An interventional study of Problem solving based intervention and Care as usual in Depression, Anxiety Disorders and Adjustment Disorders, sponsored by Karolinska Institutet. Completed at 2 sites in Sweden. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 197 is above the median of 81 across 7,063 interventional studies indexed under Depression.
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Exclusion Criteria:
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.
Behavioral: Problem solving based intervention
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.
Behavioral: Care as usual
Problem solving based intervention
Medical treatment, or behavioral therapy or a coordination of behavioral therapy and medical treatment. Meeting with a rehabilitation coordinator.
Change in total registered sickness absenteeism in number of days from baseline during the 18 month follow-up.
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.
Time frame: At baseline and 18 months after baseline.
Change from baseline in registered part-time sickness absenteeism during the 18 months follow-up
Change from baseline in registered partial sickness absenteeism (25/50/75% of full-time sickness absenteeism) during a follow-up period of 18 months. Change in registered sickness absenteeism will be calculated from baseline until the 18 months follow-up in number of days on part-time sick leave (25/50/75% of full-time sick leave). Data from the Social Insurance Agency's register MiDAS.
Time frame: From baseline to 18 months after baseline.
Change from baseline in return to work during a period of 18 months.
Change from baseline in return to work during a follow-up of 18 months. Return to work will be calculated from baseline data until the individual returns to work in ordinary hours during an uninterrupted period of at least four weeks.
Time frame: From baseline to 18 months after baseline.
Episodes of sickness absenteeism after full-time return to work
Episodes of sick leave after full-time return to work (i.e. work in ordinary hours during an uninterrupted period of at least four weeks) will be calculated from baseline until the 18 months follow-up by registered sickness absenteeism.
Time frame: From baseline during 18 months follow-up.
Change in total registered sick leave from baseline to 36 month follow-up.
Change in total registered sickness absenteeism at baseline and during the 36 months follow-up (including sickness benefit, sickness and activity compensation, disability pension). Data from the Social Insurance Agency's register MiDAS.
Time frame: Change in total registered sick leave from baseline to 36 month follow-up.
Possible interaction effects
Possible interaction effects on the primary and secondary outcomes for (1) gender x treatment, and (2) number of sessions with rehabilitation coordinator x treatment will be checked for and if statistically significant subgroup analyses will be considered.
Time frame: Change from baseline and 6, 12 and 18 months after study inclusion.
Self-reported short-term sickness absenteeism
Change in self-reported sickness absenteeism from baseline during the 12 month follow-up. Self-reported data collected every fourth week during the 12 months. These self-reported data cover shorter spells of sickness absenteeism (i.e. ≤14 consecutive days) that is not covered by the Social Insurance Agency's register.
Time frame: From baseline to 12 months after baseline.
Change from baseline in self-reported part-time sickness absenteeism during the 12 months follow-up
Change from baseline in self-reported partial sickness absenteeism (25/50/75% of full-time sickness absenteeism) during a follow-up period of 12 months. Change in self-reported sickness absenteeism will be calculated from baseline until the 12 months follow-up in number of days on part-time sick leave (25/50/75% of full-time sick leave).
Time frame: From baseline to 12 months after baseline.
Change from baseline in return to work during a period of 12 months.
Change from baseline in self-reported return to work during a follow-up of 12 months. Return to work will be calculated from baseline data until the individual returns to work in ordinary hours during an uninterrupted period of at least four weeks. Self-reported data obtained every fourth week during a period of 12 months.
Time frame: From baseline to 12 months after baseline.
Episodes of self-reported sickness absenteeism after full-time return to work.
Episodes of self-reported sickness absenteeism after full-time return to work (i.e. work in ordinary hours during an uninterrupted period of at least four weeks) will be calculated from baseline until the 12 months follow-up by self-reported sickness absenteeism.
Time frame: From baseline during 12 months follow-up.
Reduction of symptoms related to common mental disorders Hospital Anxiety and Depression scale
Hospital Anxiety and Depression Scale will be used to assess symptoms of anxiety (seven items) and depression (seven items). Each item is scored on a 4-point Likert scale indicating the extent to which an item was experienced in the past week. Response format from 0 to 3.
Time frame: Baseline and 6 and 12 months after study inclusion.
Reduction of symptoms related to common mental disorders Self-reported exhaustion
Institute of Stress Medicine's instrument for self-reported exhaustion: Change from baseline in self-reported exhaustion as measured by the Institute of Stress Medicine's instrument. Three items with the response format yes/no and one item with response format from 0 to 2.
