Clinical BurnoutReWorkNCT07079709
Returning to Work After Stress-Related Sick Leave: An Effectiveness Trial of Work-Focused Treatments in Primary Care
A study testing Workfocused CBT in people with Clinical Burnout and Exhaustion Disorder, run by Karolinska Institutet.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Clinical Burnout, Exhaustion Disorder, Adjustment Disorder With Work Inhibition
- What is being tested?
- Workfocused CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Dec 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Anastasiya Zakrevska, MS contact
About this study
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
- Being tested
- Workfocused CBT, Standard Care (in control arm)
- Keywords
- Work-focused CBT, WCBT, Sick leave, Clinical burnout, Cognitive behaviour therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workfocused CBTBehavioural
Also called WCBT
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
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.
| Study group | Role | What they receive |
|---|---|---|
| WCBT | Experimental | Work-focused Cognitive Behaviour Therapy Receives: 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. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: WAI: Baseline, 6 months, 1- and 2 year follow-up. WAS: every two weeks during the first six months.
Secondary outcomes (17)
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.
Measured: 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
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.
Measured: Baseline, every two weeks until 6 months, 1- and 2-year follow-up.
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".
Measured: Baseline, every two weeks during 6 months, 1- and 2-year follow-up.
Insomnia Severy Index (ISI)
7 items.
Measured: Baseline, 6 months, 1- and 2 year follow-up.
Checklist Individual Strength
This 20-item scale measures symptoms of fatigue. The participant is asked to rate statements and if he/she felt it during the last two weeks. Examples of questions are: "I feel tired", "I think I do a lot in a day", etc. The statements are rated on a 7-point scale with added labels as follows: "never true", "very rarely true", "rarely true", "sometimes true", "quite often true", "very often true", and "always true".
Measured: Baseline, 6 months, 1- and 2 year follow-up.
Patient Health Questionnaire (PHQ-9)
Measures depressive symptoms. The occurrence of symptoms during the past two weeks is originally rated on a four-point scale labeled "not at all" to "nearly every day". To capture a more accurate estimation, an additional option category was added following a newly published study (see ref below). In addition, the highest option was adjusted from "nearly every day" to "every day" due to a high similarity between two options. The final response scale had the following five categories: "Not at all", "once or twice", "several days", "more than half the days", and "every day". The patient also rated how difficult those symptoms have made it for the participant to handle activities in everyday life.
Ref: Makowski, D., Te, A., Neves, A., \& Chen, S. A. (2024). Measuring Depression and Anxiety with 4 items? Adaptation of the PHQ-4 to increase its Sensitivity to Subclinical Variability. PsyArXiv. https://doi.org/10.31234/osf.io/436np
Measured: Baseline, 6 months, 1- and 2 year follow-up.
Generalized Anxiety Disorder Assessment (GAD-7)
7 items. The occurrence of symptoms during the past two weeks is originally rated on a four-point scale labeled "not at all" to "nearly every day". To capture a more accurate estimation, an additional option category was added following a newly published study (see ref below). In addition, the highest option was adjusted from "nearly every day" to "every day" due to a high similarity between two options. The final response scale had the following five categories: "Not at all", "once or twice", "several days", "more than half the days", and "every day".
Ref: Makowski, D., Te, A., Neves, A., \& Chen, S. A. (2024). Measuring Depression and Anxiety with 4 items? Adaptation of the PHQ-4 to increase its Sensitivity to Subclinical Variability. PsyArXiv. https://doi.org/10.31234/osf.io/436np
Measured: Baseline, 6 months, 1- and 2 year follow-up.
Short Form Survey (SF-12)
Measures quality of life in eight domains by 12 items.
Measured: Baseline, 6 months, 1- and 2 year follow-up.
Return to work Self-efficacy Scale
Nine items from the original 11-item questionnaire were chosen, and items 3 and 11 were rewritten in order to achieve consistency in the wording. Item 2 was removed due to the overlap with item 4. Item 6 was removed since the question did not concern self-efficacy. Answers are rated on a 6-point labeled scale from "totally disagree" to "totally agree".
Measured: Baseline, 6 months, 1- and 2 year follow-up.
Work Phobia Questionnaire - short version
Items 1, 2, 7, 9, 13 from the original questionnaire were chosen. In addition, labels were added to the six-point scale: "strongly disagree", "mostly disagree", "somewhat disagree", "somewhat agree", "mostly agree", "strongly agree".
