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

Not Applicable

Active, not recruiting

• Conditions: Cystic Fibrosis
• Interventions: Other: Kintsugi voice journaling application

• Registration Number: NCT05420844
• Lead Sponsor: University of Colorado, Denver

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 interventional trials. Additionally, the investigators aim to evaluate the potential impact of the voice journaling app on key clinical outcomes in CF.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-15
• Study Start: 2022-07-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-03
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Kintsugi Usage	3 Months	Establish the feasibility of the Kintsugi voice journaling app in participants. The investigators expect that the use of the voice journaling app will be feasible based on the frequency of use by participants over a three-month period. Frequency will be assessed on number of individual journal entries completed by participants.
Kintsugi Satisfaction	3 Months	Establish the acceptability of the Kintsugi voice journaling app in participants. Likert scales will be utilized in the satisfaction survey and the percentage for each answer will be reported to determine acceptability of the application. Possible responses range from "Strongly Disagree" to "Strongly Agree" with "Strongly Agree" indicating a better outcome.

Secondary Outcome Measures

Name	Time	Method
Change in GAD-7 (Generalized Anxiety Disorder-7) Scores	3 Months	The GAD-7 (Generalized Anxiety Disorder-7) scale is used for screening, diagnosis and severity assessment of anxiety disorder. Possible scores range from 0 to 21, with higher scores indicating a worse outcome.
Change in PHQ-9 (Patient Health Questionnaire-9) Scores	3 Months	The PHQ-9 (Patient Health Questionnaire-9 measures depression severity. Possible scores range from 0 to 27, with higher scores indicating a worse outcome.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States