Table 2.
Primary and secondary outcome measures for all participants; weeks 0–26
| Evaluations | Enrollment | Randomization and interventions’ start | Follow-ups | |
|---|---|---|---|---|
| Week 0 | Week 1 | Week 12 | Week 26 | |
| Primary outcome: depression | ||||
| HRSD-17 | ✓ | ✓ | ✓ | |
| Secondary outcome: executive function | ||||
| WAIS-IV–Digit Span | ✓ | ✓ | ✓ | |
| D-KEFS Verbal Fluency Test | ✓ | ✓ | ✓ | |
| California Verbal Learning Test-II, Short form | ✓ | ✓ | ✓ | |
| Rey-Osterrieth Complex Figure–Copy Trial | ✓ | ✓ | ✓ | |
| D-KEFS Color Word Test Conditions 1–3 | ✓ | ✓ | ✓ | |
| Exploratory and screening measures: | ||||
| To be administered by examiner: | ||||
| MINI-COG | ✓ | |||
| PHQ-9 | ✓ | ✓ | ✓ | |
| ATHF | ✓ | |||
| Mini International Neuropsychiatric Interview | ✓ | |||
| CIRS-G | ✓ | |||
| CGI (Severity portion only) | ✓ | |||
| CGI (entire scale) | ✓ | ✓ | ||
| Athens Insomnia Scale | ✓ | ✓ | ✓ | |
| MoCA (London only) | ✓ | ✓ | ||
| WAIS-IV–Test of premorbid functioning | ✓ | |||
| To be completed by participant: | ||||
| FES-I (London only) | ✓ | ✓ | ✓ | |
| PHQ-9 | ✓ | ✓ | ✓ | |
| GAD-7 | ✓ | ✓ | ✓ | |
| GAI | ✓ | ✓ | ✓ | |
| WHO DAS 2.0 | ✓ | ✓ | ✓ | |
| EQ-5D-5 L | ✓ | ✓ | ✓ | |
| TTO | ✓ | ✓ | ✓ | |
| TSES | ✓ | ✓ | ✓ | |
| PCI | ✓ | ✓ | ||
| SPWB | ✓ | ✓ | ✓ | |
| FFMQ | ✓ | ✓ | ✓ | |
| Likert scale | ✓ | |||
| Participant-reported side effects | ✓ | ✓ | ||
| Other data collected: | ||||
| Assessment of eligibility | ✓ | |||
| Informed consent | ✓ | |||
| rs-fMRI/MRI/sMRI (only if enrolled in MRI sub-study) | ✓ | ✓ | ||
| Demographics (including medications) | ✓ | |||
| Changes in demographics (including medications) | ✓ | ✓ | ||
| Acti-watcha (Montreal only) | ✓ | ✓ | ||
| Gait (London only) | ✓ | ✓ | ✓ | |
| Blood draw (London only) | ✓ | ✓ | ||
athis measure is administered 2 weeks prior to week 0 and 2 weeks following week 12
MRI magnetic resonance imaging, rs-fMRI resting state functional magnetic resonance imaging, sMRI structural magnetic resonance imaging, PHQ-9 Patient Health Questionnaire 9-item, ATHF Antidepressant Treatment History Form, CIRS-G Cumulative Illness Rating Scale – Geriatric, HRSD-17 Hamilton Rating Scale for Depression 17-item, CGI Clinical Global Impression, MoCA Montreal Cognitive Assessment, FES-I Falls Efficacy Scale – International, GAD-7 Generalized Anxiety Disorder 7-item, GAI Geriatric Anxiety Inventory, WHO DAS 2.0 World Health Organization Disability Assessment Schedule 2.0, TTO Time Trade Off, TSES Toronto Side Effects Scale, PCI Phenomenology of Consciousness Inventory, SPWB Ryff’s Scales of Psychological Well-Being, FFMQ Five Facet Mindfulness Questionnaire, WAIS Wechsler Adult Intelligence Scale, D-KEFS Delis-Kaplan Executive Function System, MINI Mini International Neuropsychiatric Interview