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A randomised, controlled trial of a community-based perinatal intervention for postnatal depression in India

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN56588156
Enrollment
422
Registered
2002-11-06
Start date
2002-08-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postnatal depression

Interventions

A home-based, perinatal psycho-social intervention is given to a random half of the participants. It is based on 'listening visits' used for postnatal depression by UK health visitors, culturally adap

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pregnant women, between 26 and 34 weeks gestation at recruitment 2. At high risk of postnatal depression. A pre-recruitment screening interview is used to identify high risk women, based on: a. presence of psychological symptoms b. reporting the current pregnancy to be unplanned, and c. being vulnerable to excessive pressure to bear a male child (see interventions)

Exclusion criteria

Exclusion criteria: 1. Women who did not speak the study language (Konkani) 2. Women who planned to move away from the project area during the period of the study 3. Women with a health problem of such seriousness that it would prevent them from participating in the study

Design outcomes

Primary

MeasureTime frame
1. Depression at three and six months postnatal (using Edinburgh Postnatal Depression Scale) 2. Primary infant outcome: mental development score on the Developmental Assessment Schedules for Indian Infants (DASII), measured at six months postnatal

Secondary

MeasureTime frame
1. Maternal depression according to International Classification of Diseases (ICD-10) criteria (Revised Clinical Interview Schedule [CIS-R]), measured at three and six months postnatal 2. Disability (WHO Disability Assessment Schedule, version II [WHO-DAS II]), measured at three and six months postnatal 3. Costs of healthcare (Modified Client Services Receipt Inventory [CSRI]), measured at three and six months postnatal 4. Infant growth, measured at three and six months postnatal 5. Maternal-infant interaction (Global Rating Scale of maternal-infant interaction [GRS]), measured at three months postnatal

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026