Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application

NCT ID: NCT02484794

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-05-31

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.

Conditions

Eating Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment as Usual

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

Group Type: ACTIVE_COMPARATOR

Standard Outpatient Treatment

Intervention Type: BEHAVIORAL

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.

Treatment with Smartphone App

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.

Group Type: EXPERIMENTAL

Standard Outpatient Treatment

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Treatment as Usual (TAU); Recovery Record App

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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Aaron Keshen

Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron Keshen, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority/Dalhousie University

Locations

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32050044 (View on PubMed)

Other Identifiers

59093007

Identifier Type: -

Identifier Source: org_study_id