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

March 2, 2011 updated by: University of Nottingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2).
Time Frame: At the plenary session of the programmes.
At the plenary session of the programmes.

Secondary Outcome Measures

Outcome Measure
Time Frame
Resting heart rate.
Time Frame: At the plenary session of the programmes.
At the plenary session of the programmes.
GHQ12.
Time Frame: At the plenary session of the programmes.
At the plenary session of the programmes.
The SF-12vII.
Time Frame: At the plenary session of the programmes.
At the plenary session of the programmes.
The Rosenberg self-esteem scale.
Time Frame: At the plenary session of the programmes.
At the plenary session of the programmes.
Quality of life in depression scale.
Time Frame: At the plenary session of the programmes.
At the plenary session of the programmes.
The multidimensional scale of perceived social support.
Time Frame: At the plenary session of the programmes.
At the plenary session of the programmes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

October 17, 2007

First Submitted That Met QC Criteria

October 17, 2007

First Posted (Estimate)

October 18, 2007

Study Record Updates

Last Update Posted (Estimate)

March 3, 2011

Last Update Submitted That Met QC Criteria

March 2, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07105
  • Funder's ID: 293/350
  • Ethics ref ID: 07/H0401/110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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