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

ISRCTN	ISRCTN92195776
DOI	https://doi.org/10.1186/ISRCTN92195776
Secondary identifying numbers	HTA 99/33/51

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

Study website

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Psychological interventions for postnatal depression - randomised controlled trial and economic evaluation
Study acronym	PONDER
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2003
Completion date	31/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	4000 women from 93 General Practices
Key inclusion criteria	Women with live babies who will remain with their GP for 4 months
Key exclusion criteria	Unable to give informed consent
Date of first enrolment	01/04/2003
Date of final enrolment	31/03/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Research Leader

Huddersfield
HD1 3DH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	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	15/01/2009		Yes	No
Other publications	cost-benefit analysis	01/06/2009		Yes	No
Results article	cost-effectiveness results	01/06/2019	15/05/2020	Yes	No

Editorial Notes

15/05/2020: Publication reference added.