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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05074901
- Acronym / sponsor ID
- KANOPEE / CHUBX2020GSP0102
- Conditions
- Mental Disorder, Mental Stress, Insomnia, Depression, Anxiety
- Keywords
- e-health, embodied conversational agent, ecological momentary assessment, ecological momentary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University of BordeauxUniversity, hospital or other
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Open populational trial
| Arm | Type | Receives |
|---|---|---|
| digital behavioral intervention | Experimental | Behavioral: digital behavioral interventionDigital behavioral interventions to improve mood and decrease fatigue, sleep complaints and substance usage. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital behavioral interventioninteraction with a conversational agent to implement physical and cognitive programs | Behavioural | digital behavioral intervention |
Primary outcome
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.
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.
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 40206328Sagaspe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Philip, Pr principal investigator
University of Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital behavioral intervention in people with Mental Disorder and Mental Stress, run by University of Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Philip, Pr (+33557820172, pierre.philip@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep complaints (time frame: weekly, from the downloading of the app until two weeks after the end of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05074901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.