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

NCT ID: NCT03346395

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-11

Study Completion Date

2023-01-17

Brief Summary

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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.

Detailed Description

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Conditions

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Depression Anxiety Disorders Adjustment Disorders Common Mental Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Problem solving based intervention

Intervention Type BEHAVIORAL

Problem solving based intervention

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.

Group Type ACTIVE_COMPARATOR

Care as usual

Intervention Type BEHAVIORAL

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

Interventions

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Problem solving based intervention

Problem solving based intervention

Intervention Type BEHAVIORAL

Care as usual

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Council for Working Life and Social Research

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Elisabeth Björk Brämberg, PhD

Associate professor, docent

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elisabeth Björk Brämberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institute, Unit of intervention and implementation research

Locations

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Primary health care

Gothenburg, Region Västra Götaland, Sweden

Site Status

Elisabeth Björk Brämberg

Gothenburg, Västra Götaland County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 39501245 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39110387 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38907784 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38317150 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30021545 (View on PubMed)

Other Identifiers

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2016-07415

Identifier Type: -

Identifier Source: org_study_id

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