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Completed

NCT Number: NCT03993444

Prevent Pain and Stress Related Sickleave.

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.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Health and Medical Psychology (CHAMP) Örebro University

Örebro, 70182, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

communication and problem solving

Behavioral

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

Psychoeducation

Behavioral

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

Primary outcomes

  1. sick leave

    Time frame: 14 months

    days on sick leave based on register data

  2. sick leave

    Time frame: 8 months

    days on sick leave based on self report

Secondary outcomes

  1. stress symptoms

    Time frame: baseline, 2 months, 8 months

    change in perceived stress scale-10, assessed in employees and supervisors

  2. work ability

    Time frame: 2 months, 8 months

    work ability index, assessed in employees and supervisors

  3. exhaustion symptoms

    Time frame: baseline, 2 months, 8 months

    change in Karolinska Exhaustion Disorder Scale, assessed in employees and supervisors

  4. pain problems

    Time frame: baseline, 2 months, 8 months

    change in Örebro Musculoskeletal Pain Screening Questionaire, assessed in employees

  5. work related factors

    Time frame: 2 months, 8 months

    QPS nordic, assessed in employees and supervisors

  6. work limitations

    Time frame: 2 months, 8 months

    Work Limitations Questionnaire, assessed in employees

  7. symptom catastrophizing

    Time frame: baseline, 2 months, 8 months

    change in Symptom Catastrophizing Scale, assessed in employees

  8. problem framing

    Time frame: baseline, 2 months, 8 months

    change in Pain/stress Solutions questionnaire (PaSol), assessed in employees

  9. communication

    Time frame: baseline, 2 months, 8 months

    change in Validation Invalidation Response Scale, assessed in employees

  10. life satisfaction

    Time frame: 2 months, 8 months

    Brunnsviken Brief Quality of Life scale, assessed in employees and supervisors

  11. health

    Time frame: 2 months, 8 months

    Visual Analogue Scale (0-100, higher values better health), assessed in employees and supervisors

  12. communication behavior

    Time frame: baseline, 2 months

    change in Validating and Invalidating Behavior Coding Scale (VIBCS, two 0-7 scales, higher scores indicate higher levels of validating and invalidating communication)

Other outcomes

  1. intervention credibility

    Time frame: baseline

    participant perception of intervention credibility, one item taken from the Credibility and expectancy questionnaire

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Acronym: PS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 20, 2019
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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