Prevent Pain and Stress Related Sickleave.

Pain Clinical Trial

— PS  

Official title:

Prevent Pain and Stress Related Sickleave.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993444
• Other study ID #: MOT
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Stress, Psychological

Intervention

Behavioral:
• communication and problem solving
a program for supervisors and employees including skills training, validating communication, problem solving
• psychoeducation
lecture/course for supervisors and employees on risk factors and actions for people experiencing stress and/or pain

Locations

Country	Name	City	State
Sweden	Center for Health and Medical Psychology (CHAMP) Örebro University	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intervention credibility	participant perception of intervention credibility, one item taken from the Credibility and expectancy questionnaire	baseline
Primary	sick leave	days on sick leave based on register data	14 months
Primary	sick leave	days on sick leave based on self report	8 months
Secondary	stress symptoms	change in perceived stress scale-10, assessed in employees and supervisors	baseline, 2 months, 8 months
Secondary	work ability	work ability index, assessed in employees and supervisors	2 months, 8 months
Secondary	exhaustion symptoms	change in Karolinska Exhaustion Disorder Scale, assessed in employees and supervisors	baseline, 2 months, 8 months
Secondary	pain problems	change in Örebro Musculoskeletal Pain Screening Questionaire, assessed in employees	baseline, 2 months, 8 months
Secondary	work related factors	QPS nordic, assessed in employees and supervisors	2 months, 8 months
Secondary	work limitations	Work Limitations Questionnaire, assessed in employees	2 months, 8 months
Secondary	symptom catastrophizing	change in Symptom Catastrophizing Scale, assessed in employees	baseline, 2 months, 8 months
Secondary	problem framing	change in Pain/stress Solutions questionnaire (PaSol), assessed in employees	baseline, 2 months, 8 months
Secondary	communication	change in Validation Invalidation Response Scale, assessed in employees	baseline, 2 months, 8 months
Secondary	life satisfaction	Brunnsviken Brief Quality of Life scale, assessed in employees and supervisors	2 months, 8 months
Secondary	health	Visual Analogue Scale (0-100, higher values better health), assessed in employees and supervisors	2 months, 8 months
Secondary	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