Effects of Motivational Interviewing for Long-term Sick Absence

September 22, 2022 updated by: Norwegian University of Science and Technology

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

774

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Trondheim, Norway
        • Dept

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Treatment as usual
Treatment as usual "untouched". This is the standard The Norwegian Labour and Welfare Administration (NAV) procedure.
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.
Other Names:
  • 'untouched'
ACTIVE_COMPARATOR: Two talks
Two standard talks (not including elements from motivational interviewing)
Two structured talks (not including elements from motivational interviewing)
Other Names:
  • non-MI
EXPERIMENTAL: Motivational interviewing
Two standard talks with a motivational interviewing content.
Two structured talks (must have a valid motivational interviewing content).
Other Names:
  • MI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time until full sustainable return to work (RTW), i.e. for at least 4 weeks without relapse
Time Frame: 12 months
Register data from the national health and welfare services
12 months
Probability of working (i.e. not receiving medical benefits) each month during follow-up, measured as repeated events
Time Frame: 12 months
Register data from the national health and welfare services
12 months
Return to Work Self-Efficacy
Time Frame: 12 months
Return to Work Self-Efficacy Scale (Lagerveld et al, 2010)
12 months
Resilience
Time Frame: 12 months
Resilience Scale for Adults (Friborg et al, 2003)
12 months
Return to work expectations
Time Frame: 12 months
Expectations about length of sick leave and return to work (3 items)
12 months
Workability
Time Frame: 12 months
Single question. How will you rate your work ability (scale from 0 (no ability) to 10 (my best ability)) (1 item)
12 months
Health-related quality of life
Time Frame: 12 months
EQ- 5D- 5L Questionnaire, Herdman et al, 2011
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 12 months
Brief Pain Inventory (BPI), 1 item
12 months
Fatigue
Time Frame: 12 months
Fatigue Severity Scale (FFS), 1 item
12 months
Sleep problems
Time Frame: 12 months
Insomnia Severity Index, 5 items
12 months
Anxiety symptoms
Time Frame: 12 months
Generalized Anxiety Disorder 7-item (GAD-7)
12 months
Depression symptoms
Time Frame: 12 months
Patient Health Questionnaire (PHQ-9)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Egil Andreas Fors, phd prof, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

October 22, 2020

Study Completion (ACTUAL)

July 1, 2022

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (ACTUAL)

July 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data will not be available for other researchers due to ethical approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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