Treatment of functional symptoms due to work-related stress
| ISRCTN | ISRCTN52839015 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52839015 |
| Secondary identifying numbers | 02 |
- Submission date
- 06/03/2010
- Registration date
- 15/04/2010
- Last edited
- 15/04/2010
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Bo Netterstrøm
Scientific
Scientific
Department of Occupational and Environmental Medicine
Bispebjerg University Hospital
Bispebjerg Bakke 23
Copenhagen
2400
Denmark
| bone@hih.regionh.dk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | COPESTRESS |
| Study objectives | 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(s) | Danish Central Scientific-Ethical Committee pending as of 08/03/2010 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2010 |
| Completion date | 01/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | Both |
| Target number of participants | 210 |
| Key inclusion criteria | 1. Adults aged 18 - 64 years, either sex 2. Employed 3. On sick leave 4. Moderate to high stress symptom score |
| Key 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 |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 01/06/2012 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Department of Occupational and Environmental Medicine
Copenhagen
2400
Denmark
2400
Denmark
Sponsor information
Trygfonden (Denmark)
Research organisation
Research organisation
Lyngby Hovedgade 8
Lyngby
2800
Denmark
| ah@trygfonden.dk | |
| Website | http://www.trygfonden.dk/ |
"ROR" |
https://ror.org/02rcazp29 |
Funders
Funder type
Research organisation
Trygfonden (Denmark)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
