Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05074901

Virtual Agents-based Digital Interventions to Improve Health

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Mental Disorder Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Dyssomnias Insomnia Mental Disorders Mental Stress Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bordeaux

Bordeaux, 33000, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

digital behavioral intervention

Behavioral

interaction with a conversational agent to implement physical and cognitive programs

Primary outcomes

  1. Sleep complaints

    Time frame: 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.

  2. Fatigue complaints

    Time frame: 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.

  3. Depression and anxiety complaints

    Time frame: 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.

Secondary outcomes

  1. Total Sleep Time

    Time frame: 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)

  2. Sleep Efficiency

    Time frame: 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)

  3. Time In Bed

    Time frame: 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).

  4. Sleep Onset Latency

    Time frame: 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)

  5. Wakefulness After Sleep Onset

    Time frame: 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)

  6. Number of Awakenings

    Time frame: 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)

  7. number of episodes of craving

    Time frame: 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)

  8. amount of substance usage

    Time frame: 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

Other outcomes

  1. application's acceptance

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Etienne de Sevin, Ph.D.

CONTACT

[email protected]

+33547304242

Pierre Philip, Pr

CONTACT

[email protected]

+33557820172

Sponsors and collaborators

Lead sponsor

University of Bordeaux

Other

Registry information

Official study 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

Acronym: KANOPEE

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Oct 12, 2021
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.