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Evaluating the Feasibility of Disseminating a Novel Mobile Platform to Treat Depression (PRIME-D)

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ClinicalTrials.gov Identifier: NCT02817672
Recruitment Status : Not yet recruiting
First Posted : June 29, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: PRIME 1.0 Behavioral: PRIME 2.0 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Scaling a Smarter and More Efficient Intervention: Evaluating the Feasibility of Disseminating a Novel Mobile App Platform to Treat Depression
Study Start Date : July 2017
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: PRIME 1.0
8 weeks use of PRIME 1.0 (current version). Mobile application designed to improve psychosocial functioning and motivational deficits.
Behavioral: PRIME 1.0
Mobile application designed to improve psychosocial functioning and motivational deficits (sans NLP-powered dashboard).
Experimental: PRIME 2.0
8 weeks use of PRIME 2.0 (version with the NLP-powered dashboard). Mobile application designed to improve psychosocial functioning and motivational deficits.
Behavioral: PRIME 2.0
Mobile application designed to improve psychosocial functioning and motivational deficits (with NLP-powered dashboard).



Primary Outcome Measures :
  1. Depression severity [ Time Frame: Change from baseline to 3 month follow-up ]
    PhQ-9

  2. Functioning [ Time Frame: Change from baseline to 3 month follow-up ]
    Sheehan Disability Scale


Secondary Outcome Measures :
  1. Coaching efficiency [ Time Frame: 8 weeks ]
    Flurry analytics

  2. Coaching competence [ Time Frame: 8 weeks ]
    Fidelity and competence assessment



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02817672


Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Danielle Schlosser, PhD University of California, San Francisco