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

NCT ID: NCT02817672

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-25

Study Completion Date

2018-04-10

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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PRIME 1.0

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

Group Type ACTIVE_COMPARATOR

PRIME 1.0

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

PRIME 2.0

Intervention Type BEHAVIORAL

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

Interventions

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PRIME 1.0

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

Intervention Type BEHAVIORAL

PRIME 2.0

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danielle Schlosser, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27125771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23297786 (View on PubMed)

Other Identifiers

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1R34MH110583-01

Identifier Type: NIH

Identifier Source: org_study_id

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