ISRCTN ISRCTN41311867
DOI https://doi.org/10.1186/ISRCTN41311867
Protocol serial number NMH8C
Sponsor Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder NHS Mental Health National Research and Development Programme (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
06/12/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Terry Brugha
Scientific

Department of Psychiatry Academic Unit
Brandon Mental Health Unit
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Phone +44 (0)1533 523205
Email tsb@le.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMental and behavioural disorders: Depression, anxiety, neuroses; Pregnancy and childbirth: Childbirth
InterventionA brief structured, psychosocial intervention designed to reduce deficits in social support, based on principles of social support and problem solving plus standard antenatal care. Standard antenatal care was available to all women throughout the study. An outcome assessment was completed at 3 months with all women willing to be seen postnatally.
Intervention typeOther
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/01/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Key inclusion criteriaWomen attending their first antenatal clinical were screened to identify their risk of postnatal depression. Eligible subjects were assessed during the second trimester of pregnancy and those wishing to attend the intervention randomised to the intervention or control condition.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment10/01/1999
Date of final enrolment31/01/2002

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Psychiatry Academic Unit
Leicester
LE5 4PW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2000 Yes No