Back to resultsEvaluating the Feasibility of Disseminating a Novel Mobile Platform to Treat Depression (PRIME-D)
Primary Purpose
Depression
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRIME 1.0
PRIME 2.0
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Human, Mental Disorders, intervention, digital health
Eligibility Criteria
Inclusion Criteria:
- 18 and older
- Read and speak English
- PHQ-9 score of 5 or greater or indicate that their depressive symptoms are interfering with their daily functioning (Item 10 of the PHQ-9 > 2).
- To be consistent with the NIMH RDoC initiative, we will assess for co-morbid problems (substance abuse, anxiety, and psychosis), but will not exclude participants with psychiatric comorbidities
- Must own a mobile device on iOS or Android platforms that either Wi-Fi or 3G/4G ready;
Exclusion Criteria:
- Under 18
- Cannot read or speak in English
- Cannot attain suitable mobile device
Sites / Locations
- University of California San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
PRIME 1.0
PRIME 2.0
Arm Description
8 weeks use of PRIME 1.0 (current version). Mobile application designed to improve psychosocial functioning and motivational deficits.
8 weeks use of PRIME 2.0 (version with the NLP-powered dashboard). Mobile application designed to improve psychosocial functioning and motivational deficits.
Outcomes
Primary Outcome Measures
Depression severity
PhQ-9
Functioning
Sheehan Disability Scale
Secondary Outcome Measures
Coaching efficiency
Flurry analytics
Coaching competence
Fidelity and competence assessment
Full Information
NCT ID
NCT02817672
First Posted
June 22, 2016
Last Updated
January 17, 2020
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02817672
Brief Title
Evaluating the Feasibility of Disseminating a Novel Mobile Platform to Treat Depression
Acronym
PRIME-D
Official Title
Scaling a Smarter and More Efficient Intervention: Evaluating the Feasibility of Disseminating a Novel Mobile App Platform to Treat Depression
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The dataset was not strong enough to do NLP analysis.
Study Start Date
May 25, 2016 (Actual)
Primary Completion Date
April 10, 2018 (Actual)
Study Completion Date
April 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
5. Study Description
Brief Summary
The goal of this project is to conduct a pilot study to test the utility of a Natural Language Processing (NLP) clinical messaging tool to improve the reach and the quality (fidelity and competency) of coaches providing behavioral activation (BA) strategies through a mobile mental health app called Personalized Real-time Intervention for Motivational Enhancement (PRIME). This study will improve the reach of clinicians by using a NLP-powered messaging tool, which will ensure fidelity to the BA model and clinicians will have access to real-time clinical information about their patients to guide more targeted treatment (competence). If successful, PRIME could operate as a cost effective tool for clinicians to extend their reach and an accessible treatment for the population of those struggling with depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Human, Mental Disorders, intervention, digital health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRIME 1.0
Arm Type
Active Comparator
Arm Description
8 weeks use of PRIME 1.0 (current version). Mobile application designed to improve psychosocial functioning and motivational deficits.
Arm Title
PRIME 2.0
Arm Type
Experimental
Arm Description
8 weeks use of PRIME 2.0 (version with the NLP-powered dashboard). Mobile application designed to improve psychosocial functioning and motivational deficits.
Intervention Type
Behavioral
Intervention Name(s)
PRIME 1.0
Intervention Description
Mobile application designed to improve psychosocial functioning and motivational deficits (sans NLP-powered dashboard).
Intervention Type
Behavioral
Intervention Name(s)
PRIME 2.0
Intervention Description
Mobile application designed to improve psychosocial functioning and motivational deficits (with NLP-powered dashboard).
Primary Outcome Measure Information:
Title
Depression severity
Description
PhQ-9
Time Frame
Change from baseline to 3 month follow-up
Title
Functioning
Description
Sheehan Disability Scale
Time Frame
Change from baseline to 3 month follow-up
Secondary Outcome Measure Information:
Title
Coaching efficiency
Description
Flurry analytics
Time Frame
8 weeks
Title
Coaching competence
Description
Fidelity and competence assessment
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 and older
Read and speak English
PHQ-9 score of 5 or greater or indicate that their depressive symptoms are interfering with their daily functioning (Item 10 of the PHQ-9 > 2).
To be consistent with the NIMH RDoC initiative, we will assess for co-morbid problems (substance abuse, anxiety, and psychosis), but will not exclude participants with psychiatric comorbidities
Must own a mobile device on iOS or Android platforms that either Wi-Fi or 3G/4G ready;
Exclusion Criteria:
Under 18
Cannot read or speak in English
Cannot attain suitable mobile device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Schlosser, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27125771
Citation
Schlosser D, Campellone T, Kim D, Truong B, Vergani S, Ward C, Vinogradov S. Feasibility of PRIME: A Cognitive Neuroscience-Informed Mobile App Intervention to Enhance Motivated Behavior and Improve Quality of Life in Recent Onset Schizophrenia. JMIR Res Protoc. 2016 Apr 28;5(2):e77. doi: 10.2196/resprot.5450.
Results Reference
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PubMed Identifier
23297786
Citation
Fisher M, Loewy R, Hardy K, Schlosser D, Vinogradov S. Cognitive interventions targeting brain plasticity in the prodromal and early phases of schizophrenia. Annu Rev Clin Psychol. 2013;9:435-63. doi: 10.1146/annurev-clinpsy-032511-143134. Epub 2013 Jan 7.
Results Reference
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Learn more about this trial
Evaluating the Feasibility of Disseminating a Novel Mobile Platform to Treat Depression
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