Optimizing a Smartphone Application for Individuals With Eating Disorders
1 other identifier
interventional
3,340
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2015
CompletedFirst Posted
Study publicly available on registry
July 20, 2015
CompletedStudy Start
First participant enrolled
November 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2018
CompletedOctober 6, 2020
October 1, 2020
1.6 years
July 15, 2015
October 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Eating Disorder Severity
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.
Measured at the start of treatment (baseline), week 4, week 8 and 6 months follow-up
Secondary Outcomes (5)
Binge eating and purging episode frequency
Measured at the start of treatment (baseline), week 4, week 8 and 6 months follow-up
Changes in Clinical Impairment Severity
Measured at the start of treatment (baseline), week 4, week 8 and 6 months follow-up
Participant Satisfaction
Participants will be followed for the duration of the 8-week trial
Adherence to the mobile application intervention
Measured from the start of application utilization (baseline) to 8-weeks
Adherence to self-monitoring tasks
Measured from the start of application utilization (baseline) to 8-weeks
Study Arms (2)
Recovery Record adaptive smartphone application (RR-A)
EXPERIMENTALParticipants will have access to all Recovery Record standard functions and will additionally receive tailored, algorithm-generated content targeting cognitive distortions.
Recovery Record standard smartphone application (RR-S)
ACTIVE COMPARATORParticipants will have access to all Recovery Record standard functions, including meal monitoring, motivational enhancement, social support, and coping skill strategies.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Recovery Record Researchlead
- Stanford Universitycollaborator
Study Sites (2)
Recovery Record Research
San Francisco, California, 94107, United States
Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences
Stanford, California, 94304, United States
Related Publications (1)
Tregarthen J, Paik Kim J, Sadeh-Sharvit S, Neri E, Welch H, Lock J. Comparing a Tailored Self-Help Mobile App With a Standard Self-Monitoring App for the Treatment of Eating Disorder Symptoms: Randomized Controlled Trial. JMIR Ment Health. 2019 Nov 21;6(11):e14972. doi: 10.2196/14972.
PMID: 31750837DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2015
First Posted
July 20, 2015
Study Start
November 23, 2016
Primary Completion
July 13, 2018
Study Completion
September 13, 2018
Last Updated
October 6, 2020
Record last verified: 2020-10