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Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application

Primary Purpose

Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard Outpatient Treatment
Smartphone App
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring Eating Disorders, Smartphone, App, Mobile Health, Recovery Record, Cognitive Behavioural Therapy, Outpatient Program, Self Monitoring

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient has insufficient knowledge of English.

Sites / Locations

  • Nova Scotia Health Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment as Usual

Treatment with Smartphone App

Arm Description

Patients will receive standard outpatient treatment that consists of group psychotherapy, skills training, self-monitoring, nutritional counselling, and meal support.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Treatment acceptability as assessed by the Outpatient Client Experience Survey
A questionnaire of overall experiences with a mental health or addictions tertiary outpatient program.
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.").
Dropout rate
Dropout rates will be calculated for each group as a measure of treatment acceptability.

Full Information

First Posted
June 23, 2015
Last Updated
January 23, 2020
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT02484794
Brief Title
Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application
Official Title
Efficacy and Acceptability of Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application: A Pilot RCT
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Eating Disorders, Smartphone, App, Mobile Health, Recovery Record, Cognitive Behavioural Therapy, Outpatient Program, Self Monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Patients will receive standard outpatient treatment that consists of group psychotherapy, skills training, self-monitoring, nutritional counselling, and meal support.
Arm Title
Treatment with Smartphone App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Outpatient Treatment
Other Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone App
Other Intervention Name(s)
Recovery Record App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in eating disorder severity as assessed by the Eating Disorder Examination Questionnaire (EDE-Q)
Description
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.
Time Frame
Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Secondary Outcome Measure Information:
Title
Change in coping skill use as assessed by the Cognitive Behavioral Therapy Skills Questionnaire (CBTSQ)
Description
A self-report measure that assesses the use of CBT-taught skills.
Time Frame
Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Title
Change in coping skill use as assessed by the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL)
Description
A self-report measure that assesses the use of DBT-taught coping skills and dysfunctional coping skills.
Time Frame
Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Title
Change in coping self-efficacy as assessed by the Coping Self-Efficacy Scale (CSES)
Description
A self-report scale that assesses confidence in using various coping skills.
Time Frame
Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Title
Treatment acceptability as assessed by the Outpatient Client Experience Survey
Description
A questionnaire of overall experiences with a mental health or addictions tertiary outpatient program.
Time Frame
Post-treatment (up to 8 months after pre-treatment)
Title
Treatment acceptability as assessed by a treatment-specific questionnaire
Description
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.").
Time Frame
Post-treatment (up to 8 months after pre-treatment)
Title
Dropout rate
Description
Dropout rates will be calculated for each group as a measure of treatment acceptability.
Time Frame
Post-treatment (up to 8 months after pre-treatment)
Other Pre-specified Outcome Measures:
Title
Diagnoses validated by the Eating Disorder Diagnostic Scale (EDDS)
Description
A self-report diagnostic measure that will be used to validate clinical diagnoses (as determined by team psychiatrist or clinical psychologist).
Time Frame
Pre-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patient has insufficient knowledge of English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Keshen, MD, FRCPC
Organizational Affiliation
Nova Scotia Health Authority/Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32050044
Citation
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.
Results Reference
derived

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Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application

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