A Problem Solving Based Intervention for Facilitating Return-to-work Among People Suffering From Common Mental Disorders (PROSA)

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

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 Overview

• Status: Completed
• Conditions: Depression; Anxiety Disorders; Adjustment Disorders; Common Mental Disorder
• Intervention / Treatment: Behavioral: Problem solving based intervention; Behavioral: Care as usual

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Region Västra Götaland
    • Gothenburg, Region Västra Götaland, Sweden, 40530
      • Primary Health Care
  • Västra Götaland
    • Gothenburg, Västra Götaland, Sweden, 40530
      • Elisabeth Björk Brämberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Problem solving based intervention; Problem solving based intervention
Active Comparator: 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.	Behavioral: Care as usual; Medical treatment, or behavioral therapy or a coordination of behavioral therapy and medical treatment. Meeting with a rehabilitation coordinator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and 18 months after baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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).	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.	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.	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.	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.	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.	Baseline and 6 and 12 months after study inclusion.
Sickness presenteeism	Sickness presenteeism will be measured with a single question, response format 1-4.	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.	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).	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	Will be measured at baseline, 6 and 12 months follow-up

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Swedish Council for Working Life and Social Research
• Investigators: Principal Investigator: Elisabeth Björk Brämberg, PhD, Karolinska Institute, Unit of intervention and implementation research

Publications and helpful links

General Publications

• Bjork Bramberg E, Holmgren K, Bultmann U, Gyllensten H, Hagberg J, Sandman L, Bergstrom G. Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA). BMC Public Health. 2018 Jul 18;18(1):889. doi: 10.1186/s12889-018-5816-8.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 17, 2023

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Randomized controlled trial; Primary health care; Mental disorders; Anxiety disorders; Return to work; Problem solving; Interventional study; Adjustment disorders; Sick leave
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Trauma and Stressor Related Disorders; Depression; Disease; Psychotic Disorders; Anxiety Disorders; Mental Disorders; Adjustment Disorders
• Other Study ID Numbers: 2016-07415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No