Prevent Pain and Stress Related Sickleave.

NCT ID: NCT03993444

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-09-01

Brief Summary

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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

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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.

Conditions

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Stress, Psychological Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants receive one of two active conditions. Outcome assessors are not part of the study.

Study Groups

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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.

Group Type EXPERIMENTAL

communication and problem solving

Intervention Type BEHAVIORAL

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

psychoeducation

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

Group Type ACTIVE_COMPARATOR

psychoeducation

Intervention Type BEHAVIORAL

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

Interventions

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communication and problem solving

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

Intervention Type BEHAVIORAL

psychoeducation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ida flink, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

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Center for Health and Medical Psychology (CHAMP) Örebro University

Örebro, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 26202039 (View on PubMed)

Other Identifiers

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MOT

Identifier Type: -

Identifier Source: org_study_id

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