REMOTE: Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder: Smartphone and Wearable Sensors
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anxiety Disorders
- Sponsor
- humanITcare
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Change in Self-reported Anxiety symptoms assessed with the State-Trait Anxiety Inventory (STAI)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The objective of this study is to analyze the physiological patterns of two groups of patients, one control and one with anxiety disorder and alcoholic abuse disorder using sensor data from mobile devices and wearables. This data will be compared to the data presented by three clinical questionnaires: State-trait Anxiety Inventory (STAI), the Alcohol Use Disorders Identification Test (AUDIT), and the Beck's Depression Inventory (BDI-II) in order to determine the feasibility of remote collected data.
Detailed Description
The objective of this study is to analyze the physiological patterns of two groups of patients, one control and one with anxiety disorder and alcoholic abuse disorder using sensor data from mobile devices and wearables. This data, collected by sensors, will be compared to the data presented by three clinical questionnaires: State-trait Anxiety Inventory (STAI), the Alcohol Use Disorders Identification Test (AUDIT), and the Beck's Depression Inventory (BDI-II) in order to determine the feasibility of using remote collected data in routine clinical practice. Furthermore, patient satisfaction with the app will be evaluated after the data collection phase. This is a unicentric, case-controlled, longitudinal, evaluational, national study with two groups, one control of healthy individuals without symptoms of anxiety or depression, and another experimental group in which participants fulfill the given selection criteria for the trial. There are a total of 60 participants split evenly between the two groups.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18-65 years of age.
- •Alcohol use disorder (DSM 5) as main substance.
- •Anxiety (STAI \> percentile 33) and, if depressive symptoms, not clinically relevant as to accomplish DSM5 diagnostic criteria for mood disorders (major depressive disorder, bipolar disorder...).
- •Having a mobile phone compatible with Android.
- •Sign informed consent.
Exclusion Criteria
- •Mood disorder diagnoses (DSM5).
- •Cognitive deficits that prevent the participation.
- •Active intake of other substances (except for nicotine).
Outcomes
Primary Outcomes
Change in Self-reported Anxiety symptoms assessed with the State-Trait Anxiety Inventory (STAI)
Time Frame: One month, questionnaire taken 4 times (1/week)
Taken through the application "Ushine". Participants receive STAI scores ranging from 0-60, 0 being lowest amount of symptoms, and 60 being the greatest amount of symptoms, which are then transformed into percentiles according to age and sex.
Sleep pattern
Time Frame: One month
Monitoring of circadian rhythm using a motion sensor Fitbit and cardiac activity sensor
REM sleep time
Time Frame: One month
monitoring of REM sleep patterns using a motion sensor Fitbit and cardiac activity sensor
Heart Rate
Time Frame: One month
monitoring of heart rate using Fitbit sensor
Step count
Time Frame: One month
Monitoring of daily step count using motion sensor FitBit
Distance travelled
Time Frame: One month
Monitoring of distance travelled using GPS phone
Mobile device usage
Time Frame: One month
Monitoring how often the patient's mobile device is used, determined by tracking the presence of a signal from their device
Sociability (number of incoming an outgoing calls and text messages)
Time Frame: One month
The number of incoming and outgoing calls and text messages will be monitored using the UShine app algorithm
Change in Self-reported Depression symptoms assessed with the Beck's Depression Inventory (BDI-II)
Time Frame: One month, questionnaire taken 4 times (1/week)
Taken through the application "Ushine". Participants receive BDI-II scores ranging from 1-63, with a score of 0-13 indicating minimal depression, 14-19 indicating mild depression, 20-28 indicating moderate depression, and 29-63 indicating severe depression.
Change in Self-reported Alcohol Abuse Symptoms assesed with the Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: One month, questionnaire taken 4 times (1/week)
Taken through the application "Ushine". Participants receive AUDIT scores ranging from 0-40. A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.
Secondary Outcomes
- Usability of the mobile application(One month)
- Satisfaction with the application(One month)