Time frame: Baseline and 6 and 12 months after study inclusion.
Reduction of symptoms related to common mental disorders Karolinska Sleep Questionnaire
Karolinska Sleep Questionnaire, Insomnia subscale will be used for assessing insomnia problems. The subscale includes four items. Each item is scored on a 6 point scale ranging from 0 (never) to 5 (always) indicating to what extent an item was experienced in the last three months. Change from baseline in self-reported sleep problems.
Time frame: Baseline and 6 and 12 months after study inclusion.
Sickness presenteeism
Sickness presenteeism will be measured with a single question, response format 1-4.
Time frame: Baseline and after 6 and 12 months after study inclusion.
Work ability index (WAI)
WAI: change from baseline and after 6 and 12 months after study inclusion, self-reported work ability is assessed by 2 items from WAI (with the response format 1 - 5). These questions measures the perceived work capacity in relation to the physical (1 item) and the mental (1 item) demands of the work.
Time frame: Baseline and 6 and 12 months after study inclusion.
Work performance impairment due to health problems
Work performance due to health problems will be measured by a question from one of the items included in the Work Productivity Impairment - General Health Questionnaire (the response format is 0-10).
Time frame: Will be assessed at baseline and once a month during a 12-month follow-up period.
Work performance impairment due to problems in the working environment
Work performance due to problems in the working environment will be measured by a question from one of the items included in the Work Productivity Impairment - General Health Questionnaire (the response format is 0-10).
Time frame: Will be assessed at baseline and once a month during a 12-month follow-up period.
Demand-control-support
Demand-control-support model: Change from baseline and after 6 and 12 months after study inclusion, response format from 1 to 4. Prognostic variable.
Time frame: Baseline and after 6 and 12 months after study inclusion.
Return-to-work self-efficacy
Return-to-work self-efficacy will be measured by a question with the response format from 0 to 10. Prognostic variable.
Time frame: Change from baseline and 6 and 12 months after study inclusion.
Ongoing conflict with the superior
Ongoing conflict with the superior is measured by one item. The item is scored on a 3 point Likert-type scale ranging from 0 (never) to 3 (often or always). Prognostic variable.
Time frame: Change from baseline at 6 and 12 months after study inclusion.
Perceived loss of control over work tasks
Perceived loss of control over work tasks is measured by one item. The item is scored on a Likert-type scales with 5 response options ranging from 0 (never or almost never) to 4 (very often or always). Prognostic variable.
Time frame: Change from baseline at 6 and 12 months after study inclusion.
Conflict between employee's values and how the work actually is done
Conflict between employee's values and how the work actually is done is measured by three items. Each item is scored on a Likert-type scale5 response options ranging from 0 (never or almost never) to 4 (very often or always). Prognostic variable.
Time frame: Change from baseline at 6 and 12 months after study inclusion.
Job strain
Job strain (emotional and psychological demands) will be assessed by four items from Copenhagen psychosocial questionnaire, response format is likert-type scales with 5 response options. Prognostic variable.
Time frame: Change from baseline at 6 and 12 months after study inclusion.
Participants' satisfaction
Participants' satisfaction and experiences with their participation in the intervention or care as usual will be assessed at 6 months after completed intervention, as a part of the process evaluation. Self-reported questionnaire with ten items, response format from 0 to 10 or yes/no/do not know.
Time frame: Will be assessed at 6 months after intervention.
The rehabilitation coordinators' adherence to the intervention.
The rehabilitation coordinators' adherence to the intervention is measured by a single item with the response format from 1 to 5.
Time frame: Assessed immediately upon completion of intervention.
Health related quality of life
Health related quality of life will be measured with European Quality of Life 5 Dimensions questionnaire (EQ5D). The response format is a 3-level scale, with higher levels indicating severity.
Time frame: Will be measured at baseline, 6 and 12 months follow-up
Plan to share: Yes — There is a plan to make IPD and related data available. In line with the study's ethical approval, data may only be made available after reasonable request to the principal investigator, and after decision by the Swedish Ethical Review Authority.
Supporting information: Study protocol
Access criteria: There is a plan to make IPD and related data available. In line with the study's ethical approval, data may only be made available after reasonable request to the principal investigator, and after decision by the Swedish Ethical Review Authority.
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