Effects of Motivational Interviewing for Long-term Sick Absence
Condition: Sick Leave
Study type: Interventional

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.
    

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.
    

Intervention name(s): Treatment as usual (TAU-0); Structured talks (TAU-2); motivational interviewing (MI)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; Two structured talks (not including elements from motivational interviewing); Two structured talks (must have a valid motivational interviewing content).
Other intervention name(s): 'untouched'; non-MI; MI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sick Leave; Return to work; Motivational interviewing; Absenteeism; Occupational Health