Clinical trial NCT02484794: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Keywords: Eating Disorders
Smartphone
App
Mobile Health
Recovery Record
Cognitive Behavioural Therapy
Outpatient Program
Self Monitoring
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 91
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in eating disorder severity as assessed by the Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
Secondary outcomes:
measure: Change in coping skill use as assessed by the Cognitive Behavioral Therapy Skills Questionnaire (CBTSQ)
timeFrame: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
measure: Change in coping skill use as assessed by the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL)
timeFrame: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
measure: Change in coping self-efficacy as assessed by the Coping Self-Efficacy Scale (CSES)
timeFrame: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
measure: Treatment acceptability as assessed by the Outpatient Client Experience Survey
timeFrame: Post-treatment (up to 8 months after pre-treatment)
measure: Treatment acceptability as assessed by a treatment-specific questionnaire
timeFrame: Post-treatment (up to 8 months after pre-treatment)
measure: Dropout rate
timeFrame: Post-treatment (up to 8 months after pre-treatment)
Other outcomes:
measure: Diagnoses validated by the Eating Disorder Diagnostic Scale (EDDS)
timeFrame: Pre-treatment
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority/Dalhousie University
name: Aaron Keshen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.