DepressionNCT06364488
TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
A study testing TrueBlue App in people with Depression and Depression, Postpartum, run by BlueSkeye AI at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Depression, Postpartum, Anxiety in Pregnancy
- What is being tested?
- TrueBlue App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Oct 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ● 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
Nia Jones, Nia.Jones@nottingham.ac.uk
TrueBlue@nottingham.ac.uk
- Recruiting
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, NG3 6AA
Bonnie MILLAR, bonnie.millar@nottingham.ac.uk
TrueBlue@nottingham.ac.uk
About this study
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.
Read the detailed description
This early-phase study of the TrueBlue App will recruit participants from Nottinghamshire Healthcare NHS Foundation Trust (NHFT), Nottingham University Hospitals NHS Trust (NUH) and a number of Primary Care sites in Nottinghamshire, UK. At study inclusion participants will be at least 18 years old, in the perinatal phase (between 12 weeks of pregnancy and 12 weeks post-partum), able to give capacious consent and satisfying the other detailed inclusion/exclusion criteria provided below. Initial recruitment will be to a 5-month, within-study pilot phase during which up to 12 participants will use the TrueBlue App for a 12-week period. Participants will be asked to complete two tasks on the App each week, involving reading or speaking to the App whilst it records the user's face and voice; and to complete each of the following four validated scales every two weeks: Patient Health Questionnaire 9-item scale (PHQ9), Edinburgh Postnatal Depression Scale (EPDS), Generalized Anxiety Disorder 7-item scale (GAD7), Temporal Experience of Pleasure Scale (TEPS). Adverse Events (AEs) will be detected through structured surveillance at weeks 6 and 12, in addition to encouraging participants to report any new or recurrent health problems during their period of App use. AEs will be assessed for plausibility of relatedness to App use [Device-Related Adverse Events; (DRAEs)], seriousness and expectedness; with discussion at the Trial Management Committee (TMC) focusing on developing any necessary mitigations, including technological or informational changes. The Standard Operating Procedure (SOP) for investigation of AEs includes a break to recruitment if serious DRAEs are identified. During the 5-month within-study pilot phase, stakeholder focus groups will be convened, separately for clinicians and patients, with up to 6 participants in each group focusing on AEs, usability issues, integration into care, liaison with Perinatal Psychiatry services and study governance. These sessions will be conducted by the study team, with recorded, anonymised transcripts subjected to thematic or content analysis depending on the depth of data. Anonymised reports from these focus groups will inform the TMC and the later individual, semi-structured interviews.
Following the 5-month within-study pilot phase and any necessary adjustments to SOPs (notified appropriately to the REC), we will enter a 9-month study period to full recruitment (125 participants). In this later period, as in the pilot phase, participants will use the TrueBlue App for up to 12 weeks, as described above, with continued surveillance for AEs including the 6 and 12 week reviews. Throughout the total 14-month study metrics will be collected on usability, feasibility and acceptability, alongside the validated self-completion questionnaires assessing depression (PHQ9, EPDRS), anxiety (GAD-7) and anhedonia (TEPS). Audio-visual data recorded through the weekly tasks will be used to generate automated mood scores that will then be assessed for agreement with the validated scales.
Up to 30 study participants will also be invited to take part in individual, semi-structured interviews assessing their experience of the app, including barriers and facilitators to use. Recruitment will be to saturation of themes, or to a maximum of 30 interviews, using purposive sampling to encourage a representation of participants with high and low System Usability Scale (SUS) scores. Interview transcripts will be subjected to thematic analysis.
This study has received approval from the relevant UK ethics committee (NHS Rec reference 22/LO/0009, IRAS project reference: 295721) and regulatory authority (MHRA, CI/2023/0063/GB).
