Condition category
Mental and Behavioural Disorders
Date applied
16/09/2003
Date assigned
16/09/2003
Last edited
08/08/2011
Prospective/Retrospective
Prospectively 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 Deborah Sharp

ORCID ID

Contact details

Academic Unit of primary care
University of Bristol
Bristol
BS8 2AA
United Kingdom
+44 (0)117 3313812
debbie.sharp@bris.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 02/07/04

Study information

Scientific title

Acronym

RESPOND

Study hypothesis

The study proposes to compare the effectiveness and cost-effectiveness of antidepressant drug therapy versus a community-based psychosocial intervention (Health Visitor delivered non-directive counselling) in the treatment of moderate postnatal depression.

Protocol can be found at: http://www.hta.ac.uk/protocols/200200070004.pdf
More details can be found at: http://www.hta.ac.uk/1373

Please note that, as of 11 January 2008, the anticipated start and end dates of this trail have been updated from 1 March 2004 and 30 September 2007 to 1 June 2004 and 30 April 2008, respectively.

Ethics approval

Not provided at time of registration.

Study design

Two arm multi-centre pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Postnatal depression

Intervention

A two arm multi-centre pragmatic randomised controlled trial, with randomisation at the level of the individual woman. Women who reach the threshold for inclusion (EPDS>12, CIS-R>11) at 8 weeks will be randomised to either antidepressants or a 4 week waiting list for counselling. Women who do not respond to the allocated therapy in their group will be offered the opportunity to either switch or combined therapies after the primary outcome has been measured (4 weeks for antidepressants, 18 weeks for counselling) Thus the research design allows women to receive both antidepressants and psychological therapy is required.

Intervention type

Drug

Phase

Not Applicable

Drug names

Antidepressants

Primary outcome measures

The primary outcome measure is the EPDS at 4 weeks, 18 weeks and 44 weeks. In addition, the trial will use the SF-36 as a generic measure of functional quality of life, the EQ5D for economic analysis, the MAMA for parenting skills and attitudes towards the baby, the GRIMS for the quality of the marital relationship. The trial will ask partners to complete the GHQ12 the PAPA and the GRIMS. At 12 months we will assess the family milieu using the HOME and the child's development using the Bayley scales.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/06/2004

Overall trial end date

30/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Women with post natal depression up to 3 months post natal

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration.

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/06/2004

Recruitment end date

30/04/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of primary care
Bristol
BS8 2AA
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20860888
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21812968

Publication citations

  1. Results

    Sharp DJ, Chew-Graham C, Tylee A, Lewis G, Howard L, Anderson I, Abel K, Turner KM, Hollinghurst SP, Tallon D, McCarthy A, Peters TJ, A pragmatic randomised controlled trial to compare antidepressants with a community-based psychosocial intervention for the treatment of women with postnatal depression: the RESPOND trial., Health Technol Assess, 2010, 14, 43, iii-iv, ix-xi, 1-153, doi: 10.3310/hta14430.

  2. Results

    Howard LM, Flach C, Mehay A, Sharp D, Tylee A, The prevalence of suicidal ideation identified by the Edinburgh Postnatal Depression Scale in postpartum women in primary care: findings from the RESPOND trial., BMC Pregnancy Childbirth, 2011, 11, 57, doi: 10.1186/1471-2393-11-57.

Additional files

Editorial Notes