PACE CF, a 3-session Mind-body Pain Management Program for Adults with Cystic Fibrosis
Purpose
Many people living with cystic fibrosis (CF) experience pain. However, pain is sometimes unrecognized and under-managed in people with CF. Both medication and non-medication interventions can be used to treat pain and ideally, there is a multicomponent management approach. The goal of this study is to pilot a new 3-session non-medication mind-body pain management intervention specifically designed for adults with cystic fibrosis (CF). The intervention is titled Pain Acknowledgement Coping and Empowerment in CF (PACE CF). PACE CF will be administered by a member of the CF care team via telehealth visits to participants at home or during a hospitalization. The aim of the study is to evaluate the feasibility and patient acceptability of the intervention as well as preliminary evidence of the impact of the intervention on pain and its interference in daily life. The study will also examine outcomes such as perceived coping, quality of life, symptoms of depression or anxiety, and use of prescribed pain medication, in an exploratory manner.
Conditions
- Cystic Fibrosis (CF)
- Pain Management
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PACE CF 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. |
|
Recruiting Locations
Boston, Massachusetts 02114
Deborah Friedman, PhD
617-724-8598
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed Description
This study is a multi-center collaboration of a psychological approach to pain treatment in CF. This is the first study to elicit input from the CF community and CF care team members to develop a brief, focused psychological treatment for pain in adults with CF (MGB IRB exempt protocol# 2022P003370). Utilizing the development phase of the grant (protocol# 2022P003370), the investigators developed a brief (3-session) structured intervention manual and patient workbook based on CF community feedback (PACE CF). The intervention will be highly accessible, delivered by a member of the CF care team via telehealth in both inpatient and outpatient settings. The workbook will provide education and resources for patients and reinforce skill practice. Resources will facilitate future training and dissemination, standardization, and evaluation of feasibility, acceptability, and efficacy of the intervention in a larger trial. The PACE CF intervention integrates the well-established science of behavioral pain management with CF-specific content drawn from feedback from community stakeholders to develop an intervention specific to pain in CF. The investigators anticipate that integration of this intervention into the existing CF model of care will positively impact people with CF by increasing access to best practices in pain treatment, while minimizing additional cost and burden of care.