Virtual Agents-based Digital Interventions to Improve Health

University of Bordeaux20,000 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

20,000

Conditions

Mental Disorder

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Sleep complaints

measured by the Insomnia Severity Index (ISI), total score ranging from 0 to 28, higher score indicating higher sleep complaint.

Time frame: 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.

Time frame: 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.

Time frame: weekly, from the downloading of the app until two weeks after the end of the intervention

Secondary Outcomes

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)