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

Depression Clinical Trial

— PRIME-D  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02817672
• Other study ID #: 1R34MH110583-01
• Status: Withdrawn
• Phase: N/A
• Start date: May 25, 2016
• Est. completion date: April 10, 2018

Study information

• Verified date: January 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• PRIME 1.0
Mobile application designed to improve psychosocial functioning and motivational deficits (sans NLP-powered dashboard).
• PRIME 2.0
Mobile application designed to improve psychosocial functioning and motivational deficits (with NLP-powered dashboard).

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression severity	PhQ-9	Change from baseline to 3 month follow-up
Primary	Functioning	Sheehan Disability Scale	Change from baseline to 3 month follow-up
Secondary	Coaching efficiency	Flurry analytics	8 weeks
Secondary	Coaching competence	Fidelity and competence assessment	8 weeks