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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: PRIME 1.0
* Behavioral: PRIME 2.0


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PRIME 1.0<br>8 weeks use of PRIME 1.0 (current version). Mobile application designed to improve psychosocial functioning and motivational deficits. | Behavioral: PRIME 1.0<br>* Mobile application designed to improve psychosocial functioning and motivational deficits (sans NLP-powered dashboard).<br>|
| Experimental: PRIME 2.0<br>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<br>* Mobile application designed to improve psychosocial functioning and motivational deficits (with NLP-powered dashboard).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human, Mental Disorders, intervention, digital health