Health TrialsbyHealthPanel

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

ConditionsDepressionDepression, PostpartumAnxiety in PregnancyAnxietyAnhedoniaPerinatal Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBlueSkeye AI

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

● 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 design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

125 Participants
are divided into 1 treatment group
Group A: Device Related Adverse EventsOther 1 intervention

Trial outcomes

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).

Time frame
up to12 weeks

Secondary outcomes

1

Rate of initial use (assessing feasibility and acceptability)

Rate of initial community use (defined as at least one completed use after initial demonstration)

Time frame
up to12 weeks
2

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)

Time frame
up to12 weeks
3

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.

Time frame
up to12 weeks
4

Rate of acceptance of referrals to Perinatal Psychiatry

Rate of referred patients who are subsequently accepted by Perinatal Psychiatry services.

Time frame
up to12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BlueSkeye AI

Lead sponsor

Institute of Mental Health Nottingham

Collaborator

Nottinghamshire Healthcare NHS Trust

Collaborator

Nottingham University Hospitals NHS Trust

Collaborator

Source ClinicalTrials.gov
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