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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
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
-
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.
-
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.
-
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.