Pilot Study to Evaluate a Voice Journaling Application in Adolescents With Cystic Fibrosis

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Other: Kintsugi voice journaling application

Study type: Interventional

Funder types: Other

Identifiers

NCT05420844

21-4821

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 14 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of cystic fibrosis based on sweat chloride (≥60) or two known disease-causing mutations
2. Age 14 - 18 years
3. History of elevated GAD-7 and/or PHQ-9 on screening questionnaires completed during routine CF clinical visits within the past year
4. 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
5. Access to an iOS device (iPhone or iPad) and internet/data plan
6. Parent/participant enrolled in MyChart
7. Willing to participate in study after informed consent and assent has been obtained
8. English speaking

Exclusion criteria

1. Endorsement of suicidal ideation on the baseline PHQ-9 (item 9) questionnaire at the enrollment visit
2. Developmental or cognitive delay preventing participant from interacting with voice journaling app
3. Unable to speak and write proficiently in English
4. Enrollment in another behavioral health study
5. Actively in treatment with a mental health provider

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Kintsugi

Other group

Description:

Enrolled participants who will be using the Kintsugi voice journaling phone application.

Treatment:

Other: Kintsugi voice journaling application