Children’s Hospital Colorado Cystic Fibrosis Kintsugi Voice Journaling Study

Background

Kintsugi Health recently partnered with the Pediatric Cystic Fibrosis Center at Children’s Hospital Colorado to pilot the utility of the Kintsugi Voice Journaling app in a patient cohort. The Kintsugi Voice Journaling app is a longitudinal digital tool intended for users to be able to voice journal and monitor their mental wellness. The goal of the pilot was to evaluate the acceptability and potential impact of voice journaling and mental wellness monitoring on key clinical and behavioral health outcomes for adolescent patients with Cystic Fibrosis (CF) that may inform the development of future expanded research investigations.

The population served by this pilot is one of acute need. Between 2016 and 2020, the number of children diagnosed with depression increased by 27%, and these findings are exacerbated in youth with serious chronic illnesses.1,2,3  Specifically, a study of mental health conditions in youth with Chronic Physical Conditions (CPCs) found that the prevalence of mental health conditions in youth with CPCs was 11.5% compared to  7.1% in healthy individuals.⁴  This pilot study is particularly relevant as prior research has shown that untreated depression and anxiety in adolescents with CF is associated with worsened treatment adherence, diminished clinical outcomes, and decreased quality of life, thus making the identification and management of mental health problems in this population essential. ^5,6,7

There is evidence that implementing journaling as a therapeutic tool can lead to improvements in mental and physical health. ^8,9 This suggests that the Kintsugi app may be particularly useful for individuals struggling with CF, as online support, engagement, and connectedness were associated with improved quality of life for CF patients.^{10, 11}  This study provides foundational insights into the utility of Kintsugi's Voice Journaling app to provide patient support and mental wellness monitoring as care providers manage their patients' severe chronic illnesses, which are known to contribute to clinical outcomes. During the pilot, clinical outcomes data and user experience data were systematically collected and the analysis is presented in this research brief.

In total, 19 adolescents with CF aged 14 to 18 both with and without a documented history of depression and anxiety were offered the opportunity to provide informed consent and participate in the research study. Upon consenting, participants were instructed on how to download and utilize the Kintsugi Voice Journaling app to submit entries and monitor their mental wellness until their next routine follow-up visit when the study close-out visit would take place. The voice journaling entries were captured during a 3-month active study window. The application was only available on iOS and individuals without access to an iOS compatible phone or tablet were not enrolled. Each of these participants completed entry and exit surveys, however, only 12 interacted with the app. Clinical outcomes tracked include PHQ-9 and GAD-7 scores recorded pre- and post-study, Kintsugi Voice Device predicted low mood and stress scores, emotional sentiment and magnitude of journal entries, and key clinical outcomes in CF including Body Mass Index (BMI) and FEV-1 pre and post study. In addition to data collected during the treatment episode, all participants were asked to complete a post-participation survey to measure satisfaction and attitudes, and provide feedback and perspectives on their experiences using the app and the impact it had on their treatment.

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The Kintsugi Voice App and Study Significance

The Kintsugi Voice Journaling app captures audio through the smartphone interface, and when sufficient voice content is provided by the user, generates prediction scores for mood and stress by utilizing Kintsugi’s novel voice biomarker technology. The Artificial Intelligence integrated into the app analyzes audio samples for voice biomarkers related to mood and stress. Mood and stress symptoms were monitored during the 3-month active study window.

Findings and Implications for Future Research

This pilot study of a CF adolescent population provides early evidence that the app may be effective for more frequent users (>= 5 journal entries) of the app, and for users showing moderate to severe symptoms of depression and anxiety based on their pre/post participation PHQ-9 and GAD-7 scores. Some highlights include: Frequent users of the app had greater improvement in pre/post study administered PHQ-9 and GAD-7 scores compared to infrequent users. Participants who used the app 5 or more times had an average improvement in their PHQ-9 score of 4.8 (N=5) and an average improvement in their GAD-7 score of 3.2, whereas participants who used the app less than 5 times only had an average improvement of 1.6 (N=7) points in their PHQ-9 and 0.6 points in their GAD-7. There were no changes evident in app users' CF outcomes, such as BMI, to be able to make any conclusions from this pilot study on if the use of the app leads to improved physical health outcomes. A longer monitoring period may be necessary to detect physiological changes.

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Of the participants that frequently engaged with the app (N = 5), their exit surveys demonstrated satisfaction with the Kintsugi tool, as 100% of frequent users agreed with the following statements:

Kintsugi’s app helped me cope with my emotions.

Being able to monitor my depression and anxiety symptoms on the Kintsugi app was helpful.

