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Work Participation of Workers with Common Mental Complaints.


- candidate number10579
- NTR NumberNTR3162
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-nov-2011
- Secondary IDs11-5-038 METC
- Public TitleWork Participation of Workers with Common Mental Complaints.
- Scientific TitleA clinical trial evaluating a minimal psychological intervention, administered by trained nurses, aimed at reducing levels of fatigue and/or depression and increasing work participation in employees.
- ACRONYMWoPaCoM (Work Participation of Workers with Common Mental Complaints)
- hypothesisEmployees that comply to the inclusion criteria and receiving the MPI (Minimal Psychological Intervention), will improve more on scores on depression and fatigue than employees receiving care as usual.
- Healt Condition(s) or Problem(s) studiedSick leave, Fatigue, Work functioning, Minor depression
- Inclusion criteria1. Score PHQ-9; at least 2 depressive symptoms at least at “more than half the days” and at least one of these symptoms was depressed mood or anhedonia;
2. Score CIS-20 >76;
3. VAS score >3;
4. Completed informed consent.
- Exclusion criteria1. Recent medical events as an explanation for fatigue or recent medical events as an explanation for fatigue and/or depression;
2. Serious physical impairment;
3. Serious psycho social problems;
4. Former episodes of depression or bipolar disorder or psychiatric co morbidity;
5. Passive death wish or suicidal thoughts;
6. Alcohol or drug dependency;
7. Non Dutch speaking.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2007
- planned closingdate1-jan-2012
- Target number of participants130
- InterventionsMinimal Psychological Intervention (MPI) vs care as usual The MPI is based = on priciples of cognitive behavioural therapy and self management by occupa= tional health nurses. The number of consutations can vary from 1 to 10, dur= ing a period of max. 4 months. After the baseline measurement follow up measurements after 4, 6 and 12 mon= ths are carried out.
- Primary outcomeFatigue measured with CIS 20, and Depression measured with BDI, assessed at baseline and at 4, 6 and 12 months after inclusion.
- Secondary outcomeSick-leave, mastery, self efficacy, and perceived impairment (VAS).
- TimepointsBaseline, 4, 6 and 12 months follow up.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES E.W.M. Aelfers
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.Th.M. Eijk, van
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- PublicationsN/A
- Brief summaryMinimal Psychological Intervention (MPI) vs care as usual The MPI is based = on priciples of cognitive behavioural therapy and self management by occupa= tional health nurses. The number of consutations can vary from 1 to 10, dur= ing a period of max. 4 months. After the baseline measurement follow up measurements after 4, 6 and 12 mon= ths are carried out.
- Main changes (audit trail)
- RECORD25-nov-2011 - 17-dec-2011


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