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

NCT07079709 | Not Yet Recruiting

• 2 other identifiers: 2025-01713-012023-01487
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

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

Keywords

Work-focused CBT; WCBT; Sick leave; Clinical burnout; Cognitive behaviour therapy

Outcome Measures

Primary Outcomes (1)

• Work Ability Index (WAI) including Work Ability Score (WAS)

  Self-reported change in work ability. WAI consists of 7 domains, 11 questions in total. WAS is the first question of WAI.

  WAI: Baseline, 6 months, 1- and 2 year follow-up. WAS: every two weeks during the first six months.

Secondary Outcomes (17)

• Sick leave

  The time horizon is two years prior to and five years after the date for inclusion in the study.

• Current work status and sick leave

  Baseline, every two weeks until 6 months, 1- and 2-year follow-up.

• Shirom-Melamed Burnout Questionnaire (SMBQ-6)

  Baseline, every two weeks during 6 months, 1- and 2-year follow-up.

• Insomnia Severy Index (ISI)

  Baseline, 6 months, 1- and 2 year follow-up.

• Checklist Individual Strength

  Baseline, 6 months, 1- and 2 year follow-up.

Study Arms (2)

WCBT

EXPERIMENTAL

Work-focused Cognitive Behaviour Therapy

Behavioral: Workfocused CBT

Standard Care

ACTIVE COMPARATOR

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.

Other: Standard Care (in control arm)

Interventions

Workfocused CBT 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.

Also known as: WCBT

WCBT

Standard Care (in control arm) 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.

Standard Care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• be on sick leave at least 50%
• be diagnosed with a primary diagnosis adjustment disorder (F43.2-F.43.9) including exhaustion disorder (F43.8A)
• be of working age (18-60 years)
• be able to understand verbal and written Swedish or English
• give informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Göteborg University: collaborator
• Academic Primary Health Care Centre, SLSO, Region Stockholm: collaborator

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Anna C Finnes, PhD

CONTACT

+46 70 374 08 79; anna.finnes@ki.se

Anastasiya Zakrevska, MS

CONTACT

anastasiya.zakrevska@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Non-randomized controlled multi-center study, where control group centers providing treatment as usual are matched using the Care Need Index. Estimation of treatment effects will be conducted using either doubly robust inverse probability of treatment weights or targeted maximum likelihood estimation, depending on the outcome.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2034
• Last Updated: July 23, 2025

Record last verified: 2025-07