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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-01487 | Other Grant/Funding Number | Forte |
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| Name | Class |
|---|---|
| Göteborg University | OTHER |
| Region Stockholm | OTHER_GOV |
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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:
Participants will participate in:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WCBT | Experimental | Work-focused Cognitive Behaviour Therapy |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The time horizon is two years prior to and five years after the date for inclusion in the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna C Finnes, PhD | Contact | +46 70 374 08 79 | anna.finnes@ki.se | |
| Anastasiya Zakrevska, MS | Contact | anastasiya.zakrevska@ki.se |
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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.
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| 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. |
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| 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. | 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". | Baseline, every two weeks during 6 months, 1- and 2-year follow-up. |
| Insomnia Severy Index (ISI) | 7 items. | 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". | 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 | 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 | Baseline, 6 months, 1- and 2 year follow-up. |
| Short Form Survey (SF-12) | Measures quality of life in eight domains by 12 items. | 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". | 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". | Baseline, every two weeks until 6 months, 1- and 2 year follow-up. |
| Perceived Competence Scale | 4 items. | 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. | Baseline, every two weeks during 6 months, 1- and 2 year follow-up. |
| Lifestyle habits | 12 items. | 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". | Only for the experimental group: 4 weeks after inclusion. |
| Working Alliance Inventory | 6 items. | Only for the experimental group: 4 weeks after baseline and 6 months post enrollment. |
| Client Satisfaction Questionnaire | 8 items. | 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. | 6 months post enrollment. |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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