Exercise therapy for Stress-related Mental Disorder

ISRCTN	ISRCTN15609105
DOI	https://doi.org/10.1186/ISRCTN15609105
Protocol serial number	4200.0004
Sponsor	Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) - small ailments fund (file nr 42000004)

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

Dorpsstraat 12-14
de Bilt
3732 HJ
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised controlled parallel group open label clinical trial multicentre in general practice
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	General health, assessed by questionnaire (SF-36) at 6 weeks after start of the intervention
Key secondary outcome measure(s)	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
Completion date	01/05/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes