Returning to Work After Stress-Related Sick Leave: An Effectiveness Trial of Work-Focused Treatments in Primary Care

NCT ID: NCT07079709

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2034-12-01

Brief Summary

The goal of this clinical trial is to learn if work-focused cognitive behaviour (WCBT) works to treat patients on sick leave due to non-traumatic long-term stress-related disorders. The main questions it aims to answer are:

• Is WCBT more effective in improving work ability compared to standard care?
• Do participants in WCBT have less sick leave days than those in standard care?
• Is WCBT more effective in improving health outcomes and function than standard care?
• Is WCBT a more cost-effective treatment option than standard care? Researchers will compare WCBT to standad care to see if there are differences in effect.

Participants will participate in:

• WCBT
• Standard care

Conditions

Clinical Burnout; Exhaustion Disorder; Adjustment Disorder With Work Inhibition

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WCBT

Work-focused Cognitive Behaviour Therapy

Group Type: EXPERIMENTAL

Workfocused CBT

Intervention Type: BEHAVIORAL

In WCBT, the central idea is that CBT techniques can be applied in a work context with the aim of achieving both usual treatment goals related to symptoms and RTW. To ensure positive effects at both symptomatic and functional levels, a work perspective must be fully integrated into the intervention to optimize the treatment effect which demands collaboration with the sick leave prescribing doctor and the patient's employer. The protocol is based on principles of increasing return-to-work self-efficacy (RTW-SE). Work-specific components, such as work anamnesis, adjusting the difficulty of work tasks, and developing a return-to-work plan that includes recommendations for workplace accommodations, are integrated into all treatment sessions.

Standard Care

Standard Care is defined as care by the sick leave prescribing physician and the rehab coordinator. Other interventions such as psychological treatment, physiotherapy etc. may also be included in this arm.

Group Type: ACTIVE_COMPARATOR

Standard Care (in control arm)

Intervention Type: OTHER

Standard Care is defined as care by the sick leave prescribing physician and the rehab coordinator. Other interventions such as psychological treatment, physiotherapy etc. may also be included in this arm.

Interventions

Workfocused CBT

In WCBT, the central idea is that CBT techniques can be applied in a work context with the aim of achieving both usual treatment goals related to symptoms and RTW. To ensure positive effects at both symptomatic and functional levels, a work perspective must be fully integrated into the intervention to optimize the treatment effect which demands collaboration with the sick leave prescribing doctor and the patient's employer. The protocol is based on principles of increasing return-to-work self-efficacy (RTW-SE). Work-specific components, such as work anamnesis, adjusting the difficulty of work tasks, and developing a return-to-work plan that includes recommendations for workplace accommodations, are integrated into all treatment sessions.

Intervention Type: BEHAVIORAL

Standard Care (in control arm)

Standard Care is defined as care by the sick leave prescribing physician and the rehab coordinator. Other interventions such as psychological treatment, physiotherapy etc. may also be included in this arm.

Intervention Type: OTHER

Other Intervention Names

WCBT

Eligibility Criteria

Inclusion Criteria

1. be on sick leave at least 50%

2. be diagnosed with a primary diagnosis adjustment disorder (F43.2-F.43.9) including exhaustion disorder (F43.8A)

3. be of working age (18-60 years)

4. be able to understand verbal and written Swedish or English

5. give informed consent

Exclusion Criteria

1. other psychiatric conditions that require prioritization for immediate or simultaneous treatment: specifically, a current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or organic mental disorder; current high risk of suicide; or recent (within 3 months) history of substance use disorder)

2. other ongoing or recent (within 6 months) psychological treatment for stress-related disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

Academic Primary Health Care Centre, SLSO, Region Stockholm

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Anna Finnes

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Anna C Finnes, PhD

Role: CONTACT

anna.finnes@ki.se

+46 70 374 08 79

Anastasiya Zakrevska, MS

Role: CONTACT

anastasiya.zakrevska@ki.se

Other Identifiers

2023-01487

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025-01713-01

Identifier Type: -

Identifier Source: org_study_id