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Table 3 Study periods at which measures and data are collected

From: Cost-utility and biological underpinnings of Mindfulness-Based Stress Reduction (MBSR) versus a psychoeducational programme (FibroQoL) for fibromyalgia: a 12-month randomised controlled trial (EUDAIMON study)

Study measures

Baseline

During treatment

2 months

12-months

Demographic information (gender, age, etc.)

X

   

History of FMS (years of illness)

X

   

Contact details

X

   

SCID-I (depression module)

X

   

Screening measures

    

 MMSE (cognitive impairment)

X

   

Primary outcome measure

    

 FIQR (functional impairment)

X

 

X

X

Secondary outcome measures

    

 FSDC (fibromyalginess)

X

 

X

X

 HADS (anxiety and depression)

X

 

X

X

 PSS-10 (perceived stress)

X

 

X

X

 MISCI (subjective cognitive impairment)

X

 

X

X

 EQ-5D-5L (quality of life)

X

  

X

 CSRI (health economic evaluation)

X

  

X

 FFMQa (mindfulness facets)

X

 

X

X

 PCSa (pain catastrophizing)

X

 

X

X

 PIPSa (psychological inflexibility)

X

 

X

X

 SCS-12a (self-compassion)

X

 

X

X

Other measures

    

 Structural + Functional Neuroimaging data

X

 

X

 

 Inflammatory data

X

 

X

 

 CEQ (Expectation/Satisfaction with treatment)

X (EXP)

 

X (SAT)

 

 PGIC & PSIC (Impression of change)

  

X

X

 Treatment attendance form: Attendance at each scheduled MBSR/FibroQoL session

 

X

  

 Log of MBSR and FibroQoL practices

 

X

  

 Treatment fidelity (review of video-taped MBSR sessions) & monitoring of adverse events

 

X

X

X

  1. CEQ Credibility/Expectancy Questionnaire, CSRI Client Service Receipt Inventory, EQ-5D-5L EuroQoL questionnaire, FFMQ Five Facet Mindfulness Questionnaire, FIQR Revised Fibromyalgia Impact Questionnaire, FSDC Fibromyalgia Survey Diagnostic Criteria, HADS Hospital Anxiety and Depression Scale, MISCI Multidimensional Inventory of Subjective Cognitive Impairment, MMSE Mini-Mental State Examination, PCS Pain Catastrophizing Scale, PGIC & PSIC Patient Global and Specific Impression of Change, respectively, PIPS Psychological Inflexibility in Pain Scale, PSS-10 Perceived Stress Scale, SCID-I Structured Clinical Interview for DSM Axis I Disorders, SCS-12 Self-Compassion Scale
  2. aSecondary outcome measures that also considered process variables
  3. Inflammatory data = Cytokines Th1: IL-6, IL-8; cytokines Th2: IL-10; + high-sensitivity CRP test
  4. Structural and Functional Neuroimaging = Voxel-Based Morphometry, Diffusion Tensor Imaging, pCASL, and rs-fMRI