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

Table 1 Outcome measures

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
Safety	Ophthalmological examination	X									X
Compliance	Participant-report compliance			X	X	X	X
Compliance	Light meter		X				X				X

ISSN: 1471-244X