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Table 1 Schedule of enrolment, interventions, and assessments

From: Strengthening Mental Abilities with Relational Training (SMART) in multiple sclerosis (MS): study protocol for a feasibility randomised controlled trial

Procedure/assessment

Screen 1

Screen 2

Baseline (0 months)

Intervention period

FU1 (3 months)

Interval b/w FUs

FU2 (6 months)

Enrolment:

       

 Initial eligibility screen

X

      

 Informed consent

X

      

 Demographic information

X

      

 Randomisation

  

X

    

Interventions:

       

 SMART + TAU

   

X

   

 Active control training + TAU

   

X

   

 TAU

   

X

   

Assessments:

       

 PDQ

X

   

X

 

X

 Symbol Digit Modalities Test (SDMT)

 

X

  

X

 

X

 RBANS

  

X

 

X

 

X

 Generalized Anxiety Disorder Scale-7 (GAD-7)

       

 Patient Health Questionnaire-9 (PHQ-9)

  

X

 

X

 

X

 Modified Fatigue Impact Scale–5-Item (MFIS-5)

  

X

 

X

 

X

 Personal Questionnaire (PQ)

  

X

 

X

 

X

 EQ-5D-5L

  

X

 

X

 

X

 MS Impact Scale–29 (MSIS-8D; v.2)

  

X

 

X

 

X

 ICECAP-A

  

X

 

X

 

X

 Service- and resource-use questionnaire

  

X

 

X

 

X

 Feedback interviews

     

Xa

 
  1. FU follow-up, Screen screening appointment, ICECAP-A Investigating Choice Experiments Capability Measure for Adults, TAU treatment-as-usual
  2. aWith selected participants who will be consented prior to the interview