Sick LeaveNCT03212118
Effects of Motivational Interviewing for Long-term Sick Absence
A study testing Treatment as usual (TAU-0), Structured talks (TAU-2) and motivational interviewing (MI) in people with Sick Leave, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sick Leave
- What is being tested?
- Treatment as usual (TAU-0), Structured talks (TAU-2) and motivational interviewing (MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2018to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Living in the county Sør-Trøndelag
- On sick leave for 8 weeks
- Current sick leave status of 50-100%
Who cannot join
- no employment
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Motivational Interviewing for Long-term Sick Absence: A Randomized Controlled Trial With Mixed Methods
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.
Read the 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.
- Conditions
- Sick Leave
- Being tested
- Treatment as usual (TAU-0), Structured talks (TAU-2), motivational interviewing (MI)
- Keywords
- Sick Leave, Return to work, Motivational interviewing, Absenteeism, Occupational Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usual (TAU-0)Behavioural
Also called 'untouched'
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)Behavioural
Also called non-MI
Two structured talks (not including elements from motivational interviewing)
motivational interviewing (MI)Behavioural
Also called MI
Two structured talks (must have a valid motivational interviewing content).
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Other | Treatment as usual "untouched". This is the standard The Norwegian Labour and Welfare Administration (NAV) procedure. Receives: Behavioral: Treatment as usual (TAU-0) |
| Two talks | Active comparator | Two standard talks (not including elements from motivational interviewing) Receives: Behavioral: Structured talks (TAU-2) |
| Motivational interviewing | Experimental | Two standard talks with a motivational interviewing content. Receives: Behavioral: motivational interviewing (MI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of sickness absence days during the year after enrollment in the study (i.e. after randomization)
Register data from the national health and welfare services
Measured: 12 months
Secondary outcomes (7)
The time until full sustainable return to work (RTW), i.e. for at least 4 weeks without relapse
Register data from the national health and welfare services
Measured: 12 months
Probability of working (i.e. not receiving medical benefits) each month during follow-up, measured as repeated events
Register data from the national health and welfare services
Measured: 12 months
Return to Work Self-Efficacy
Return to Work Self-Efficacy Scale (Lagerveld et al, 2010)
Measured: 12 months
Resilience
Resilience Scale for Adults (Friborg et al, 2003)
Measured: 12 months
Return to work expectations
Expectations about length of sick leave and return to work (3 items)
Measured: 12 months
Workability
Single question. How will you rate your work ability (scale from 0 (no ability) to 10 (my best ability)) (1 item)
Measured: 12 months
Health-related quality of life
EQ- 5D- 5L Questionnaire, Herdman et al, 2011
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Jan 2018
- Primary completion22 Oct 2020
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sick LeaveStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, University of Oslo, National Center for Occupational Rehabilitation, Rauland, Deakin University
- Responsible party
- Sponsor
- Investigators
- Egil Andreas Fors, phd prof, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212118
- Sponsor's protocol ID
- 2016/2300-C
- Status last verified
- Sep 2022
- First submitted
- 12 Jun 2017
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be available for other researchers due to ethical approval.
Publications
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.
PubMed 29914463Foldal 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.
PubMed 33761083Foldal 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.
PubMed 32111199
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motivational Interviewing for Long-term Sick Absence: A Randomized Controlled Trial With Mixed Methods
- ClinicalTrials.gov ID
- NCT03212118
- Acronym / sponsor ID
- 2016/2300-C
- Conditions
- Sick Leave
- Keywords
- Sick Leave, Return to work, Motivational interviewing, Absenteeism, Occupational Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Bergen, University of Oslo, National Center for Occupational Rehabilitation, Rauland, Deakin University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Other | Behavioral: Treatment as usual (TAU-0)Treatment as usual "untouched". This is the standard The Norwegian Labour and Welfare Administration (NAV) procedure. |
| Two talks | Active comparator | Behavioral: Structured talks (TAU-2)Two standard talks (not including elements from motivational interviewing) |
| Motivational interviewing | Experimental | Behavioral: motivational interviewing (MI)Two standard talks with a motivational interviewing content. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Living in the county Sør-Trøndelag
- On sick leave for 8 weeks
- Current sick leave status of 50-100%
Key exclusion criteria (2 listed)
- no employment
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usual (TAU-0)Also: 'untouched'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. | Behavioural | Treatment as usual |
| Structured talks (TAU-2)Also: non-MITwo structured talks (not including elements from motivational interviewing) | Behavioural | Two talks |
| motivational interviewing (MI)Also: MITwo structured talks (must have a valid motivational interviewing content). | Behavioural | Motivational interviewing |
Primary outcome
Total number of sickness absence days during the year after enrollment in the study (i.e. after randomization)
Time frame: 12 months
Register data from the national health and welfare services
7 secondary outcomes
The time until full sustainable return to work (RTW), i.e. for at least 4 weeks without relapse
Time frame: 12 months
Probability of working (i.e. not receiving medical benefits) each month during follow-up, measured as repeated events
Time frame: 12 months
Return to Work Self-Efficacy
Time frame: 12 months
Resilience
Time frame: 12 months
Return to work expectations
Time frame: 12 months
Workability
Time frame: 12 months
Health-related quality of life
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Background: PubMed 29914463Aasdahl 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.
- Derived from this study: PubMed 33761083Foldal 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.
- Derived from this study: PubMed 32111199Foldal 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.
- Individual participant dataSharing planned: No. Individual data will not be available for other researchers due to ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egil Andreas Fors, phd prof principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual (TAU-0), Structured talks (TAU-2) and motivational interviewing (MI) in people with Sick Leave, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of sickness absence days during the year after enrollment in the study (i.e. after randomization) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212118, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.