Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Area Under the health and disability Curve at 6 months |
The 'area under the curve' for health and disability is based on the 36-item self-report World Health Organisation Disability Assessment Schedule (WHODAS 2.0). The WHODAS 2.0 captures the level of functioning in six domains of life: Cognition, Mobility, Self-care, Getting along, Life activities, Participation. Possible total scores of the items across all domains range 0 - 100. Lower scores indicate less disability. |
baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months |
|
| Secondary |
Area Under the health and disability Curve at 12 months |
The 'area under the curve' for health and disability is based on the 36-item self-report World Health Organisation Disability Assessment Schedule (WHODAS 2.0). The WHODAS 2.0 captures the level of functioning in six domains of life: Cognition, Mobility, Self-care, Getting along, Life activities, Participation. Possible total scores of the items across all domains range 0 - 100. Lower scores indicate less disability. |
baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months |
|
| Secondary |
Change from baseline in severity of anxiety symptoms at post-treatment |
Severity of anxiety-related disorder, measured with the following disorder-specific severity questionnaires: the 24-item Liebowitz Social Anxiety Scale self-report version, the 7-item Panic Disorder Severity Scale self-report version, the 15-item Fear Questionnaire, the 16-item Penn State Worry Questionnaire, the 10-item Yale-Brown Obsessive Compulsive Scale self-report version, the 20-item PTSD checklist for the DSM-5, or the 14-item Whitely Index. Higher scores indicate higher symptom severity. Z-scores will be calculated from individual scores for group-level analyses. |
baseline and 3 or 6 months |
|
| Secondary |
Change from baseline in severity of anxiety symptoms at 3 months |
Severity of anxiety-related disorder, measured with the following disorder-specific severity questionnaires: the 24-item Liebowitz Social Anxiety Scale self-report version, the 7-item Panic Disorder Severity Scale self-report version, the 15-item Fear Questionnaire, the 16-item Penn State Worry Questionnaire, the 10-item Yale-Brown Obsessive Compulsive Scale self-report version, the 20-item PTSD checklist for the DSM-5, or the 14-item Whitely Index. Higher scores indicate higher symptom severity. Z-scores will be calculated from individual scores for group-level analyses. |
baseline and 3 months |
|
| Secondary |
Change from baseline in severity of anxiety symptoms at 12 months |
Severity of anxiety-related disorder, measured with the following disorder-specific severity questionnaires: the 24-item Liebowitz Social Anxiety Scale self-report version, the 7-item Panic Disorder Severity Scale self-report version, the 15-item Fear Questionnaire, the 16-item Penn State Worry Questionnaire, the 10-item Yale-Brown Obsessive Compulsive Scale self-report version, the 20-item PTSD checklist for the DSM-5, or the 14-item Whitely Index. Higher scores indicate higher symptom severity. Z-scores will be calculated from individual scores for group-level analyses. |
baseline and 12 months |
|
| Secondary |
Change from baseline in severity of depressive symptoms at post-treatment |
Severity of depressive symptoms are measured with the 30-item Inventory for Depressive Symptomatology self-report questionnaire. Higher scores indicate higher symptom severity. |
baseline and 3 or 6 months |
|
| Secondary |
Change from baseline in severity of depressive symptoms at 3 months |
Severity of depressive symptoms are measured with the 30-item Inventory for Depressive Symptomatology self-report questionnaire. Higher scores indicate higher symptom severity. |
baseline and 3 months |
|
| Secondary |
Change from baseline in severity of depressive symptoms at 12 months |
Severity of depressive symptoms are measured with the 30-item Inventory for Depressive Symptomatology self-report questionnaire. Higher scores indicate higher symptom severity. |
baseline and 12 months |
|
| Secondary |
Remission rates from anxiety-related disorder at post-treatment |
Remission of diagnoses of anxiety-related disorders is assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5, Dutch version 1.1 (Overbeek & Schruers, 2019). |
3 or 6 months |
|
| Secondary |
Remission rates from anxiety-related disorder at 12 months |
Remission of diagnoses of anxiety-related disorders is assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5, Dutch version 1.1 (Overbeek & Schruers, 2019). |
12 months |
|
| Secondary |
New-onset anxiety-related or depressive disorder post-treatment |
The new onset of anxiety-related or depressive disorder between baseline and post-treatment is assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5, Dutch version 1.1 (Overbeek & Schruers, 2019) |
baseline, 3 or 6 months |
|
| Secondary |
New-onset anxiety-related or depressive disorder at 12 months |
The new onset of anxiety-related or depressive disorder between baseline and post-treatment is assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5, Dutch version 1.1 (Overbeek & Schruers, 2019) |
12 months |
|
| Secondary |
Productivity costs over 12 months |
Productivity losses are assessed using the iMTA Productivity Cost Questionnaire (iPCQ). The iPCQ is a 12-item self-report questionnaire including three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work in the past 3 months. |
3months, 6months, 12 months |
|
| Secondary |
Medical costs over 12 months |
Medical costs from a mental health care perspective are assessed using the iMTA Medical Cost Questionnaire (iMCQ). The iMCQ is a 23-item self-report questionnaire, which apart from some general questions include questions on medical consumption from different healthcare providers in the past 3 months. |
3months, 6months, 12 months |
|
| Secondary |
Change from baseline in health-related quality of life over 12 months |
Quality of life is measured using the EQ-5D-5L. The EQ-5D-5L scores (reflecting the level of perceived problems on the dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are used to calculate utilities using the Dutch tariff. Quality Adjusted Life Years are calculated using linear interpolation between time points. Higher QALY scores indicate more improvement in quality of life. |
baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months |
|
| Secondary |
Drop-out rates at post-treatment |
Percentage of patiënts who missed more than 25% of CBT sessions. |
3 or 6 months |
|
| Secondary |
Patient satisfaction at post-treatment |
The 3-item CSQ-3 include the CSQScales® items most salient to the measurement of The three items of the CSQ are the main items for measuring overall satisfaction of health and human services. Each item on the CSQ-3 is scored from 1 (low satisfaction) to 4 (high satisfaction), possible total scores ranging 3-12. |
3 or 6 months |
|
