Examining the Feasibility of a Mobile Mental Health Application in Psychotherapy

NCT04200170 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-12-16

No results posted yet for this study

Summary

There is an urgent need to better understand and manage the mental health burden among working adults. Up to 40% of persons with serious mental illnesses do not receive care or stop intervention programs due to negative stigma. Additionally, nearly 50 percent of respondents diagnosed with an anxiety disorder said it interfered with their relationships with coworkers. Close to $6000 USD is lost per working person each year due to depression and its effects.

Rose (Recognition of Speech and Emotion) is a mental health-focused application that utilizes artificial intelligence to identify symptoms and provides targeted, tailored in-person therapy solutions for its users. The RoSE application provides solutions to supplement ongoing in-person psychotherapy. This includes journaling and daily assessments that provide curated content and feedback. The current feasibility study aims to recruit 45 established outpatients with at least mild depressive and/or anxiety symptoms who will be consented and enrolled in a five to ten-week study. There are two study arms: (1) the intervention arm and (2) a waitlist control arm. During the course of the study, the participants in the intervention arm will use the RoSE application daily. They will receive either weekly in-person psychotherapy with their established psychotherapist for a total of four sessions over four weeks or biweekly in-person psychotherapy with their established psychotherapist for a total of four sessions over eight weeks. The participants in the waitlist arm will serve as controls unless there is attrition from the intervention group at which time waitlist participants will be offered a spot in the intervention arm. The primary objectives of the study are (1) To assess the usability of the RoSE application and (2) To evaluate the short-term impact on mood and anxiety of using the RoSE application to augment in-person psychotherapy. The secondary objectives are (1) To examine the usage and utility of an in-application journaling function and (2) To examine the usage and utility of in-application curated insights.

Conditions

Interventions

DEVICE

Rose

Rose is a patient-centric, mobile mental health platform designed for in-between clinical mental health monitoring in form of mood tracking, clinical surveys and daily journaling. Rose is used as a participant-facing mobile app and clinician-facing dashboard. Each day, they complete mood and anxiety scales and update their journals. Biweekly, they are also asked to complete the PHQ-9 and GAD-7 assessments as well. The Rose mobile app sends timely self-help articles and notifications for users. The curated insights are selected based on participant responses to the daily mood and anxiety surveys, as well as a built-in sentiment analysis of the journaling. The clinical dashboard is a secure, web-based portal that has a unique login for each provider. Providers have access to only their patients through the system and are able to see all the health metrics collected with the Rose mobile app and the summarized metrics produced by our models.

Sponsors & Collaborators

  • Ask Rose

    lead INDUSTRY

Principal Investigators

  • Ameena Jain · Key Point Health Services

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2019-11-29
Completion
2019-12-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04200170 on ClinicalTrials.gov