Mental DisorderKANOPEENCT05074901
Virtual Agents-based Digital Interventions to Improve Health
A study testing digital behavioral intervention in people with Mental Disorder and Mental Stress, run by University of Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Mental Stress, Insomnia
- What is being tested?
- digital behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2020to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Mental Disorder, Mental Stress, Insomnia, Depression, Anxiety
- Being tested
- digital behavioral intervention
- Keywords
- e-health, embodied conversational agent, ecological momentary assessment, ecological momentary intervention
- Medical subject headings
- Mental Disorders, Stress, Psychological, Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital behavioral interventionBehavioural
interaction with a conversational agent to implement physical and cognitive programs
| Study group | Role | What they receive |
|---|---|---|
| digital behavioral intervention | Experimental | Digital behavioral interventions to improve mood and decrease fatigue, sleep complaints and substance usage. Receives: Behavioral: digital behavioral intervention |
| e-diaries | No intervention | Ecological momentary assessment based on e-diaries on a weekly basis to evaluate sleep/wake schedules, physical activity, substance usage and nutrition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep complaints
measured by the Insomnia Severity Index (ISI), total score ranging from 0 to 28, higher score indicating higher sleep complaint.
Measured: 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.
Measured: 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.
Measured: weekly, from the downloading of the app until two weeks after the end of the intervention
Secondary outcomes (8)
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)
Measured: daily, from the downloading of the app until two weeks after the end of the intervention
Sleep Efficiency
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)
Measured: daily, from the downloading of the app until two weeks after the end of the intervention
Time In Bed
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).
Measured: daily, from the downloading of the app until two weeks after the end of the intervention
Sleep Onset Latency
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)
Measured: daily, from the downloading of the app until two weeks after the end of the intervention
Wakefulness After Sleep Onset
calculated based on the sleep diary data, corresponding to the total amount of time awake during the night (in hh:mm:ss)
Measured: daily, from the downloading of the app until two weeks after the end of the intervention
Number of Awakenings
calculated based on the sleep diary data, corresponding to the total number of time awakenings during the night (number from 0 to 15)
Measured: daily, from the downloading of the app until two weeks after the end of the intervention
number of episodes of craving
self-reporting number of moment during a day when the user felt the irresistible need to consume a substance (e.g., tobacco, alcohol)
Measured: daily, from the downloading of the app until two weeks after the end of the intervention
amount of substance usage
self-reporting number of substance (e.g., cigarette, drinks) consumed during a day
Measured: daily, from the downloading of the app until two weeks after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start22 Apr 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open populational trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Philip, University of Bordeaux
- Investigators
- Pierre Philip, Pr, Principal investigator, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074901
- Sponsor's protocol ID
- CHUBX2020GSP0102
- Acronym
- KANOPEE
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40206328