Prevent Pain and Stress Related Sickleave.

Study Overview
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Brief Summary
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Problems with stress and pain are common reasons for long-term sick-leave, and need preventive interventions. This RCT builds on a successful previous project (see reference section), where a program involving the work place, the individual and occupational health care resulted in decreased sick-leave and healthcare visits and a higher quality of life as compared to TAU for individuals with musculoskeletal pain. This study will replicate and evaluate the mechanisms behind the involvement from the work place. According to the transdiagnostic model, problems with stress and pain are maintained by similar processes. Consequently, the study will be extended to include both problems, and it will be explored how a refined version of the program affects sick leave and work ability in the employees.

Detailed Description
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Compared to the earlier study, this RCT will include: A focused program targeting supervisors and employees An active control group An evaluation of the effects on both supervisor and employee Knowledge on the mechanisms involved Replication and extension of earlier findings The project will produce knowledge about: A procedure for identifying individuals at risk for sick-leave. The effects of a program targeting both workplace and individual to prevent problems with stress and pain. The role of the supervisor in preventing sick-leave. Mechanisms linked to decreased levels of sick-leave.

Official Title
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Prevent Pain and Stress Related Sickleave.

Conditions
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Stress, Psychological, Pain

Intervention / Treatment
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* Behavioral: communication and problem solving
* Behavioral: psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participating employee has self rated symptoms of stress and/or pain and supervisor also partakes in intervention employed at a workplace within Regionhälsans (occupational health care center) uptake area Exclusion Criteria: pain and/or stress symptoms due to medical conditions severe psychiatric conditions full time sick leave

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: communication and problem solving<br>Three smal group sessions (separate for employees (length 2 hours each) and for supervisors (length 2,5 hours each)) focused on training communication and problem solving skills. | Behavioral: communication and problem solving<br>* a program for supervisors and employees including skills training, validating communication, problem solving<br>|
| Active Comparator: psychoeducation<br>Two, 1 hour, lectures, one on the topic of pain and one on the topic of stress (for employees and supervisors combined). | Behavioral: psychoeducation<br>* lecture/course for supervisors and employees on risk factors and actions for people experiencing stress and/or pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sick leave | days on sick leave based on register data | 14 months | 
| sick leave | days on sick leave based on self report | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stress symptoms | change in perceived stress scale-10, assessed in employees and supervisors | baseline, 2 months, 8 months | 
| work ability | work ability index, assessed in employees and supervisors | 2 months, 8 months | 
| exhaustion symptoms | change in Karolinska Exhaustion Disorder Scale, assessed in employees and supervisors | baseline, 2 months, 8 months | 
| pain problems | change in Örebro Musculoskeletal Pain Screening Questionaire, assessed in employees | baseline, 2 months, 8 months | 
| work related factors | QPS nordic, assessed in employees and supervisors | 2 months, 8 months | 
| work limitations | Work Limitations Questionnaire, assessed in employees | 2 months, 8 months | 
| symptom catastrophizing | change in Symptom Catastrophizing Scale, assessed in employees | baseline, 2 months, 8 months | 
| problem framing | change in Pain/stress Solutions questionnaire (PaSol), assessed in employees | baseline, 2 months, 8 months | 
| communication | change in Validation Invalidation Response Scale, assessed in employees | baseline, 2 months, 8 months | 
| life satisfaction | Brunnsviken Brief Quality of Life scale, assessed in employees and supervisors | 2 months, 8 months | 
| health | Visual Analogue Scale (0-100, higher values better health), assessed in employees and supervisors | 2 months, 8 months | 
| communication behavior | change in Validating and Invalidating Behavior Coding Scale (VIBCS, two 0-7 scales, higher scores indicate higher levels of validating and invalidating communication) | baseline, 2 months |