Condition category
Mental and Behavioural Disorders
Date applied
04/06/2009
Date assigned
27/07/2009
Last edited
21/03/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Amanda Daley

ORCID ID

Contact details

Primary Care Clinical Sciences
School of Medical and Dental Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
a.daley@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3

Study information

Scientific title

The effectiveness of exercise as a treatment for post-natal depression: a randomised controlled trial with a nested qualitative study

Acronym

PAM-PeRS

Study hypothesis

Participants randomised to the exercise plus usual care group will report lower post-natal depression scores than the usual care only group

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial with a nested qualitative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Post-natal depression

Intervention

The intervention will last 6 months. Women randomised to the exercise intervention will be offered two (40 - 60 minutes) personal home-based exercise consultations in the first two months and two further supportive phone calls that promote exercise in the following two months. Participants will also be mailed information on local opportunities to exercise with updates sent on three occasions during the six-month intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Post-natal depression. Measured at baseline, 6 months and 12 months.

Secondary outcome measures

1. Physical activity
2. Body weight
3. Vitality
4. Quality of life
5. Body image
6. Self-efficacy for exercise

Measured at baseline, 6 months and 12 months.

Overall trial start date

12/11/2009

Overall trial end date

11/11/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. An International Classification of Diseases, 10th Edition (ICD-10) diagnosis of depression, following screening using the Edinburgh Postnatal Depression Scale (EPDS) at 6 and 8 - 10 weeks and the Clinical Interview Schedule - Revised (CIS-R) at 8 - 10 weeks after giving birth
2. Non-pregnant at baseline
3. Not experiencing psychotic symptoms
4. Not dependent on illicit drugs or alcohol
5. Aged greater than or equal to 18 years
6. Currently inactive (defined as not meeting the current public health guidelines for physical activity, i.e. less than 150 minutes of moderate intensity physical activity per week in previous six weeks)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

208

Participant exclusion criteria

1. Not proficient in English at a level to complete research assessments
2. General Practitioner (GP) considers patient unsuitable for the trial
3. Women whose babies have died

Recruitment start date

12/11/2009

Recruitment end date

11/11/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care Clinical Sciences
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Contracts and Governance
Research and Enterprise Services
Birmingham
B30 2EH
United Kingdom
+44 (0)121 414 7618
b.w.laverty@bham.ac.uk

Sponsor type

University/education

Website

http://www.bham.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - National School of Primary Care Research

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. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22682671

Publication citations

  1. Protocol

    Daley AJ, Jolly K, Sharp DJ, Turner KM, Blamey RV, Coleman S, McGuinness M, Roalfe AK, Jones I, MacArthur C, The effectiveness of exercise as a treatment for postnatal depression: study protocol., BMC Pregnancy Childbirth, 2012, 12, 45, doi: 10.1186/1471-2393-12-45.

Additional files

Editorial Notes