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

This study has been completed.
Sponsor:
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
  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
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, see Learn About Clinical Studies.

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 September 15, 2014