Eating DisordersNCT02484794
Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application
A study testing Standard Outpatient Treatment and Smartphone App in people with Eating Disorders, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Cognitive behavioural therapy (CBT) is the most empirically supported and researched treatment for eating disorders. A central component of CBT for eating disorders is self-monitoring which involves patients keeping a paper food record of their meals and associated thoughts, feelings, and behaviours and receiving… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Standard Outpatient Treatment and Smartphone App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to 31 May 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with an eating disorder (anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified) according to DSM-V criteria (American Psychiatric Association, 2013) as determined through a standard clinical interview by either a team psychiatrist or clinical psychologist, and validated with a self-report diagnostic measure.
- Patients with an Apple or Android smartphone (a mobile phone with access to third-party applications and advanced features) with an active data plan or frequent (e.g., daily) Wi-Fi access.
- Patients 17 years or older.
- Signed consent from patient.
Who cannot join
- Patient has insufficient knowledge of English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Acceptability of Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application: A Pilot RCT
Cognitive behavioural therapy (CBT) is the most empirically supported and researched treatment for eating disorders. A central component of CBT for eating disorders is self-monitoring which involves patients keeping a paper food record of their meals and associated thoughts, feelings, and behaviours and receiving feedback from a clinician to help target dysfunctional cognitions and behaviours. Given the issues associated with paper journals such as non-compliance, feelings of shame when used in public, and delayed feedback, researchers have developed an evidence-based smartphone application (Recovery Record) for eating disorder self-monitoring that links patients with their clinicians and offers additional features designed to enhance treatment.
The current pilot randomised controlled trial (RCT) seeks to evaluate this smartphone application in a clinical setting alongside standard eating disorder outpatient treatment. Patients will be recruited from the Nova Scotia Health Authority Eating Disorder Outpatient Program and randomised to receive either standard treatment or standard treatment with the app (instead of the paper food record). The efficacy and acceptability of both treatments will be assessed and compared. Coping skill use and self-efficacy among patients will also be examined given the skill building focus of treatment and in-app capabilities to deliver real-time coping skill suggestions to patients.
This pilot study will be the first to examine the efficacy and acceptability of a smartphone application in eating disorder clinical treatment and if successful, should provide preliminary support for the use of smartphone applications over traditional paper food journals as a self-monitoring tool for augmenting specialty eating disorder clinical treatment.
- Conditions
- Eating Disorders
- Being tested
- Standard Outpatient Treatment, Smartphone App
- Keywords
- Eating Disorders, Smartphone, App, Mobile Health, Recovery Record, Cognitive Behavioural Therapy, Outpatient Program, Self Monitoring
- Medical subject headings
- Feeding and Eating Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Outpatient TreatmentBehavioural
Also called Treatment as Usual (TAU)
Standard treatment offered by the Nova Scotia Health Authority Eating Disorder Outpatient Program varies in intensity but involves therapy groups (e.g., goal setting and skill building groups), individual contact, and meal experiences. Minimal participation in the program consists of a weekly nutritional counselling group (Nutri-Logical) and one supervised meal a week. In the nutritional counselling group, patients keep a food journal (self-monitor), set eating goals, receive feedback from a psychologist and dietitian, and share experiences with the group.
Smartphone AppBehavioural
Also called Recovery Record App
The smartphone app is a mobile eating disorder self-monitoring tool that incorporates discrete reminders, positive feedback, social support, summative feedback, coping skill suggestions, and linking patients with their treating clinicians (psychologist and dietician). The app is CBT-based and was designed as an alternative to paper food records for use in clinical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | Patients will receive standard outpatient treatment that consists of group psychotherapy, skills training, self-monitoring, nutritional counselling, and meal support. Receives: Behavioral: Standard Outpatient Treatment |
| Treatment with Smartphone App | Experimental | Patients will receive the same standard outpatient treatment but will use the smartphone application instead of the paper food record. Patients in this group will receive daily feedback through the app, as opposed to weekly, but will still attend the weekly nutritional counselling group. Receives: Behavioral: Standard Outpatient Treatment; Behavioral: Smartphone App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eating disorder severity as assessed by the Eating Disorder Examination Questionnaire (EDE-Q)
A self-report scale that assesses the severity of 4 areas of eating disorder pathology: Eating Concern, Weight Concern, Dietary Restraint, and Shape Concern. Overall eating disorder severity is also assessed.
