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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20,000
- Locations
- 1
- Primary Endpoint
- Sleep complaints
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
digital behavioral intervention
Digital behavioral interventions to improve mood and decrease fatigue, sleep complaints and substance usage.
Intervention: digital behavioral intervention (Behavioral)
e-diaries
Ecological momentary assessment based on e-diaries on a weekly basis to evaluate sleep/wake schedules, physical activity, substance usage and nutrition.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Time In Bed(daily, from the downloading of the app until two weeks after the end of the intervention)
- Total Sleep Time(daily, from the downloading of the app until two weeks after the end of the intervention)
- amount of substance usage(daily, from the downloading of the app until two weeks after the end of the intervention)
- Sleep Onset Latency(daily, from the downloading of the app until two weeks after the end of the intervention)
- Sleep Efficiency(daily, from the downloading of the app until two weeks after the end of the intervention)
- Wakefulness After Sleep Onset(daily, from the downloading of the app until two weeks after the end of the intervention)
- Number of Awakenings(daily, from the downloading of the app until two weeks after the end of the intervention)
- number of episodes of craving(daily, from the downloading of the app until two weeks after the end of the intervention)
Investigators
Pierre Philip
Professor
University of Bordeaux