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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22682671
Publication citations
-
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.