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

Primary Purpose

Depression

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Psychosocial support exercise programme

Prescribed exercise

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Mental health, Exercise, Prescribed exercise, Physical health, Social wellbeing

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Nottingham City Primary Care Trust
Nottinghamshire County Teaching Primary Care Trust
Nottinghamshire Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Psychosocial support

Prescribed exercise

Arm Description

Comprising 22 participants engaging in the experimental exercise programme, exercising with psychosocial support.

Comprising 21 participants engaging in a programme of typical prescribed exercise.

Outcomes

Primary Outcome Measures

The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2).

Secondary Outcome Measures

Resting heart rate.

GHQ12.

The SF-12vII.

The Rosenberg self-esteem scale.

Quality of life in depression scale.

The multidimensional scale of perceived social support.

Full Information

NCT ID

NCT00546221

First Posted

October 17, 2007

Last Updated

March 2, 2011

Sponsor

University of Nottingham

Collaborators

Burdett Trust for Nursing, Nottinghamshire Healthcare NHS Trust, Nottingham City Primary Care Trust, Nottinghamshire County Teaching Primary Care Trust

1. Study Identification

Unique Protocol Identification Number

NCT00546221

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Nottingham

Collaborators

Burdett Trust for Nursing, Nottinghamshire Healthcare NHS Trust, Nottingham City Primary Care Trust, Nottinghamshire County Teaching Primary Care Trust

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Depression, Mental health, Exercise, Prescribed exercise, Physical health, Social wellbeing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Psychosocial support

Arm Type

Experimental

Arm Description

Comprising 22 participants engaging in the experimental exercise programme, exercising with psychosocial support.

Arm Title

Prescribed exercise

Arm Type

Active Comparator

Arm Description

Comprising 21 participants engaging in a programme of typical prescribed exercise.

Intervention Type

Behavioral

Intervention Name(s)

Psychosocial support exercise programme

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Prescribed exercise

Intervention Description

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.

Primary Outcome Measure Information:

Title

The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2).

Time Frame