Virtual Agents-based Digital Interventions to Improve Health

Depression Clinical Trial

— KANOPEE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05074901
• Other study ID #: CHUBX2020GSP0102
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2021
• Source: University of Bordeaux
• Contact: Pierre Philip, Pr
• Phone: +33557820172
• Email: pierre.philip[@]u-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Insomnia
• Mental Disorder
• Mental Disorders
• Mental Stress
• Stress, Psychological

Intervention

Behavioral:
• digital behavioral intervention
interaction with a conversational agent to implement physical and cognitive programs

Locations

Country	Name	City	State
France	University of Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University of Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	application's acceptance	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	facultative questionnaire that user can fill up after any interaction with the app (thus weekly)
Primary	Sleep complaints	measured by the Insomnia Severity Index (ISI), total score ranging from 0 to 28, higher score indicating higher sleep complaint.	weekly, from the downloading of the app until two weeks after the end of the intervention
Primary	Fatigue complaints	measured by the Fatigue Severity Scale (FSS), total score ranging from 1 to 7, higher score indicating higher perceived fatigue.	weekly, from the downloading of the app until two weeks after the end of the intervention
Primary	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.	weekly, from the downloading of the app until two weeks after the end of the intervention
Secondary	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)	daily, from the downloading of the app until two weeks after the end of the intervention
Secondary	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)	daily, from the downloading of the app until two weeks after the end of the intervention
Secondary	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).	daily, from the downloading of the app until two weeks after the end of the intervention
Secondary	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)	daily, from the downloading of the app until two weeks after the end of the intervention
Secondary	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)	daily, from the downloading of the app until two weeks after the end of the intervention
Secondary	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)	daily, from the downloading of the app until two weeks after the end of the intervention
Secondary	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)	daily, from the downloading of the app until two weeks after the end of the intervention
Secondary	amount of substance usage	self-reporting number of substance (e.g., cigarette, drinks) consumed during a day	daily, from the downloading of the app until two weeks after the end of the intervention