Table 1.
Study measures and assessment timepoints
| 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 | ||
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
a Ascertained by self-report
b Confirmed by physician or nurse practitioner