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

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.

Conditions

• Depression

Interventions

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).

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.

Sponsors & Collaborators

• Burdett Trust for Nursing

  collaborator OTHER

• Nottinghamshire Healthcare NHS Trust

  collaborator OTHER_GOV

• Nottingham City Primary Care Trust

  collaborator UNKNOWN

• Nottinghamshire County Teaching Primary Care Trust

  collaborator UNKNOWN

• University of Nottingham

  lead OTHER

Principal Investigators

• Patrick Callaghan, RN BSc MSc PhD CPsychol · University of Nottingham

• Elizabeth B Khalil, BSc MSc PhD (Cant.) · University of Nottingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2009-05-31

Completion

2009-05-31

Countries

• United Kingdom

Study Locations