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Completed

NCT Number: NCT02484794

Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application

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.

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Key information

Conditions

Eating Disorders Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Feeding and Eating Disorders Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Tauopathies

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H2E2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Outpatient Treatment

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.

Other names: Treatment as Usual (TAU)

Smartphone App

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.

Other names: Recovery Record App

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change in coping skill use as assessed by the Cognitive Behavioral Therapy Skills Questionnaire (CBTSQ)

    Time frame: 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.

  2. Change in coping skill use as assessed by the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL)

    Time frame: 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.

  3. Change in coping self-efficacy as assessed by the Coping Self-Efficacy Scale (CSES)

    Time frame: 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.

  4. Treatment acceptability as assessed by the Outpatient Client Experience Survey

    Time frame: Post-treatment (up to 8 months after pre-treatment)

    A questionnaire of overall experiences with a mental health or addictions tertiary outpatient program.

  5. Treatment acceptability as assessed by a treatment-specific questionnaire

    Time frame: 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.").

  6. Dropout rate

    Time frame: Post-treatment (up to 8 months after pre-treatment)

    Dropout rates will be calculated for each group as a measure of treatment acceptability.

Other outcomes

  1. Diagnoses validated by the Eating Disorder Diagnostic Scale (EDDS)

    Time frame: Pre-treatment

    A self-report diagnostic measure that will be used to validate clinical diagnoses (as determined by team psychiatrist or clinical psychologist).

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 30, 2015
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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