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

This study is not yet open for participant recruitment.
Verified June 2016 by University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT02817672
First Posted: June 29, 2016
Last Update Posted: June 29, 2016
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.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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 Intervention
Depression Behavioral: PRIME 1.0 Behavioral: PRIME 2.0

Study Type: Interventional
Study Design: 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

Further study details as provided by University of California, San Francisco:

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

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


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

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


Estimated Enrollment: 120
Study Start Date: July 2017
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02817672     History of Changes
Other Study ID Numbers: 1R34MH110583-01 ( U.S. NIH Grant/Contract )
First Submitted: June 22, 2016
First Posted: June 29, 2016
Last Update Posted: June 29, 2016
Last Verified: June 2016

Keywords provided by University of California, San Francisco:
Human
Mental Disorders
intervention
digital health

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders


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