Promoting Wellbeing for Women With Depression: A Pragmatic Randomised Controlled Trial (RCT) of an Exercise Programme
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00546221 |
Recruitment Status :
Completed
First Posted : October 18, 2007
Last Update Posted : March 3, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depression | Behavioral: Psychosocial support exercise programme Behavioral: Prescribed exercise | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
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 |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
---|---|
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. |
- The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2). [ Time Frame: At the plenary session of the programmes. ]
- Resting heart rate. [ Time Frame: At the plenary session of the programmes. ]
- GHQ12. [ Time Frame: At the plenary session of the programmes. ]
- The SF-12vII. [ Time Frame: At the plenary session of the programmes. ]
- The Rosenberg self-esteem scale. [ Time Frame: At the plenary session of the programmes. ]
- Quality of life in depression scale. [ Time Frame: At the plenary session of the programmes. ]
- The multidimensional scale of perceived social support. [ Time Frame: At the plenary session of the programmes. ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546221
United Kingdom | |
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 |
Principal Investigator: | Patrick Callaghan, RN BSc MSc PhD CPsychol | University of Nottingham | |
Principal Investigator: | Elizabeth B Khalil, BSc MSc PhD (Cant.) | University of Nottingham |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mr Paul Cartledge, University of Nottingham |
ClinicalTrials.gov Identifier: | NCT00546221 |
Other Study ID Numbers: |
07105 Funder's ID: 293/350 Ethics ref ID: 07/H0401/110 |
First Posted: | October 18, 2007 Key Record Dates |
Last Update Posted: | March 3, 2011 |
Last Verified: | March 2011 |
Depression Mental health Exercise |
Prescribed exercise Physical health Social wellbeing |
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |