Skip to main content

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

Descriptive and Clinical Variables
 Demographic characteristicsAge, sex,a gender,a race, ethnicity, relationship status, education (years), residence (country/state/zip code), employment status, all assessed by self-reportX   
 Clinical variablesMS duration and diagnosis dateb
MS severity: Expanded Disability Status Scale-self-report [18]
MS course: NINDS CDE self-report questions on course [19]
 Pain characteristicsLocation of pain sites
PainDETECT: pain type, including neuropathic pain [20]
 Medications and treatmentsList of all pain medications, disease modifying therapies, & non-pharmacologic pain treatmentsXXXX
Primary Outcome
 Pain intensityThe 0–10 numeric rating scale of average pain intensity in past week [21]XXXX
Secondary Outcomes
 Other pain intensity outcomesPercentage 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
 Pain interferenceBrief Pain Inventory–Interference scale (modified version for MS) [21]XXXX
 Physical functionPROMIS-29: 4 item version [22]XXXX
 Depressive symptomsPatient Health Questionnaire – 9 [23]XXXX
 Fatigue severityModified Fatigue Impact Scale [24]XXXX
 Sleep disturbancePROMIS Sleep Disturbance scale [25]XXXX
 Pain self-efficacyUW CORR Pain Self-Efficacy Scale [26]XXXX
 Treatment satisfactionPatient Global Impression of Change [27]
Patient Global Assessment of Treatment Satisfaction [27]
 Global quality of lifeGlobal Quality of Life Scale [28]XXXX
Primary Moderators
 Pain catastrophizingPain Catastrophizing Scale [29]XXXX
 MindfulnessFive Facet Mindfulness Questionnaire [30]XXXX
 Behavioral activationBehavioral Activation for Depression Scale [31]XXXX
Exploratory Moderators
 Pre-treatment pain intensityThe 0–10 numeric rating of average pain intensity [21]X   
 Positive affectPositive Affect scale of the Positive and Negative Affect Scale [32]XXXX
 Pain acceptanceChronic Pain Acceptance Questionnaire [33]XXXX
 Pain beliefsSurvey of Pain Attitudes: 2-item versions of harm and control subscales [34]XXXX
 Pain resiliencePain Resilience Scale [35]XXXX
 Tx outcome expectancy5-point Likert scaleX   
 Cognitive functioningBrief Test of Adult Cognition by Telephone [36]X   
 Age, sex, race/ethnicityDemographic variablesX   
Process and Treatment-related Variables
 Therapeutic allianceWorking Alliance Inventory [37] XX 
 Group climateGroup Climate Questionnaire-Engage scale [38] XX 
 Treatment doseNumber, frequency, and duration of sessions attended XX 
  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