Clinical trial NCT02817672: Evaluating the Feasibility of Disseminating a Novel Mobile Platform to Treat Depression
Official title: Scaling a Smarter and More Efficient Intervention: Evaluating the Feasibility of Disseminating a Novel Mobile App Platform to Treat Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Keywords: Human
Mental Disorders
intervention
digital health
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Depression severity
timeFrame: Change from baseline to 3 month follow-up
measure: Functioning
timeFrame: Change from baseline to 3 month follow-up
Secondary outcomes:
measure: Coaching efficiency
timeFrame: 8 weeks
measure: Coaching competence
timeFrame: 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Danielle Schlosser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.