Anxiety, Depression, Insomnia, Mental Disorder, Mental Stress
Conditions
Keywords
e-health, embodied conversational agent, ecological momentary assessment, ecological momentary intervention
Brief summary
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
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.
Interventions
BEHAVIORALdigital behavioral intervention
interaction with a conversational agent to implement physical and cognitive programs
Sponsors
University of Bordeaux
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
Open populational trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression and anxiety complaints | weekly, from the downloading of the app until two weeks after the end of the intervention | 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. |
| Sleep complaints | weekly, from the downloading of the app until two weeks after the end of the intervention | measured by the Insomnia Severity Index (ISI), total score ranging from 0 to 28, higher score indicating higher sleep complaint. |
| Fatigue complaints | weekly, from the downloading of the app until two weeks after the end of the intervention | measured by the Fatigue Severity Scale (FSS), total score ranging from 1 to 7, higher score indicating higher perceived fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time In Bed | daily, from the downloading of the app until two weeks after the end of the intervention | 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). |
| Sleep Onset Latency | daily, from the downloading of the app until two weeks after the end of the intervention | 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) |
| Wakefulness After Sleep Onset | daily, from the downloading of the app until two weeks after the end of the intervention | calculated based on the sleep diary data, corresponding to the total amount of time awake during the night (in hh:mm:ss) |
| number of episodes of craving | daily, from the downloading of the app until two weeks after the end of the intervention | self-reporting number of moment during a day when the user felt the irresistible need to consume a substance (e.g., tobacco, alcohol) |
| amount of substance usage | daily, from the downloading of the app until two weeks after the end of the intervention | self-reporting number of substance (e.g., cigarette, drinks) consumed during a day |
| Number of Awakenings | daily, from the downloading of the app until two weeks after the end of the intervention | calculated based on the sleep diary data, corresponding to the total number of time awakenings during the night (number from 0 to 15) |
| Total Sleep Time | daily, from the downloading of the app until two weeks after the end of the intervention | 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) |
| Sleep Efficiency | daily, from the downloading of the app until two weeks after the end of the intervention | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| application's acceptance | facultative questionnaire that user can fill up after any interaction with the app (thus weekly) | measured by the Acceptability of E-health Scale (AES), total score ranging from 0 to 30, higher score indicating a better acceptance of the app |
Countries
France
Contacts
Primary ContactPierre Philip, Pr
Backup ContactEtienne de Sevin, Ph.D.
Outcome results
None listed