Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application

Not Applicable

Completed

• Conditions: Eating Disorders
• Interventions: Behavioral: Standard Outpatient Treatment; Behavioral: Smartphone App

• Registration Number: NCT02484794
• Lead Sponsor: Nova Scotia Health Authority

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-06-30
• Study Start: 2015-09
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as Usual	Standard Outpatient Treatment	Patients will receive standard outpatient treatment that consists of group psychotherapy, skills training, self-monitoring, nutritional counselling, and meal support.
Treatment with Smartphone App	Standard Outpatient Treatment	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.
Treatment with Smartphone App	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.

Primary Outcome Measures

Name	Time	Method
Change in eating disorder severity as assessed by the Eating Disorder Examination Questionnaire (EDE-Q)	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.

Secondary Outcome Measures

Name	Time	Method
Change in coping self-efficacy as assessed by the Coping Self-Efficacy Scale (CSES)	Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up	A self-report scale that assesses confidence in using various coping skills.
Change in coping skill use as assessed by the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL)	Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up	A self-report measure that assesses the use of DBT-taught coping skills and dysfunctional coping skills.
Treatment acceptability as assessed by the Outpatient Client Experience Survey	Post-treatment (up to 8 months after pre-treatment)	A questionnaire of overall experiences with a mental health or addictions tertiary outpatient program.
Treatment acceptability as assessed by a treatment-specific questionnaire	Post-treatment (up to 8 months after pre-treatment)	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.").
Change in coping skill use as assessed by the Cognitive Behavioral Therapy Skills Questionnaire (CBTSQ)	Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up	A self-report measure that assesses the use of CBT-taught skills.
Dropout rate	Post-treatment (up to 8 months after pre-treatment)	Dropout rates will be calculated for each group as a measure of treatment acceptability.

Trial Locations

Locations (1)

Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada