Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial

Table 2 The Schedule of Enrolment, Interventions, and Assessments

	Screening	Baseline		Allocation	Post intervention		6-week follow-up
Timepoint (week)	− 12	0		1	7		13
Enrolment:
Eligibility screening	X
Informed consent	X	X
Allocation				X
Interventions:
CBT-I		X		X	X		X
Waitlist control (WLC)		X		X	X		X
Assessments:
Primary outcome measures		CBT-I	WLC		CBT-I	WLC	CBT-I	WLC
Depression severity (CES-D)		X	X		X	X	X	X
Insomnia severity (ISI)		X	X		X	X	X	X
Sleep quality (PSQI)		X	X		X	X	X	X
Secondary outcome measures		CBT-I	WLC		CBT-I	WLC	CBT-I	WLC
Subjective health (SF-12 Version 1)		X	X		X	X	X	X
Anxiety (HADS-A)		X	X		X	X	X	X
Treatment expectancy (modified CEQ)		X	X		X			X
Treatment acceptability (modified PARS)		X	X		X			X
Demographics	X
Clinical comorbidity	X
Post-screening eligibility assessments		CBT-I	WLC		CBT-I	WLC	CBT-I	WLC
Withdrawal criteria					X	X	X	X
Cross-condition contamination check						X		X

CES-D Center for Epidemiologic Studies Depression Scale, ISI Insomnia Severity Index, PSQI Pittsburgh Sleep Quality Index, HADS-A Hospital Anxiety and Depression Scale—Anxiety subscale, CEQ Credibility/Expectancy Questionnaire, PARS Participant Acceptability/Usability Rating Scale

ISSN: 1745-6215