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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02817672
Acronym
PRIME-D
Enrollment
0
Registered
2016-06-29
Start date
2016-05-25
Completion date
2018-04-10
Last updated
2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Human, Mental Disorders, intervention, digital health

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.

Interventions

BEHAVIORALPRIME 1.0

Mobile application designed to improve psychosocial functioning and motivational deficits (sans NLP-powered dashboard).

BEHAVIORALPRIME 2.0

Mobile application designed to improve psychosocial functioning and motivational deficits (with NLP-powered dashboard).

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Depression severityChange from baseline to 3 month follow-upPhQ-9
FunctioningChange from baseline to 3 month follow-upSheehan Disability Scale

Secondary

MeasureTime frameDescription
Coaching efficiency8 weeksFlurry analytics
Coaching competence8 weeksFidelity and competence assessment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026