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A pragmatic randomised controlled TRial to Evaluate physical Activity as a treatment for Depression
ISRCTN ISRCTN16900744
DOI 10.1186/ISRCTN16900744
ClinicalTrials.gov identifier
EudraCT number
Public title A pragmatic randomised controlled TRial to Evaluate physical Activity as a treatment for Depression
Scientific title
Acronym TREAD
Serial number at source HTA 03/45/07
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?

As of 10/04/2012, the target number of participants has been amended from 762 to 361 in order to reflect our revised recruitment target approved under version 5 of the study protocol
Lay summary Not provided at time of registration
Ethics approval West Midlands Multi-centre Research Ethics Committee, approved on 20 October 2005, ref: 05/MRE07/42
Study design Two arm, multi-centre pragmatic randomised controlled trial with randomisation at the level of the individual participant
Countries of recruitment United Kingdom
Disease/condition/study domain Mild/moderate depression
Participants - 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)
Participants - 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
Anticipated start date 01/08/2006
Anticipated end date 31/01/2011
Status of trial Completed
Patient information material
Target number of participants 361
Interventions 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.
Primary outcome measure(s) Current primary outcome measure(s) as of 10/04/2012
Change in clinical symptoms of depression assessed using Beck Depression Inventory at 4-months post-randomisation.

Previous primary outcome measure (s)
Change in clinical symptoms of depression assessed using Beck Depression Inventory at 3-months post-randomisation.
Secondary outcome measure(s) Current secondary outcome measure (s) 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 measure (s)
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.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21073712
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22674921
3. 2012 cost-effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/22398106
Contact name Prof  Glyn  Lewis
  Address Academic Unit of Psychiatry
School of Social and Community Medicine
University of Bristol
Oakfield House
Oakfield Grove
  City/town Bristol
  Zip/Postcode BS8 2BN
  Country United Kingdom
  Tel +44 (0)117 331 4027
  Fax +44 (0)117 331 4026
  Email glyn.lewis@bristol.ac.uk
Sponsor University of Bristol (UK)
  Address Research, Enterprise and Development office
University of Bristol
Senate House
Tyndall Avenue
Bristol
BS8 1TH
  City/town Bristol
  Zip/Postcode BS8 1TH
  Country United Kingdom
  Tel +44 (0)117 928 9000
  Email vince.boyle@bristol.ac.uk
Date applied 15/02/2007
Last edited 15/08/2012
Date ISRCTN assigned 16/02/2007
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