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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of intervention, up to 2 months for reporting.

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 more

Awards & 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.

0 / 4Eligibility criteria met