Measured: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Secondary outcomes (6)
Change in coping skill use as assessed by the Cognitive Behavioral Therapy Skills Questionnaire (CBTSQ)
A self-report measure that assesses the use of CBT-taught skills.
Measured: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Change in coping skill use as assessed by the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL)
A self-report measure that assesses the use of DBT-taught coping skills and dysfunctional coping skills.
Measured: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Change in coping self-efficacy as assessed by the Coping Self-Efficacy Scale (CSES)
A self-report scale that assesses confidence in using various coping skills.
Measured: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Treatment acceptability as assessed by the Outpatient Client Experience Survey
A questionnaire of overall experiences with a mental health or addictions tertiary outpatient program.
Measured: Post-treatment (up to 8 months after pre-treatment)
Treatment acceptability as assessed by a treatment-specific questionnaire
Additional Likert scale/open-ended questions pertaining to the self-monitoring tool used (app or paper food record) were developed to assess patient satisfaction with treatment (e.g., "I felt that I could discretely log my meals.").
Measured: Post-treatment (up to 8 months after pre-treatment)
Dropout rate
Dropout rates will be calculated for each group as a measure of treatment acceptability.
Measured: Post-treatment (up to 8 months after pre-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startSep 2015
- Primary completion31 May 2019
- Study completion31 May 2019
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.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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
- 91 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/Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484794
- Sponsor's protocol ID
- 59093007
- Status last verified
- Jan 2020
- First submitted
- 23 Jun 2015
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Keshen A, Helson T, Ali S, Dixon L, Tregarthen J, Town J. Efficacy and acceptability of self-monitoring via a smartphone application versus traditional paper records in an intensive outpatient eating disorder treatment setting. Eur Eat Disord Rev. 2020 Jul;28(4):473-479. doi: 10.1002/erv.2727. Epub 2020 Feb 12.
PubMed 32050044
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Acceptability of Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application: A Pilot RCT
- ClinicalTrials.gov ID
- NCT02484794
- Acronym / sponsor ID
- 59093007
- Conditions
- Eating Disorders
- Keywords
- Eating Disorders, Smartphone, App, Mobile Health, Recovery Record, Cognitive Behavioural Therapy, Outpatient Program, Self Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 30 Jun 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.
Cognitive behavioural therapy (CBT) is the most empirically supported and researched treatment for eating disorders. A central component of CBT for eating disorders is self-monitoring which involves patients keeping a paper food record of their meals and associated thoughts, feelings, and behaviours and receiving feedback from a clinician to help target dysfunctional cognitions and behaviours. Given the issues associated with paper journals such as non-compliance, feelings of shame when used in public, and delayed feedback, researchers have developed an evidence-based smartphone application (Recovery Record) for eating disorder self-monitoring that links patients with their clinicians and offers additional features designed to enhance treatment.
The current pilot randomised controlled trial (RCT) seeks to evaluate this smartphone application in a clinical setting alongside standard eating disorder outpatient treatment. Patients will be recruited from the Nova Scotia Health Authority Eating Disorder Outpatient Program and randomised to receive either standard treatment or standard treatment with the app (instead of the paper food record). The efficacy and acceptability of both treatments will be assessed and compared. Coping skill use and self-efficacy among patients will also be examined given the skill building focus of treatment and in-app capabilities to deliver real-time coping skill suggestions to patients.
