Digital assessment of wellbeing in new parents

INTERVENTION: Feasibility RCT Following baseline assessment, participants (birthing parents, n=80) will be randomly allocated (1:1) using an online service (www.sealedenvelope.com) to usual care or digital screening with usual care. Random allocation sequences in blocks of size 4 or 6 are generated, with separate sequences generated for each Trust to maintain balanced treatment allocation. Participants in the control group will receive usual NHS care, which typically includes some midwife and/or health visitor screening of mood. The participants in the digital screening group will be asked to use the CareLoop PND app to track their mental health from study entry until 8 weeks postpartum, in addition to their usual NHS care. Partner sub‐study Partners (n=20) will not be randomised. They will be asked to use the CareLoop PND app from study entry until 8 weeks postpartum. Healthcare professional sub‐study Healthcare professionals (n=30) will not receive an intervention but will take part in qualitative interviews only. CONDITION: Postnatal Depression ; Mental and Behavioural Disorders PRIMARY OUTCOME: ; Feasibility of delivering a full‐scale, single‐blind, RCT within NHS services:; 1. App engagement: overall percentage of app‐based assessments completed during the app‐use period; percentage of participants completing >50% app‐based assessments.; 2. Retention: percentage of participants retained at 8 weeks postpartum; percentage of participants retained at 6 months postpartum; 3. Outcome completion: percentage completion of candidate primary outcome measures for the proposed full‐scale RCT; INCLUSION CRITERIA: Feasibility RCT: 1. =36 weeks pregnant 2. Under care of Manchester Foundation Trust (MFT) or St Helens and Knowsley Teaching Hospitals NHS Trust (STHK) 3. Aged =18 years 4. Sufficient English fluency to complete baseline assessments (and/or partner speaks English fluently). Partner sub‐study: 1. Partner of a pregnant participant assigned to the digital screening group, or father/non‐gestational parent of a foetus after 36 weeks' gestation whose gestational parent is under MFT/SHKT care 2. Aged >18 years 3. Sufficient English fluency to complete baseline assessments Healthcare professional sub‐study Employed in a role related to the care of pregnant and/or postnatal parents. This could include research midwives who facilitated app use, health visitors with participating women on their caseload, as well as GPs, midwives, health visitors, commissioners, psychologists, psychiat SECONDARY OUTCOME: ; 1. Acceptability of the study app is measured using qualitative interviews and the abridged Mobile App Rating Scale at 8 weeks postpartum.; 2. Feasibility of recruitment to the study is measured at using the following metrics at baseline: number of eligible participants approached; number agreeing to participate; number declining to participate; reasons for non‐participation.; 3. The validity of digital screening and standard screening will be measured using the following metrics (evaluated for the period from baseline until 8 weeks postpartum): Number of positive screens identified; number of true positives (PHQ‐9 >= 10 OR GAD‐7 >= 10); number of false positives (PHQ‐9 <10 AND GAD‐7 < 10).; 4. Safety of the app and study procedures will be measured in terms of the number of Adverse Events and Serious Adverse Events throughout the study period, and whether they are judged to be related to the app and/or study procedures.; 5. Feasibility of the study procedures is measured using the following metrics: proportion of each outcome measure* completed at each time point (baseline, 8 weeks postpartum, 6 months postpartum); *Outcome measures in question are: Patient Health Questionnaire / PHQ‐9, Generalised Anxiety Disorder questionnaire / GAD‐7, Mini International Neuropsychiatric Interview, Postpartum Bonding Questionnaire, Abridged Mobile App Rating Scale, EQ‐5D and healthcare resource utilisation questionnaire.; 6. Acceptability of the study procedures is measured using qualitative interviews at 8 weeks postpartum; 7. The key drivers of cost for digital screening and standard care will be measured using the Healthcare Resource Use Questionnaire at 8 weeks postpartum and 6 months postpartum.; 8. Qualitative data on participants’ experiences of using the study app will be assessed in a qualitative interview at 8 weeks postpartum.; 9. Potential clinical and demographic predictors of app engagement will be measured at baseline using the PHQ‐9, GAD‐7, EQ‐5D‐5L, a demographic questionnaire, and information gathered from medical records.; 10. In partners: overall percentage of app‐based assessments completed during the app‐use period; percentage of participants completing >50% app‐based assessments; percentage of participants retained at 8 weeks postpartum.; 11. Acceptability of digital screening using a smartphone app, and likely barriers and facilitators, will be measured in one‐off qualitative interviews with healthcare professionals (n=30);