Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Symptom level comparison |
Comparison of the intervention group and the control group regarding the number and severity of symptoms via the Bodily Distress Syndrome 25 (BDS-25) symptom checklist. This checklist asks 'have you been bothered by', followed by a list of 25 symptoms comprising the four symptom clusters of Bodily Distress Syndrome (BDS). The checklist measures symptoms on a 5-point rating scale from 0 ('not at all bothersome') to 4 ('a lot bothersome'). The sum score is calculated by adding the single item scores from the 25 items (ranging from 0 to 100, where a higher score implies greater bother from symptoms). |
At 3- and 12 months follow-up |
|
Other |
Health anxiety |
Comparison of the intervention group and the control group regarding health anxiety using Whiteley-6-R index. The Whiteley indices measure health anxiety. The Whiteley-6-R, which excludes two items on somatic symptoms while adding one item on obsessive rumination has been found to have better psychometric properties. The Whiteley-6-R has a total score range of 0-24, where a higher score indicates a higher level of health anxiety. |
At 3- and 12 months follow-up |
|
Other |
Overall physical health |
Overall health is assessed with a single item from the 36-item Short-Form Health Survey (SF-36), estimating self-perceived health on a 5-point rating scale from 'excellent' to 'poor'. Higher score on this item indicates poorer health. |
At 3- and 12 months follow-up |
|
Primary |
Healthcare services utilization (i.e. direct costs) |
Comparison of healthcare services utilization (of secondary and tertiary sector care) by the intervention group, compared to the control group. Data shall be drawn from Danish national and regional healthcare service registers. |
12 months prior to randomization and 12 months' follow-up |
|
Primary |
Cost-effectiveness analysis (CEA) (direct and indirect costs) |
Cost-effectiveness analysis (CEA), comparing the intervention and the control group from both a healthcare (direct costs) and a societal perspective (indirect costs) combining data on incremental costs and incremental effects; adjusted for differences in mean utility score and mean costs at baseline (1 year prior to randomization). |
12 months prior to randomization and 12 months' follow-up |
|
Secondary |
Public expenses associated with occupational status and social benefits (i.e. indirect costs) |
Comparison of expenses associated with occupational status and social benefits of the intervention group, compared to the control group. Data shall be drawn from the Danish Register-based Evaluation of Marginalisation (DREAM) database. |
12 months prior to randomization and 12 months' follow-up |
|
Secondary |
Effectiveness: Health-related quality of life (via the the Short Form 36 Total Score) |
Difference between the intervention group and the control group in health-related quality of life, measured by the Total Score of the Short Form 36 (SF-36). The SF-36 is summarized in a score on a scale from 0-100 where 100 is the best possible health-related quality of life. |
Baseline, 3- and 12-months' follow-up |
|
Secondary |
Effectiveness: Perceived physical health |
Difference between the intervention group and the control group in perceived physical health, measured by an aggregate score of the 'physical functioning', 'bodily pain' and 'vitality' subscales of the Short Form-36. This aggregate score has a minimum of 15 and a maximum of 65 and a higher score indicates better physical health. This outcome encompasses physical domains which have been previously found to be affected in functional somatic disorders. |
Baseline, 3- and 12-months' follow-up |
|
Secondary |
Effectiveness (via Patient-reported Clinical Global Improvement) |
Patients evaluate their overall health as "much worse", " somewhat worse ", "about the same", "somewhat better" or "much better" compared to 1 year prior, at 3 and 12 months after randomization. Specifically, we shall compare the share of patients in the intervention group vs. the control group who evaluate their overall health as "somewhat better" or "much better". |
At 3- and 12-months' follow-up |
|