Promoting Wellbeing for Women With Depression: A Pragmatic Randomised Controlled Trial (RCT) of an Exercise Programme
Pragmatic Randomised Controlled Trial of a Preferred Intensity Exercise Programme to Improve Physiological and Associated Psychological, Social, and Wellbeing Outcomes of Women Living With Depression
3 other identifiers
interventional
43
1 country
3
Brief Summary
The investigators want to find out if their specially designed exercise programme will be more successful at helping women with depression to feel better than a basic programme will, by measuring the effect the programme has on mood, physical health, and social wellbeing. Their specially designed exercise programme will involve physical exertion at the participants' chosen level of intensity (how hard the body has to work during exercise), and will include motivational support. By contrast, the basic exercise programme will be at an intensity recommended by national guidelines, of the type that may be prescribed by a general practitioner (GP), and will include no extra motivational support.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 depression
Started Nov 2007
Shorter than P25 for phase_2 depression
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2007
CompletedFirst Posted
Study publicly available on registry
October 18, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedMarch 3, 2011
March 1, 2011
1.5 years
October 17, 2007
March 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2).
At the plenary session of the programmes.
Secondary Outcomes (6)
Resting heart rate.
At the plenary session of the programmes.
GHQ12.
At the plenary session of the programmes.
The SF-12vII.
At the plenary session of the programmes.
The Rosenberg self-esteem scale.
At the plenary session of the programmes.
Quality of life in depression scale.
At the plenary session of the programmes.
- +1 more secondary outcomes
Study Arms (2)
Psychosocial support
EXPERIMENTALComprising 22 participants engaging in the experimental exercise programme, exercising with psychosocial support.
Prescribed exercise
ACTIVE COMPARATORComprising 21 participants engaging in a programme of typical prescribed exercise.
Interventions
The experimental arm will experience 12 sessions of intervention, at a rate of three sessions a week for four weeks, exercising in groups of ten women. Each session will comprise: fifteen minutes of psychosocial and motivational support, run by a qualified rehabilitation psychologist and overseen by a qualified health psychologist; a half hour preferred intensity exercise session run by a qualified sports physiotherapist. Participants preferred intensity (chosen exertion level) will be established using the Borg RPE scale (Borg G 1998).
This group will experience 12 sessions of intervention, at a rate of three sessions a week for four weeks, exercising in groups of ten women. Each session will be an half hour exercise session, at a typically (GP) prescribed level, designed in accordance with national guidelines and run by a qualified sports physiotherapist.
Eligibility Criteria
You may qualify if:
- Living with depression
- Aged 18 (age at first session of programme)
- Female
- Living in the community
- Resident within Nottinghamshire (personal address has Nottinghamshire postcode)
You may not qualify if:
- Women who, at the time of the study, are unable to participate on account of any injury or physical health problem that precludes their participation
- Women participating in research that may undermine the scientific basis of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nottinghamlead
- Burdett Trust for Nursingcollaborator
- Nottinghamshire Healthcare NHS Trustcollaborator
- Nottingham City Primary Care Trustcollaborator
- Nottinghamshire County Teaching Primary Care Trustcollaborator
Study Sites (3)
Nottingham City Primary Care Trust
Nottingham, Nottinghamshire, United Kingdom
Nottinghamshire County Teaching Primary Care Trust
Nottingham, Nottinghamshire, United Kingdom
Nottinghamshire Healthcare NHS Trust
Nottingham, Nottinghamshire, United Kingdom
Related Publications (1)
Callaghan P, Khalil E, Morres I, Carter T. Pragmatic randomised controlled trial of preferred intensity exercise in women living with depression. BMC Public Health. 2011 Jun 12;11:465. doi: 10.1186/1471-2458-11-465.
PMID: 21663696DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Callaghan, RN BSc MSc PhD CPsychol
University of Nottingham
- PRINCIPAL INVESTIGATOR
Elizabeth B Khalil, BSc MSc PhD (Cant.)
University of Nottingham
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 17, 2007
First Posted
October 18, 2007
Study Start
November 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
March 3, 2011
Record last verified: 2011-03