This pilot study will be the first to examine the efficacy and acceptability of a smartphone application in eating disorder clinical treatment and if successful, should provide preliminary support for the use of smartphone applications over traditional paper food journals as a self-monitoring tool for augmenting specialty eating disorder clinical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Behavioral: Standard Outpatient TreatmentPatients will receive standard outpatient treatment that consists of group psychotherapy, skills training, self-monitoring, nutritional counselling, and meal support. |
| Treatment with Smartphone App | Experimental | Behavioral: Standard Outpatient Treatment, Behavioral: Smartphone AppPatients will receive the same standard outpatient treatment but will use the smartphone application instead of the paper food record. Patients in this group will receive daily feedback through the app, as opposed to weekly, but will still attend the weekly nutritional counselling group. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with an eating disorder (anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified) according to DSM-V criteria (American Psychiatric Association, 2013) as determined through a standard clinical interview by either a team psychiatrist or clinical psychologist, and validated with a self-report diagnostic measure.
- Patients with an Apple or Android smartphone (a mobile phone with access to third-party applications and advanced features) with an active data plan or frequent (e.g., daily) Wi-Fi access.
- Patients 17 years or older.
- Signed consent from patient.
Key exclusion criteria (1 listed)
- Patient has insufficient knowledge of English.
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 |
|---|---|---|
| Standard Outpatient TreatmentAlso: Treatment as Usual (TAU)Standard treatment offered by the Nova Scotia Health Authority Eating Disorder Outpatient Program varies in intensity but involves therapy groups (e.g., goal setting and skill building groups), individual contact, and meal experiences. Minimal participation in the program consists of a weekly nutritional counselling group (Nutri-Logical) and one supervised meal a week. In the nutritional counselling group, patients keep a food journal (self-monitor), set eating goals, receive feedback from a psychologist and dietitian, and share experiences with the group. | Behavioural | Treatment as Usual, Treatment with Smartphone App |
| Smartphone AppAlso: Recovery Record AppThe smartphone app is a mobile eating disorder self-monitoring tool that incorporates discrete reminders, positive feedback, social support, summative feedback, coping skill suggestions, and linking patients with their treating clinicians (psychologist and dietician). The app is CBT-based and was designed as an alternative to paper food records for use in clinical treatment. | Behavioural | Treatment with Smartphone App |
Primary outcome
Change in eating disorder severity as assessed by the Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
A self-report scale that assesses the severity of 4 areas of eating disorder pathology: Eating Concern, Weight Concern, Dietary Restraint, and Shape Concern. Overall eating disorder severity is also assessed.
6 secondary outcomes
Change in coping skill use as assessed by the Cognitive Behavioral Therapy Skills Questionnaire (CBTSQ)
Time frame: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Change in coping skill use as assessed by the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL)
Time frame: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Change in coping self-efficacy as assessed by the Coping Self-Efficacy Scale (CSES)
Time frame: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Treatment acceptability as assessed by the Outpatient Client Experience Survey
Time frame: Post-treatment (up to 8 months after pre-treatment)
Treatment acceptability as assessed by a treatment-specific questionnaire
Time frame: Post-treatment (up to 8 months after pre-treatment)
Dropout rate
Time frame: Post-treatment (up to 8 months after pre-treatment)
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 27 Jan 2020.
- Derived from this study: PubMed 32050044Keshen A, Helson T, Ali S, Dixon L, Tregarthen J, Town J. Efficacy and acceptability of self-monitoring via a smartphone application versus traditional paper records in an intensive outpatient eating disorder treatment setting. Eur Eat Disord Rev. 2020 Jul;28(4):473-479. doi: 10.1002/erv.2727. Epub 2020 Feb 12.
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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/Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Outpatient Treatment and Smartphone App in people with Eating Disorders, 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 4 inclusion and 1 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 27 Jan 2020. 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 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?
Change in eating disorder severity as assessed by the Eating Disorder Examination Questionnaire (EDE-Q) (time frame: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 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 NCT02484794, 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 27 Jan 2020.