Evaluation of a preventative intervention for postnatal depression and associated difficulties in the mother-infant relationship, a controlled trial.
| ISRCTN | ISRCTN15503755 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15503755 |
| Protocol serial number | MCH 01-44 |
| Sponsor | Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK) |
| Funder | NHS Mother and Child Health National Research and Development Programme (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 19/09/2012
- 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 Peter Cooper
Scientific
Scientific
University of Reading
3 Earley Gate
Whiteknights Road
Reading
RG6 6AL
United Kingdom
| Phone | +44 (0)1223 33 6974 or 33 6063 |
|---|---|
| p.j.cooper@reading.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To produce a treatment manual for the prevention of postnatal depression. To evaluate the impact of this treatment on maternal mood, the mother-infant relationship and infant development outcome. To determine whether this treatment can be delivered effectively by trained NHS Health Visitors. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Postpartum depression |
| Intervention | Not provided at time of registration |
| Intervention type | Other |
| Primary outcome measure(s) |
Report in medical, health visitor and psychiatric journals. The treatment will be revised in the light of the study findings and made available in the form of a manual to Health Visitor services. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 240 |
| Key inclusion criteria | 240 women at risk from postpartum depression |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/10/1996 |
| Date of final enrolment | 01/10/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Reading
Reading
RG6 6AL
United Kingdom
RG6 6AL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/09/2006 | Yes | No |
