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Evaluation of a randomized controlled trial on the effect on return to work with light therapy/magnetic field therapy and coaching for workers with burnout


- candidate number19504
- NTR NumberNTR4794
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-sep-2014
- Secondary IDsNL49345.018.14 METC AMC Amsterdam
- Public TitleEvaluation of a randomized controlled trial on the effect on return to work with light therapy/magnetic field therapy and coaching for workers with burnout
- Scientific TitleRe-integration study xentix
- ACRONYMROX
- hypothesisCombination of light therapy / magnetic field therapy can increase return to work by patients suffering from burnout.
- Healt Condition(s) or Problem(s) studiedBurnout , Work load, Stress, Fatigue
- Inclusion criteria- Employees with burnout symptoms between 18 and 65 years with at least 50% sickness absenteeism
- Diagnostic criteria for overstrain (symptoms 0-6 months)
- Not be able to perform total or part of daily work
- Speaking Dutch language
- Exclusion criteria- Pregnancy
- Serious somatic problems such as diabetes and epilepsy
- Serious ocular diseases
- Presumption of confusion or severe gloom
- Use of psychotropic drugs other than selective serotonin reuptake inhibitors SSRIs
- Pacemaker / neurostimulators
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2014
- planned closingdate31-dec-2015
- Target number of participants90
- InterventionsParticipants will be treated for 12 weeks, 2 times a week for 40 minutes on the treatment platform with light therapy / magnetic field therapy / coaching (group 1). A placebo group receives the same treatment which the light therapy / magnetic field therapy is not activated (group 2) and a control group receives coaching only (group 3).
- Primary outcomeReturn to work
- Secondary outcome- Fatigue
- Stress
- Quality of life
- Timepointsbaseline week -1
T1 week 6
T2 week 12
T3 week 24
- Trial web sitehttp://www.letec-eindhoven.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J. Sluiter
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J. Sluiter
- Sponsor/Initiator Academic Medical Center (AMC), Coronel Institute for Work and Health
- Funding
(Source(s) of Monetary or Material Support)
Letec - Life Enhancement Technology, Fluxplus Tilburg
- PublicationsN/A
- Brief summaryBurnout (work-related chronic stress) is a problem that is common in the workplace, and implies that the employee feels exhausted. It is not only an attack on health, well-being and functioning of the employee, also for the employer and for society it is costly as an employee is absent due to absenteeism costs, lost productivity and medical expenses. The usual treatment of burnout is the cognitive-behavioral approach (coaching) which induced factors that have contributed to the onset of the problem. With this treatment reduction in symptoms and increasing the reintegration of work is the main goal.

Objective:
Letec developed a technique that utilizes the light therapy / magnetic field therapy treatment platform Xentix besides coaching. In order to demonstrate the effectiveness of this method, a "proof of concept" is necessary. This can be obtained by means of a scientific study in which the research question is whether the therapy using light / magnetic field therapy can contribute return to return to work, reducing stress and fatigue and improve the quality of life. The intention is to implement the proven efficacy of the treatment within the care of people with burnout.

Intervention:
Light therapy / magnetic field therapy / coaching treatment for 12 weeks, 2 times a week for 40 minutes on the treatment platform (group 1). A placebo group receives the same treatment which the light therapy / magnetic field therapy is not activated (group 2) and a control group receives only coaching (group 3).

Study design:
The study is a randomized placebo-controlled study and will take approximately one year in burnout patients (n = 90). Subjects with the aforementioned problems are treated in three groups namely: group 1 receives light therapy / magnetic field- therapy and coaching, group 2 receives the same treatment with the light therapy / magnetic field- therapy which is not activated and Group 3 will only receive coaching.

Study population:
The population consists of employees (18yr -65yr) from the South of the Netherlands with burnout complaints with at least 50% absenteeism

Main study parameters / endpoints:
Return to work score between baseline (week 0) and endpoint (week 12)
- Main changes (audit trail)
- RECORD18-sep-2014 - 8-nov-2014


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