ISRCTN - ISRCTN16900744: A pragmatic randomised controlled trial to evaluate physical activity as a treatment for depression

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Glyn Lewis

ORCID ID

Contact details

Academic Unit of Psychiatry
School of Social and Community Medicine
University of Bristol
Oakfield House
Oakfield Grove
Bristol
BS8 2BN
United Kingdom
+44 (0)117 331 4027
glyn.lewis@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 03/45/07

Study information

Scientific title

A pragmatic randomised controlled TRial to Evaluate physical Activity as a treatment for Depression

Acronym

TREAD

Study hypothesis

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

West Midlands Multi-centre Research Ethics Committee, 20/10/2005, ref: 05/MRE07/42

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

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

01/08/2006

Overall trial end date

31/01/2011

Reason abandoned (if study stopped)

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

361

Participant 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

Recruitment start date

01/08/2006

Recruitment end date

31/01/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 2BN
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location