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Behavioral Intervention
Mind-Body Pain Management for Cystic Fibrosis
N/A
Recruiting
Led By Amanda Bruce, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Report of pain affecting them at least moderately (score ≥ 2) on the IPOS item
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of intervention, up to 2 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a new 3-session non-medication mind-body pain management program called PACE CF for adults with cystic fibrosis. The program will be delivered by a CF care team
Who is the study for?
This trial is for adults with cystic fibrosis who experience pain. Participants must be able to attend three telehealth sessions and may be at home or hospitalized. Specific eligibility criteria are not provided, but typically include factors like age range, disease severity, and ability to comply with study requirements.
What is being tested?
The PACE CF program is being tested; it's a non-medication mind-body intervention designed for cystic fibrosis patients' pain management. The study aims to assess its feasibility, acceptability, and preliminary impact on pain interference in daily life.
What are the potential side effects?
Since the PACE CF program is a non-medication intervention involving coping strategies taught via telehealth sessions, there are no direct medical side effects expected as commonly seen with drug treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience moderate to severe pain.
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I am older than 18 years.
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I have been diagnosed with cystic fibrosis.
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I have been experiencing pain for at least one month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of intervention, up to 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of intervention, up to 2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability - measured by treatment acceptability interview
Acceptability -Client Satisfaction Questionnaire-8 (CSQ-8)
Feasibility - participant attrition during the intervention period.
Secondary study objectives
Change in Health-Related Quality of Life, measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Change in anxiety symptoms, measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)
Change in depressive symptoms, measured by the Patient Health Questionnaire-9 (PHQ-9)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PACE CF InterventionExperimental Treatment1 Intervention
Participants will complete an baseline series of questionnaires, and then meet with the psychologist on their cystic fibrosis care team for 3 weekly meetings to complete the PACE CF program and learn mind-body strategies for pain management. Following completion of the program, they will complete a second assessment that includes another set of questionnaires and a brief qualitative interview to provide feedback about the program.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,002 Previous Clinical Trials
13,309,580 Total Patients Enrolled
University of Kansas Medical CenterOTHER
504 Previous Clinical Trials
174,127 Total Patients Enrolled
1 Trials studying Pain Management
80 Patients Enrolled for Pain Management
Amanda Bruce, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
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