Measured: Baseline, every two weeks until 6 months, 1- and 2 year follow-up.
Perceived Competence Scale
4 items.
Measured: Baseline, 6 months, 1- and 2 year follow-up.
Psychological avoidance of stress - The psychological inflexibility in stress scale
A subscale concering aviodance from the psychological inflexibility in pain scale was modified to measure aviodance related to stress. The word "pain" from the original scale was replaced by "stress". 8 items.
Measured: Baseline, every two weeks during 6 months, 1- and 2 year follow-up.
Lifestyle habits
12 items.
Measured: Baseline, 6 months, 1- and 2 year follow-up.
Expactancy of improvement/Credibility
The questions are inspired from the questionnaire "Credibility/Expectancy Questionnaire" but are designed for this study. 3 items: (I) how relevant the treatment seems at the moment, from "not at all" to "completely", (II) prediction of how the treatment will affect symptoms and (III) work ability, from "it will become much worse" to "it will be much better".
Measured: Only for the experimental group: 4 weeks after inclusion.
Working Alliance Inventory
6 items.
Measured: Only for the experimental group: 4 weeks after baseline and 6 months post enrollment.
Client Satisfaction Questionnaire
8 items.
Measured: Only for the intervention group: 6 months after enrollment.
Negative Effects Questionnaire - short version
Five questions are used from the original instrument, the Negative Effects Questionnaire. Included items: (I) the perception of being less competent, (II) worsening of the problem, (III) thoughts that the issue would not get better, (IV) feeling of shame due to having the treatment, (V) and development of dependency towards the therapist. If any of the statesmen were experienced, the participant rates how much it affects him/her on a scale from "not at all" to "extremely" and if it was caused by the treatment or other circumstances.
Measured: 6 months post enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical BurnoutStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University, Region Stockholm
- Responsible party
- Principal investigator, Anna Finnes, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079709
- Sponsor's protocol ID
- 2025-01713-01
- Other IDs
- 2023-01487, 2023, 2025
- Acronym
- ReWork
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Returning to Work After Stress-Related Sick Leave: An Effectiveness Trial of Work-Focused Treatments in Primary Care
- ClinicalTrials.gov ID
- NCT07079709
- Acronym / sponsor ID
- ReWork / 2025-01713-01
- Keywords
- Work-focused CBT, WCBT, Sick leave, Clinical burnout, Cognitive behaviour therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Göteborg University, Region Stockholm
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2034 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| WCBT | Experimental | Behavioral: Workfocused CBTWork-focused Cognitive Behaviour Therapy |
| Standard Care | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Workfocused CBTAlso: WCBTIn 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. | Behavioural | WCBT |
| 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. | Other | Standard Care |
Primary outcome
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.
Self-reported change in work ability. WAI consists of 7 domains, 11 questions in total. WAS is the first question of WAI.
17 secondary outcomes
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.
Lifestyle habits
Time frame: Baseline, 6 months, 1- and 2 year follow-up.
Expactancy of improvement/Credibility
Time frame: Only for the experimental group: 4 weeks after inclusion.
Working Alliance Inventory
Time frame: Only for the experimental group: 4 weeks after baseline and 6 months post enrollment.
Client Satisfaction Questionnaire
Time frame: Only for the intervention group: 6 months after enrollment.
Negative Effects Questionnaire - short version
Time frame: 6 months post enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Clinical Burnout
Recruiting
A Study Of Resilience And Mental Well-Being Through Breathing Practice For Clinical Care Professionals
Burnout, Healthcare Workers, Breathing Exercises
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Recruiting
Comparing ACT, Recuperation, and ACT Plus Vocational Support for Clinical Burnout
Burnout, Clinical Burnout
Active, not recruiting
Feasibility and Acceptability of the Unified Protocol for Burnout
Clinical Burnout
Recruiting
Ambient AI Scribe (Voa Health) in Outpatient Clinics: Draft Notes, Documentation Burden, and Well-Being
Burnout, Professionals, Medical Records Systems, Computerized
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anastasiya Zakrevska, MS contact
Questions about this trial
What is this clinical trial studying?
A study testing Workfocused CBT in people with Clinical Burnout and Exhaustion Disorder, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna C Finnes, PhD (+46 70 374 08 79, anna.finnes@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.