Exercise therapy for Stress-related Mental Disorder
| ISRCTN | ISRCTN15609105 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15609105 |
| Secondary identifying numbers | 4200.0004 |
- Submission date
- 16/03/2010
- Registration date
- 27/05/2010
- Last edited
- 22/11/2011
- 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
Not provided at time of registration
Contact information
Dr A. Otto Quartero
Scientific
Scientific
Dorpsstraat 12-14
de Bilt
3732 HJ
Netherlands
Study information
| Study design | Randomised controlled parallel group open label clinical trial multicentre in general practice |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Exercise therapy for Stress-related Mental Disorder: A randomised controlled parallel group trial |
| Study acronym | ODIN |
| Study objectives | 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(s) | Ethics Committee of University Medical Centre of Utrecht approved on the 27th of October 2003 (protocol number: 03/109) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2003 |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Patients of 18 years old or more, presenting to their general practitioner with signs and symptoms of stress-related mental disorder |
| Key exclusion criteria | Patients with florid depression, anxiety disorder, addiction or otherwise pathological state of mind |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 01/05/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Dorpsstraat 12-14
de Bilt
3732 HJ
Netherlands
3732 HJ
Netherlands
Sponsor information
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Government
Government
Laan van nieuw Oost Indie 224 PO Box 93245
Den Haag
2509 AE
Netherlands
| Phone | +31 (0)70 349 5111 |
|---|---|
| slijper@zonmw.nl | |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Government
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) - small ailments fund (file nr 42000004)
No information available
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? |
|---|---|---|---|---|---|
| Results article | results | 26/07/2011 | Yes | No |
