NCT02817672

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2018

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

June 22, 2016

Last Update Submit

January 17, 2020

Conditions

Depression

Keywords

HumanMental Disordersinterventiondigital health

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Coaching efficiency

    8 weeks

  • Coaching competence

    8 weeks

Study Arms (2)

PRIME 1.0

ACTIVE COMPARATOR

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

Behavioral: PRIME 1.0

PRIME 2.0

EXPERIMENTAL

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

Interventions

PRIME 1.0BEHAVIORAL

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

PRIME 1.0
PRIME 2.0BEHAVIORAL

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

PRIME 2.0

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Under 18
  • Cannot read or speak in English
  • Cannot attain suitable mobile device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (2)

  • 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.

    PMID: 27125771BACKGROUND

  • 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.

    PMID: 23297786BACKGROUND

MeSH Terms

Conditions

DepressionMental Disorders

Interventions

prime and bond 2.0

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Danielle Schlosser, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 29, 2016

Study Start

May 25, 2016

Primary Completion

April 10, 2018

Study Completion

April 10, 2018

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

US(1)