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Table 1 Outcome measures

From: Light therapy for better mood and insulin sensitivity in patients with major depression and type 2 diabetes: a randomised, double-blind, parallel-arm trial

Weeks relative to start intervention (T)   0 1 2 3 4 5 6 7 8
Visits S 1     2     3
Telephone contact    1 2 3    4   
Run-in phase X-es X-es         
Intervention phase    X-es X-es X-es X-es     
Follow-up phase        X-es X-es X-es X-es
Participant characteristics Psychiatric diagnosis, seasonality, chronotype, sleep apnoea, medical history, current medication, biochemical blood tests, sociodemographic factors X X         
Psychometrical measures Depressive symptoms   X X X X X     X
Anxiety symptoms   X X X X X     X
Diabetes-related distress   X     X     X
Quality of life, disability   X     X     X
Glucometabolic measures Insulin sensitivity   X     X     
HbA1c level   X     X     X
Fasting glucose level   X     X     X
Hypoglycaemic events   X X X X X     X
Circadian mediating factors Diurnal HPA axis activity   X     X     X
Objective sleep   X     X     X
Subjective sleep   X X X X X     X
Other factors Body weight, body mass index, waist-hip ratio, body composition   X     X     X
Physical activity   X     X     X
Autonomic nervous system function   X     X     X
Safety Adverse effects   X X X X X     X
Ophthalmological examination X          X
Compliance Participant-report compliance    X X X X     
Light meter   X     X     X
  1. Abbreviations: S screening, HPA hypothalamic-pituitary-adrenal