Contact information
Type
Scientific
Primary contact
Prof Terry Brugha
ORCID ID
Contact details
Department of Psychiatry Academic Unit
Brandon Mental Health Unit
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0)1533 523205
tsb@le.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NMH8C
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Mental and behavioural disorders: Depression, anxiety, neuroses; Pregnancy and childbirth: Childbirth
Intervention
A 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 type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
10/01/1999
Overall trial end date
31/01/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Women 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.
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
10/01/1999
Recruitment end date
31/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Psychiatry Academic Unit
Leicester
LE5 4PW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Mental Health National Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2000 results in: http://www.ncbi.nlm.nih.gov/pubmed/11097068
Publication citations
-
Results
Brugha TS, Wheatley S, Taub NA, Culverwell A, Friedman T, Kirwan P, Jones DR, Shapiro DA, Pragmatic randomized trial of antenatal intervention to prevent post-natal depression by reducing psychosocial risk factors., Psychol Med, 2000, 30, 6, 1273-1281.