Postnatal Depression Mental and Behavioural Disorders
Conditions
Interventions
Feasibility RCT:
Following baseline assessment, participants (birthing parents, n = 80) will be randomly allocated (1:1) using an online service (https://www.sealedenvelope.com) to usual care or digit
Sponsors
Greater Manchester Mental Health NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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hospital admission (participants experiencing these conditions in relation to childbirth during the study will be withdrawn) 4.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 Current stillbirth (parents experiencing a stillbirth during the study will be withdrawn), partner of a pregnant participant assigned to the 4.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 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) | — |
Countries
England, United Kingdom
Outcome results
None listed