Antidepressant drug therapy vs a community-based psychosocial intervention for the treatment of moderate postnatal depression: a pragmatic randomised controlled trial
| ISRCTN | ISRCTN16479417 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16479417 |
| Secondary identifying numbers | HTA 02/07/04 |
- Submission date
- 16/09/2003
- Registration date
- 16/09/2003
- Last edited
- 08/08/2011
- 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 Deborah Sharp
Scientific
Scientific
Academic Unit of primary care
University of Bristol
Bristol
BS8 2AA
United Kingdom
| Phone | +44 (0)117 3313812 |
|---|---|
| debbie.sharp@bris.ac.uk |
Study information
| Study design | Two arm multi-centre pragmatic randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | RESPOND |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Antidepressants |
| Primary outcome measure | 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 study start date | 01/06/2004 |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration. |
| Key inclusion criteria | Women with post natal depression up to 3 months post natal |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 30/04/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Unit of primary care
Bristol
BS8 2AA
United Kingdom
BS8 2AA
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2010 | Yes | No | |
| Results article | results | 03/08/2011 | Yes | No |
