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Not yet recruiting NCT07079709

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

No phase Interventional Clinical Burnout Exhaustion Disorder Adjustment Disorder With Work Inhibition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Workfocused CBT, Standard Care (in control arm).
Who it may be relevant to
Registry conditions: Clinical Burnout, Exhaustion Disorder, Adjustment Disorder With Work Inhibition. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Behavioral 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-ef
  • Other 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.

Primary outcome measures

  • Work Ability Index (WAI) including Work Ability Score (WAS) [Time frame: WAI: Baseline, 6 months, 1- and 2 year follow-up. WAS: every two weeks during the first six months.]
Secondary outcome measures (12)
  • Sick leave [Time frame: 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 [Time frame: Baseline, every two weeks until 6 months, 1- and 2-year follow-up.]
  • Shirom-Melamed Burnout Questionnaire (SMBQ-6) [Time frame: Baseline, every two weeks during 6 months, 1- and 2-year follow-up.]
  • Insomnia Severy Index (ISI) [Time frame: Baseline, 6 months, 1- and 2 year follow-up.]
  • Checklist Individual Strength [Time frame: Baseline, 6 months, 1- and 2 year follow-up.]
  • Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, 6 months, 1- and 2 year follow-up.]
  • Generalized Anxiety Disorder Assessment (GAD-7) [Time frame: Baseline, 6 months, 1- and 2 year follow-up.]
  • Short Form Survey (SF-12) [Time frame: Baseline, 6 months, 1- and 2 year follow-up.]
  • Return to work Self-efficacy Scale [Time frame: Baseline, 6 months, 1- and 2 year follow-up.]
  • Work Phobia Questionnaire - short version [Time frame: Baseline, every two weeks until 6 months, 1- and 2 year follow-up.]
  • Perceived Competence Scale [Time frame: Baseline, 6 months, 1- and 2 year follow-up.]
  • Psychological avoidance of stress - The psychological inflexibility in stress scale [Time frame: Baseline, every two weeks during 6 months, 1- and 2 year follow-up.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07079709 · 2025-01713-01 · 2023-01487

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