Evaluating the Feasibility of Disseminating a Novel Mobile Platform to Treat Depression

Not Applicable

Withdrawn

• Conditions: Depression
• Interventions: Behavioral: PRIME 1.0; Behavioral: PRIME 2.0

• Registration Number: NCT02817672
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-25
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-29
• Primary Completion: 2018-04-10
• Study Completion: 2018-04-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
PRIME 1.0	PRIME 1.0	8 weeks use of PRIME 1.0 (current version). Mobile application designed to improve psychosocial functioning and motivational deficits.
PRIME 2.0	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.

Primary Outcome Measures

Name	Time	Method
Functioning	Change from baseline to 3 month follow-up	Sheehan Disability Scale
Depression severity	Change from baseline to 3 month follow-up	PhQ-9

Secondary Outcome Measures

Name	Time	Method
Coaching efficiency	8 weeks	Flurry analytics
Coaching competence	8 weeks	Fidelity and competence assessment

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States