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Completed

NCT Number: NCT05420844

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

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.

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Key information

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Actively in treatment with a mental health provider

Treatment and study plan

Kintsugi voice journaling application

Other

Participants will use the Kintsugi voice journaling phone application for three months.

Primary outcomes

  1. Kintsugi Usage

    Time frame: 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.

  2. Kintsugi Satisfaction

    Time frame: 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 outcomes

  1. Change in GAD-7 (Generalized Anxiety Disorder-7) Scores

    Time frame: 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.

  2. Change in PHQ-9 (Patient Health Questionnaire-9) Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Pilot Study to Evaluate the Feasibility and Acceptability of a Voice Journaling Application in Adolescents With Cystic Fibrosis

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2022
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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