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Can a voice journaling app help teens with cystic fibrosis feel better?

NCT ID NCT05420844

Symptom relief Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a voice journaling app called Kintsugi is easy and acceptable for teens with cystic fibrosis to use. Twenty teens aged 14-18 with a history of anxiety or depression tried the app for three months. The goal was to see if it could help improve their emotional well-being and guide future research.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Jul 2022

Finished

Apr 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

Contacts and locations

Locations

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.