An interventional study of Treatment as usual (TAU-0) and Structured talks (TAU-2) in Sick Leave, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Supportive care
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.
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:
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.
Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment as usual "untouched". This is the standard The Norwegian Labour and Welfare Administration (NAV) procedure.
Behavioral: Treatment as usual (TAU-0)
Two standard talks (not including elements from motivational interviewing)
Behavioral: Structured talks (TAU-2)
Two standard talks with a motivational interviewing content.
Behavioral: motivational interviewing (MI)
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.
Also known as: 'untouched'
Two structured talks (not including elements from motivational interviewing)
Also known as: non-MI
Two structured talks (must have a valid motivational interviewing content).
Also known as: MI
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
Time frame: 12 months
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
Time frame: 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
Time frame: 12 months
Return to Work Self-Efficacy
Return to Work Self-Efficacy Scale (Lagerveld et al, 2010)
Time frame: 12 months
Resilience
Resilience Scale for Adults (Friborg et al, 2003)
Time frame: 12 months
Return to work expectations
Expectations about length of sick leave and return to work (3 items)
Time frame: 12 months
Workability
Single question. How will you rate your work ability (scale from 0 (no ability) to 10 (my best ability)) (1 item)
Time frame: 12 months
Health-related quality of life
EQ- 5D- 5L Questionnaire, Herdman et al, 2011
Time frame: 12 months
Pain
Brief Pain Inventory (BPI), 1 item
Time frame: 12 months
Fatigue
Fatigue Severity Scale (FFS), 1 item
Time frame: 12 months
Sleep problems
Insomnia Severity Index, 5 items
Time frame: 12 months
Anxiety symptoms
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: 12 months
Depression symptoms
Patient Health Questionnaire (PHQ-9)
Time frame: 12 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual data will not be available for other researchers due to ethical approval.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Norwegian University of Science and Technology