Clinical trial NCT05074901: Virtual Agents-based Digital Interventions to Improve Health
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Disorder
Mental Stress
Insomnia
Depression
Anxiety
Keywords: e-health
embodied conversational agent
ecological momentary assessment
ecological momentary intervention
Lead sponsor: University of Bordeaux
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open populational trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep complaints
timeFrame: weekly, from the downloading of the app until two weeks after the end of the intervention
measure: Fatigue complaints
timeFrame: weekly, from the downloading of the app until two weeks after the end of the intervention
measure: Depression and anxiety complaints
timeFrame: weekly, from the downloading of the app until two weeks after the end of the intervention
Secondary outcomes:
measure: Total Sleep Time
timeFrame: daily, from the downloading of the app until two weeks after the end of the intervention
measure: Sleep Efficiency
timeFrame: daily, from the downloading of the app until two weeks after the end of the intervention
measure: Time In Bed
timeFrame: daily, from the downloading of the app until two weeks after the end of the intervention
measure: Sleep Onset Latency
timeFrame: daily, from the downloading of the app until two weeks after the end of the intervention
measure: Wakefulness After Sleep Onset
timeFrame: daily, from the downloading of the app until two weeks after the end of the intervention
measure: Number of Awakenings
timeFrame: daily, from the downloading of the app until two weeks after the end of the intervention
measure: number of episodes of craving
timeFrame: daily, from the downloading of the app until two weeks after the end of the intervention
measure: amount of substance usage
timeFrame: daily, from the downloading of the app until two weeks after the end of the intervention
Other outcomes:
measure: application's acceptance
timeFrame: facultative questionnaire that user can fill up after any interaction with the app (thus weekly)
Locations:
city: Bordeaux
country: France
facility: University of Bordeaux
Study officials:
affiliation: University of Bordeaux
name: Pierre Philip, Pr
role: PRINCIPAL_INVESTIGATOR
References: