Condition category
Mental and Behavioural Disorders
Date applied
09/02/2010
Date assigned
19/02/2010
Last edited
09/08/2013
Prospective/Retrospective
Retrospectively 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

Hillerød Hospital
Helsevej 2
Hillerød
3400
Denmark

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

Sponsor information

Organisation

Hillerød Hospital (Denmark)

Sponsor details

Hillerød Hospital
Helsevej 2
DK 3400 Hillerød
Hillerød
3400
Denmark

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes