NCT05420844Completed
Pilot Study to Evaluate a Voice Journaling Application in Adolescents With Cystic Fibrosis
Pilot Study to Evaluate the Feasibility and Acceptability of a Voice Journaling Application in Adolescents With Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 13 Nov 2025
Brief summary (registry, in English)
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 interventional trials. Additionally, the investigators aim to evaluate the potential impact of the voice journaling app on key clinical outcomes in CF.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 18 May 2022
- Start date
- 29 Jul 2022
- Primary completion date
- 16 Apr 2024
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Cystic fibrosis
- NCT number
- NCT05420844
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 29 Jul 2022 to the primary completion date, 16 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Actively in treatment with a mental health provider
Other
- 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
Who the study is looking for
- 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
Age in the registry: 14 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.