Table 2

Screening and data collection across the trial: summary of the key trial processes from receipt of the invite reply from the potential participant to the data collection time points

CRF	Completed by	Database	Preconsent	Baseline	3 m	6 m	12 m	Ongoing or during treatment	Ref
Invite reply	P	RT	X						na
Screening Questionnaire	P/TT	M	X						na
Consent	P	R		X					na
Sample requisition form	RN	RT		X					na
Adverse events form	TT	M						X	na
Drop-out event form	TT	M						X	na
Note review form	TT	M					X		na
IBS-SSS	P	R		X	X	X	X		23
WASAS	P	R		X	X	X	X		24
SGA	P	R			X	X	X		25
EQ5D	P	R		X	X	X	X		26
Patient enablement	P	R			X	X	X		27
Hospital Anxiety and Depression Scale	P	R		X	X	X	X		28
Client Service Receipt Inventory	P	R		X	X	X	X		29
Cognitive Scale CG-FBD	P	R		X	X	X	X		30
B-IPQ for IBS	P	R		X	X	X	X		31
IBS Behavioural Responses Questionnaire	P	R		X	X	X	X		32
BES	P	R		X	X	X	X		33
“Impoverished Emotional Experience (IEE)” factor of the Emotional Processing Scale-25	P	R		X	X	X	X		34
PANAS	P	R		X	X	X	X		35
Demographics	P	R		X					na
About your IBS	P	R		X					na
Safety questions	P	R			X	X	X		na
Rating of satisfaction	P	R			X	X	X		22
Thoughts on my treatment	P	R			X	X	X		36
Therapist database	T	MT						X	na

BES, Beliefs about Emotions Scale; B-IPQ, Brief Illness Perception Questionnaire; CG-FBD, Cognitive Scale for Functional Bowel Disoders; CRF, Case Report Form; IBS, Irritable bowel syndrome; IBS-SSS, IBS Symptom Severity Score; M, MACRO Clinical Trials Unit database; MT, MACRO Therapist database; na, not significant; P, patient; PANAS, Positive and Negative Affect Schedule; SGA, Subject's Global Assessment of Relief; R, LifeGuide Regul8; RN, Research Nurse/Phlebotomist; RT, Research Team database; T, therapist; TT, trial team; WASAS, Work & Social Adjustment Scale.