A Problem Solving Based Intervention in Primary Health Care for Facilitating Return-to-work Among People Suffering From Common Mental Disorders - a Cluster-randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 197
- Locations
- 2
- Primary Endpoint
- Change in total registered sickness absenteeism in number of days from baseline during the 18 month follow-up.
Study Overview
Brief Summary
Problem solving based intervention involving the workplace has shown promising effects on return-to-work among persons with common mental disorders. A key element is cooperation between the person on sick leave, the participant's employer and health care professionals. The aim of the present study is to evaluate the effects of a problem solving based intervention in the Swedish primary health care system on an employed population on sick leave due to common mental disorders. Cluster randomized controlled trial. The investigators hypothesize that:
Participants who have undergone the work-related problem solving based intervention will have fewer total days on sick leave than the participants who receive treatment as usual at 18 months.
Participants who receive the work-related problem solving based intervention will have fewer recurrent periods of sick leave than the participants who receive treatment as usual at 18 months.
Participants who receive the work-related problem solving therapy intervention will score better on the secondary outcomes than the participants in the control group.
Population: Employed, aged 18 - 59, on short-term sick leave (min. 2 - max. 12 weeks) due to common mental disorders.
Intervention: Work-related problem solving based intervention in addition to treatment as usual. The intervention will be given by rehabilitation coordinators on max. five occasions and includes: making an inventory of problems and/or opportunities related to return-to-work; identifying the support needed to implement the solutions; a meeting with the person on sick leave, his/her employer and the rehabilitation coordinator to discuss solutions; making an action plan and evaluation.
Control: The control group will receive care as usual (i.e. cognitive behavioral therapy and/or medical treatment, and meeting with a rehabilitation coordinator if this is a part of care as usual at the primary health care centre). A total of 220 persons on sick leave and 30 rehabilitation coordinators will be included.
Primary outcome: total number of days on sick leave at 18 months after baseline. A parallel process evaluation will be conducted to examine: to what extent it is possible to implement problem-solving therapy according to the protocol; the relationship between the key elements of problem-solving intervention and the effect outcome; how the participants perceive the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •employed women and men aged 18-59, short-term sick leave (i.e. a minimum of 2 weeks and a maximum of 12 weeks) due to mild to moderate depression, anxiety or adjustment disorder (F 32, F 41, F 43) as the primary reason for sick leave, diagnosed by a general practitioner (GP) or physician according to the Swedish version of international statistical classification of diseases and related health problems - tenth revision (ICD-10) contact with a GP or physician at a primary health care center in the vestra gotaland region.
Exclusion Criteria
- •Severe depression, other severe mental disorders, i.e. psychotic or bipolar disorders; pregnancy, somatic complaints or disorders that will influence work ability; not able to read, write and understand Swedish.
Arms & Interventions
Problem solving based intervention
The problem solving based intervention contains a problem solving process and cooperation between the person on sick leave, his/her employer and health care professionals. The intervention consists of five steps: 1) Making an inventory of problems and/or opportunities related to return to work; 2) brainstorming about solutions; 3) writing down solutions, identifying the support needed to implement the solutions; 4) a three-party meeting with the person on sick leave, his/her employer and the rehabilitation coordinator; 5) evaluation of the action plan and implementation of solutions, relapse prevention. The intervention takes the form of two to five consultations. The first and fourth steps are key elements.
Intervention: Problem solving based intervention (Behavioral)
Care as usual
Medical treatment, or behavioral therapy or in combination. Meeting with a rehabilitation coordinator if that is a part or care as usual within primary health care.
Intervention: Care as usual (Behavioral)
Outcomes
Primary Outcomes
Change in total registered sickness absenteeism in number of days from baseline during the 18 month follow-up.
Time Frame: At baseline and 18 months after baseline.
Change in total registered sickness absenteeism in number of days from baseline during the 18 months follow-up (including sickness benefit, sickness and activity compensation, disability pension). Data from the Social Insurance Agency's register MiDAS. The analyses will be repeated for outcomes on registered sickness absence at a three-year follow-up.
Secondary Outcomes
- Change from baseline in self-reported part-time sickness absenteeism during the 12 months follow-up(From baseline to 12 months after baseline.)
- Reduction of symptoms related to common mental disorders Self-reported exhaustion(Baseline and 6 and 12 months after study inclusion.)
- Change in total registered sick leave from baseline to 36 month follow-up.(Change in total registered sick leave from baseline to 36 month follow-up.)
- Self-reported short-term sickness absenteeism(From baseline to 12 months after baseline.)
- Episodes of sickness absenteeism after full-time return to work(From baseline during 18 months follow-up.)
- Possible interaction effects(Change from baseline and 6, 12 and 18 months after study inclusion.)
- Episodes of self-reported sickness absenteeism after full-time return to work.(From baseline during 12 months follow-up.)
- Change from baseline in registered part-time sickness absenteeism during the 18 months follow-up(From baseline to 18 months after baseline.)
- Change from baseline in return to work during a period of 18 months.(From baseline to 18 months after baseline.)
- Ongoing conflict with the superior(Change from baseline at 6 and 12 months after study inclusion.)
- Change from baseline in return to work during a period of 12 months.(From baseline to 12 months after baseline.)
- Reduction of symptoms related to common mental disorders Hospital Anxiety and Depression scale(Baseline and 6 and 12 months after study inclusion.)
- Work performance impairment due to problems in the working environment(Will be assessed at baseline and once a month during a 12-month follow-up period.)
- Job strain(Change from baseline at 6 and 12 months after study inclusion.)
- Reduction of symptoms related to common mental disorders Karolinska Sleep Questionnaire(Baseline and 6 and 12 months after study inclusion.)
- Sickness presenteeism(Baseline and after 6 and 12 months after study inclusion.)
- Work ability index (WAI)(Baseline and 6 and 12 months after study inclusion.)
- Work performance impairment due to health problems(Will be assessed at baseline and once a month during a 12-month follow-up period.)
- Demand-control-support(Baseline and after 6 and 12 months after study inclusion.)
- Return-to-work self-efficacy(Change from baseline and 6 and 12 months after study inclusion.)
- Perceived loss of control over work tasks(Change from baseline at 6 and 12 months after study inclusion.)
- Conflict between employee's values and how the work actually is done(Change from baseline at 6 and 12 months after study inclusion.)
- The rehabilitation coordinators' adherence to the intervention.(Assessed immediately upon completion of intervention.)
- Participants' satisfaction(Will be assessed at 6 months after intervention.)
- Health related quality of life(Will be measured at baseline, 6 and 12 months follow-up)
Investigators
Elisabeth Björk Brämberg, PhD
Associate professor, docent
Karolinska Institutet