Plain English Summary
Not provided at time of registration
Trial website
http://www.sheffield.ac.uk/scharr/sections/heds/staff/ponder.html
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 99/33/51
Study information
Scientific title
Acronym
PONDER
Study hypothesis
The central aim of the study is to assess the costs, effectiveness and broad impact of screening for postnatal depression alongside two counselling interventions, non-directive counselling and cognitive behavioural counselling, delivered by health visitors in their usual clinical setting. Screened women at risk of depression will be interviewed to assess symptom severity. The study will assess effectiveness according to severity, history and duration of depression. The design will reflect the practicalities of primary care service delivery and will ensure that a wide range of effects is identified. In addition, the trial will examine an important practical question, with no loss of statistical power, on the efficiency and value of face-to-face screening by health visitors, compared with postnatal screening.
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
GP practices
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Mental and behavioural disorders: Depression, anxiety, neuroses; Pregnancy and childbirth: Childbirth
Intervention
Non-directive counselling (NDC) v Cognitive Behavioural-type Counselling (CBC) delivered by Health Visitors in their usual clinical setting v standard care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The efficiency and value of face-to-face screening by health visitors, compared with postnatal screening. Women's postal questionnaires, casenotes and activity data will be used to monitor changes in symptoms, health outcomes, hospital admissions, NHS service use, family well-being and infant progress to eighteen months
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/04/2003
Overall trial end date
31/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Women with live babies who will remain with their GP for 4 months
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
4000 women from 93 General Practices
Participant exclusion criteria
Unable to give informed consent
Recruitment start date
01/04/2003
Recruitment end date
31/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Research Leader
Huddersfield
HD1 3DH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
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. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19147636
2. 2009 cost-benefit analysis in http://www.ncbi.nlm.nih.gov/pubmed/19555590
Publication citations
-
Results
Morrell CJ, Slade P, Warner R, Paley G, Dixon S, Walters SJ, Brugha T, Barkham M, Parry GJ, Nicholl J, Clinical effectiveness of health visitor training in psychologically informed approaches for depression in postnatal women: pragmatic cluster randomised trial in primary care., BMJ, 2009, 338, a3045.
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Morrell CJ, Warner R, Slade P, Dixon S, Walters S, Paley G, Brugha T, Psychological interventions for postnatal depression: cluster randomised trial and economic evaluation. The PoNDER trial., Health Technol Assess, 2009, 13, 30, iii-iv, xi-xiii, 1-153, doi: 10.3310/hta13300.