- Conditions
- Depression, Depression, Postpartum, Anxiety in Pregnancy, Anxiety, Anhedonia, Perinatal Depression
- Being tested
- TrueBlue App
- Keywords
- Depression, Anxiety, Perinatal
- Medical subject headings
- Depression, Depression, Postpartum, Anxiety Disorders, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrueBlue AppDevice
The use of the TrueBlue App, to generate automated measures of mood that can be assessed for agreement with validated clinical scales eg. PHQ9.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: TrueBlue App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to12 weeks
Secondary outcomes (10)
Rate of initial use (assessing feasibility and acceptability)
Rate of initial community use (defined as at least one completed use after initial demonstration)
Measured: up to12 weeks
Rate of New Depression or Risk (Suicidality) events
Percentage of participants who generate amber or red flag warnings through inputs to validated depression measures (PHQ9, EPDRS)
Measured: up to12 weeks
Rate of referral to Perinatal Psychiatry services
Percentage of patients referred to Perinatal Psychiatry services, based on study team assessment of amber or red flag warnings.
Measured: up to12 weeks
Rate of acceptance of referrals to Perinatal Psychiatry
Rate of referred patients who are subsequently accepted by Perinatal Psychiatry services.
Measured: up to12 weeks
Diagnosis rate for depression, or other mental health problems, during the period of study.
Rate of patients diagnosed with a new or recurrent episode of depression, or other mental health problem during the period of study. Rate of these events picked up through App use (and Perinatal Psychiatry referral system).
Measured: 14 months
Continued use (acceptability)
Frequency of device usage by participants, following initial use in the community
Measured: up to12 weeks
Loss to follow-up
Rate of loss to follow-up within study.
Measured: 14 months
Usability (quantitative measure)
Analysis of System Usability Scale (SUS) score at following completion of app use (minimum value= 0, maximum value = 100).
Measured: up to12 weeks
Agreement between TrueBlue generated score and validated scales
Assessment of the agreement between TrueBlue generated scores (through processed audio-visual data) and the validated scales (PHQ9, EPDS, GAD7, TEPS).
Measured: 14 months
Thematic results
Results from thematic analyses of transcripts from stakeholder meetings and individual semi-structured interviews.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Oct 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BlueSkeye AI
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute of Mental Health Nottingham, Nottinghamshire Healthcare NHS Trust, Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Neil Nixon, MBBS, Principal investigator, School of Medicine, University of Nottingham and Nottinghamshire Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364488
- Sponsor's protocol ID
- 295721
- Status last verified
- Sep 2025
- First submitted
- 21 Mar 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To comply with the data protection act, personal data will be deleted as soon as possible after it is no longer needed for the study.
Publications
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.
PubMed 36713144Gard 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
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.
PubMed 16717171Kroenke 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.
PubMed 11556941Cox 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.
PubMed 3651732Braun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 2006 Jan 1;3(2):77-101.
Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996 Jun 11;189(194):4-7.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
- ClinicalTrials.gov ID
- NCT06364488
- Acronym / sponsor ID
- 295721
- Conditions
- Depression, Depression, Postpartum, Anxiety in Pregnancy, Anxiety, Anhedonia, Perinatal Depression
- Keywords
- Depression, Anxiety, Perinatal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- BlueSkeye AIIndustry (pharma, biotech, devices)
- Collaborators
- Institute of Mental Health Nottingham, Nottinghamshire Healthcare NHS Trust, Nottingham University Hospitals NHS Trust
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This early-phase study of the TrueBlue App will recruit participants from Nottinghamshire Healthcare NHS Foundation Trust (NHFT), Nottingham University Hospitals NHS Trust (NUH) and a number of Primary Care sites in Nottinghamshire, UK. At study inclusion participants will be at least 18 years old, in the perinatal phase (between 12 weeks of pregnancy and 12 weeks post-partum), able to give capacious consent and satisfying the other detailed inclusion/exclusion criteria provided below. Initial recruitment will be to a 5-month, within-study pilot phase during which up to 12 participants will use the TrueBlue App for a 12-week period. Participants will be asked to complete two tasks on the App each week, involving reading or speaking to the App whilst it records the user's face and voice; and to complete each of the following four validated scales every two weeks: Patient Health Questionnaire 9-item scale (PHQ9), Edinburgh Postnatal Depression Scale (EPDS), Generalized Anxiety Disorder 7-item scale (GAD7), Temporal Experience of Pleasure Scale (TEPS). Adverse Events (AEs) will be detected through structured surveillance at weeks 6 and 12, in addition to encouraging participants to report any new or recurrent health problems during their period of App use. AEs will be assessed for plausibility of relatedness to App use [Device-Related Adverse Events; (DRAEs)], seriousness and expectedness; with discussion at the Trial Management Committee (TMC) focusing on developing any necessary mitigations, including technological or informational changes. The Standard Operating Procedure (SOP) for investigation of AEs includes a break to recruitment if serious DRAEs are identified. During the 5-month within-study pilot phase, stakeholder focus groups will be convened, separately for clinicians and patients, with up to 6 participants in each group focusing on AEs, usability issues, integration into care, liaison with Perinatal Psychiatry services and study governance. These sessions will be conducted by the study team, with recorded, anonymised transcripts subjected to thematic or content analysis depending on the depth of data. Anonymised reports from these focus groups will inform the TMC and the later individual, semi-structured interviews.
