Condition category
Mental and Behavioural Disorders
Date applied
30/06/2005
Date assigned
25/08/2005
Last edited
24/09/2007
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 Peter Verhaak

ORCID ID

Contact details

PO Box 1568
Utrecht
3513 CR
Netherlands
+31 (0)30 272 9735
p.verhaak@nivel.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2200.0100

Study information

Scientific title

Acronym

Study hypothesis

Is a brief, activating treatment by social workers more successful in reducing long term absenteeism and in increasing patient well-being than General Practitioners' (GPs') usual care in patients with minor mental disorders ((e.g. mild depression, generalised anxiety disorder, adjustment disorder) who are on sick leave?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Minor mental disorders

Intervention

Usual GP care or five sessions in ten weeks with a social worker trained in the technique, including homework assignments and a focus on early work resumption. The main aims of the experimental treatment were:
1. To focus on the most recent and actual problems
2. To regain functionality and control
3. To resume work as early as possible

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The groups did not differ at baseline, nor after three, six or 18 months with respect to levels of depression, anxiety, somatisation, distress, functional status or sick leave duration. In both groups, well-being improved significantly in the first months after baseline, regardless of treatment.

Secondary outcome measures

Patients who received the brief activating treatment by social workers reported higher satisfaction than patients who received GPs' usual care.

Overall trial start date

05/03/2001

Overall trial end date

31/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Included were primary care patients who:
1. Were suffering from minor mental disorder(s) according to GP and patient
2. Had paid employment
3. Were on sick leave or planning to be directly after visit to GP, but had not been on sick leave for longer than three months
4. Were aged 18 to 60 years
5. Were Dutch speaking

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

370 primary care patients

Participant exclusion criteria

Excluded were patients who were already receiving psychotherapy, or who, according to the Composite International Diagnostic Interview (CIDI), had a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of:
1. Moderately severe or severe mood disorder
2. Agoraphobia
3. Panic disorder
4. Social phobia

Recruitment start date

05/03/2001

Recruitment end date

31/10/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

PO Box 1568
Utrecht
3513 CR
Netherlands

Sponsor information

Organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Sponsor details

Laan van Nieuw Oost Indië 334
PO Box 93245
The Hague
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl

Sponsor type

Research organisation

Website

http://www.zonmw.nl

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 2200.0100)

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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=16837516

Publication citations

  1. Brouwers EP, de Bruijne MC, Terluin B, Tiemens BG, Verhaak PF, Cost-effectiveness of an activating intervention by social workers for patients with minor mental disorders on sick leave: a randomized controlled trial., Eur J Public Health, 2007, 17, 2, 214-220, doi: 10.1093/eurpub/ckl099.

Additional files

Editorial Notes