Clinical trial NCT03993444: Prevent Pain and Stress Related Sickleave.
Official title: Prevent Pain and Stress Related Sickleave.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Pain
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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: Compared to the earlier study, this RCT will include:

1. A focused program targeting supervisors and employees
2. An active control group
3. An evaluation of the effects on both supervisor and employee
4. Knowledge on the mechanisms involved
5. 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.

Eligibility criteria: 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

Primary outcomes:
measure: sick leave
timeFrame: 14 months
measure: sick leave
timeFrame: 8 months
Secondary outcomes:
measure: stress symptoms
timeFrame: baseline, 2 months, 8 months
measure: work ability
timeFrame: 2 months, 8 months
measure: exhaustion symptoms
timeFrame: baseline, 2 months, 8 months
measure: pain problems
timeFrame: baseline, 2 months, 8 months
measure: work related factors
timeFrame: 2 months, 8 months
measure: work limitations
timeFrame: 2 months, 8 months
measure: symptom catastrophizing
timeFrame: baseline, 2 months, 8 months
measure: problem framing
timeFrame: baseline, 2 months, 8 months
measure: communication
timeFrame: baseline, 2 months, 8 months
measure: life satisfaction
timeFrame: 2 months, 8 months
measure: health
timeFrame: 2 months, 8 months
measure: communication behavior
timeFrame: baseline, 2 months
Other outcomes:
measure: intervention credibility
timeFrame: baseline
Locations:
city: Örebro
country: Sweden
facility: Center for Health and Medical Psychology (CHAMP) Örebro University
Study officials:
affiliation: Örebro University, Sweden
name: ida flink, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Linton SJ, Boersma K, Traczyk M, Shaw W, Nicholas M. Early Workplace Communication and Problem Solving to Prevent Back Disability: Results of a Randomized Controlled Trial Among High-Risk Workers and Their Supervisors. J Occup Rehabil. 2016 Jun;26(2):150-9. doi: 10.1007/s10926-015-9596-z.