The effectiveness of exercise as a treatment for post-natal depression

ISRCTN	ISRCTN84245563
DOI	https://doi.org/10.1186/ISRCTN84245563
Secondary identifying numbers	3

Submission date: 04/06/2009
Registration date: 27/07/2009
Last edited: 31/08/2018

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 Amanda Daley
Scientific

Primary Care Clinical Sciences
School of Medical and Dental Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Email	a.daley@bham.ac.uk

Study information

Study design	Randomised controlled trial with a nested qualitative study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effectiveness of exercise as a treatment for post-natal depression: a randomised controlled trial with a nested qualitative study
Study acronym	PAM-PeRS
Study objectives	Participants randomised to the exercise plus usual care group will report lower post-natal depression scores than the usual care only group
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	12/11/2009
Completion date	11/11/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	208
Key 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)
Key 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
Date of first enrolment	12/11/2009
Date of final enrolment	11/11/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Primary Care Clinical Sciences

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Contracts and Governance
Research and Enterprise Services
Birmingham
B30 2EH
England
United Kingdom

Phone	+44 (0)121 414 7618
Email	b.w.laverty@bham.ac.uk
Website	http://www.bham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

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

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?
Protocol article	protocol	09/06/2012		Yes	No
Results article	results	01/04/2020		Yes	No

Editorial Notes

31/08/2018: publication reference added