Effectiveness of Motivational Interviewing on Return to Work in People on Sick Leave Due to Musculoskeletal Disorders

NCT03871712 | Completed

• 1 other identifier: The MI-NAV Study
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Musculoskeletal disorders are the main causes for sickness absence and disability benefits in Norway and the leading causes of disability worldwide. There is strong evidence that long-term sickness absence due to musculoskeletal disorders provides a poor prognosis, both in terms of work-related disability, physical and mental health, and health related quality-of-life. To assist people return to work a range of vocational rehabilitation programs exist, but the initiatives have not been able to reduce the number of people who are on sick leave due to musculoskeletal disorders. In Norway, The Norwegian Labour and Welfare Administration (NAV) case-workers have taken such approaches in use, primarily by teaching their employees with user contact in how to use Motivational Interviewing (MI). However, the evidence on the effectiveness of MI on return to work is highly uncertain. The objectives of this project are to compare the effectiveness and cost-effectiveness of usual case management alone with usual case management plus MI or usual case management plus stratified vocational advice intervention (SVAI), on RTW among people on sick leave due to musculoskeletal (MSK) disorders. All musculoskeletal diagnoses will be included. A multi-arm randomised controlled trial with 150 participants in each group will be conducted within the NAV system in Norway to evaluate these research questions.

Conditions

Musculoskeletal Disease; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Sickness absence days

  Total number of sickness absence days up to the 6-month's follow-up

  6 months

Secondary Outcomes (8)

• Sickness absence days

  12 months

• Sustainable return to work

  12 months

• Medical benefits

  12 months

• Cost-utility

  6 months

• Cost-utility

  12 months

Study Arms (3)

Motivational Interview (MI)

EXPERIMENTAL

In the MI arm, a NAV case worker will meet the participants after the baseline assessment (electronic questionnaires) and randomisation and conduct the MI. The NAV case-worker will either meet (or call) again after a few weeks (anticipated 2-4 weeks) and conduct another MI.

Behavioral: Motivational interview

Stratified vocational advice intervention (SVAI)

ACTIVE COMPARATOR

A trained physiotherapist will call the participants after the baseline assessment and randomisation. The SVAI intervention will be stratified due to the participants risk of long term sick leave estimated by the Orebro Screening Questionnaire and The Keele STarT MSK Tool. The low/moderate risk group will receive 1-2 phone calls, and the high risk group will be followed up 2-4 times. The follow-up can include face to face Meetings bewteen the Physical therapist and the participant, and also the employer and general practitioner when needed. The intervention will include an assessment of the participants obstacles for returning to work and help to develop and implement an action plan to overcome obstacles. The physical therapists' will cooperate with other health care providers and employer when needed.

Behavioral: Stratified vocational advice

Usual follow-up

NO INTERVENTION

This arm will be the control group receiving usual NAV follow-up. The other two groups will also receive usual NAV follow-up additionally to the interventions.

Interventions

Motivational interview BEHAVIORAL

The participants will be called twice with 2-4 weeks interval after the randomisation. This will be after 8 weeks of sick leave.

Motivational Interview (MI)

Stratified vocational advice BEHAVIORAL

The participants will be called after the randomisation. The amount of calls/meetings will be decided after each call, but with a maximum of 4 for the high risk group. This may include physical meetings.

Also known as: Vocational advice

Stratified vocational advice intervention (SVAI)

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have musculoskeletal disorders
• Live in South-East Norway
• Have been on sick leave for 8 weeks with a current sick-leave status of 50%-100%
• Have a job to return to

You may not qualify if:

• Have serious somatic or psychological disorders (e.g. cancer, psychotic disorders)
• Have specific disorder requiring specialized, ongoing treatment;
• Are pregnant
• Are self-employed or work free lance
• Have insufficient Norwegian or English speaking or writing skills to participate in group session and fill out questionnaire.

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• Norwegian Labour and Welfare Administration: collaborator

Study Sites (1)

Oslo Metropolitan Universtiy

Oslo, 0130, Norway

Location

Related Publications (5)

• Killingmo RM, Rysstad T, Maas E, Pripp AH, Aanesen F, Tingulstad A, Tveter AT, Oiestad BE, Grotle M. Modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders: a replication study. BMC Musculoskelet Disord. 2024 Dec 3;25(1):990. doi: 10.1186/s12891-024-08132-3.

  PMID: 39627785 DERIVED

• Tingulstad A, Maas ET, Rysstad T, Oiestad BE, Aanesen F, Pripp AH, Van Tulder MW, Grotle M. Six-month cost-effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management for workers with musculoskeletal disorders: the MI-NAV economic evaluation. J Occup Med Toxicol. 2023 Nov 14;18(1):25. doi: 10.1186/s12995-023-00394-2.

  PMID: 37964240 DERIVED

• Cashin AG, Oiestad BE, Aanesen F, Storheim K, Tingulstad A, Rysstad TL, Lee H, McAuley JH, Sowden G, Wynne-Jones G, Tveter AT, Grotle M. Mechanisms of vocational interventions for return to work from musculoskeletal conditions: a mediation analysis of the MI-NAV trial. Occup Environ Med. 2023 May;80(5):246-253. doi: 10.1136/oemed-2022-108716. Epub 2023 Mar 2.

  PMID: 36863864 DERIVED

• Aanesen F, Grotle M, Rysstad TL, Tveter AT, Tingulstad A, Lochting I, Smastuen MC, van Tulder MW, Berg R, Foster NE, Wynne-Jones G, Sowden G, Fors E, Bagoien G, Hagen R, Storheim K, Oiestad BE. Effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders: the MI-NAV randomised controlled trial. Occup Environ Med. 2023 Jan;80(1):42-50. doi: 10.1136/oemed-2022-108637. Epub 2022 Nov 25.

  PMID: 36428098 DERIVED

• Oiestad BE, Aanesen F, Lochting I, Storheim K, Tingulstad A, Rysstad TL, Smastuen MC, Tveter AT, Sowden G, Wynne-Jones G, Fors EA, van Tulder M, Berg RC, Foster NE, Grotle M. Study protocol for a randomized controlled trial of the effectiveness of adding motivational interviewing or stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders. The MI-NAV study. BMC Musculoskelet Disord. 2020 Jul 28;21(1):496. doi: 10.1186/s12891-020-03475-z.

  PMID: 32723318 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases; Musculoskeletal Pain

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hege Bentzen, PhD

  OsloMet - Oslo Metropolitan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In the written consent, the three groups will be described. Thus the participants will understand which group they are in after the first telephone call, and consequently not be blinded. The interventions are: 1. Motivational interview by 2 meetings between participant and the NAV case-worker. Both the NAV case-workers and the participants will know that the intervention is motivational interviewing because it is only in this arm a NAV case-worker will do the intervention. 2. Stratified vocational advice intervention (SVAI): a physiotherapist will call the study participants, and both the physiotherapist and the participants will know that they are in the SVAI intervention group from the informed consent. The researchers will be blinded to group allocation throughout the study recruitment and assessment up to the 6-month follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A multi-arm randomised controlled trial with two intervention groups and one control group doing as usual (ordinary NAV practice). The allocation will be prepared with block randomisation for risk of long term sick leave as predicted by the Orebro Screening Questionnaire and The Keele STarT MSK Tool. Preliminary data suggests a low/medium risk group (80% of the recruited participants) and a high risk group (20%). These numbers were calculated in another study of individuals on sick leave in Norway.

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 12, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)