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

NCT03346395 | Completed

• 1 other identifier: 2016-07415
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; Anxiety Disorders; Adjustment Disorders; Common Mental Disorder

Keywords

Adjustment disorders; Anxiety disorders; Depression; Mental disorders; Interventional study; Primary health care; Problem solving; Randomized controlled trial; Return to work; Sick leave

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• 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.

• Episodes of sickness absenteeism after full-time return to work

  From baseline during 18 months follow-up.

• 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.

• Possible interaction effects

  Change from baseline and 6, 12 and 18 months after study inclusion.

Study Arms (2)

Problem solving based intervention

EXPERIMENTAL

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

Care as usual

ACTIVE COMPARATOR

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

Interventions

Problem solving based intervention BEHAVIORAL

Problem solving based intervention

Problem solving based intervention

Care as usual BEHAVIORAL

Medical treatment, or behavioral therapy or a coordination of behavioral therapy and medical treatment. Meeting with a rehabilitation coordinator.

Care as usual

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swedish Council for Working Life and Social Research: collaborator

Study Sites (2)

Primary health care

Gothenburg, Region Västra Götaland, 40530, Sweden

Location

Elisabeth Björk Brämberg

Gothenburg, Västra Götaland County, 40530, Sweden

Location

Related Publications (5)

• Eklund A, Karlsson I, Bergstrom G, Lisa H, Elisabeth BB. The effectiveness of a problem-solving intervention with workplace involvement on self-reported sick leave, psychological symptoms and work ability: a cluster randomised clinical trial. BMC Public Health. 2024 Nov 5;24(1):3052. doi: 10.1186/s12889-024-20564-z.

  PMID: 39501245 DERIVED

• Karlsson I, Frantz A, Axen I, Bergstrom G, Bultmann U, Finnes A, Holmgren K, Kwak L, Bjork Bramberg E. Is a Problem-Solving Intervention with Workplace Involvement for Employees on Sickness Absence Due to Common Mental Disorders More Effective, than Care as Usual, in Reducing Sickness Absence Days? Results of a Cluster-Randomised Controlled Trial in Primary Health Care. J Occup Rehabil. 2025 Sep;35(3):615-624. doi: 10.1007/s10926-024-10229-4. Epub 2024 Aug 7.

  PMID: 39110387 DERIVED

• Toropova A, Bjork Bramberg E, Bergstrom G. Return to Work Trajectories of Swedish Employees on Sick-Leave Due to Common Mental Disorders. J Occup Rehabil. 2025 Sep;35(3):479-490. doi: 10.1007/s10926-024-10216-9. Epub 2024 Jun 22.

  PMID: 38907784 DERIVED

• Holmlund L, Ljungberg HT, Bultmann U, Bramberg EB. Navigating work and life- a qualitative exploration of managers' and employees' views of return-to-work after sick leave due to common mental disorders. BMC Public Health. 2024 Feb 5;24(1):372. doi: 10.1186/s12889-024-17765-x.

  PMID: 38317150 DERIVED

• 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.

  PMID: 30021545 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Adjustment Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Trauma and Stressor Related Disorders

Study Officials

• Elisabeth Björk Brämberg, PhD

  Karolinska Institute, Unit of intervention and implementation research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, docent

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: November 17, 2017
• Study Start: January 11, 2018
• Primary Completion: December 31, 2022
• Study Completion: January 17, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

SE (2)