PACE CF, a 3-session Mind-body Pain Management Program for Adults With Cystic Fibrosis

During visit 5, post-intervention, participants will be asked to complete a brief qualitative interview conducted by a research coordinator regarding treatment acceptability that will be recorded. Interviews will be qualitatively coded utilizing content analysis to summarize feedback regarding intervention acceptability.

Feedback on the intervention will be obtained from pilot subjects at both sites to assess acceptability of the pain management program.

At the end of visit 4, after the participant has completed the PACE CF program, participants will complete the Client Satisfaction Questionnaire (CSQ), an 8-item empirically-derived, validated, self-report measure assessing patient satisfaction with health services, rated on a 4-point scale from 1= lowest to 4 = highest satisfaction. The scale has a minimum score of 0, maximum score of 32, with higher scores indicating greater satisfaction.

Completion rates will be a key indicator of feasibility. Completion rate will be calculated as the percentage of intervention sessions completed out of the total number of possible sessions (the intervention is 3 sessions) among those enrolled.

This construct will be assessed using the 6-item catastrophizing scale from the Coping Strategies Questionnaire (CSQ-CAT). The catastrophizing scale score ranges from 0 to 36 with higher scores indicating greater pain catastrophizing.

The Patient Health Questionnaire-9 (PHQ-9) consists of nine questions measuring frequency of depressive symptoms, rated on a Likert scale from 0 "not at all" to 3 ";nearly every day"; with total score ranging 0-27. Clinical severity scores have been established with scores of 5, 10, 15, and 20 representing cut-off scores for mild, moderate, moderately severe, and severe depression, respectively. Higher scores indicate greater clinical severity of depressive symptoms.

The Generalized Anxiety Disorder scale (GAD-7) is a 7-item measure of symptoms of anxiety, rated on a Likert scale from 0 "not at all" to 3, "nearly every day", with total scores ranging 0-21. Scores of 5, 10, and 15 correspond to severity ratings of mild, moderate and severe anxiety. Higher scores indicate greater clinical severity of anxiety symptoms.

The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a well-established measure of health-related quality of life for people with CF that has been validated in a national, multicenter longitudinal study, demonstrating consistent associations with health outcomes in CF. It consists of 12 scales measuring physical HrQoL (e.g., physical functioning, eating disturbances) or psychosocial HrQoL (e.g., treatment burden, emotional functioning). Each of the 12 scales yield standardized scores ranging from 0 to 100 with higher scores indicating greater health-related quality of life.

The PROMIS Sleep Disturbance Scale short form (PROMIS SF v1.0 - Sleep Disturbance 6a) is a 6-item validated scale of self-reported perception of sleep quality and disturbance over 7 days. Each item has a 5-point response option. Raw scores range from 6 to 30 and are converted to T-scores, with higher scores indicating greater sleep disturbance.

The PROMIS(r) Pain Intensity Instrument (PROMIS Scale v2.0 - Pain Intensity 3a) is a 3- question self-report assessment of pain intensity on a scale from 1 "had no pain" to 5 "very severe." The first 2 questions utilize a 7-day recall and the last question rates pain "right now". Raw summary scores range from 3 to 15, and convert to T-scores, with higher scores indicating greater pain intensity.

The PROMIS(r) Pain Interference Adult Short Form (6 items on a 5-point Likert Scale) measures self-reported consequences of pain on aspects of a person's life. Raw summary scores range from 4 to 20 and convert to T-scores, with higher scores indicating greater pain interference.

The Cystic Fibrosis Coping Self-Efficacy Scale was developed by investigators with CF community input. It is a 21-item measure with items rated on a 10-pt scale from "very uncertain" to "very certain," which asks participants to rate their certainty with being able to use a variety of skills and strategies to cope with stress. Some of these strategies reflect core components of CBT; some are specific to coping with CF; many will be targeted in the proposed pain management intervention. The CF Coping Self Efficacy measure contains four subscales: Acceptance/Self-Compassion (4 items), Cognitive Coping/Self-Awareness (8 items), Active Stress Management (4 items) , and Coping with Daily Self-Care Demands (5 items). Higher scores indicated greater coping self-efficacy in each domain of coping skills.