Condition category
Mental and Behavioural Disorders
Date applied
16/03/2010
Date assigned
27/05/2010
Last edited
22/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A. Otto Quartero

ORCID ID

Contact details

Dorpsstraat 12-14
de Bilt
3732 HJ
Netherlands

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 measures

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

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

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21791041

Publication citations

  1. 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.

Additional files

Editorial Notes