Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application

Eating Disorders Clinical Trial

Official title:

Efficacy and Acceptability of Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application: A Pilot RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484794
• Other study ID #: 59093007
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: May 31, 2019

Study information

• Verified date: January 2020
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Standard Outpatient Treatment
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 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.

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnoses validated by the Eating Disorder Diagnostic Scale (EDDS)	A self-report diagnostic measure that will be used to validate clinical diagnoses (as determined by team psychiatrist or clinical psychologist).	Pre-treatment
Primary	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.	Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Secondary	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.	Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Secondary	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.	Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Secondary	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.	Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Secondary	Treatment acceptability as assessed by the Outpatient Client Experience Survey	A questionnaire of overall experiences with a mental health or addictions tertiary outpatient program.	Post-treatment (up to 8 months after pre-treatment)
Secondary	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.").	Post-treatment (up to 8 months after pre-treatment)
Secondary	Dropout rate	Dropout rates will be calculated for each group as a measure of treatment acceptability.	Post-treatment (up to 8 months after pre-treatment)