NCT03993444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

3.5 years

First QC Date

May 29, 2019

Last Update Submit

September 20, 2022

Conditions

Stress, PsychologicalPain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • stress symptoms

    baseline, 2 months, 8 months

  • work ability

    2 months, 8 months

  • exhaustion symptoms

    baseline, 2 months, 8 months

  • pain problems

    baseline, 2 months, 8 months

  • work related factors

    2 months, 8 months

  • +7 more secondary outcomes

Other Outcomes (1)

  • intervention credibility

    baseline

Study Arms (2)

communication and problem solving

EXPERIMENTAL

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

psychoeducation

ACTIVE COMPARATOR

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

Behavioral: psychoeducation

Interventions

communication and problem solvingBEHAVIORAL

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

communication and problem solving
psychoeducationBEHAVIORAL

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

psychoeducation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pain and/or stress symptoms due to medical conditions
  • severe psychiatric conditions
  • full time sick leave

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health and Medical Psychology (CHAMP) Örebro University

Örebro, 70182, Sweden

Location

Related 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.

    PMID: 26202039BACKGROUND

MeSH Terms

Conditions

Stress, PsychologicalPain

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ida flink, PhD

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants receive one of two active conditions. Outcome assessors are not part of the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 20, 2019

Study Start

March 1, 2019

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)