Status:
COMPLETED
Pilot Study to Evaluate a Voice Journaling Application in Adolescents With Cystic Fibrosis
Lead Sponsor:
University of Colorado, Denver
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
14-18 years
Phase:
NA
Brief Summary
The overall goal of this pilot study is to evaluate the feasibility and acceptability of the Kintsugi voice journaling app in adolescents with CF to inform the design of future observational and inter...
Eligibility Criteria
Inclusion
- Diagnosis of cystic fibrosis based on sweat chloride (≥60) or two known disease-causing mutations
- Age 14 - 18 years
- History of elevated GAD-7 and/or PHQ-9 on screening questionnaires completed during routine CF clinical visits within the past year
- Clinically stable at the time of enrollment, without increased respiratory and/or GI symptoms or treatment with IV and/or oral antibiotics for an acute illness for the 14 days prior to enrollment visit. Participants receiving inhaled antibiotics every other month are eligible to enroll. Participants receiving chronic oral antibiotics, including thrice weekly azithromycin will be eligible to participate
- Access to an iOS device (iPhone or iPad) and internet/data plan
- Parent/participant enrolled in MyChart
- Willing to participate in study after informed consent and assent has been obtained
- English speaking
Exclusion
- Endorsement of suicidal ideation on the baseline PHQ-9 (item 9) questionnaire at the enrollment visit
- Developmental or cognitive delay preventing participant from interacting with voice journaling app
- Unable to speak and write proficiently in English
- Enrollment in another behavioral health study
- Actively in treatment with a mental health provider
Key Trial Info
Start Date :
July 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05420844
Start Date
July 29 2022
End Date
April 16 2024
Last Update
November 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045