Psychological interventions for postnatal depression - randomised controlled trial and economic evaluation

ISRCTN ISRCTN92195776
DOI https://doi.org/10.1186/ISRCTN92195776
Protocol serial number HTA 99/33/51
Sponsor Department of Health (UK)
Funder NIHR Health Technology Assessment Programme - HTA (UK)
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
15/05/2020
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

Dr C J Morrell
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titlePsychological interventions for postnatal depression - randomised controlled trial and economic evaluation
Study acronymPONDER
Study objectivesThe 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(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedMental and behavioural disorders: Depression, anxiety, neuroses; Pregnancy and childbirth: Childbirth
InterventionNon-directive counselling (NDC) v Cognitive Behavioural-type Counselling (CBC) delivered by Health Visitors in their usual clinical setting v standard care
Intervention typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Not provided at time of registration.

Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration4000
Key inclusion criteriaWomen with live babies who will remain with their GP for 4 months
Key exclusion criteriaUnable to give informed consent
Date of first enrolment01/04/2003
Date of final enrolment31/03/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Research Leader
Huddersfield
HD1 3DH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/01/2009 Yes No
Results article cost-effectiveness results 01/06/2019 15/05/2020 Yes No
Other publications cost-benefit analysis 01/06/2009 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

15/05/2020: Publication reference added.

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