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

January 17, 2020 updated by: University of California, San Francisco

Scaling a Smarter and More Efficient Intervention: Evaluating the Feasibility of Disseminating a Novel Mobile App Platform to Treat Depression

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression severity
Time Frame: Change from baseline to 3 month follow-up
PhQ-9
Change from baseline to 3 month follow-up
Functioning
Time Frame: Change from baseline to 3 month follow-up
Sheehan Disability Scale
Change from baseline to 3 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coaching efficiency
Time Frame: 8 weeks
Flurry analytics
8 weeks
Coaching competence
Time Frame: 8 weeks
Fidelity and competence assessment
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Danielle Schlosser, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2016

Primary Completion (Actual)

April 10, 2018

Study Completion (Actual)

April 10, 2018

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34MH110583-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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