Clinical trial NCT06364488: TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
Official title: TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Depression, Postpartum
Anxiety in Pregnancy
Anxiety
Anhedonia
Perinatal Depression
Keywords: Depression
Anxiety
Perinatal
Lead sponsor: BlueSkeye AI
Sponsor class: INDUSTRY
Collaborators: name: Institute of Mental Health Nottingham
name: Nottinghamshire Healthcare NHS Trust
name: Nottingham University Hospitals NHS Trust
First posted: 2024-04-15
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.

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).

Eligibility criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

* ● 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.

Primary outcomes:
measure: The rate of device related adverse events
timeFrame: up to12 weeks
Secondary outcomes:
measure: Rate of initial use (assessing feasibility and acceptability)
timeFrame: up to12 weeks
measure: Rate of New Depression or Risk (Suicidality) events
timeFrame: up to12 weeks
measure: Rate of referral to Perinatal Psychiatry services
timeFrame: up to12 weeks
measure: Rate of acceptance of referrals to Perinatal Psychiatry
timeFrame: up to12 weeks
measure: Diagnosis rate for depression, or other mental health problems, during the period of study.
timeFrame: 14 months
measure: Continued use (acceptability)
timeFrame: up to12 weeks
measure: Loss to follow-up
timeFrame: 14 months
measure: Usability (quantitative measure)
timeFrame: up to12 weeks
measure: Agreement between TrueBlue generated score and validated scales
timeFrame: 14 months
measure: Thematic results
timeFrame: 14 months
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
city: Nottingham
country: United Kingdom
facility: Nottinghamshire Healthcare NHS Foundation Trust
Study officials:
affiliation: School of Medicine, University of Nottingham and Nottinghamshire Healthcare NHS Trust
name: Neil Nixon, MBBS
role: PRINCIPAL_INVESTIGATOR
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