Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application

Sponsor

Nova Scotia Health Authority (Other)

Overall Status

Completed

CT.gov ID

NCT02484794

Collaborator

(none)

Enrollment

Location

Arms

44.9

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Disorders	Behavioral: Standard Outpatient Treatment Behavioral: Smartphone App	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

May 31, 2019

Actual Study Completion Date :

May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment as Usual Patients will receive standard outpatient treatment that consists of group psychotherapy, skills training, self-monitoring, nutritional counselling, and meal support.	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. Other Names: Treatment as Usual (TAU)
Experimental: 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.	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. Other Names: Treatment as Usual (TAU) 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. Other Names: Recovery Record App

Arm

Intervention/Treatment

Active Comparator: Treatment as Usual

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

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.

Other Names:

Treatment as Usual (TAU)

Experimental: 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.

Behavioral: Standard Outpatient Treatment

Other Names:

Treatment as Usual (TAU)

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.

Other Names:

Recovery Record App

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
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.").
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.

Other Outcome Measures

Diagnoses validated by the Eating Disorder Diagnostic Scale (EDDS) [Pre-treatment]
A self-report diagnostic measure that will be used to validate clinical diagnoses (as determined by team psychiatrist or clinical psychologist).

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts 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.