Prevent Pain and Stress Related Sickleave. (PS)

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.

Study Overview

• Status: Completed
• Conditions: Pain; Stress, Psychological
• Intervention / Treatment: Behavioral: communication and problem solving; Behavioral: psychoeducation

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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70182
    • Center for Health and Medical Psychology (CHAMP) Örebro University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: communication and problem solving; 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; a program for supervisors and employees including skills training, validating communication, problem solving
Active Comparator: psychoeducation; Two, 1 hour, lectures, one on the topic of pain and one on the topic of stress (for employees and supervisors combined).	Behavioral: psychoeducation; lecture/course for supervisors and employees on risk factors and actions for people experiencing stress and/or pain

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
intervention credibility	participant perception of intervention credibility, one item taken from the Credibility and expectancy questionnaire	baseline

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Investigators: Principal Investigator: ida flink, PhD, Örebro University, Sweden

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: MOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No