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一种数字生物数据驱动的焦虑和抑郁干预措施的可行性、参与度及初步临床结果

Feasibility, engagement, and preliminary clinical outcomes of a digital biodata-driven intervention for anxiety and depression.

作者信息

Tsirmpas Charalampos, Andrikopoulos Dimitrios, Fatouros Panagiotis, Eleftheriou Georgios, Anguera Joaquin A, Kontoangelos Konstantinos, Papageorgiou Charalabos

机构信息

Feel Therapeutics Inc., San Francisco, CA, United States.

Departments of Neurology and Psychiatry, University of California, San Francisco, San Francisco, CA, United States.

出版信息

Front Digit Health. 2022 Jul 22;4:868970. doi: 10.3389/fdgth.2022.868970. eCollection 2022.

Abstract

HYPOTHESIS

The main hypothesis is that a digital, biodata-driven, and personalized program would exhibit high user retention and engagement, followed by more effective management of their depressive and anxiety symptoms.

OBJECTIVE

This pilot study explores the feasibility, acceptability, engagement, and potential impact on depressive and anxiety and quality of life outcomes of the 16-week Feel Program. Additionally, it examines potential correlations between engagement and impact on mental health outcomes.

METHODS

This single-arm study included 48 adult participants with mild or moderate depressive or anxiety symptoms who joined the 16-week Feel Program, a remote biodata-driven mental health support program created by Feel Therapeutics. The program uses a combination of evidence-based approaches and psychophysiological data. Candidates completed an online demographics and eligibility survey before enrolment. Depressive and anxiety symptoms were measured using the Patient Health Questionnaire and Generalized Anxiety Disorder Scale, respectively. The Satisfaction with Life Scale and the Life Satisfaction Questionnaire were used to assess quality of life. User feedback surveys were employed to evaluate user experience and acceptability.

RESULTS

In total, 31 participants completed the program with an overall retention rate of 65%. Completed participants spent 60 min in the app, completed 13 Mental Health Actions, including 5 Mental Health Exercises and 4.9 emotion logs on a weekly basis. On average, 96% of the completed participants were active and 76.8% of them were engaged with the sensor during the week. Sixty five percent of participants reported very or extremely high satisfaction, while 4 out of 5 were very likely to recommend the program to someone. Additionally, 93.5% of participants presented a decrease in at least one of the depressive or anxiety symptoms, with 51.6 and 45% of participants showing clinically significant improvement, respectively. Finally, our findings suggest increased symptom improvement for participants with higher engagement throughout the program.

CONCLUSIONS

The findings suggest that the Feel Program may be feasible, acceptable, and valuable for adults with mild or moderate depressive and/or anxiety symptoms. However, controlled trials with bigger sample size, inclusion of a control group, and more diverse participant profiles are required in order to provide further evidence of clinical efficacy.

摘要

假设

主要假设是一个数字化、由生物数据驱动且个性化的项目将表现出高用户留存率和参与度,进而更有效地管理他们的抑郁和焦虑症状。

目的

这项试点研究探讨了为期16周的“感受计划”的可行性、可接受性、参与度以及对抑郁、焦虑和生活质量结果的潜在影响。此外,它还研究了参与度与对心理健康结果的影响之间的潜在相关性。

方法

这项单臂研究纳入了48名有轻度或中度抑郁或焦虑症状的成年参与者,他们参加了为期16周的“感受计划”,这是由感受疗法公司创建的一个远程生物数据驱动的心理健康支持项目。该项目结合了循证方法和心理生理数据。候选人在入组前完成了一份在线人口统计学和资格调查问卷。分别使用患者健康问卷和广泛性焦虑障碍量表来测量抑郁和焦虑症状。使用生活满意度量表和生活满意度问卷来评估生活质量。采用用户反馈调查来评估用户体验和可接受性。

结果

总共有31名参与者完成了该项目,总体留存率为65%。完成项目的参与者在应用程序中花费了60分钟,每周完成13项心理健康行动,包括5项心理健康练习和4.9篇情绪日志。平均而言,96%的完成项目的参与者每周都很活跃,其中76.8%的人在一周内使用了传感器。65%的参与者表示非常或极其满意,五分之四的人非常有可能向他人推荐该项目。此外,93.5%的参与者至少有一项抑郁或焦虑症状有所减轻,分别有51.6%和45%的参与者表现出临床上的显著改善。最后,我们的研究结果表明,在整个项目中参与度较高的参与者症状改善更为明显。

结论

研究结果表明,“感受计划”对于有轻度或中度抑郁和/或焦虑症状的成年人可能是可行的、可接受的且有价值的。然而,需要进行更大样本量、纳入对照组且参与者特征更多样化的对照试验,以便为临床疗效提供进一步的证据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bb6/9359094/e0c243258977/fdgth-04-868970-g0001.jpg

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