TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This trial will assess the safety, feasibility, acceptability, usability and agreement with validated scales of an automated mood monitoring App (TrueBlue), in adult, perinatal participants (recruited between 12 weeks of pregnancy and 12 weeks post-partum), recruited across multiple sites in Nottinghamshire, United Kingdom (UK). An initial within-study pilot phase will assess key aspects of the study including recruitment rate, usability issues and a detailed understanding of any device related adverse events; prior to full recruitment of a total 125 participants over a total 14-month period.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ \- 18 years or older

• Fluent in spoken and written English

• Has capacity to provide consent

• At least 12 weeks pregnant or less than 12 weeks postpartum

• Access to internet connectivity

• Access to a compatible smart phone device (for up to 10 participants, where needed through not having a personal device, this access may be provided through the study team).

• Has a current GP within Nottinghamshire

Locations
Other Locations
United Kingdom
Nottingham University Hospitals NHS Trust
NOT_YET_RECRUITING
Nottingham
Nottinghamshire Healthcare NHS Foundation Trust
RECRUITING
Nottingham
Contact Information
Primary
John Michaelis, BSc
john@blueskeye.com
01689 856664
Backup
Neil Nixon, MBBS
Neil.Nixon@nottshc.nhs.uk
0115 969 1300
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 125
Treatments
Other: Device Related Adverse Events
The primary aim of the study is to demonstrate that use of the TrueBlue app to monitor depression is safe
Related Therapeutic Areas
Sponsors
Collaborators: Nottingham University Hospitals NHS Trust, Institute of Mental Health Nottingham, Nottinghamshire Healthcare NHS Trust
Leads: BlueSkeye AI

This content was sourced from clinicaltrials.gov