Following the 5-month within-study pilot phase and any necessary adjustments to SOPs (notified appropriately to the REC), we will enter a 9-month study period to full recruitment (125 participants). In this later period, as in the pilot phase, participants will use the TrueBlue App for up to 12 weeks, as described above, with continued surveillance for AEs including the 6 and 12 week reviews. Throughout the total 14-month study metrics will be collected on usability, feasibility and acceptability, alongside the validated self-completion questionnaires assessing depression (PHQ9, EPDRS), anxiety (GAD-7) and anhedonia (TEPS). Audio-visual data recorded through the weekly tasks will be used to generate automated mood scores that will then be assessed for agreement with the validated scales.
Up to 30 study participants will also be invited to take part in individual, semi-structured interviews assessing their experience of the app, including barriers and facilitators to use. Recruitment will be to saturation of themes, or to a maximum of 30 interviews, using purposive sampling to encourage a representation of participants with high and low System Usability Scale (SUS) scores. Interview transcripts will be subjected to thematic analysis.
This study has received approval from the relevant UK ethics committee (NHS Rec reference 22/LO/0009, IRAS project reference: 295721) and regulatory authority (MHRA, CI/2023/0063/GB).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Device Related Adverse Events | Other | Device: TrueBlue AppThe primary aim of the study is to demonstrate that use of the TrueBlue app to monitor depression is safe |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- ● Current clinically diagnosed psychiatric disorder other than depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrueBlue AppThe use of the TrueBlue App, to generate automated measures of mood that can be assessed for agreement with validated clinical scales eg. PHQ9. | Device | Device Related Adverse Events |
Primary outcome
The rate of device related adverse events
Time frame: up to12 weeks
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).
10 secondary outcomes
Rate of initial use (assessing feasibility and acceptability)
Time frame: up to12 weeks
Rate of New Depression or Risk (Suicidality) events
Time frame: up to12 weeks
Rate of referral to Perinatal Psychiatry services
Time frame: up to12 weeks
Rate of acceptance of referrals to Perinatal Psychiatry
Time frame: up to12 weeks
Diagnosis rate for depression, or other mental health problems, during the period of study.
Time frame: 14 months
Continued use (acceptability)
Time frame: up to12 weeks
Loss to follow-up
Time frame: 14 months
Usability (quantitative measure)
Time frame: up to12 weeks
Agreement between TrueBlue generated score and validated scales
Time frame: 14 months
Thematic results
Time frame: 14 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 36713144Braun 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.
- BackgroundGard 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: PubMed 16717171Spitzer 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 3651732Cox 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.
- BackgroundBraun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 2006 Jan 1;3(2):77-101.
- BackgroundBrooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996 Jun 11;189(194):4-7.
- Individual participant dataSharing planned: No. To comply with the data protection act, personal data will be deleted as soon as possible after it is no longer needed for the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neil Nixon, MBBS principal investigator
School of Medicine, University of Nottingham and Nottinghamshire Healthcare NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TrueBlue App in people with Depression and Depression, Postpartum, run by BlueSkeye AI at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Michaelis, BSc (01689 856664, john@blueskeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of device related adverse events (time frame: up to12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06364488, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.