Clinical trial NCT03212118: Effects of Motivational Interviewing for Long-term Sick Absence
Official title: Effects of Motivational Interviewing for Long-term Sick Absence: A Randomized Controlled Trial With Mixed Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sick Leave
Keywords: Sick Leave
Return to work
Motivational interviewing
Absenteeism
Occupational Health
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: University of Oslo
name: National Center for Occupational Rehabilitation, Rauland
name: Deakin University
First posted: 2017-07-11
Enrollment: 774
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Long-term sickness absence has considerable impact on social functioning, families involved, the employer, and society as a whole. Preventing long-term sickness absence and increase the likelihood of return to work (RTW) are critical concerns for industrialized countries across the world. Motivational factors contributing to RTW and maintenance of work participation are therefore of importance to explore in order to get the person back to work after long-term sick leave. Motivational interviewing (MI) is an empirically validated psychological approach that may be particularly useful in a RTW context. Even though MI has been widely studied and is considered a flexible intervention strategy in different domains, its effectiveness in improving RTW has not yet been studied.

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.

Detailed description: The main study will be preceded by a pilot study (anticipated start medio august 2017). The aim of the pilot is to test the practical aspects of the study. If no changes are made to the study protocol, the intervention or one of the other arms, participants from the pilot will be included in the main study, In case of modifications to the study protocol after the pilot, participants from the pilot study will not be included in the main study. Data for primary and secondary outcomes will not be assessed before the end of the main study.

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.

Eligibility criteria: Inclusion Criteria:

* Living in the county Sør-Trøndelag
* On sick leave for 8 weeks
* Current sick leave status of 50-100%

Exclusion Criteria:

* no employment
* pregnancy

Primary outcomes:
measure: Total number of sickness absence days during the year after enrollment in the study (i.e. after randomization)
timeFrame: 12 months
Secondary outcomes:
measure: The time until full sustainable return to work (RTW), i.e. for at least 4 weeks without relapse
timeFrame: 12 months
measure: Probability of working (i.e. not receiving medical benefits) each month during follow-up, measured as repeated events
timeFrame: 12 months
measure: Return to Work Self-Efficacy
timeFrame: 12 months
measure: Resilience
timeFrame: 12 months
measure: Return to work expectations
timeFrame: 12 months
measure: Workability
timeFrame: 12 months
measure: Health-related quality of life
timeFrame: 12 months
Other outcomes:
measure: Pain
timeFrame: 12 months
measure: Fatigue
timeFrame: 12 months
measure: Sleep problems
timeFrame: 12 months
measure: Anxiety symptoms
timeFrame: 12 months
measure: Depression symptoms
timeFrame: 12 months
Locations:
city: Trondheim
country: Norway
facility: Dept
Study officials:
affiliation: Norwegian University of Science and Technology
name: Egil Andreas Fors, phd prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.