Protocol for a randomised controlled feasibility trial of an integrated psychosexual intervention for sexual difficulties in people with Multiple Sclerosis: the PIMS trial

Table 2 Summary of trial procedures by key timepoint/visit

	Screening	Consent	Baseline	Randomisation	Facilitated sessions	Follow-up (14 weeks)
Screening	x
Informed consent		x
Socio-demographic			x
Clinical characteristics			x
GNDS			x			x
PHQ-9			x			x
GAD-7			x			x
FFMQ			x			x
EQ-5D-5L			x			x
SFEQ			x			x
MSISQ-19			x			x
FSDS-R			x			x
DSC			x			x
NSSS-S			x			x
Self-reported adverse events						x
Randomisation				x
Facilitator report					x
Study adherence						x
TFA						x
Interviews						x
AD-SUS						x

GNDS Guy’s Neurological Disability Scale, PHQ-9 the Patient Health Questionnaire-9, GAD-7 Generalised Anxiety Disorders-7 questionnaire, FFMQ Five Factor Mindfulness Questionnaire, EQ-5D-5L EuroQol, SFEQ Sexual Function Evaluation Questionnaire, MSISQ-19 Multiple Sclerosis Intimacy and Sexuality Questionnaire, FSDS-R Female Sexual Distress Scale-Revised, DSC Dyadic Sexual Communication Scale, NSSS-S New Sexual Satisfaction Scale – Short form, TFA Theoretical Framework of Acceptability questionnaire, AD-SUS adult service use schedule Study adherence questions will depend on trial arm (e.g., questions about material covered)

ISSN: 2055-5784