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

NCT06364488 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

  • Depression
  • Depression, Postpartum
  • Anxiety in Pregnancy
  • Anxiety
  • Anhedonia
  • Perinatal Depression

Interventions

DEVICE

TrueBlue App

The use of the TrueBlue App, to generate automated measures of mood that can be assessed for agreement with validated clinical scales eg. PHQ9.

Sponsors & Collaborators

  • Institute of Mental Health Nottingham

    collaborator OTHER

  • Nottinghamshire Healthcare NHS Trust

    collaborator OTHER_GOV

  • Nottingham University Hospitals NHS Trust

    collaborator OTHER

  • BlueSkeye AI

    lead INDUSTRY

Principal Investigators

  • Neil Nixon, MBBS · School of Medicine, University of Nottingham and Nottinghamshire Healthcare NHS Trust

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-07-31
Completion
2026-12-30

Countries

  • United Kingdom

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 NCT06364488 on ClinicalTrials.gov