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Acceptability, Feasibility and Preliminary Efficacy of CFWP to Treat Clinically Elevated Fatigue in Adults With CF

NCT04809207 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-28

No results posted yet for this study

Summary

This research is being done to learn more ways to treat non-respiratory symptoms in people with CF including fatigue, pain, mood, sleep problems and the use of a wellness program to treat them.

Conditions

Interventions

OTHER

CF Wellness Program Sessions

The intervention will last approximately 12 weeks. During this time, up to 9 coaching sessions will be delivered. Each will last approximately 45 - 60 minutes. Sessions will be delivered either by web-based video chat (e.g., Zoom) or by telephone. Sessions will cover content such as understanding the physiological, cognitive, affective, behavioral contributors to CF fatigue; understanding the role of physical activity/exercise and fatigue including the importance of balancing activity and rest periods; cognitive restructuring; addressing attention and interpretation processes contributing to fatigue; teaching techniques such as mindfulness meditation relaxation strategies, good sleep hygiene, and activity scheduling and behavioral activation; and engaging social support. Physical activity goals will be set each session. Participants will be encouraged to use the provided fitness tracker and to sync weekly prior the coaching session so that the results can inform session content.

Sponsors & Collaborators

Principal Investigators

  • Kristin Riekert, PhD · Johns Hopkins University

  • Chris Goss, MD · University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-07-25
Completion
2023-07-25

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04809207 on ClinicalTrials.gov