Table 3.
Clinical neuropsychological assessments
| Assessment | Description/Purpose | Outcome Value | Timepoint of Collection |
|---|---|---|---|
| MINIg | Confirm diagnosis of MDE [68] | Yes/No | Baseline |
| ATHFg | History of antidepressant use and resistance [69] | Type, dosage | Baseline |
| CONMEDg | Current medication use [70] | Yes (type, dosage)/No | Baseline |
| HRSD-17e,g | Severity of depression [71] | Score range: 0–53 (0–7 no depression; 8–13, mild depression; 14–18 moderate depression; 19–22, severe depression; ≥ 23 very severe depression) | Baseline, end of week 2 and 4 (and final week of additional treatment for non-remittersd); beginning of maintenance weeks 1–13, 15, 17, 19, 21, and final visit (week 24) |
| MADRSf,g | Severity of depression [72] | Score range: 0–60 (0–6, absence of symptoms; 7–19, mild depression; 20–34, moderate depression; 35–60, severe depression) | Baseline, end of week 4 (and final week of additional treatment for non-remittersd); final visit (week 24) |
| SRRSg | Depression-related psychomotor impairments [73] | Score range: 0–60 | Baseline, end of week 4 (and final week of additional treatment for non-remittersd); final visit (week 24) |
| YMRSf,g | Presence and severity of manic or hypomanic symptoms [74, 75] | Score range: 0–60 (2, euthymia; 3, depression; 12, mania) | Baseline, end of week 2 and 4 (and final week of additional treatment for non-remittersd); beginning of maintenance weeks 1–13, 15, 17, 19, 21, and final visit (week 24) |
| C-SSRSa,g | Quantify suicidal ideation and behaviour [76] | 5 items rated yes or no, with additional clarifying questions | Baseline and end of weeks 1–4 (and both weeks of additional treatment for non-remittersd); beginning of maintenance weeks 1–13, 15, 17, 19, 21, and final visit (week 24) |
| MMSEb,g | Presence of dementia [77] | Score range: 0–30 (30–26, could be normal; 25–20, mild; 19–10, moderate; 9–0, severe) | Screening visit |
| Physician consultationg | Verify general suitability for TBS; clinical oversight | N/A | Before participants consent to the study, end of week 4 (or final week of additional treatment for non-remittersd), end of maintenance, and/or as needed throughout the study |
| QIDS-SR16f | Depressive symptoms [78] | Score range: 0–27 (0–5, no depression; 6–10, mild depression; 11–15 moderate depression; 16–20 severe depression; ≥ 21, very severe depression) | Baseline, end of weeks 1–4 (and both weeks of additional treatment for non-remittersd); beginning of maintenance weeks 1–13, 15, 17, 19, 21, and final visit (week 24) |
| ASRMf | Manic or hypomanic symptoms [79] | Score range: 0–20 (0–5, low probability of mania; ≥ 6, high probability of manic or hypomanic condition) | Baseline, end of weeks 1–4 (and both weeks of additional treatment for non-remittersd) |
| BAIf | Severity of anxiety [80] | Score range: 0–63 (0–21, low anxiety; 22–35, moderate anxiety; ≥ 36 potentially concerning levels of anxiety) | Baseline, end of weeks 1–4 (and both weeks of additional treatment for non-remittersd); beginning of maintenance weeks 1–13, 15, 17, 19, 21, and final visit (week 24) |
| BSS | Suicidal ideations and behaviors [81] | Score range: 0–38 (higher scores indicate higher suicide risk) | Baseline, end of weeks 1–4 (and both weeks of additional treatment for non-remittersd); beginning of maintenance weeks 1–13, 15, 17, 19, 21, and final visit (week 24) |
| Q-LES-Q-SFf | Enjoyment and satisfaction in routine activities [82] | Score range: 14–70. Raw scores are transformed into a percentage maximum possible score | Baseline, at the end of week 4 (and final week of additional treatment for non-remittersd); final visit (week 24) |
| WEMWBSf | Overview of mental well-being [83] | Score range: 7–35 (higher scores indicate higher positive mental wellbeing) | Baseline, at the end of week 4 (and final week of additional treatment for non-remittersd); final visit (week 24) |
| PSQI | Quality and pattern of sleep prior to the start of treatment [84] | Score range: 0–21 (0, no difficulty; 21 severe difficulty in all areas) | Baseline, at the end of week 4 (and final week of additional treatment for non-remittersd); final visit (week 24) |
| LSEQ | Sleep quality [85] | Score range: 0–100 (visual analog scale) | Baseline, end of weeks 1–4 (and both weeks of additional treatment for non-remittersd); beginning of maintenance weeks 1–13, 15, 17, 19, 21, and final visit (week 24) |
| PCL-5fc | Post-traumatic stress disorder symptoms [86] | Score range: 0–80 (scored pre- post treatment; 5–10 point change, reliable change not due to chance; 10–20 point change, clinically significant change) | Baseline, end of weeks 1–4 (and both weeks of additional treatment for non-remittersd); beginning of maintenance weeks 1–13, 15, 17, 19, 21, and final visit (week 24) |
| TSSS | To assess rate of sleepiness in the moment [87] | Score range: 1–7 | Baseline, end of week 4 (and final week of additional treatment for non-remittersd); final visit (week 24) |
| IPAQ-SF | To assess levels of physical activity and sedentarism [88] | Continuous data: Duration (e.g., minutes) and frequency (e.g., days) of activities performed and multiple of resting metabolic rates (e.g., energy expenditure). Categorical data: 1) inactive, 2) minimally active, and 3) highly active | Baseline, end of week 4 (and final week of additional treatment for non-remittersd); final visit (week 24) |
ASRM Altman Self-Rating Mania Scale, ATHF Antidepressant Treatment History Form, BAI Beck Anxiety Inventory, BSS Beck Scale for Suicidal Ideation, CONMED Concomitant Medication Log, C-SSRS Columbia-Suicide Severity Rating Scale, HRSD-17 Hamilton Rating Scale for Depression 17-item, IPAQ-SF International Physical Activity Questionnaire—Short Form, LSEQ Leeds Sleep Evaluation Questionnaire, MADRS Montgomery–Asberg Depression Rating Scale, MINI Mini International Neuropsychiatric Interview, MMSE Mini Mental State Evaluation, PCL-5 Posttraumatic Stress Disorder Checklist for DSM-5, PSQI Pittsburgh Sleep Quality Index, QIDS-SR16 16-item Quick Inventory of Depressive Symptoms –self report, Q-LES-Q-SF Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form, SRRS Salpêtrière Retardation Rating Scale, TSSS The Stanford Sleepiness Scale, WEMWBS Short Warwick Edinburgh Mental Well-Being Scale, YMRS Young Mania Rating Scale
aAfter baseline assessment, only administered if BSS shows active suicidal ideation
bAdministered only for participants who are > 65 years-old
cAdministered only if comorbid post-traumatic stress disorder diagnosis
dNon-remitters: participants who do not demonstrate a score of ≤ 7 (i.e., no depression) in the 17-item Hamilton Depression Rating Scale (HRSD-17)
ePrimary outcome measure
fSecondary outcome measure
gOutcome measures that are administered by trained personnel