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Voice Journaling Application for Cystic Fibrosis

N/A
Waitlist Available
Led By Jordana Hoppe, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of cystic fibrosis based on sweat chloride (≥60) or two known disease-causing mutations
Age 14 - 18 years
Must not have
Unable to speak and write proficiently in English
Actively in treatment with a mental health provider
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a journaling app for adolescents with CF. The goal is to see if it is feasible and acceptable, and if it impacts key clinical outcomes.

Who is the study for?
This trial is for adolescents aged 14-18 with cystic fibrosis, who have had signs of anxiety or depression in the past year. They must be stable health-wise, not on acute illness antibiotics recently but can be on routine treatments. Participants need access to an iOS device and speak English. Those with suicidal thoughts, cognitive delays preventing app use, non-English proficiency, participation in another mental health study or active mental health treatment are excluded.
What is being tested?
The Kintsugi voice journaling application is being tested to see if it's practical and liked by teenagers with cystic fibrosis and to check its effect on their clinical outcomes. This pilot study will help design future research based on these initial findings.
What are the potential side effects?
Since this trial involves a voice journaling app rather than medication, traditional physical side effects aren't expected. However, participants may experience emotional discomfort while reflecting upon personal experiences during journaling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with cystic fibrosis.
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I am between 14 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot speak or write English well.
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I am currently seeing a mental health professional.
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I have had thoughts of harming myself recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Kintsugi Satisfaction
Kintsugi Usage
Secondary study objectives
Change in GAD-7 (Generalized Anxiety Disorder-7) Scores
Change in PHQ-9 (Patient Health Questionnaire-9) Scores

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: KintsugiExperimental Treatment1 Intervention
Enrolled participants who will be using the Kintsugi voice journaling phone application.

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Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,870 Total Patients Enrolled
18 Trials studying Cystic Fibrosis
953 Patients Enrolled for Cystic Fibrosis
Jordana Hoppe, MDPrincipal InvestigatorChildren's Hospital Colorado
~9 spots leftby Nov 2025
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