Promoting Wellbeing for Women With Depression: A Pragmatic Randomised Controlled Trial (RCT) of an Exercise Programme
This study has been completed.
Sponsor:
University of Nottingham
Collaborators:
Burdett Trust for Nursing
Nottinghamshire Healthcare NHS Trust
Nottingham City Primary Care Trust
Nottinghamshire County Teaching Primary Care Trust
Information provided by:
University of Nottingham
ClinicalTrials.gov Identifier:
NCT00546221
First received: October 17, 2007
Last updated: March 2, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Behavioral: Psychosocial support exercise programme Behavioral: Prescribed exercise |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by University of Nottingham:
Primary Outcome Measures:
- The primary outcome measure is score on the BDI−II (Beck Depression Inventory version 2). [ Time Frame: At the plenary session of the programmes. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Resting heart rate. [ Time Frame: At the plenary session of the programmes. ] [ Designated as safety issue: No ]
- GHQ12. [ Time Frame: At the plenary session of the programmes. ] [ Designated as safety issue: No ]
- The SF−12vII. [ Time Frame: At the plenary session of the programmes. ] [ Designated as safety issue: No ]
- The Rosenberg self−esteem scale. [ Time Frame: At the plenary session of the programmes. ] [ Designated as safety issue: No ]
- Quality of life in depression scale. [ Time Frame: At the plenary session of the programmes. ] [ Designated as safety issue: No ]
- The multidimensional scale of perceived social support. [ Time Frame: At the plenary session of the programmes. ] [ Designated as safety issue: No ]
| Enrollment: | 43 |
| Study Start Date: | November 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Psychosocial support
Comprising 22 participants engaging in the experimental exercise programme, exercising with psychosocial support.
|
Behavioral: Psychosocial support exercise programme
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).
|
|
Active Comparator: Prescribed exercise
Comprising 21 participants engaging in a programme of typical prescribed exercise.
|
Behavioral: Prescribed exercise
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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Living with depression
- Aged 18 (age at first session of programme)
- Female
- Living in the community
- Resident within Nottinghamshire (personal address has Nottinghamshire postcode)
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546221
Locations
| United Kingdom | |
| Nottinghamshire Healthcare NHS Trust | |
| Nottingham, Nottinghamshire, United Kingdom | |
| Nottingham City Primary Care Trust | |
| Nottingham, Nottinghamshire, United Kingdom | |
| Nottinghamshire County Teaching Primary Care Trust | |
| Nottingham, Nottinghamshire, United Kingdom | |
Sponsors and Collaborators
University of Nottingham
Burdett Trust for Nursing
Nottinghamshire Healthcare NHS Trust
Nottingham City Primary Care Trust
Nottinghamshire County Teaching Primary Care Trust
Investigators
| Principal Investigator: | Patrick Callaghan, RN BSc MSc PhD CPsychol | University of Nottingham |
| Principal Investigator: | Elizabeth B Khalil, BSc MSc PhD (Cant.) | University of Nottingham |
More Information
Additional Information:
No publications provided by University of Nottingham
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mr Paul Cartledge, University of Nottingham |
| ClinicalTrials.gov Identifier: | NCT00546221 History of Changes |
| Other Study ID Numbers: | 07105, Funder's ID: 293/350, Ethics ref ID: 07/H0401/110 |
| Study First Received: | October 17, 2007 |
| Last Updated: | March 2, 2011 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by University of Nottingham:
|
Depression Mental health Exercise |
Prescribed exercise Physical health Social wellbeing |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013