Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2002-1-46
Study information
Scientific title
Effects of a multidisciplinary stress treatment programme: a non-randomised controlled study from a stress clinic
Acronym
Study hypothesis
Stress treatment programme accelerate return to work
Ethics approval
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).
Study design
Non-randomised follow-up study of two treatment groups
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet (in Danish).
Condition
Adjustment disorders
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
01/10/2002
Overall trial end date
01/10/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Stress symptoms for more than a few weeks
2. Adults, male or female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 (97 final recruitment)
Participant exclusion criteria
Major somatic or psychiatric disease
Recruitment start date
01/10/2002
Recruitment end date
01/10/2004
Locations
Countries of recruitment
Denmark
Trial participating centre
Hillerød Hospital
Hillerød
3400
Denmark
Funders
Funder type
Other
Funder name
Treatment funded by the employer or insurrance company of each participant
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
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21040559
Publication citations
-
Results
Netterstrøm B, Bech P, Effect of a multidisciplinary stress treatment programme on the return to work rate for persons with work-related stress. A non-randomized controlled study from a stress clinic., BMC Public Health, 2010, 10, 658, doi: 10.1186/1471-2458-10-658.