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. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

George 2020.

Study characteristics
Methods Study design: cluster‐RCT
Duration of study: the study intervention and assessment period extended from June 2011 to January 2013.
Country: India
Income classification: lower‐middle‐income country between 2011‐2013
Geographical scope: rural coastal villages in India
Healthcare setting: community spaces
Participants 1. Age: 24.96 (3.21)
2. Gender: female
3. Socioeconomic background: 1 to 4% were employed
4. Educational background: education below
matric: 28 (43.8%) in intervention, 11 (15.1%) in the positive control, and 19 (29.7%) in the negative control
Inclusion criteria:
stayed in the village for the period of the intervention.
Exclusion criteria:
a. were > 32 weeks of pregnancy (as traditionally these women are discouraged from venturing out of their homes);
b. had pregnancy‐related complications such as a history of antepartum haemorrhage or had been advised bed rest.
Note: 11 to 14% of participants scored above 10 on the Edinburgh Postnatal Depression Scale (EPDS).
Stated purpose: assess the effectiveness of a low‐intensity group intervention led by lay workers during the antenatal period in reducing postnatal depression at 6‐12 weeks postpartum
Interventions Name: problem‐based low‐intensity group intervention
Title/name of PW and number: lay health workers (4)
1. Selection: these workers had earlier been trained to deliver simple supportive measures and life skills programmes for 5 years prior to the current investigation.
2. Educational background: not specified
3. Training: the training was conducted over a period of 50 hours and included principles of group work, problem‐solving, simple cognitive strategies, and coping skills both emotional and behavioural. About 20 hours of this was part of ongoing training for other psychosocial interventions. This was conducted by a psychiatrist.
4. Supervision: not specified
5. Incentives/remuneration: not specified
Prevention type: universal – all participants were eligible for inclusion; less than 15% of them presented with depression levels above the cut‐off for the measure at baseline.
Intervention details: the active intervention was delivered over 3 days, with three sessions per day, each 45 to 60 minutes long. The intervention involved a framework provided by risk factors for postnatal depression and common concerns of childbearing women in the community. The intervention involved eliciting common problems, discussing principles of problem‐solving, understanding the importance of interpersonal relationships, illustrating simple cognitive strategies, and a discussion of specific emotional and behavioural strategies for problems elicited. Concerns regarding delivery, breastfeeding, and a session on postnatal depression, specifically common symptoms, consequences, and appropriate help‐seeking behaviour were also included. Structured modules were designed for the delivery of the intervention and handouts in the local language were employed where necessary.
Control (2 control groups):
1. active control, which consisted of general sessions on pregnancy, delivery, breastfeeding, immunization, development, nutritional and hygiene needs of the child
2. usual care, which consisted of regular antenatal visits and supplements recommended during pregnancy
Outcomes Participants’outcomes of interest for this review
  1. Diagnosis of mental disorders – EPDS, score > 10 as proxy


Note: we included data from the problem‐based low‐intensity group intervention and active control group.
Carers’outcomes of interest for this review
Nil
Economic outcomes
Nil
Time points: baseline, post‐intervention (1‐6 months)
Notes Source of funding: unclear
Notes on validation of instruments (screening and outcomes): the instruments were translated to the local languages using standardized procedures (EPDS, Global Assessment of Functioning scale).
Additional information: none
Handling the data: not applicable
Prospective trial registration number: not reported