A pragmatic randomised controlled trial to evaluate physical activity as a treatment for depression

ISRCTN	ISRCTN16900744
DOI	https://doi.org/10.1186/ISRCTN16900744
Protocol serial number	HTA 03/45/07
Sponsor	University of Bristol (UK)
Funder	Health Technology Assessment Programme

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Glyn Lewis
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
Email	glyn.lewis@bristol.ac.uk

Study information

Primary study design	Interventional
Study design	Two-arm multi-centre pragmatic randomised controlled trial with randomisation at the level of the individual participant
Secondary study design	Randomised controlled trial
Study type	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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	69 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

University of Bristol

Bristol
BS8 2BN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Protocol article	protocol	12/11/2010		Yes	No
Other publications	rationale and development	01/12/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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