|- candidate number||6349|
|- NTR Number||NTR1963|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-aug-2009|
|- Secondary IDs||METc 2009/135 METc UMCG|
|- Public Title||Prevention of recurrent sickness absence among employees with common mental disorders: A randomised controlled trial with (cost-) effectiveness evaluation.|
|- Scientific Title||Tools for Two: The SHARP-at work study. Effectiveness of an intervention Stimulating Healthy Participation and Relapse Prevention. A cluster randomised controlled trial.|
|- ACRONYM||SHARP-at work study|
|- hypothesis||Workers who return to work after sickness absence because of a common mental disorder and who undergo the SHARP-at work intervention will have less recurrent sickness absence days compared to workers who receive care as usual.|
|- Healt Condition(s) or Problem(s) studied||Mental disorders|
|- Inclusion criteria||1. Age between 18 and 63 years;|
2. Employed in a paid job;
3. Period of sickness absence of at least two weeks due to a common mental disorder diagnosed by the occupational physician;
4. Planned return-to-work (full, partial) within two weeks.
|- Exclusion criteria||1. Period of sickness absence because of a common mental disorder in the year prior to the present sickness absence spell;|
2. Present sickness absence spell longer than 12 months;
3. Severe mental disorders, like personality disorders, psychotic disorders, bipolar disorder, and PTSD;
4. Alcohol and/or drug abuse;
5. Predominant influence of somatic complaints or disorders on work disability;
7. Upcoming retirement, resignation, dismissal, or sabbatical;
8. Not able to understand, speak, read, and write the Dutch language.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2009|
|- planned closingdate||1-nov-2011|
|- Target number of participants||500|
|- Interventions||At the level of the occupational physician:|
Occupational physicians in the intervention group receive a two-day training in the SHARP-at work intervention to prevent recurrent sickness absence and improve work functioning among employees who have returned to work after a period of sickness absence because of a common mental disorder. Occupational physicians in the control condition receive no training and deliver care as usual according to the guideline of the Dutch Association for Occupational Physicians.
At the level of the employee:
Employees in the intervention condition will be guided and supported during their first eight weeks following return to work by their occupational physician. This intervention is an extension of the guideline of the Dutch Association for Occupational Physicians on treating sickness absence because of mental health problems. The intervention is focused on the prevention of recurrent sickness absence and the improvement of work functioning. Employees in the control group will receive care as usual.
|- Primary outcome||Recurrent sickness absence days measured by record linkages with the sickness absence registry of the participating Occupational Health Service.|
|- Secondary outcome||1. Work functioning (WRFQ);|
2. Psychological complaints (4DSQ and HADS);
3. Coping (UCL);
4. Direct and indirect costs (Tic-P);
5. Aherence to the protocol by the occupational physician;
6. Worker satisfaction with treatment.
|- Timepoints||Baseline and 3, 6, and 12 months after baseline measurement.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. I. Arends|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J.J.L. Klink, van der|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Department of Health Sciences|
(Source(s) of Monetary or Material Support)
|- Brief summary||BACKGROUND: |
Common mental disorders, such as depression, anxiety disorder, and adjustment disorder, have emerged as a major public and occupational health problem in many countries. These disorders can have severe consequences such as absenteeism and work disability. A large proportion of employees experiences health and work problems after they have returned to work. For this reason, an intervention will be developed to prevent recurrent sickness absence in employees who have returned to work after a period of sickness absence because of common mental disorders.
First, to determine the effectiveness of the intervention in preventing recurrent sickness absence in employees who have returned to work after a period of sickness absence because of a common mental disorder. Second, to determine the effectiveness of the intervention in improving mental health and work functioning, and facilitating an adequate coping style. Next to the effect evaluation, the cost-effectiveness and the process of the intervention will be evaluated.
Employees aged 18 to 63 years who have returned to work after a period of sickness absence because of a common mental disorder.
A cluster randomised controlled trial with randomisation at the level of the occupational physician. Occupational physicians will be randomly assigned to the intervention condition or the control condition. Occupational physicians in the intervention condition will receive a training in the intervention. Occupational physicians in the control condition will deliver care as usual.
Employees in the intervention condition will be guided and supported during their first weeks after return to work by their occupational physician. This intervention is an extension of the guideline of the Dutch Association for Occupational Physicians on treating sickness absence because of mental health problems. Employees in the control group will receive care as usual.
Outcome measures are: recurrent sickness absence days, work functioning, psychological complaints, coping, the process of the intervention and direct and indirect costs. Measurements take place at baseline and 3, 6, and 12 months after baseline.
|- Main changes (audit trail)|
|- RECORD||25-aug-2009 - 11-mrt-2011|