ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimizing a Smartphone Application for Individuals With Eating Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02503098
Recruitment Status : Recruiting
First Posted : July 20, 2015
Last Update Posted : February 20, 2017
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Recovery Record Research

Brief Summary:
This study will augment an existing mobile application for individuals with eating disorders by developing adaptive, tailored content targeting remediation of cognitive distortions. The adaptive application will be deployed and assessed for efficacy relative to the standard product in a randomized controlled trial.

Condition or disease Intervention/treatment Phase
Eating Disorders Binge Eating Disorder Bulimia Nervosa Behavioral: Recovery Record adaptive smartphone application Behavioral: Recovery Record standard smartphone application Not Applicable

Detailed Description:

Eating Disorders (ED) are common and serious psychological disorders. Anorexia Nervosa (AN) has a prevalence estimated at between 0.48% and 0.70% among young females. Bulimia Nervosa (BN) is a serious mental health problem, with a prevalence of between 1-2% of young women while clinically significant bulimic behaviors occur in an additional 2-3%. There are significant barriers to access of evidence-based treatments and current models of individual psychotherapy will likely never meet the enormous need for psychological services for ED. Unfortunately, even with treatment, rates of recovery are modest with the best performing treatments achieving remission in only about 50% of cases while relapse rates are high, especially if the ED becomes chronic. It is widely acknowledged that a major shift in intervention practice is needed and that smartphone apps will almost certainly play a role due to their reach and breadth of functionality.

As the first commercially available smartphone app for EDs, Recovery Record (RR) has established wide reach and user acceptability. The app provides users with meal and ED symptom self-monitoring and coping skill strategies in an evidence-based CBT format. Preliminary pilot data suggest that for a proportion of RR users, using RR is associated with clinically significant symptom reduction. However, a limitation of the current app is that it is a "one-size-fits-all" product that does not account for the heterogeneity of ED symptoms. Genetic, personality and neurocognitive data support distinct clusters of ED presentations that also differ according to response to treatment, course and outcome. Pilot data confirm that clinical response to RR is not homogenous across groups and that extent of cognitive distortions is the most potent factor to predict outcome. There is considerable opportunity to increase RR's effectiveness across a range of ED symptoms and behaviors by creating adaptive and tailored content focused on remediation of cognitive distortions.

During Phase 1 of this study screening algorithm will be validated against an unseen, prospective test dataset of approximately 2,000 users. All candidate predictor variables will be entered into a Signal Detection Analysis to confirm the sensitivity and specificity of the screen. Informed by the resultant algorithms, adaptive content will be developed that targets ED-specific cognitive distortions. To evaluate acceptability, adapted content will be piloted with approximately 200 individuals for a period of one month. Participant feedback and utilization data will inform content acceptability and feasibility. By the end of the first phase tailored content that is acceptable to individuals with specific symptom presentations will be developed.

Phase 2 will focus on an evaluation of whether an adaptive app offering tailored content addressing eating related cognitive distortions in a stepped way can outperform the current standard app. The adaptive content will be integrated into a new, dynamic version of the app (RR-A) that will then be evaluated against the current app (RR-S). Approximately 5,000 registered users of RR will be randomized to receive either RR augmented with targeted content (RR-A), or RR in its current standard format (RR-S) over a two-month period. Outcome data will be measured at baseline, one month, end of treatment, and at six-month follow-up. At the end of the study period it is predicted that the resultant evidence-based product will have demonstrated ability to bring about clinically significant reduction in symptoms in more users than the current app, and thus will have potential to make a substantial public health impact.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Optimizing a Smartphone Application for Individuals With Eating Disorders
Actual Study Start Date : November 23, 2016
Estimated Primary Completion Date : March 23, 2018
Estimated Study Completion Date : May 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Recovery Record adaptive smartphone application (RR-A)
Participants will have access to all Recovery Record standard functions and will additionally receive tailored, algorithm-generated content targeting cognitive distortions.
Behavioral: Recovery Record adaptive smartphone application
Active Comparator: Recovery Record standard smartphone application (RR-S)
Participants will have access to all Recovery Record standard functions, including meal monitoring, motivational enhancement, social support, and coping skill strategies.
Behavioral: Recovery Record standard smartphone application



