Condition category
Mental and Behavioural Disorders
Date applied
17/01/2005
Date assigned
19/04/2005
Last edited
15/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.emgo.nl/research_prog/common/researchprojects_37.asp

Contact information

Type

Scientific

Primary contact

Dr Berend Terluin

ORCID ID

Contact details

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 93 68
b.terluin@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4200.0003

Study information

Scientific title

Acronym

MISS

Study hypothesis

The objective of this study is to assess the effectiveness of the minimal intervention package (MISS) for distressed patients in general practice.

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

GP practices

Trial type

Treatment

Patient information sheet

Condition

Common mental disorders and sick leave

Intervention

This study is a pragmatic randomized controlled trial in general practice. Forty GPs will be randomized to the intervention group or the usual care group. The GPs in the intervention group will receive training in the implementation of the MISS intervention. This intervention package has been developed to assist the GPs in dealing with distressed patients. Within the limits of three 10-minute consultations, the GP should be able to:
1. Detect significant depression and anxiety, and to deal with it specifically
2. Educate the patient about distress and the best ways to cope with the situation
3. Advise the patient to see an occupational physician
4. Evaluate any progress four weeks later, and refer the patient to a psychological professional if no progress has been made

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Duration of occupational disability

Secondary outcome measures

Social functioning/quality of life, application for disability benefit after one year of sick leave (WAO), unemployment, psychological symptoms, and utilization of medical services. The outcomes will be assessed after 2, 6 and 12 months of follow-up.

Overall trial start date

01/09/2003

Overall trial end date

31/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (20-60 years old) who visited their GP, having distress complaints, paid work and sick leave no longer than three months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

415

Participant exclusion criteria

Severe psychiatric disorders (mania or psychosis), patients who were terminally ill or who couldn't speak Dutch properly.

Recruitment start date

01/09/2003

Recruitment end date

31/01/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

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

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. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16674806
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17549228
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19647973

Publication citations

  1. Results

    Bakker IM, Terluin B, van Marwijk HW, Gundy CM, Smit JH, van Mechelen W, Stalman WA, Effectiveness of a Minimal Intervention for Stress-related mental disorders with Sick leave (MISS); study protocol of a cluster randomised controlled trial in general practice [ISRCTN43779641]., BMC Public Health, 2006, 6, 124, doi: 10.1186/1471-2458-6-124.

  2. Results

    Bakker IM, Terluin B, van Marwijk HW, van der Windt DA, Rijmen F, van Mechelen W, Stalman WA, A cluster-randomised trial evaluating an intervention for patients with stress-related mental disorders and sick leave in primary care., PLoS Clin Trials, 2007, 2, 6, e26, doi: 10.1371/journal.pctr.0020026.

  3. Results

    Bakker IM, van Marwijk HW, Terluin B, Anema JR, van Mechelen W, Stalman WA, Training GP's to use a minimal intervention for stress-related mental disorders with sick leave (MISS): Effects on performance: Results of the MISS project; a cluster-randomised controlled trial [ISRCTN43779641]., Patient Educ Couns, 2010, 78, 2, 206-211, doi: 10.1016/j.pec.2009.07.006.

Additional files

Editorial Notes