A pragmatic randomised controlled trial to evaluate physical activity as a treatment for depression
| ISRCTN | ISRCTN16900744 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16900744 |
| Secondary identifying numbers | HTA 03/45/07 |
- Submission date
- 15/02/2007
- Registration date
- 16/02/2007
- Last edited
- 07/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
There is some evidence that exercise can improve outcome in depression but the current evidence is rather limited and the studies have been too small to provide accurate estimates of any possible benefit. Exercise on prescription is used to describe arrangements whereby a doctor will recommend to a patient that they carry out a systematic programme of exercise. They have mostly been provided for people with cardiovascular (heart) disease. The aim of this study is to investigate whether exercise on prescription affects outcome in depression when used in addition to the usual care of depression that is usually treated with antidepressants.
Who can participate?
Patients aged 18-69 with mild/moderate depression
What does the study involve?
Participants are randomly allocated to one of two groups. One group receives exercise on prescription in addition to usual care. The other group receives usual care. We measure depression over 24 months and also measure antidepressant use, quality of life and costs.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
August 2006 to January 2011
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Prof. Glyn Lewis
glyn.lewis@bristol.ac.uk
Contact information
Scientific
Academic Unit of Psychiatry
School of Social and Community Medicine
University of Bristol
Oakfield House
Oakfield Grove
Bristol
BS8 2BN
United Kingdom
| Phone | +44 (0)117 331 4027 |
|---|---|
| glyn.lewis@bristol.ac.uk |
Study information
| Study design | Two-arm multi-centre pragmatic randomised controlled trial with randomisation at the level of the individual participant |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A pragmatic randomised controlled TRial to Evaluate physical Activity as a treatment for Depression |
| Study acronym | TREAD |
| Study objectives | Current study hypothesis as of 10/04/2012 Does facilitated physical activity, in addition to usual care in primary health care, change the outcome in depression and alter the subsequent use of antidepressant medication? Previous study hypothesis Does physical activity, in addition to usual care in primary health care, change the outcome in depression and alter the subsequent use of antidepressant medication? More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/034507 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0013/51007/PRO-03-45-07.pdf |
| Ethics approval(s) | West Midlands Multi-centre Research Ethics Committee, 20/10/2005, ref: 05/MRE07/42 |
| Health condition(s) or problem(s) studied | Mild/moderate depression |
| Intervention | Current interventions as of 10/04/2012 The TREAD intervention aims to increase self-esteem, confidence and social interaction as well as the take-up of physical activity, through the use of motivational techniques and drawing upon the theories of social cognition and self-determination. It comprises a series of face-to-face meetings and telephone contacts, negotiated between participants and a designated Physical Activity Facilitator (PAF) over a 8-month period. Previous interventions The TREAD intervention aims to increase self-esteem, confidence and social interaction as well as the take-up of physical activity, through the use of motivational techniques and drawing upon the theories of social cognition and self-determination. It comprises a series of face-to-face meetings and telephone contacts, negotiated between participants and a designated Physical Activity Facilitator (PAF) over a 12-month period. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measures as of 10/04/2012: Change in clinical symptoms of depression assessed using Beck Depression Inventory at 4-months post-randomisation. Previous primary outcome measures: Change in clinical symptoms of depression assessed using Beck Depression Inventory at 3-months post-randomisation. |
| Secondary outcome measures | Current secondary outcome measures as of 10/04/2012: A number of secondary outcomes will be measured at various points throughout the trial (4-months, 8-months, 12-months post-randomisation) including change in use of anti-depressants, uptake of physical activity, exercise efficacy and quality of life . Previous secondary outcome measures: A number of secondary outcomes will be measured at various points throughout the trial (3-months, 12-months, 24-months post-randomisation) including change in use of anti-depressants, uptake of physical activity, physical self-perceptions, exercise efficacy, psychiatric co-morbidity, quality of life and social support. |
| Overall study start date | 01/08/2006 |
| Completion date | 31/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 69 Years |
| Sex | Both |
| Target number of participants | 361 |
| Key inclusion criteria | Patients aged 18-69 diagnosed by GPs as having a new episode of mild/moderate depression (ICD-10 diagnosis and a score of 14 or more on Beck Depression Inventory) |
| Key exclusion criteria | 1. Physical contraindications to exercise 2. Inability to complete self-administered questionnaires 3. Psychosis 4. Serious drug or alcohol abuse 5. Pregnancy at time of randomisation |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 31/01/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BS8 2BN
United Kingdom
Sponsor information
University/education
Research, Enterprise and Development office
University of Bristol
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
| Phone | +44 (0)117 928 9000 |
|---|---|
| vince.boyle@bristol.ac.uk | |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/11/2010 | Yes | No | |
| Other publications | rationale and development | 01/12/2010 | Yes | No | |
| Results article | results | 01/04/2011 | Yes | No | |
| Results article | cost-effectiveness results | 01/06/2012 | Yes | No | |
| Results article | results | 06/06/2012 | Yes | No |
Editorial Notes
07/06/2016: Plain English summary added.
10/04/2012: the target number of participants was changed from 762 to 361 in order to reflect our revised recruitment target approved under version 5 of the study protocol
