← Back to Search

Behavioural Intervention

CF Wellness Program Sessions for Cystic Fibrosis

N/A
Waitlist Available
Led By Kristin Riekert, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a score of >4 on the Fatigue Severity Scale
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to approximately 13 weeks post intervention
Awards & highlights

Study Summary

This trial is researching new ways to treat non-respiratory symptoms in people with CF, like fatigue, pain, mood, and sleep problems. They'll be using a wellness program to see if it helps.

Eligible Conditions
  • Cystic Fibrosis
  • Fatigue

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have severe fatigue, with a score above 4 on the Fatigue Severity Scale.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to approximately 13 weeks post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to approximately 13 weeks post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion enrolled in the CF Wellness Program (CFWP)
Proportion of cognitive behavioral therapy (CBT) sessions completed
Proportion of weeks participant synced the fitness tracker watch to the Smartphone app
Secondary outcome measures
Acceptability of the CF Wellness Program as assessed by the Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients
Change in exercise capacity as assessed by the 1 Minute Sit to Stand Test (1MSTST) test and Fitness tracker watch
Anxiety
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CF Wellness ProgramExperimental Treatment1 Intervention
Participants will receive CF Wellness Program sessions.

Find a Location

Who is running the clinical trial?

University of WashingtonOTHER
1,724 Previous Clinical Trials
1,821,347 Total Patients Enrolled
22 Trials studying Cystic Fibrosis
44,980 Patients Enrolled for Cystic Fibrosis
Cystic Fibrosis FoundationOTHER
187 Previous Clinical Trials
36,323 Total Patients Enrolled
180 Trials studying Cystic Fibrosis
33,386 Patients Enrolled for Cystic Fibrosis
Johns Hopkins UniversityLead Sponsor
2,239 Previous Clinical Trials
14,816,486 Total Patients Enrolled
20 Trials studying Cystic Fibrosis
7,154 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant quota for this clinical experiment?

"Affirmative. Clinicaltrials.gov has documented that this medical trial, first published on May 1st 2021, is currently recruiting participants. This project necessitates 50 volunteers from two distinct healthcare facilities."

Answered by AI

What is the primary aim of this investigation?

"This clinical trial seeks to assess, over a 13 week period post-intervention, the proportion of cognitive behavioural therapy sessions completed. Secondary outcomes include changes in exercise capacity and self-reported pain as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity scale and qualitative interviews which will be analysed using thematic analysis with Nvivo Statistical & Qualitative Data Analysis Software. Additionally, participants' heart rate recovery after 1 Minute Sit to Stand Tests (1MSTSTs) and daily step counts from their fitness trackers watches will also be monitored in order to determine if there are any changes"

Answered by AI

Are there any openings for new enrollees in this trial?

"Affirmative. The clinical trial is actively recruiting participants as indicated on the information posted to clinicaltrials.gov. This study, initially brought to light in May 2021, has recently been updated and calls for 50 individuals between two sites."

Answered by AI
~10 spots leftby Mar 2025