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

 

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