Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder

Study 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.

Official Title
-----------------
REMOTE: Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder: Smartphone and Wearable Sensors

Conditions
-----------------
Anxiety Disorders, Alcohol Use Disorder, Depressive Disorder

Intervention / Treatment
-----------------
* Behavioral: Monitoring with a device


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>n=30 healthy participants will be recruited using social networks and leaflets of information distributed by the research team at the Hospital Cliníc de Barcelona. The participants will be monitored over the course of one month using the humanITcare app U-Shine, which will track participant's sociability, device usage, and location frequency using mobile sensors. Participants' data will also be monitored with a FitBit device to track sleep schedules, heart rate, and step count. During the weekly follow-up, they will have to complete the three clinical questionnaires taken at the initial visit. | Behavioral: Monitoring with a device<br>* Participants will be monitored by an App.<br>|
| Experimental<br>The recruitment process will be carried out in patients of external consultations and the day hospital of the Addictions Unit at the Hospital Clinic of Barcelona. n=30 patients with Anxiety and Alcohol Use Disorder. The participants will be monitored over the course of one month using the humanITcare app U-Shine, which will track participant's sociability, device usage, and location frequency using mobile sensors. Participants will also be monitored using a FitBit device to track sleep schedules, heart rate, and step count. During the weekly follow-up, they will have to complete the three clinical questionnaires taken at the initial visit. | Behavioral: Monitoring with a device<br>* Participants will be monitored by an App.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-reported Anxiety symptoms assessed with the State-Trait Anxiety Inventory (STAI) | 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. | One month, questionnaire taken 4 times (1/week) | 
| Sleep pattern | Monitoring of circadian rhythm using a motion sensor Fitbit and cardiac activity sensor | One month | 
| REM sleep time | monitoring of REM sleep patterns using a motion sensor Fitbit and cardiac activity sensor | One month | 
| Heart Rate | monitoring of heart rate using Fitbit sensor | One month | 
| Step count | Monitoring of daily step count using motion sensor FitBit | One month | 
| Distance travelled | Monitoring of distance travelled using GPS phone | One month | 
| Mobile device usage | Monitoring how often the patient's mobile device is used, determined by tracking the presence of a signal from their device | One month | 
| Sociability (number of incoming an outgoing calls and text messages) | The number of incoming and outgoing calls and text messages will be monitored using the UShine app algorithm | One month | 
| Change in Self-reported Depression symptoms assessed with the Beck's Depression Inventory (BDI-II) | 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. | One month, questionnaire taken 4 times (1/week) | 
| Change in Self-reported Alcohol Abuse Symptoms assesed with the Alcohol Use Disorders Identification Test (AUDIT) | 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. | One month, questionnaire taken 4 times (1/week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the mobile application | Ease of usability of the mobile applications by participants will be scaled using the System Usability Scale (SUS). Final scores range from 0-100. A score of 51 or under means the system has serious faults in usability, a score of 68 means the system usability is about average, and a score of 80.3 or higher means the system usability is considered appreciable. | One month | 
| Satisfaction with the application | Participants' satisfaction with the Ushine application will be scaled using the Post-Study Usability Questionnaire (PSSUQ). Scores range from 0-100, 0 being least satisfactory and 100 being the most satisfactory. The PSSUQ has 3 sub-scores representing system usefulness, information quality, and interface quality, also scaled from 0-100. In all score sets, 0 is considered the least satisfactory and 100 is considered the most satisfactory. | One month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wearable, sensor, anxiety, monitoring, ehealth, Alcohol Use Disorder, depression