Condition category
Mental and Behavioural Disorders
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
09/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.sheffield.ac.uk/scharr/sections/heds/staff/ponder.html

Contact information

Type

Scientific

Primary contact

Dr C J Morrell

ORCID ID

Contact details

Research Leader
Centre for Health and Social Care Research
University of Huddersfield
Queensgate
Huddersfield
HD1 3DH
United Kingdom

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

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. 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

  1. 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.

  2. 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.

Additional files

Editorial Notes