Condition category
Mental and Behavioural Disorders
Date applied
06/03/2010
Date assigned
15/04/2010
Last edited
15/04/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.trygfonden.dk/

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

Publication citations

Additional files

Editorial Notes