Mind-body pain management program for adults with cystic fibrosis
Pilot of PACE CF, a 3-session Mind-body Pain Management Program for Adults with CF
This study is testing a new online pain management program for adults with cystic fibrosis to see if it helps them handle pain better and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06606457 on ClinicalTrials.gov |
What this trial studies
This study aims to pilot a new three-session non-medication mind-body pain management intervention called Pain Acknowledgment Coping and Empowerment in CF (PACE CF) for adults with cystic fibrosis. The intervention will be delivered via telehealth by a member of the CF care team, focusing on improving pain management through a psychological approach tailored to the needs of the CF community. The study will evaluate the feasibility and acceptability of the intervention, as well as its preliminary effects on pain, coping, quality of life, and symptoms of depression or anxiety.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with cystic fibrosis who experience moderate to severe pain.
Not a fit: Patients presenting an acute safety risk to themselves or others may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve pain management and overall quality of life for adults living with cystic fibrosis.
How similar studies have performed: While this approach is innovative in the context of cystic fibrosis, similar mind-body interventions have shown promise in other chronic pain conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. diagnosis of CF; 2. age \> 18 years; 3. report of pain affecting them at least moderately (score ≥ 2) on the IPOS item; 4. pain lasting at least one month; 5. English-speaking; 6. participant willing and able to give informed consent. Exclusion Criteria: Presenting an acute safety risk to self or others at baseline. Participants will not be excluded for the following reasons: 1. CF severity or lung/liver transplant status, if they are otherwise able to participate in CBT; 2. Participation in concomitant pain treatments (e.g., pain medications), as ideally, patients will engage in multi-component pain interventions; 3. psychosocial treatments (with the exception of another formal CBT for pain) or psychopharmacologic treatments at baseline. All concomitant psychosocial and pain-directed treatments will be tracked and considered in analysis.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Amanda Bruce, PhD — University of Kansas Medical Center
- Study coordinator: Deborah Friedman, PhD
- Email: DFRIEDMAN@mgh.harvard.edu
- Phone: 617-724-8598
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.