Virtual Agents-based Digital Interventions to Improve Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: digital behavioral intervention.
- Who it may be relevant to
- Registry conditions: Mental Disorder, Mental Stress, Insomnia, Depression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
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.
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
- Behavioral digital behavioral intervention
interaction with a conversational agent to implement physical and cognitive programs
Primary outcome measures
- Sleep complaints [Time frame: weekly, from the downloading of the app until two weeks after the end of the intervention]
- Fatigue complaints [Time frame: weekly, from the downloading of the app until two weeks after the end of the intervention]
- Depression and anxiety complaints [Time frame: weekly, from the downloading of the app until two weeks after the end of the intervention]
Secondary outcome measures (8)
- Total Sleep Time [Time frame: daily, from the downloading of the app until two weeks after the end of the intervention]
- Sleep Efficiency [Time frame: daily, from the downloading of the app until two weeks after the end of the intervention]
- Time In Bed [Time frame: daily, from the downloading of the app until two weeks after the end of the intervention]
- Sleep Onset Latency [Time frame: daily, from the downloading of the app until two weeks after the end of the intervention]
- Wakefulness After Sleep Onset [Time frame: daily, from the downloading of the app until two weeks after the end of the intervention]
- Number of Awakenings [Time frame: daily, from the downloading of the app until two weeks after the end of the intervention]
- number of episodes of craving [Time frame: daily, from the downloading of the app until two weeks after the end of the intervention]
- amount of substance usage [Time frame: daily, from the downloading of the app until two weeks after the end of the intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
France · 1 center
- University of Bordeaux — Bordeaux
Publications
- Sagaspe P, Sanchez-Ortuno MM, Dupuy L, Pecune F, Coelho J, Micoulaud-Franchi JA, Levavasseur Y, de Sevin E, Chanteclair A, Philip P, Salles N. Perceptions and Effectiveness of a Fully Automated Brief Behavioral Insomnia Therapy, Delivered by a Virtual Companion, in Older and Young Adults. Innov Aging. 2024 Sep 24;9(2):igae086. doi: 10.1093/geroni/igae086. eCollection 2025. PMID 40206328
Identifiers
NCT: NCT05074901 · CHUBX2020GSP0102