My mood improved as a result of the Kintsugi app.

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Amongst all participants, many (N=8) stated they would change nothing about the app, however, several (N=4) stated that more reminders would be helpful to increase their engagement. This is evident in the journal entries, as eight participants did not make any journal entries, and another seven participants made less than five entries over the 3-month active study window.

This pilot was not intended to generate definitive conclusions about the Kintsugi app, but instead to provide preliminary insight about the impact of the tool being embedded in a treatment episode for adolescents with CF for patients to monitor their mental wellness and benefit from journaling. Based upon this pilot, there is reasonable acceptability among the participants who engaged with the Kintsugi app. Patients reported satisfaction with the app and users who engaged with the app greater than five times during the study experienced greater improvement in their PHQ-9 and GAD-7 scores between the baseline screening and final screening relative to users who engaged with the app less frequently or not at all.

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¹ Includes only participants who had at least one entry in the app. 8 of the 20 participants did not use the app at all. There is exciting potential for the Kintsugi voice app to improve emotional outcomes for individuals living with chronic health conditions such as Cystic Fibrosis. Future research will build upon this early study by recruiting a larger and more demographically representative sample, expanding the availability of the tool to non-iOS users, increasing the study duration, and providing more frequent reminders for individuals to utilize the app through the study period to improve utilization. Because depression and anxiety have the potential to impact motivation, more frequent reminders and efforts towards getting users to engage with the app may be particularly important. Additionally, data on low mood and stress status could be used to tailor future journaling prompts to make the Kintsugi app personalized to the patients’ mental health needs. Future study should further evaluate the Kintsugi app’s impact on both physical (BMI, FEV-1) and mental health (depression and anxiety) outcomes to further characterize the potential efficacy of the app to address challenges in mental health monitoring and management among youth with chronic illness.

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References

^1. 2022 National Healthcare Quality and Disparities Report [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2022 Oct. CHILD AND ADOLESCENT MENTAL HEALTH. Available from: https://www.ncbi.nlm.nih.gov/books/NBK587174/

^2. Stewart SM, Rao U, White P. Depression and diabetes in children and adolescents. Curr Opin Pediatr. 2005 Oct;17(5):626-31. doi: 10.1097/01.mop.0000176441.49743.ea. PMID: 16160538.

^3. Benton TD, Ifeagwu JA, Smith-Whitley K. Anxiety and depression in children and adolescents with sickle cell disease. Curr Psychiatry Rep. 2007 Apr;9(2):114-21. doi: 10.1007/s11920-007-0080-0. PMID: 17389120.

^4. Adams JS, Chien AT, Wisk LE. Mental Illness Among Youth With Chronic Physical Conditions. Pediatrics. 2019 Jul;144(1):e20181819. doi: 10.1542/peds.2018-1819. Epub 2019 Jun 14. PMID: 31201229.

^5. Quittner, A.L., Barker, D.H., Snell, C., Grimley, M.E., Marciel, K., & Cruz, I. (2008). Prevalence and impact of depression in cystic fibrosis. Current Opinion in Pulmonary Medicine, 4, 582-588.

^6. Quittner, A.L., et al. (2013). The international depression and anxiety epidemiological study (TIDES): International Comparisons. Data obtained from Quittner, A.L.

⁷. Cruz I, Marciel KK, Quittner AL, Schechter MS. Anxiety and depression in cystic fibrosis. Semin Respir Crit Care Med. 2009 Oct;30(5):569-78. doi: 10.1055/s-0029-1238915. Epub 2009 Sep 16. PMID: 19760544.

^8. Allen SF, Wetherell MA, Smith MA. Online writing about positive life experiences reduces depression and perceived stress reactivity in socially inhibited individuals. Psychiatry Res. 2020 Feb;284:112697. doi: 10.1016/j.psychres.2019.112697. Epub 2019 Nov 20. PMID: 31791707.

^9. D.S. Berry, J.W. Pennebaker: Nonverbal and verbal emotional expression and health. Psychother Psychosom. 59:11-19 1993 PMID: 8441791

^10. Kirk S, Milnes L. An exploration of how young people and parents use online support in the context of living with cystic fibrosis. Health expectations : an international journal of public participation in health care and health policy. 2016;19(2):309-21. doi: 10.1111/hex.12352. PubMed PMID: 25691209; PubMed Central PMCID: PMC5055278.

^11. Helms SW, Dellon EP, Prinstein MJ. Friendship quality and health-related outcomes among adolescents with cystic fibrosis. Journal of pediatric psychology. 2015;40(3):349-58. doi: 10.1093/jpepsy/jsu063. PubMed PMID: 25096236.