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Table 1 Study measures and assessment timepoints

From: Mindfulness-based cognitive therapy and cognitive behavioral therapy for chronic pain in multiple sclerosis: a randomized controlled trial protocol

  Measures Pre Mid Post f/u
Descriptive and Clinical Variables
 Demographic characteristics Age, sex,a gender,a race, ethnicity, relationship status, education (years), residence (country/state/zip code), employment status, all assessed by self-report X    
 Clinical variables MS duration and diagnosis dateb
MS severity: Expanded Disability Status Scale-self-report [18]
MS course: NINDS CDE self-report questions on course [19]
X    
 Pain characteristics Location of pain sites
PainDETECT: pain type, including neuropathic pain [20]
X    
 Medications and treatments List of all pain medications, disease modifying therapies, & non-pharmacologic pain treatments X X X X
Primary Outcome
 Pain intensity The 0–10 numeric rating scale of average pain intensity in past week [21] X X X X
Secondary Outcomes
 Other pain intensity outcomes Percentage with a meaningful improvement in average pain intensity (≥ 30% reduction from pre-treatment)
Least, worst, and present pain assessed with 0–10 numeric rating scale
X X X X
 Pain interference Brief Pain Inventory–Interference scale (modified version for MS) [21] X X X X
 Physical function PROMIS-29: 4 item version [22] X X X X
 Depressive symptoms Patient Health Questionnaire – 9 [23] X X X X
 Fatigue severity Modified Fatigue Impact Scale [24] X X X X
 Sleep disturbance PROMIS Sleep Disturbance scale [25] X X X X
 Pain self-efficacy UW CORR Pain Self-Efficacy Scale [26] X X X X
 Treatment satisfaction Patient Global Impression of Change [27]
Patient Global Assessment of Treatment Satisfaction [27]
   X X
 Global quality of life Global Quality of Life Scale [28] X X X X
Primary Moderators
 Pain catastrophizing Pain Catastrophizing Scale [29] X X X X
 Mindfulness Five Facet Mindfulness Questionnaire [30] X X X X
 Behavioral activation Behavioral Activation for Depression Scale [31] X X X X
Exploratory Moderators
 Pre-treatment pain intensity The 0–10 numeric rating of average pain intensity [21] X    
 Positive affect Positive Affect scale of the Positive and Negative Affect Scale [32] X X X X
 Pain acceptance Chronic Pain Acceptance Questionnaire [33] X X X X
 Pain beliefs Survey of Pain Attitudes: 2-item versions of harm and control subscales [34] X X X X
 Pain resilience Pain Resilience Scale [35] X X X X
 Tx outcome expectancy 5-point Likert scale X    
 Cognitive functioning Brief Test of Adult Cognition by Telephone [36] X    
 Age, sex, race/ethnicity Demographic variables X    
Process and Treatment-related Variables
 Therapeutic alliance Working Alliance Inventory [37]   X X  
 Group climate Group Climate Questionnaire-Engage scale [38]   X X  
 Treatment dose Number, frequency, and duration of sessions attended   X X  
  1. pre pre-treatment, mid mid-treatment, post post-treatment, f/u 6-month follow up, MS multiple sclerosis, NINDS CDE National Institute of Neurological Disorders and Stroke Common Data Elements, PROMIS Patient-Reported Outcome Measurement System, UW CORR University of Washington Center on Outcomes Research in Rehabilitation
  2. a Ascertained by self-report
  3. b Confirmed by physician or nurse practitioner