Virtual Agents-based Digital Interventions to Improve Health

NCT ID: NCT05074901

Last Updated: 2021-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-22

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Mental Disorder Mental Stress Insomnia Depression Anxiety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Open populational trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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digital behavioral intervention

Digital behavioral interventions to improve mood and decrease fatigue, sleep complaints and substance usage.

Group Type EXPERIMENTAL

digital behavioral intervention

Intervention Type BEHAVIORAL

interaction with a conversational agent to implement physical and cognitive programs

e-diaries

Ecological momentary assessment based on e-diaries on a weekly basis to evaluate sleep/wake schedules, physical activity, substance usage and nutrition.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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digital behavioral intervention

interaction with a conversational agent to implement physical and cognitive programs

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Pierre Philip

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre Philip, Pr

Role: PRINCIPAL_INVESTIGATOR

University of Bordeaux

Locations

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University of Bordeaux

Bordeaux, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre Philip, Pr

Role: CONTACT

+33557820172

Etienne de Sevin, Ph.D.

Role: CONTACT

+33547304242

References

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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.

Reference Type DERIVED
PMID: 40206328 (View on PubMed)

Other Identifiers

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CHUBX2020GSP0102

Identifier Type: -

Identifier Source: org_study_id