The Beyond Ageing Project Phase 2 - a double-blind, selective prevention, randomised, placebo-controlled trial of omega-3 fatty acids and sertraline in an older age cohort at risk for depression: study protocol for a randomized controlled trial

Table 2 Complete list of outcome measures and assessments

	Recruitment	Screening/baseline assessment	Visit 1	Visit 2	Monitoring calls	Three month assessment	12 month assessment	Early termination
Week(s):	−6 to -2	−2 to 0	4	8	1, 2, 6, 10 then monthly	12	52
Informed consent	X
Inclusion/exclusion criteria		X
Self-report (includes PHQ-9, K-10, GAD-7, WHODAS, PSQI)		X				X	X
Medical assessment (includes semi-structured psychiatric interview)		X				X	X	X
Neuropsychological assessment (includes CANTAB RT and PAL, Trailmaking A & B, RAVLT, DKEFS, COWAT)		X				X	X
MRS assessment		X				X	X
Clinical review and medication collection and return		X^a	X^a	X^a		X^b
Compliance (capsule count)			X	X	X	X	X
Compliance (fatty acid blood analysis)		X				X	X
Monitor for depressive symptoms and suicidality		X	X	X	X	X	X	X
Monitor adverse events			X	X	X	X	X	X
Mail out of medications	Months seven and 10 (three month supply)
Early termination/trial cessation follow-up phone call	Within three to five days following treatment cessation

PHQ-9 Patient Health Questionnaire, K-10 Kessler-10 Psychological Distress Scale, GAD-7 Generalised Anxiety Disorder Scale, WHODAS World Health Organisation Disability Assessment Scale, PSQI Pittsburgh Sleep Quality Index, CANTAB RT and PAL Cambridge Neuropsychological Test Automated Battery Reaction Time Test and Paired Associate Learning Test, RAVLT Rey Auditory Verbal Learning Test, DKEFS Delis-Kaplan Executive Function System Stroop Task, COWAT Controlled Oral Word Association Test, MRS Magnetic resonance spectroscopy
^a One month supply
^b Three month supply

ISSN: 1745-6215