Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4200.0004
Study information
Scientific title
Exercise therapy for Stress-related Mental Disorder: A randomised controlled parallel group trial
Acronym
ODIN
Study hypothesis
Exercise therapy will enhance recovery from stress-related mental disorder
Stress-related Mental Disorder (SMD) is a common problem in general practice. In DSM-IV SMD is partly but not exclusively covered by adjustment disorder, in ICD by adjustment disorder (F43.2), neurasthenia (F48.0), to some extent Burn-out (Z73.0), and work-related disorders (Z56.1-7). In a more general way it is also known as nervous breakdown, "overstressed", or "overburdened".
Ethics approval
Ethics Committee of University Medical Centre of Utrecht approved on the 27th of October 2003 (protocol number: 03/109)
Study design
Randomised controlled parallel group open label clinical trial multicentre in general practice
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Stress-related Mental Disorder
Intervention
Patients in the intervention group are referred to a physical therapist for structured exercise at 70% (50-85%) of maximum intensity, for at least 30 minutes, 5 days per week, over 12 weeks. The control group will receive care as usual from the GP.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
General health, assessed by questionnaire (SF-36) at 6 weeks after start of the intervention
Secondary outcome measures
1. General health, assessed by questionnaire (SF-36) at 12 and 24 weeks
2. Social health, assessed by questionnaire (SF-36) at 6,12 and 24 weeks
3. Mental health, assessed by questionnaire (SF-36) at 6,12 and 24 weeks
4. Level of distress, assessed by four-dimensional health questionnaire (4DSQ) at 6,12 and 24 weeks
5. Mean abstinence from work at 6 and 12 weeks
Overall trial start date
01/11/2003
Overall trial end date
01/05/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients of 18 years old or more, presenting to their general practitioner with signs and symptoms of stress-related mental disorder
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
Patients with florid depression, anxiety disorder, addiction or otherwise pathological state of mind
Recruitment start date
01/11/2003
Recruitment end date
01/05/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Dorpsstraat 12-14
de Bilt
3732 HJ
Netherlands
Sponsor information
Organisation
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
Laan van nieuw Oost Indie 224 PO Box 93245
Den Haag
2509 AE
Netherlands
+31 (0)70 349 5111
slijper@zonmw.nl
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) - small ailments fund (file nr 42000004)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21791041
Publication citations
-
Results
Quartero AO, Burger H, Donker M, de Wit NJ, Exercise therapy for stress-related mental disorder, a randomised controlled trial in primary care., BMC Fam Pract, 2011, 12, 76, doi: 10.1186/1471-2296-12-76.