Virtual Agents-based Digital Interventions to Improve Health

Study Overview
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Brief Summary
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KANOPEE is a free smartphone application providing screening, follow-up tools and autonomous digital interventions to lower psycho-social stress and its repercussions on sleep and behaviors in the general population. Additionally, KANOPEE permits an adaptation of the intervention to the subject (i.e., an adapted waiting period, frequency, and content), enabling to perform innovative trial conditions. The objective of this long-term study is to evaluate the efficacy of KANOPEE on users among the French general population exposed to psycho-social stress.

Detailed Description
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KANOPEE was designed by sleep specialists and psychiatrists to propose autonomous interventions to improve sleep, physical activity and substance abuse ; aiming at lowering psycho-social stress's repercussions. The app provides weekly interactions with a virtual companion. At each interaction, users answer standardized questionnaires (e.g., Insomnia Severity Index, Cigarette Dependence Scale) enabling to characterize users' health status (i.e;, the severity of the complaints) and evolution over time, and therefore provide adapted interventions based on the literature (e.g., digital Cognitive Behavioral Therapies, diaries, sleep hygiene recommendations, motivational interviewing). The app is freely available to the general population in France, enabling very large sample size, and the possibility to perform non-randomized trials depending on the selected interventions by the users and the subject's group.

Official Title
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Acceptance and Efficacy of a Smartphone-based App Using a Conversational Agent to Monitor Health Status and/or Deliver Behavioral Intervention to Reduce Psycho-social Stress

Conditions
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Mental Disorder, Mental Stress, Insomnia, Depression, Anxiety

Intervention / Treatment
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* Behavioral: digital behavioral intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being aged 18 years old and over (the app is available for younger users but their data will not be analyzed) having downloaded the app having a smartphone Android or Iphone being located in France having accepted the electronic informed consent Exclusion Criteria: having clicked on the emergency button (in the app, there is a warning message : this app is not for emergency situations. If you need an urgent psychological support, click here) having downloaded the app but without answering any questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open populational trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: digital behavioral intervention<br>Digital behavioral interventions to improve mood and decrease fatigue, sleep complaints and substance usage. | Behavioral: digital behavioral intervention<br>* interaction with a conversational agent to implement physical and cognitive programs<br>|
| No Intervention: e-diaries<br>Ecological momentary assessment based on e-diaries on a weekly basis to evaluate sleep/wake schedules, physical activity, substance usage and nutrition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep complaints | measured by the Insomnia Severity Index (ISI), total score ranging from 0 to 28, higher score indicating higher sleep complaint. | weekly, from the downloading of the app until two weeks after the end of the intervention | 
| Fatigue complaints | measured by the Fatigue Severity Scale (FSS), total score ranging from 1 to 7, higher score indicating higher perceived fatigue. | weekly, from the downloading of the app until two weeks after the end of the intervention | 
| Depression and anxiety complaints | measured by the Patient Health Questionnaire 4 items (PHQ-4), total score ranging from 0 to 12, higher scores indicating higher depression or anxiety complaints. | weekly, from the downloading of the app until two weeks after the end of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time | calculated based on the sleep diary data, corresponding to the actual time slept (Time in Bed - Sleep Onset Latency - Wakefulness After Sleep Onset - Terminal Wakefulness) (in hh:mm:ss) | daily, from the downloading of the app until two weeks after the end of the intervention | 
| Sleep Efficiency | calculated based on the sleep diary data, corresponding to the percent of time in bed spent asleep (Total Sleep Time/Time in Bed * 100) (percentage) | daily, from the downloading of the app until two weeks after the end of the intervention | 
| Time In Bed | calculated based on the sleep diary data, time starting from the moment of intention to fall asleep and concluding with the final arising (in hh:mm:ss). | daily, from the downloading of the app until two weeks after the end of the intervention | 
| Sleep Onset Latency | calculated based on the sleep diary data, corresponding to the time it takes to fall asleep, starting from the moment of intention to fall asleep (in hh:mm:ss) | daily, from the downloading of the app until two weeks after the end of the intervention | 
| Wakefulness After Sleep Onset | calculated based on the sleep diary data, corresponding to the total amount of time awake during the night (in hh:mm:ss) | daily, from the downloading of the app until two weeks after the end of the intervention | 
| Number of Awakenings | calculated based on the sleep diary data, corresponding to the total number of time awakenings during the night (number from 0 to 15) | daily, from the downloading of the app until two weeks after the end of the intervention | 
| number of episodes of craving | self-reporting number of moment during a day when the user felt the irresistible need to consume a substance (e.g., tobacco, alcohol) | daily, from the downloading of the app until two weeks after the end of the intervention | 
| amount of substance usage | self-reporting number of substance (e.g., cigarette, drinks) consumed during a day | daily, from the downloading of the app until two weeks after the end of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-health, embodied conversational agent, ecological momentary assessment, ecological momentary intervention