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Prevent Pain and Stress Related Sickleave.

Prevent Pain and Stress Related Sickleave.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03993444
Acronym
PS
Enrollment
182
Registered
2019-06-20
Start date
2019-03-01
Completion date
2022-09-01
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Stress, Psychological

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.

Interventions

BEHAVIORALcommunication and problem solving

a program for supervisors and employees including skills training, validating communication, problem solving

BEHAVIORALpsychoeducation

lecture/course for supervisors and employees on risk factors and actions for people experiencing stress and/or pain

Sponsors

Örebro University, Sweden
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants receive one of two active conditions. Outcome assessors are not part of the study.

Intervention model description

randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
sick leave14 monthsdays on sick leave based on register data

Secondary

MeasureTime frameDescription
stress symptomsbaseline, 2 months, 8 monthschange in perceived stress scale-10, assessed in employees and supervisors
work ability2 months, 8 monthswork ability index, assessed in employees and supervisors
exhaustion symptomsbaseline, 2 months, 8 monthschange in Karolinska Exhaustion Disorder Scale, assessed in employees and supervisors
pain problemsbaseline, 2 months, 8 monthschange in Örebro Musculoskeletal Pain Screening Questionaire, assessed in employees
work related factors2 months, 8 monthsQPS nordic, assessed in employees and supervisors
work limitations2 months, 8 monthsWork Limitations Questionnaire, assessed in employees
problem framingbaseline, 2 months, 8 monthschange in Pain/stress Solutions questionnaire (PaSol), assessed in employees
communicationbaseline, 2 months, 8 monthschange in Validation Invalidation Response Scale, assessed in employees
life satisfaction2 months, 8 monthsBrunnsviken Brief Quality of Life scale, assessed in employees and supervisors
health2 months, 8 monthsVisual Analogue Scale (0-100, higher values better health), assessed in employees and supervisors
communication behaviorbaseline, 2 monthschange in Validating and Invalidating Behavior Coding Scale (VIBCS, two 0-7 scales, higher scores indicate higher levels of validating and invalidating communication)
symptom catastrophizingbaseline, 2 months, 8 monthschange in Symptom Catastrophizing Scale, assessed in employees

Other

MeasureTime frameDescription
intervention credibilitybaselineparticipant perception of intervention credibility, one item taken from the Credibility and expectancy questionnaire

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026