Table 2.
Schedule of assessments
| Measurement instruments | Assessment target | Time pointsa | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | Intervention period | Follow-up | |||||||
| < T0 | T1 | T2 | T4 | T6 | T7 | T8 | T10 | ||
| Primary and secondary outcomes | |||||||||
| HDRS17 | Depressive symptoms (clinician-rated) | x | x | x | x | x | x | x | |
| IDS-SR | Depressive symptoms (patient-rated) | x | x | x | x | x | x | x | |
| CGI | Overall depression severity and change | x | x | x | x | x | x | x | |
| SHAPS | Hedonic capacity | x | x | x | |||||
| BSS | Suicidal ideation | x | x | x | |||||
| AMT | Autobiographical memory | x | x | x | |||||
| EQ-5D-5 L | Health related quality of life | x | x | x | |||||
| QPE | Psychotic experiences | x | x | x | x | ||||
| DSS | Dissociative features | x | x | x | x | ||||
| ISDI | Sleep disturbance | x | x | x | x | ||||
| SAFTEE | Side effects in any organ system | x | x | x | x | x | x | x | x |
| Physical examination | Heart rate, blood pressure, weight | x | x | x | x | x | x | x | x |
| Blood collection (I) | Liver enzyme levels | x | x | ||||||
| Demographics questionnaire | Demographics | x | |||||||
| DM-TRD | Treatment-resistance | x | |||||||
| NEO-FFI | Neuroticism | x | |||||||
| CEQ | Credibility and expectancy of intervention | x | |||||||
| Additional outcomes | |||||||||
| BAI | Anxiety symptoms | x | x | x | |||||
| GCPS | Pain | x | x | x | |||||
| FTND | Nicotine dependence | x | x | x | |||||
| Blood collection (II) | Biomarkers, gene expression, pharmacokinetics, CYP enzymes | x | x | x | x | ||||
| Urine collection | Biomarkers | x | x | x | |||||
| ZGV | Health care consumption | x | x | x | |||||
aNumber illustrates number of weeks after baseline. AMT Autobiographical Memory Test, BAI Beck Anxiety Inventory, BSS Beck Scale for Suicide Ideation, CEQ Credibility/expectancy questionnaire, CGI Clinical Global Impression, CYP Cytochrome P450, DM-TRD Dutch Measure for quantification of Treatment Resistance in Depression, DSS Dissociation Tension Scale, EQ-5D-5 L EuroQol 5D, FTND Fagerström Test for Nicotine Dependence, GCPS Graded Chronic Pain Scale, HDRS17 Hamilton Depression Rating Scale, IDS-SR Inventory of Depressive Symptomatology, ISDI Iowa Sleep Disturbance Inventory, NEO-FFI NEO Five-Factor Inventory, QPE Questionnaire for Psychotic Experiences, SAFTEE Systematic Assessment for Treatment Emergent Events, SHAPS Snaith Hamilton Anhedonia and Pleasure Scale, ZGV Health care use questionnaire (Zorggebruik Vragenlijst) – adapted from the TicP [63] to the context of the current study