NCT03212118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
774

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

2.8 years

First QC Date

June 12, 2017

Last Update Submit

September 22, 2022

Conditions

Keywords

Sick LeaveReturn to workMotivational interviewingAbsenteeismOccupational Health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • The time until full sustainable return to work (RTW), i.e. for at least 4 weeks without relapse

    12 months

  • Probability of working (i.e. not receiving medical benefits) each month during follow-up, measured as repeated events

    12 months

  • Return to Work Self-Efficacy

    12 months

  • Resilience

    12 months

  • Return to work expectations

    12 months

  • +2 more secondary outcomes

Other Outcomes (5)

  • Pain

    12 months

  • Fatigue

    12 months

  • Sleep problems

    12 months

  • +2 more other outcomes

Study Arms (3)

Treatment as usual

OTHER

Treatment as usual "untouched". This is the standard The Norwegian Labour and Welfare Administration (NAV) procedure.

Behavioral: Treatment as usual (TAU-0)

Two talks

ACTIVE COMPARATOR

Two standard talks (not including elements from motivational interviewing)

Behavioral: Structured talks (TAU-2)

Motivational interviewing

EXPERIMENTAL

Two standard talks with a motivational interviewing content.

Behavioral: motivational interviewing (MI)

Interventions

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'
Treatment as usual

Two structured talks (not including elements from motivational interviewing)

Also known as: non-MI
Two talks

Two structured talks (must have a valid motivational interviewing content).

Also known as: MI
Motivational interviewing

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Living in the county Sør-Trøndelag
  • On sick leave for 8 weeks
  • Current sick leave status of 50-100%

You may not qualify if:

  • no employment
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept

Trondheim, Norway

Location

Related Publications (3)

  • 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.

    PMID: 29914463BACKGROUND
  • Foldal 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.

  • Foldal 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.

MeSH Terms

Interventions

TherapeuticsMotivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Egil Andreas Fors, phd prof

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2017

First Posted

July 11, 2017

Study Start

January 1, 2018

Primary Completion

October 22, 2020

Study Completion

July 1, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

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

Locations