Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones– the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial

Table 1 Outcome assessment overview- The MONARCA II trial

	SCAN ^a	Baseline characteristics	Rating scales ^b	Questionnaires ^c	Clinical information ^d	Biological samples ^e
Inclusion and baseline	x	x	X	X	x	X
Randomization (2:1) to using a smartphone with the MONARCA II system (the intervention group) or to use a smartphone for normal communicative purposes (the control group)
4 weeks			X	X	x	X
3 months			X	X	x	X
6 months			X	X	x	x
9 months			X	X	x	x

^aSchedules for Clinical Assessment in Neuropsychiatry interview (37).
^bDepressive symptoms according to Hamilton Depression Rating Scale 17-item (29), manic symptoms according to Young Mania Rating Scale (30) and psychosocial functioning according to Functioning Assessment Short Test (FAST) (38).
^cPerceived stress according to Cohen's Perceived Stress scale (39), quality of life according to WHO Quality of Life-BREF (WHOQOL-BREF) (40), self-rated depressive symptoms according to Becks Depressive Inventory (BDI) (41–43), self-rated manic symptoms according to Altman Self Rating scale for Mania (ASRM) (44), recovery according to Recovery Assessment Scale (45), empowerment according to Rogers empowerment scale (47) and medicine adherence according to Medicine Adherence Rating Scale (MARS) (46).
^dNumber of affective episodes, number of contacts to clinicians and psychiatric emergency rooms, number of hospitalizations, medication status etc.
^eBlood samples is obtained by venipuncture, 90 ml in total and a freshly voided spot urine sample is collected.

ISSN: 1471-244X