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Completed

NCT Number: NCT03212118

Effects of Motivational Interviewing for Long-term Sick Absence

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.

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Key information

Conditions

Sick Leave

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept

Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment as usual (TAU-0)

Behavioral

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'

Structured talks (TAU-2)

Behavioral

Two structured talks (not including elements from motivational interviewing)

Other names: non-MI

Motivational Interviewing (MI)

Behavioral

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

Other names: MI

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Deakin University
  • National Center for Occupational Rehabilitation, Rauland
  • University of Bergen
  • University of Oslo

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jul 11, 2017
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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