Contact information
Type
Scientific
Primary contact
Dr Bo Netterstrøm
ORCID ID
Contact details
Department of Occupational and Environmental Medicine
Bispebjerg University Hospital
Bispebjerg Bakke 23
Copenhagen
2400
Denmark
bone@hih.regionh.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02
Study information
Scientific title
A randomised controlled trial of a immediate versus delayed stress management program versus traditional psychological therapy in adults suffering from work-related stress symptoms
Acronym
COPESTRESS
Study hypothesis
This study will evaluate the effectiveness of a stress management program, designed to treat work-related stress symptoms, help the participant back to work and prevent relapse.
Ethics approval
Danish Central Scientific-Ethical Committee pending as of 08/03/2010
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stress, adjustment disorders
Intervention
This study will analyse the effect of a stress management program. The program is composed of:
1. Stress management therapy
2. Mindfulness therapy
3. Dialogue with the participants workplace/employer
4. Physical exercise plan
210 participants are randomly assigned to three treatment groups (70 participants in each group):
Group 1: Start in the stress management program immediately
Group 2: Start in the stress management program after a latency of 4 months. This is a control group, to see the effect of the stress management program compared to no treatment, measured after 4 months, and the effect of the waiting time measured after 8 months.
Group 3: 12 sessions of psychological therapy, starting the therapy immediately. This is a control group, to compare the stress management program with traditional psychological therapy.
Total duration of treatment for all arms is 4 months and follw up will be one year after baseline.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Return to work rate, measured at 4 months and one year.
Secondary outcome measures
1. Symptom Checklist 92, measured at 4 months
2. World Health Organization (WHO) Major Depression Inventory, measured at 4 months
3. Absenteeism, measured at 4 months
4. Copenhagen Psychosocial Questionnaire (COPSOQ), measured at 4 months
5. Objective measures:
5.1. Salivary cortisol, measured at 4 months
5.2. High density lipoprotein (HDL) cholesterol, total cholesterol, blood pressure, measured at 4 months
5.3. C-reactive protein (CRP) and interleukin-6 (IL-6) (immunological status), measured at 4 months
5.4. HbA1C and dehydroepiandrosterone sulfate (DHEA-S) (metabolic condition), measured at 4 months
5.5. Heart rate variability (HRV), measured at 4 months
5.6. Neo Pi-r Personality Inventory (personality testing), measured at baseline
Overall trial start date
01/05/2010
Overall trial end date
01/06/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults aged 18 - 64 years, either sex
2. Employed
3. On sick leave
4. Moderate to high stress symptom score
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
210
Participant exclusion criteria
1. If alcohol or substance abuse has contributed substantially to the load condition
2. Unemployment
3. Major illnesses for example cancer and heart diseases, which has contributed substantially to the load condition
4. Physically impaired abilities, which prevent physical activity as a fast walk
5. Major mental disorder
Recruitment start date
01/05/2010
Recruitment end date
01/06/2012
Locations
Countries of recruitment
Denmark
Trial participating centre
Department of Occupational and Environmental Medicine
Copenhagen
2400
Denmark
Sponsor information
Organisation
Trygfonden (Denmark)
Sponsor details
Lyngby Hovedgade 8
Lyngby
2800
Denmark
ah@trygfonden.dk
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Trygfonden (Denmark)
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