Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Patient Health Questionnaire-9 score |
Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9). Minimum score is 0, maximum score is 27. Higher scores mean a worse outcome. |
Post-intervention (week 9) |
|
Secondary |
Physical activity |
Physical activity will be measured continuously by accelerometers and between baseline, post-intervention and follow-up (weeks 21 and 33) using the International Physical Activity Questionnaire (IPAQ). The minimum score is 0, and there is no maximum score. A higher score means more physical activity. |
Baseline assessment period (between weeks -1 and 0) to post-intervention (week 9), and follow-up (weeks 21 and 33) |
|
Secondary |
Aerobic capacity: CPET |
Aerobic capacity will be measured by the Cardiopulmonary Exercise Test (CPET), which is a physical fitness test. |
Baseline (between weeks -1 and 0) and post-intervention (week 9) |
|
Secondary |
Ecological Momentary Assessment |
Brief daily depressive symptoms will be recorded throughout the intervention, using abbreviated scales, through the Neureka smartphone app. Minimum score per item is -3, maximum score per item is 3. Higher scores mean a worse outcome. |
Baseline assessment period (between weeks -1 and 0) to post-intervention (week 9) |
|
Secondary |
Inflammatory response (cytokines) |
Inflammatory cytokines (pg/mL) will assess changes in inflammatory responses. |
Baseline (between weeks -1 and 0), mid-intervention (week 3), and post-intervention (week 9) |
|
Secondary |
Inflammatory response (genetic markers) |
Transcriptional markers (fold change) will assess changes in inflammatory responses. |
Baseline (between weeks -1 and 0), mid-intervention (week 3), and post-intervention (week 9) |
|
Secondary |
Inflammatory response (flow cytometry immunophenotype) |
Flow cytometry immunophenotype (% cells) will assess changes in inflammatory responses. |
Baseline (between weeks -1 and 0), mid-intervention (week 3), and post-intervention (week 9) |
|
Secondary |
Neuroendocrine system |
Cortisol over the day (pg/mL) will assess changes in the neuroendocrine system. |
Baseline (between weeks -1 and 0), mid-intervention (week 3), and post-intervention (week 9) |
|
Secondary |
Metabolic function |
Metabolic blood markers (mg/dl) will assess changes in metabolic function. |
Baseline (between weeks -1 and 0), mid-intervention (week 3), and post-intervention (week 9) |
|
Secondary |
Dopamine synthesis capacity |
In a subset of participants, dopamine synthesis capacity measured by 18F-DOPA PET will be taken. |
Baseline (between weeks -1 and 0) and post-intervention (week 4-9) |
|
Secondary |
Functional magnetic resonance imaging (fMRI) during cognitive tasks |
Participants will complete effort-based decision making and cognitive control tasks during fMRI. |
Baseline (between weeks -1 and 0) and post-intervention (week 9) |
|
Secondary |
Online cognitive tasks |
Participants will complete online cognitive tests of effort-based decision-making and cognitive control, alongside other tests of reward processing. |
During every other week of the intervention (weeks -1/0, week 1, week 3, week 5, week 7, week 9) |
|
Secondary |
Depression symptoms |
Depression symptoms will be measured by the Patient Health Questionnaire-9 (PHQ-9). Minimum score is 0, maximum score is 27. Higher scores mean a worse outcome. |
During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 8) |
|
Secondary |
Anxiety (GAD7 score) |
Anxiety will be measured by the Generalised Anxiety Disorder Assessment (GAD7). Minimum score is 0, maximum score is 21. Higher scores mean a worse outcome. |
During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 8, week 9) |
|
Secondary |
Anxiety (STAI score) |
Anxiety will be measured by the State-Trait Anxiety Inventory (STAI). Minimum score is 20, maximum score is 80. Higher scores mean a worse outcome. |
During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 8, week 9) |
|
Secondary |
Anhedonia (SHAPS score) |
Anhedonia will be measured by the Snaith-Hamilton Pleasure Scale (SHAPS). Minimum score is 14, maximum score is 56. Higher scores mean a better outcome. |
During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 8, week 9) |
|
Secondary |
Anhedonia (DARS score) |
Anhedonia will be measured by the Dimensional Anhedonia Rating Scale (DARS). Minimum score is 0, maximum score is 68. Higher scores mean a better outcome. |
During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 8, week 9) |
|
Secondary |
Apathy |
Apathy will be measured by the Apathy Evaluation Scale (AES). Minimum score is 18, maximum score is 72. Higher scores mean a worse outcome. |
During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 8, week 9) |
|
Secondary |
Fatigue |
Fatigue will be measured by the Fatigue Severity Scale (FSS). Minimum score is 9, maximum score is 63. Higher scores mean a worse outcome. |
During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 8, week 9) |
|
Secondary |
Cognitive impairment |
Cognitive impairment will be measured by the British Columbia Cognitive Complaints Inventory (BC-CCI). Minimum score is 0, maximum score is 18. Higher scores mean a worse outcome. |
During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 8, week 9) |
|
Secondary |
Self-efficacy |
Self-efficacy will be measured by the General Self-Efficacy Scale (GSES). Minimum score is 8, maximum score is 40. Higher scores mean a better outcome. |
During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 8, week 9) |
|
Secondary |
Self-esteem |
Self-esteem will be measured by the Single-Item Self-Esteem Scale (SISES). Minimum score is 1, maximum score is 7. Higher scores mean a better outcome. |
During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 8, week 9) |
|
Secondary |
Sleep quality |
Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI). Minimum score is 0, maximum score is 21. Higher scores mean a worse outcome. |
During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 8, week 9) |
|