Virtual Agents-based Digital Interventions to Improve Health (KANOPEE)

University of Bordeaux

Status: Enrolling

Conditions: Mental Stress; Mental Disorder; Insomnia; Depression; Anxiety

Treatments: Behavioral: digital behavioral intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05074901

CHUBX2020GSP0102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20,000 participants in 2 patient groups

digital behavioral intervention

Experimental group

Description:

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

Treatment:

Behavioral: digital behavioral intervention

e-diaries

No Intervention group

Description:

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