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ISRCTN
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ISRCTN04354658
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ClinicalTrials.gov identifier
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Public title
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Effects of a multidisciplinary stress treatment programme
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Scientific title
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Effects of a multidisciplinary stress treatment programme: A non-randomised controlled study from a stress clinic
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Acronym
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NA
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Serial number at source
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2002-1-46
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Study hypothesis
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Stress treatment programme accelerate return to work
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Lay summary
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Ethics approval
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Assessed by the regional Committee System on Biomedical Research Ethics in 2002. Judged as a quality development project and therefore not requiring committee approval based on the "Guidelines about Notification of a Biomedical Research Project". (ref: 2002-1-46)
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Study design
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Non randomised follow up study of two treatment groups
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Countries of recruitment
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Denmark
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Disease/condition/study domain
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Adjustment disorders
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Participants - inclusion criteria
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1. Stress symptoms for more than few weeks
2. Adults, male or female
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Participants - exclusion criteria
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Major somatic or psychiatric disease
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Anticipated start date
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01/10/2002
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Anticipated end date
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01/10/2004
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet (in Danish).
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Target number of participants
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100 (97 final recruitment)
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Interventions
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The stress treatment programme consisted of the following:
1. Identification of relevant stressors
2. Changing the coping strategies of the participants
3. Decreasing the workload and tasks
4. Relaxation techniques
5. Physical exercise
6. Psychiatric evaluation if there were a high score on the depression test
On average each patient attended six one-hour sessions during four months.
A group of 34 employees referred to the Clinic of Occupational Medicine by their GPs served as a control group. They had a one-hour consultation at baseline and after four months. All sessions were carried out by a specialist in occupational medicine.
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Primary outcome measure(s)
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Return to work rate
Absenteeism was registered at baseline, 4 months after and after one and two years simply by postal questionnaire. Non-responders were followed up by telephone.
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Secondary outcome measure(s)
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Symptom score
SF-36 and Major Depression Inventory (MDI) questionnaires regarding stress symptoms were filled out at baseline, after four months and after one and two years.
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Sources of funding
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Treatment funded by the employer or insurrance company of each participant
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Trial website
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21040559
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Contact name
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Dr
Bo
Netterstrøm
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Address
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Hillerød Hospital
Helsevej 2
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City/town
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Hillerød
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Zip/Postcode
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3400
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Country
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Denmark
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Sponsor
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Hillerød Hospital (Denmark)
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Address
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Hillerød Hospital
Helsevej 2
DK 3400 Hillerød
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City/town
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Hillerød
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Zip/Postcode
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3400
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Country
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Denmark
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Date applied
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09/02/2010
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Last edited
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30/03/2011
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Date ISRCTN assigned
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19/02/2010
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