Primary Outcome Measures :
  1. Changes in Eating Disorder Severity [ Time Frame: Measured at the start of treatment (baseline), week 4, week 8 and 6 months follow-up ]
    Self-reported eating disorder symptom severity. To measure changes in eating disorder severity over time, the Eating Disorder Evaluation Questionnaire (EDE-Q) will be used.


Secondary Outcome Measures :
  1. Binge eating and purging episode frequency [ Time Frame: Measured at the start of treatment (baseline), week 4, week 8 and 6 months follow-up ]
    Self-reported disordered behavior frequency will be assessed via behaviors self-monitored in the application in addition to symptom frequency questions in the Eating Disorder Evaluation Questionnaire.

  2. Changes in Clinical Impairment Severity [ Time Frame: Measured at the start of treatment (baseline), week 4, week 8 and 6 months follow-up ]
    To measure changes in eating disorder related clinical impairment over time, the self-reported Clinical Impairment Assessment (CIA) will be used.

  3. Participant Satisfaction [ Time Frame: Participants will be followed for the duration of the 8-week trial ]
    Self-reported satisfaction

  4. Adherence to the mobile application intervention [ Time Frame: Measured from the start of application utilization (baseline) to 8-weeks ]
    Adherence will be measured via dichotomous outcome of drop-out (an individual will be considered a system drop-out if they fail to login to the app at all for a period of 14 consecutive days). Adherence will be assessed through application usage data.

  5. Adherence to self-monitoring tasks [ Time Frame: Measured from the start of application utilization (baseline) to 8-weeks ]
    Frequency of self-monitoring entries will be tracked automatically through the program server.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets criteria for clinically significant symptoms of eating disorder using self-report measures
  • Has an Android or iPhone and is willing to use phone for the study
  • Is able to speak and read English
  • Lives within the United States of America
  • Is at least 16 years of age

Exclusion Criteria:

  • Has visual, hearing, voice, or motor impairment that would prevent completion of study and treatment procedures
  • Has any psychiatric condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders, bipolar disorders, severe post traumatic stress disorder, etc.).
  • Exhibits severe suicidality, including ideation, plan, and intent.
  • Currently receiving weekly psychotherapy or planning to receive weekly psychotherapy for eating disorder during the 12 weeks of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503098


Contacts
Contact: Jenna P Tregarthen 6504047098 jenna@recoveryrecord.com
Contact: Alison M Darcy, PhD 650 736 7972 adarcy@stanford.edu

Locations
United States, California
Recovery Record Research Recruiting
San Francisco, California, United States, 94107
Contact: Jenna P Tregarthen    650-404-7098    jenna@recoveryrecord.com   
Principal Investigator: Jenna P Tregarthen, PgDip         
Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences Recruiting
Stanford, California, United States, 94304
Contact: Alison Darcy, PhD    650-736-7972    adarcy@stanford.edu   
Principal Investigator: James Lock, M.D., PhD         
Sub-Investigator: Alison Darcy, PhD         
Sub-Investigator: Kim J Piak, PhD         
Sponsors and Collaborators
Recovery Record Research
Stanford University

Additional Information:
Responsible Party: Recovery Record Research
ClinicalTrials.gov Identifier: NCT02503098     History of Changes
Other Study ID Numbers: RRR-023
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017

Keywords provided by Recovery Record Research:
Eating Disorders
Cognitive Behavioral Therapy
Mobile Phone
Smartphone
App
Binge Eating Disorder
Bulimia Nervosa
Signal Detection Analysis

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Bulimia Nervosa
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms