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Prevent Pain and Stress Related Sickleave. (PS)

Primary Purpose

Stress, Psychological, Pain

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
communication and problem solving
psychoeducation
Sponsored by
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

communication and problem solving

psychoeducation

Arm Description

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.

Two, 1 hour, lectures, one on the topic of pain and one on the topic of stress (for employees and supervisors combined).

Outcomes

Primary Outcome Measures

sick leave
days on sick leave based on register data
sick leave
days on sick leave based on self report

Secondary Outcome Measures

stress symptoms
change in perceived stress scale-10, assessed in employees and supervisors
work ability
work ability index, assessed in employees and supervisors
exhaustion symptoms
change in Karolinska Exhaustion Disorder Scale, assessed in employees and supervisors
pain problems
change in Örebro Musculoskeletal Pain Screening Questionaire, assessed in employees
work related factors
QPS nordic, assessed in employees and supervisors
work limitations
Work Limitations Questionnaire, assessed in employees
symptom catastrophizing
change in Symptom Catastrophizing Scale, assessed in employees
problem framing
change in Pain/stress Solutions questionnaire (PaSol), assessed in employees
communication
change in Validation Invalidation Response Scale, assessed in employees
life satisfaction
Brunnsviken Brief Quality of Life scale, assessed in employees and supervisors
health
Visual Analogue Scale (0-100, higher values better health), assessed in employees and supervisors
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)

Full Information

First Posted
May 29, 2019
Last Updated
September 20, 2022
Sponsor
Örebro University, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT03993444
Brief Title
Prevent Pain and Stress Related Sickleave.
Acronym
PS
Official Title
Prevent Pain and Stress Related Sickleave.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Örebro University, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Participants receive one of two active conditions. Outcome assessors are not part of the study.
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
communication and problem solving
Arm Type
Experimental
Arm Description
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.
Arm Title
psychoeducation
Arm Type
Active Comparator
Arm Description
Two, 1 hour, lectures, one on the topic of pain and one on the topic of stress (for employees and supervisors combined).
Intervention Type
Behavioral
Intervention Name(s)
communication and problem solving
Intervention Description
a program for supervisors and employees including skills training, validating communication, problem solving
Intervention Type
Behavioral
Intervention Name(s)
psychoeducation
Intervention Description
lecture/course for supervisors and employees on risk factors and actions for people experiencing stress and/or pain
Primary Outcome Measure Information:
Title
sick leave
Description
days on sick leave based on register data
Time Frame
14 months
Title
sick leave
Description
days on sick leave based on self report
Time Frame
8 months
Secondary Outcome Measure Information:
Title
stress symptoms
Description
change in perceived stress scale-10, assessed in employees and supervisors
Time Frame
baseline, 2 months, 8 months
Title
work ability
Description
work ability index, assessed in employees and supervisors
Time Frame
2 months, 8 months
Title
exhaustion symptoms
Description
change in Karolinska Exhaustion Disorder Scale, assessed in employees and supervisors
Time Frame
baseline, 2 months, 8 months
Title
pain problems
Description
change in Örebro Musculoskeletal Pain Screening Questionaire, assessed in employees
Time Frame
baseline, 2 months, 8 months
Title
work related factors
Description
QPS nordic, assessed in employees and supervisors
Time Frame
2 months, 8 months
Title
work limitations
Description
Work Limitations Questionnaire, assessed in employees
Time Frame
2 months, 8 months
Title
symptom catastrophizing
Description
change in Symptom Catastrophizing Scale, assessed in employees
Time Frame
baseline, 2 months, 8 months
Title
problem framing
Description
change in Pain/stress Solutions questionnaire (PaSol), assessed in employees
Time Frame
baseline, 2 months, 8 months
Title
communication
Description
change in Validation Invalidation Response Scale, assessed in employees
Time Frame
baseline, 2 months, 8 months
Title
life satisfaction
Description
Brunnsviken Brief Quality of Life scale, assessed in employees and supervisors
Time Frame
2 months, 8 months
Title
health
Description
Visual Analogue Scale (0-100, higher values better health), assessed in employees and supervisors
Time Frame
2 months, 8 months
Title
communication behavior
Description
change in Validating and Invalidating Behavior Coding Scale (VIBCS, two 0-7 scales, higher scores indicate higher levels of validating and invalidating communication)
Time Frame
baseline, 2 months
Other Pre-specified Outcome Measures:
Title
intervention credibility
Description
participant perception of intervention credibility, one item taken from the Credibility and expectancy questionnaire
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ida flink, PhD
Organizational Affiliation
Örebro University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health and Medical Psychology (CHAMP) Örebro University
City
Örebro
ZIP/Postal Code
70182
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26202039
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.
Results Reference
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Prevent Pain and Stress Related Sickleave.

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