Study protocol and methods for Easing Pelvic Pain Interventions Clinical Research Program (EPPIC): a randomized clinical trial of brief, low-intensity, transdiagnostic cognitive behavioral therapy vs education/support for urologic chronic pelvic pain syndrome (UCPPS)

Table 3 Enrollment, intervention, and assessment schedule for primary outcomes, mediators, and predictors

	Screening	BL	Acute phase						Follow-up
Timepoint (week)	−2	0	1	3	5	7	8	10	12	22	34
Enrollment:
Eligibility confirmation	x
Informed consent	x
Allocation		x
Interventions:
Minimal-contact CBT (MC-CBT)			X	T	X	T	X	X
UCPPS Education			X	T	X	T	X	X
Assessments:
Primary outcome
Global symptom improvement (CGI-I)				x		x	x	x	x	x	x
Secondary outcomes
Emotional distress (BSI-18)		x							x	x	x
Patient satisfaction (CSQ)									x
Comorbid COPCs (CMSI)		x							x	x	x
Pelvic pain severity (GUPI)		x		x		x	x	x	x	x	x
Urinary problem severity (ICPI)		x		x		x	x	x	x	x	x
Urinary symptom severity (ICSI)		x		x		x	x	x	x	x	x
Pain interference (PPI SF-6a)		x							x	x	x
Quality of life (SF-12 v2)		x							x	x	x
Mediators
Perspective broadening (CERQ-PB)		x		x					x	x	x
Self-distancing (EQ-D)		x		x					x	x	x
Perceived control (MAIA-2)		x		x					x	x	x
Repetitive thinking (PTQ)		x				x			x	x	x
Context sensitivity (CSI)		x					x		x	x	x
Coping flexibility (CFS-R)		x						x	x	x	x
Prescriptive predictors (moderators)
Trait self-regulation (BRIEF-A)		x
Prognostic predictors
Comorbidities: medical and psychiatric		x							x	x	x
Concomitant treatments		x							x	x	x
Demographics, chronicity, etc.		x

BL baseline, CGI-I Clinical Global Impression-Improvement, BSI-18 Brief Symptom Inventory-18, CSQ Client Satisfaction Questionnaire, CMSI Complex Medical Symptoms Inventory, GUPI Genitourinary Pain Index, ICPI Interstitial Cystitis Problem Index, ICSI Interstitial Cystitis Symptom Index, PPI SF-6a PROMIS - Pain Interference SF-6a, SF-12 v2 Short Form-12 Health Survey v2, CERQ-PB Cognitive Emotion Regulation Questionnaire-Perspective Broadening, EQ-D Experiences Questionnaire-Decentering, MAIA-2 Multidimensional Assessment of Interoceptive Awareness-2 (Noticing, Non-Distracting, Not-Worrying and Attention Regulation scales), PTQ Perseverative Thinking Questionnaire, CSI Context Sensitivity Index, CFS-R Coping Flexibility Scale-Revised, BRIEF-A Behavior Rating Inventory of Executive Functioning-Adult. Bolded Capped X = clinic session (intervention); T = telephone check in (intervention)

ISSN: 1745-6215