acknowledged that a major shift in intervention practice is needed and that smartphone apps will almost certainly play a role due to their reach and breadth of functionality.
As the first commercially available smartphone app for EDs, Recovery Record (RR) has established wide reach and user acceptability. The app provides users with meal and ED symptom self-monitoring and coping skill strategies in an evidence-based CBT format. Preliminary pilot data suggest that for a proportion of RR users, using RR is associated with clinically significant symptom reduction. However, a limitation of the current app is that it is a "one-size-fits-all" product that does not account for the heterogeneity of ED symptoms. Genetic, personality and neurocognitive data support distinct clusters of ED presentations that also differ according to response to treatment, course and outcome. Pilot data confirm that clinical response to RR is not homogenous across groups and that extent of cognitive distortions is the most potent factor to predict outcome. There is considerable opportunity to increase RR's effectiveness across a range of ED symptoms and behaviors by creating adaptive and tailored content focused on remediation of cognitive distortions.
During Phase 1 of this study screening algorithm will be validated against an unseen, prospective test dataset of approximately 2,000 users. All candidate predictor variables will be entered into a Signal Detection Analysis to confirm the sensitivity and specificity of the screen. Informed by the resultant algorithms, adaptive content will be developed that targets ED-specific cognitive distortions. To evaluate acceptability, adapted content will be piloted with approximately 200 individuals for a period of one month. Participant feedback and utilization data will inform content acceptability and feasibility. By the end of the first phase tailored content that is acceptable to individuals with specific symptom presentations will be developed.
Phase 2 will focus on an evaluation of whether an adaptive app offering tailored content addressing eating related cognitive distortions in a stepped way can outperform the current standard app. The adaptive content will be integrated into a new, dynamic version of the app (RR-A) that will then be evaluated against the current app (RR-S). Approximately 5,000 registered users of RR will be randomized to receive either RR augmented with targeted content (RR-A), or RR in its current standard format (RR-S) over a two-month period. Outcome data will be measured at baseline, one month, end of treatment, and at six-month follow-up. At the end of the study period it is predicted that the resultant evidence-based product will have demonstrated ability to bring about clinically significant reduction in symptoms in more users than the current app, and thus will have potential to make a substantial public health impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery Record adaptive smartphone application (RR-A) | Experimental | Behavioral: Recovery Record adaptive smartphone applicationParticipants will have access to all Recovery Record standard functions and will additionally receive tailored, algorithm-generated content targeting cognitive distortions. |
| Recovery Record standard smartphone application (RR-S) | Active comparator | Behavioral: Recovery Record standard smartphone applicationParticipants will have access to all Recovery Record standard functions, including meal monitoring, motivational enhancement, social support, and coping skill strategies. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Meets criteria for clinically significant symptoms of eating disorder using self-report measures
- Has an Android or iPhone and is willing to use phone for the study
- Is able to speak and read English
- Lives within the United States of America
- Is at least 16 years of age
Key exclusion criteria (4 listed)
- Has visual, hearing, voice, or motor impairment that would prevent completion of study and treatment procedures
- Has any psychiatric condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders, bipolar disorders, severe post traumatic stress disorder, etc.).
- Exhibits severe suicidality, including ideation, plan, and intent.
- Currently receiving weekly psychotherapy or planning to receive weekly psychotherapy for eating disorder during the 12 weeks of the study.
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 |
|---|---|---|
| Recovery Record adaptive smartphone application | Behavioural | Recovery Record adaptive smartphone application (RR-A) |
| Recovery Record standard smartphone application | Behavioural | Recovery Record standard smartphone application (RR-S) |
Primary outcome
Changes in Eating Disorder Severity
Time frame: Measured at the start of treatment (baseline), week 4, week 8 and 6 months follow-up
Self-reported eating disorder symptom severity. To measure changes in eating disorder severity over time, the Eating Disorder Evaluation Questionnaire (EDE-Q) will be used.
5 secondary outcomes
Binge eating and purging episode frequency
Time frame: Measured at the start of treatment (baseline), week 4, week 8 and 6 months follow-up
Changes in Clinical Impairment Severity
Time frame: Measured at the start of treatment (baseline), week 4, week 8 and 6 months follow-up
Participant Satisfaction
Time frame: Participants will be followed for the duration of the 8-week trial
Adherence to the mobile application intervention
Time frame: Measured from the start of application utilization (baseline) to 8-weeks
Adherence to self-monitoring tasks
Time frame: Measured from the start of application utilization (baseline) to 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Derived from this study: PubMed 31750837Tregarthen J, Paik Kim J, Sadeh-Sharvit S, Neri E, Welch H, Lock J. Comparing a Tailored Self-Help Mobile App With a Standard Self-Monitoring App for the Treatment of Eating Disorder Symptoms: Randomized Controlled Trial. JMIR Ment Health. 2019 Nov 21;6(11):e14972. doi: 10.2196/14972.
- Recovery Record smartphone application websiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Record adaptive smartphone application and Recovery Record standard smartphone application in people with Eating Disorders and Binge Eating Disorder, run by Recovery Record Research at 2 sites in United States.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Eating Disorder Severity (time frame: Measured at the start of treatment (baseline), week 4, week 8 and 6 months 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 NCT02503098, 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 6 Oct 2020.