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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKarolinska Institutet

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Standard Care (in control arm)

    Other intervention

    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.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: WCBTExperimental treatment 1 intervention
Group B: Standard CareActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Sick leave

Register data MiDAS from the Swedish Social Insurance Agency reflecting sickness absence - start- and stop date, both episodes and monthly panels for sickness benefit and activity compensation, diagnose, employment/occupation and paid out compensation.

Time frame
The time horizon is two years prior to and five years after the date for inclusion in the study.
2

Current work status and sick leave

Participants will respond to the questions "Have you worked during the past week?" and "Are you currently on sick leave?". If yes, participants reports the proportion (25, 50, 75 or 100%) related to normal working hours.

Time frame
Baseline, every two weeks until 6 months, 1- and 2-year follow-up.
3

Shirom-Melamed Burnout Questionnaire (SMBQ-6)

Six items. Labels have been added to the original response scale. The participant can rate whether they experience the symptom "never", "almost never", "rarely", "sometimes" "fairy often", "almost always", "always".

Time frame
Baseline, every two weeks during 6 months, 1- and 2-year follow-up.
4

Insomnia Severy Index (ISI)

7 items.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Göteborg University

Collaborator

Region Stockholm

Collaborator

This trial is not recruiting at the moment. You can still explore other options: