NCT04200170

Examining the Feasibility of a Mobile Mental Health Application in Psychotherapy

Status unknown NA Last updated 16 December 2019

What this trial tests

NA trial testing Rose in Mental Health Wellness 1 in 45 participants. Status unknown.

Timeline

1 August 2019

Primary endpoint
29 November 2019

27 December 2019

Quick facts

Lead sponsor	Ask Rose
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	45
Start date	1 August 2019
Primary completion	29 November 2019
Estimated completion	27 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Rose

Conditions studied

• Mental Health Wellness 1 — all drugs for Mental Health Wellness 1 →
• Depression — all drugs for Depression →

Sponsor

Ask Rose

Who can join

18 and older, any sex, with Mental Health Wellness 1 or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Use of a Mobile App to Augment Psychotherapy in a Community Psychiatric Clinic: Feasibility and Fidelity Trial.
   Adam A, Jain A, Pletnikova A, Bagga R, et al · · 2020 · cited 10× · PMID 32618572 · DOI 10.2196/17722