Promoting Wellbeing for Women With Depression: A Pragmatic Randomised Controlled Trial (RCT) of an Exercise Programme

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546221
• Other study ID #: 07105
• Secondary ID: Funder's ID: 293
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2007
• Last updated: March 2, 2011
• Start date: November 2007
• Est. completion date: May 2009

Study information

• Verified date: March 2011
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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).
• 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.

Locations

Country	Name	City	State
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

Sponsors (5)

Lead Sponsor	Collaborator
University of Nottingham	Burdett Trust for Nursing, Nottingham City Primary Care Trust, Nottinghamshire County Teaching Primary Care Trust, Nottinghamshire Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2).		At the plenary session of the programmes.	No
Secondary	Resting heart rate.		At the plenary session of the programmes.	No
Secondary	GHQ12.		At the plenary session of the programmes.	No
Secondary	The SF-12vII.		At the plenary session of the programmes.	No
Secondary	The Rosenberg self-esteem scale.		At the plenary session of the programmes.	No
Secondary	Quality of life in depression scale.		At the plenary session of the programmes.	No
Secondary	The multidimensional scale of perceived social support.		At the plenary session of the programmes.	No

External Links

•   project website
•   University of Nottingham, School of Nursing Mental Health Research Group