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Trial record 1 of 1 for:    NCT03212118
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Effects of Motivational Interviewing for Long-term Sick Absence

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ClinicalTrials.gov Identifier: NCT03212118
Recruitment Status : Active, not recruiting
First Posted : July 11, 2017
Last Update Posted : April 27, 2021
Sponsor:
Collaborators:
University of Bergen
University of Oslo
National Center for Occupational Rehabilitation, Rauland
Deakin University
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.


Condition or disease Intervention/treatment Phase
Sick Leave Behavioral: Treatment as usual (TAU-0) Behavioral: Structured talks (TAU-2) Behavioral: motivational interviewing (MI) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 774 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Motivational Interviewing for Long-term Sick Absence: A Randomized Controlled Trial With Mixed Methods
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : October 22, 2020
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Treatment as usual
Treatment as usual "untouched". This is the standard The Norwegian Labour and Welfare Administration (NAV) procedure.
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.
Other Name: 'untouched'

Active Comparator: Two talks
Two standard talks (not including elements from motivational interviewing)
Behavioral: Structured talks (TAU-2)
Two structured talks (not including elements from motivational interviewing)
Other Name: non-MI

Experimental: Motivational interviewing
Two standard talks with a motivational interviewing content.
Behavioral: motivational interviewing (MI)
Two structured talks (must have a valid motivational interviewing content).
Other Name: MI




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Return to Work Self-Efficacy [ Time Frame: 12 months ]
    Return to Work Self-Efficacy Scale (Lagerveld et al, 2010)

  4. Resilience [ Time Frame: 12 months ]
    Resilience Scale for Adults (Friborg et al, 2003)

  5. Return to work expectations [ Time Frame: 12 months ]
    Expectations about length of sick leave and return to work (3 items)

  6. 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)

  7. Health-related quality of life [ Time Frame: 12 months ]
    EQ- 5D- 5L Questionnaire, Herdman et al, 2011


Other Outcome Measures:
  1. Pain [ Time Frame: 12 months ]
    Brief Pain Inventory (BPI), 1 item

  2. Fatigue [ Time Frame: 12 months ]
    Fatigue Severity Scale (FFS), 1 item

  3. Sleep problems [ Time Frame: 12 months ]
    Insomnia Severity Index, 5 items

  4. Anxiety symptoms [ Time Frame: 12 months ]
    Generalized Anxiety Disorder 7-item (GAD-7)

  5. Depression symptoms [ Time Frame: 12 months ]
    Patient Health Questionnaire (PHQ-9)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212118


Locations
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Norway
Dept
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
University of Bergen
University of Oslo
National Center for Occupational Rehabilitation, Rauland
Deakin University
Investigators
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Principal Investigator: Egil Andreas Fors, phd prof Norwegian University of Science and Technology
  Study Documents (Full-Text)

Documents provided by Norwegian University of Science and Technology:
Statistical Analysis Plan  [PDF] March 30, 2020

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03212118    
Other Study ID Numbers: 2016/2300-C
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not be available for other researchers due to ethical approval.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Sick Leave
Return to work
Motivational interviewing
Absenteeism
Occupational Health