Toward good practice in thematic analysis: Avoiding common problems and be(com)ing a knowing researcher.
Virginia Braun, Victoria Clarke
https://pubmed.ncbi.nlm.nih.gov/36713144Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06364488
TrueBlue Clinical Study Investigating a Mobile Phone App for Monitoring Depression and Anxiety in Perinatal Women
Led by BlueSkeye AI · Updated on 2025-09-19
125
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
B
BlueSkeye AI
Lead Sponsor
I
Institute of Mental Health Nottingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, usability, and acceptability of the TrueBlue mobile phone App, which automatically monitors mood in adult women during the perinatal period (from 12 weeks pregnant to 12 weeks postpartum). This early-phase study aims to compare the mood scores generated by the App with validated clinical scales for depression, anxiety, and anhedonia, recruiting participants across various healthcare sites in Nottinghamshire, UK. An initial 5-month pilot phase with up to 12 participants will test recruitment, usability, and adverse events before expanding to a total of 125 participants over 14 months. Participants will use the TrueBlue App for up to 12 weeks, completing two weekly tasks involving reading or speaking to the App while it records their face and voice. Every two weeks, they will complete four validated self-assessment scales: PHQ9, Edinburgh Postnatal Depression Scale, GAD7, and TEPS. Adverse events related to device use will be monitored at 6 and 12 weeks, and focus groups with patients and clinicians will explore usability and integration into care. Following the pilot, the full recruitment phase will continue with similar procedures and additional individual interviews with up to 30 participants to assess app experience. Throughout the study, researchers will collect data on feasibility, acceptability, usability, adverse events, and agreement between the App's automated mood scores and validated scales. Participants will be regularly assessed for new or recurrent health issues, referrals to perinatal psychiatry services, and depression diagnoses. The study runs for a total of 14 months, with safety surveillance and thematic analysis of qualitative data to inform future use and improvements of the TrueBlue App.
CONDITIONS
Brief Title
TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
Who Can Participate
Age: 18Years +
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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 (may be provided if needed for a limited number of participants)
- Has a current general practitioner within Nottinghamshire
You will not qualify if you...
- Current clinically diagnosed psychiatric disorder other than depression
- Previous history of clinically diagnosed psychiatric disorders other than depression and generalized anxiety disorder, including psychosis, bipolar disorder, personality disorder, substance abuse disorders, and eating disorders
- Clinical diagnosis of autistic spectrum disorder, attention deficit hyperactivity disorder, Parkinson's disease, or other current neurological disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm eligibility and consent
Implementation
Duration - Up to 12 weeks
Participants use the TrueBlue App to monitor depression and anxiety by completing weekly tasks involving reading or speaking to the App, and biweekly validated mood questionnaires.
Weekly app tasks and biweekly questionnaire submissions; 2 assessment visits at weeks 6 and 12 for adverse event surveillance
Long-term Monitoring
Duration - Up to 14 months from study start
Participants may be invited to take part in individual interviews to discuss their experience using the app, including usability and barriers to use.
Up to 30 interviews, scheduled as needed
Trial Site Locations
Total: 2 locations
1
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Not Yet Recruiting
2
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, United Kingdom, NG3 6AA
Actively Recruiting
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Research Team
J
John Michaelis, BSc
N
Neil Nixon, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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Published Research Related To This Trial
A brief measure for assessing generalized anxiety disorder: the GAD-7.
Robert L Spitzer, Kurt Kroenke, Janet B W Williams...
https://pubmed.ncbi.nlm.nih.gov/16717171The PHQ-9: validity of a brief depression severity measure.
K Kroenke, R L Spitzer, J B Williams
https://pubmed.ncbi.nlm.nih.gov/11556941Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale.
J L Cox, J M Holden, R Sagovsky
https://pubmed.ncbi.nlm.nih.gov/3651732