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van CCT (UK)

Effectiveness of a Minimal Intervention Strategy for patients with common mental disorders on sick leave: a pragmatic randomized controlled trial in General Practice.

- candidate number0
- NTR NumberNTR328
- Date ISRCTN created19-apr-2005
- date ISRCTN requested
- Date Registered NTR12-sep-2005
- Secondary IDs4200.0003 
- Public TitleEffectiveness of a Minimal Intervention Strategy for patients with common mental disorders on sick leave: a pragmatic randomized controlled trial in General Practice.
- Scientific TitleEffectiveness of a Minimal Intervention Strategy for patients with common mental disorders on sick leave: a pragmatic randomized controlled trial in General Practice.
- hypothesisThe objective of this study is to assess the effectiveness of the minimal intervention package (MISS) for distressed patients in general practice.
- Healt Condition(s) or Problem(s) studiedMental health problems, Sick leave
- Inclusion criteriaPatients (20-60 years old) who visited their GP, having distress complaints, paid work and sick leave no longer than three months.
- Exclusion criteriaSevere psychiatric disorders (mania or psychosis), patients who were terminally ill or who couldn't speak Dutch properly.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2003
- planned closingdate31-jan-2005
- Target number of participants415
- InterventionsThis 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.
- Primary outcomeDuration of occupational disability.
- Secondary outcomeSocial 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.
- TimepointsN/A
- Trial web site
- statusstopped: trial finished
- Sponsor/Initiator VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsBMC Public Health. 2006 May 4;6:124.
- Brief summaryStress-related mental disorders with sick leave are often presented in general practice. Yet, general practitioners (GPs) experience two major problems managing these patients. First, GPs tend to overlook depressive and anxious reactions in distressed patients, which results in inadequate treatment. Second, patients with stress-related mental disorders, who are on sick leave, are at risk for long-term absence from work and ultimately loss of employment, due to their tendency to stay passive and to avoid difficulties. Dutch sickness absence statistics have shown that 1 in every 5 employees who are sick listed due to stress-related mental disorders, stay on sick leave for a whole year and apply for disability benefit or loose their jobs. GPs tend to go along with the patientsí desire to be left alone, increasing - unintentionally - the risk for long-term absence from work. In order to reduce this risk, we developed a minimal intervention for stress-related mental disorders with sick leave in general practice. In the course of 3 consultations, the GP detects depressive and anxious reactions, and initiates specific treatments for these problems. Furthermore, the GP provides education and motivates the patient to actively deal with his/her difficulties. Moreover, the patient is advised to contact his/her occupational physician. Finally, the GP monitors the clinical condition in the first 4 weeks, and when there is not any improvement, the patient is referred to professional mental health care. The aim of this study is to investigate the effects of this approach in general practice. Half of the GPs received a training to deliver the minimal intervention outlined above, while the other half of the GPs deliver usual care.
Forty-six GPs participate in the study. The inclusion of 433 distressed patients on sick leave has been completed in January 2005. Between September 2003 and January 2005 a total of 22.740 patients (aged 20-60 years) who had visited the GP, have been screened for distress and sick leave. This way, 286 women and 147 men who had distress with sick leave were included. The state of affairs at October 1 2005 is as follows: A total of 299 respondents have completed the final telephone interview after 1 year follow-up. Of these patients 256 also completed the written questionnaire. We expect to end up with 320 complete telephone interviews and 280 written questionnaires in January 2006.
- Main changes (audit trail)
- RECORD11-okt-2005 - 23-jun-2008

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