Digital assessment of wellbeing in new parents

Not Applicable

• Conditions: Postnatal Depression; Mental and Behavioural Disorders

• Registration Number: ISRCTN10781027
• Lead Sponsor: Greater Manchester Mental Health NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-03
• Last Update Posted: 15 April 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 118

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, psychiatrists or other health professionals not directly involved in the study

Exclusion Criteria

Feasibility RCT
1. Fetal abnormality
2. Major depression (PHQ-9 =10), generalised anxiety disorder or perinatal psychosis at study entry
3. Stillbirth, pre-eclampsia or another medical emergency requiring hospital admission (participants experiencing these conditions in relation to childbirth during the study will be withdrawn)
4. Participants in the care of MFT who live outside the Greater Manchester area
5. Participants in the care of SHKT who live outside of the St Helen’s area

Partner sub-study
1. Fetal abnormality
2. Major depression (PHQ-9 =10) or generalised anxiety disorder (GAD-7=10) at study entry
3. Current stillbirth (parents experiencing a stillbirth during the study will be withdrawn), partner of a pregnant participant assigned to the 4. Treatment as usual group of the RCT

Healthcare professional sub-study
None.

Study & Design

• Study Type: Interventional
• Study Design: Not specified