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Table 2 Study objectives and outcomes

From: Online singing interventions for postnatal depression in times of social isolation: a feasibility study protocol for the SHAPER-PNDO single-arm trial

Primary feasibility objectives Outcome measures/endpoints
To assess the feasibility and acceptability of a group online singing intervention in order to ensure adequate recruitment for a future RCT We will assess recruitment rates, retention rates, study completion rates, acceptability of intervention, and scalability to power a subsequent RCT
Secondary patient-centred objectives Outcome measures/endpoints
To assess the effectiveness of a group online singing intervention on symptoms of postnatal depression Depressive symptoms measured before, during, and after the intervention using the EPDS
The secondary outcome measure is change in total EPDS score between baseline and week 6 (endpoint of intervention)
To assess whether online singing improves further aspects of mental health Depressive, anxious, and stress symptoms measured before, during, and after the intervention using the SCID, HDRS, BDI, ONS, STAI, and PSS
The secondary outcome measure is change in total scores between baseline and week 6 (endpoint of intervention)
To ascertain whether online singing affects the mother-infant relationship Aspects of the mother-infant relationship measured before, during, and after the intervention using the CCI, MPAS, and PRFQ
The secondary outcome measure is change in total scores between baseline and week 6 (endpoint of intervention)
To ascertain whether online singing improves perceived social support and reduces loneliness Social support and loneliness measured before, during, and after the intervention using the UCLA Loneliness Scale, MSPSS, and GSE-6
The secondary outcome measure is change in total scores between baseline and week 6 (endpoint of intervention)
To identify whether there are biological changes in stress mechanisms underpinning the psychological outcomes assessed Cortisol from saliva samples
The secondary outcome measure is change in circulating biomarkers
To explore the uptake and continued involvement in online singing groups Qualitative interviews with a sub-sample of 20–30 women and the intervention deliverers