Effects of Motivational Interviewing for Long-term Sick Absence

Sick Leave Clinical Trial

Official title:

Effects of Motivational Interviewing for Long-term Sick Absence: A Randomized Controlled Trial With Mixed Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212118
• Other study ID #: 2016/2300-C
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 774
• Est. completion date: July 1, 2022
• Est. primary completion date: October 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Sick Leave

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
Norway	Dept	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Deakin University, National Center for Occupational Rehabilitation, Rauland, University of Bergen, University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Aasdahl L, Foldal VS, Standal MI, Hagen R, Johnsen R, Solbjør M, Fimland MS, Fossen H, Jensen C, Bagøien 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain	Brief Pain Inventory (BPI), 1 item	12 months
Other	Fatigue	Fatigue Severity Scale (FFS), 1 item	12 months
Other	Sleep problems	Insomnia Severity Index, 5 items	12 months
Other	Anxiety symptoms	Generalized Anxiety Disorder 7-item (GAD-7)	12 months
Other	Depression symptoms	Patient Health Questionnaire (PHQ-9)	12 months
Primary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	Return to Work Self-Efficacy	Return to Work Self-Efficacy Scale (Lagerveld et al, 2010)	12 months
Secondary	Resilience	Resilience Scale for Adults (Friborg et al, 2003)	12 months
Secondary	Return to work expectations	Expectations about length of sick leave and return to work (3 items)	12 months
Secondary	Workability	Single question. How will you rate your work ability (scale from 0 (no ability) to 10 (my best ability)) (1 item)	12 months
Secondary	Health-related quality of life	EQ- 5D- 5L Questionnaire, Herdman et al, 2011	12 months