Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
06/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes