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

NCT06364488 | Recruiting DMC

• 1 other identifier: 295721
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Depression; Anxiety; Perinatal

Outcome Measures

Primary Outcomes (1)

• The rate of device related adverse events

  Percentage of participants who experience at least one device related adverse event during the 12-week period from baseline to end of app use (ascertained through both voluntary reporting and active surveillance at 6 and 12 weeks).

  up to12 weeks

Secondary Outcomes (10)

• Rate of initial use (assessing feasibility and acceptability)

  up to12 weeks

• Rate of New Depression or Risk (Suicidality) events

  up to12 weeks

• Rate of referral to Perinatal Psychiatry services

  up to12 weeks

• Rate of acceptance of referrals to Perinatal Psychiatry

  up to12 weeks

• Diagnosis rate for depression, or other mental health problems, during the period of study.

  14 months

Study Arms (1)

Device Related Adverse Events

OTHER

The primary aim of the study is to demonstrate that use of the TrueBlue app to monitor depression is safe

Device: TrueBlue App

Interventions

TrueBlue App DEVICE

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

Device Related Adverse Events

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• ● Current clinically diagnosed psychiatric disorder other than depression
• Previous history of a clinically diagnosed psychiatric disorder, other than depression and generalised anxiety disorder (including previous Psychosis, Bipolar Disorder, Personality Disorder, Substance Abuse Disorders, Eating Disorders)
• Clinical diagnosis of an Autistic Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Parkinson's Disease or other current Neurological Disorder.

Sponsors & Collaborators

• BlueSkeye AI: lead
• Institute of Mental Health Nottingham: collaborator
• Nottinghamshire Healthcare NHS Trust: collaborator
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (2)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

NOT YET RECRUITING

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, NG3 6AA, United Kingdom

RECRUITING

Related Publications (7)

• Braun V, Clarke V. Toward good practice in thematic analysis: Avoiding common problems and be(com)ing a knowing researcher. Int J Transgend Health. 2022 Oct 25;24(1):1-6. doi: 10.1080/26895269.2022.2129597. eCollection 2023. No abstract available.

  PMID: 36713144 BACKGROUND

• Gard D, Gard M, Kring A, John O. Anticipatory and consummatory components of the experience of pleasure: A scale development study. J Res Pers. 2006;40:1086-110

  BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• Braun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 2006 Jan 1;3(2):77-101.

  BACKGROUND

• Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996 Jun 11;189(194):4-7.

  BACKGROUND

MeSH Terms

Conditions

Depression; Depression, Postpartum; Anxiety Disorders; Anhedonia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Neil Nixon, MBBS

  School of Medicine, University of Nottingham and Nottinghamshire Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Michaelis, BSc

CONTACT

01689 856664; john@blueskeye.com

Neil Nixon, MBBS

CONTACT

0115 969 1300; Neil.Nixon@nottshc.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 125 participants, of whom 12 will enter the initial 5-month within-study pilot phase aimed at understanding any device-related adverse events and usability issues.

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 15, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)