Effects of Motivational Interviewing for Long-term Sick Absence
NCT ID: NCT03212118
Last Updated: 2022-09-23
Study Results
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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COMPLETED
NA
774 participants
INTERVENTIONAL
2018-01-01
2022-07-01
Brief Summary
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The aim of this study is to evaluate whether MI provided by trained caseworkers at The Norwegian Labour and Welfare Administration (NAV) to sick-listed users with unselected diagnoses facilitates RTW compared with follow-up as usual.
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Detailed Description
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In addition to the intention to treat and per protocol analyses, subgroup analyses will be performed if sufficient power for age, gender, diagnoses for sick leave, occupational category and length of previous sick leave.
In addition to the effect evaluation, qualitative studies, a feasibility/process evaluation study and a health economic evaluation (cost-effectiveness, cost-utility and cost-benefit) will be performed. The qualitative studies will be based on data from focus group discussions. The main areas for investigation will be:
* The participants' expectations to return to work before and after motivational interviewing.
* Perceived facilitators and obstacles for return to work among participants
* The perceived benefits and challenges in using motivational interview to facilitate a return to work process
Changes made Sept.29 2017: Due to slow recruitment, it was decided to leave out one of the arms from the study (TAU-1: extra phone call to employer). The extra phone call element was also taken out from the other arms where it was included. Another reason for this change was that the TAU-1 intervention arm was not ideally designed to evaluate the extra phone call. It was decided this intervention arm is better evaluated in a separate trial. Currently 12 persons are included and randomized in the trial. Those who are randomized to TAU-1 and have not received an intervention, will be randomized again. The ones randomized to TAU-1 who already have got an intervention will stop participating in the study.
Changes made Aug. 26 2019: Due to problems with implementation of the intervervention the first couple of months, it was decided to start inclusion from Jan 1st 2018 (instead of Aug 2017). The planned number of participants has not changed.
Clarification added April 25 2021. Regarding exclusion criterion unemployment: only sick listed individuals listed with an employer were identified in the sick leave registries and invited to take part in the study. That means individuals who were unemployed, self-employed or for other reasons without an employer were not included.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Treatment as usual
Treatment as usual "untouched". This is the standard The Norwegian Labour and Welfare Administration (NAV) procedure.
Treatment as usual (TAU-0)
The standard NAV procedure, which consists of a telephone call within 8 weeks to an employer who have employees on 100% sick leave, in addition to regular NAV conversations "on-demand" (not "fixed intervals") between the NAV caseworkers and the employees.
Two talks
Two standard talks (not including elements from motivational interviewing)
Structured talks (TAU-2)
Two structured talks (not including elements from motivational interviewing)
Motivational interviewing
Two standard talks with a motivational interviewing content.
motivational interviewing (MI)
Two structured talks (must have a valid motivational interviewing content).
Interventions
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Treatment as usual (TAU-0)
The standard NAV procedure, which consists of a telephone call within 8 weeks to an employer who have employees on 100% sick leave, in addition to regular NAV conversations "on-demand" (not "fixed intervals") between the NAV caseworkers and the employees.
Structured talks (TAU-2)
Two structured talks (not including elements from motivational interviewing)
motivational interviewing (MI)
Two structured talks (must have a valid motivational interviewing content).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On sick leave for 8 weeks
* Current sick leave status of 50-100%
Exclusion Criteria
* pregnancy
18 Years
60 Years
ALL
No
Sponsors
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University of Bergen
OTHER
University of Oslo
OTHER
National Center for Occupational Rehabilitation, Rauland
UNKNOWN
Deakin University
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Egil Andreas Fors, phd prof
Role: PRINCIPAL_INVESTIGATOR
Norwegian University of Science and Technology
Locations
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Dept
Trondheim, , Norway
Countries
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References
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Aasdahl L, Foldal VS, Standal MI, Hagen R, Johnsen R, Solbjor M, Fimland MS, Fossen H, Jensen C, Bagoien G, Halsteinli V, Fors EA. Motivational interviewing in long-term sickness absence: study protocol of a randomized controlled trial followed by qualitative and economic studies. BMC Public Health. 2018 Jun 18;18(1):756. doi: 10.1186/s12889-018-5686-0.
Foldal VS, Solbjor M, Standal MI, Fors EA, Hagen R, Bagoien G, Johnsen R, Hara KW, Fossen H, Lochting I, Eik H, Grotle M, Aasdahl L. Barriers and Facilitators for Implementing Motivational Interviewing as a Return to Work Intervention in a Norwegian Social Insurance Setting: A Mixed Methods Process Evaluation. J Occup Rehabil. 2021 Dec;31(4):785-795. doi: 10.1007/s10926-021-09964-9. Epub 2021 Mar 24.
Foldal VS, Standal MI, Aasdahl L, Hagen R, Bagoien G, Fors EA, Johnsen R, Solbjor M. Sick-listed workers' experiences with motivational interviewing in the return to work process: a qualitative interview study. BMC Public Health. 2020 Feb 28;20(1):276. doi: 10.1186/s12889-020-8382-9.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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2016/2300-C
Identifier Type: -
Identifier Source: org_study_id
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