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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
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 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.
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.
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.
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.
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.
Insomnia Severy Index (ISI)
7 items.
Time frame: 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".
Time frame: 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
Time frame: 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
Time frame: Baseline, 6 months, 1- and 2 year follow-up.
Short Form Survey (SF-12)
Measures quality of life in eight domains by 12 items.
Time frame: 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".
Time frame: 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".
Time frame: Baseline, every two weeks until 6 months, 1- and 2 year follow-up.
Perceived Competence Scale
4 items.
Time frame: 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.
Time frame: Baseline, every two weeks during 6 months, 1- and 2 year follow-up.
Lifestyle habits
12 items.
Time frame: 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".
Time frame: Only for the experimental group: 4 weeks after inclusion.
Working Alliance Inventory
6 items.
Time frame: Only for the experimental group: 4 weeks after baseline and 6 months post enrollment.
Client Satisfaction Questionnaire
8 items.
Time frame: 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.
Time frame: 6 months post enrollment.
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