Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364488
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-03-21
Brief Title:
TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
Sponsor:
BlueSkeye AI
Organization:
BlueSkeye AI
Study Overview
Official Title:
TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inclusionexclusion 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 users 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 22LO0009 IRAS project reference 295721 and regulatory authority MHRA CI20230063GB
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 22LO0009 IRAS project reference 295721 and regulatory authority MHRA CI20230063GB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None