Alcohol Use Disorder, Anxiety Disorders, Depressive Disorder
Conditions
Keywords
wearable, sensor, anxiety, monitoring, ehealth, Alcohol Use Disorder, depression
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.
Interventions
BEHAVIORALMonitoring with a device
Participants will be monitored by an App.
Sponsors
Hospital Clinic of Barcelona
European Institute of Innovation and Technology
humanITcare
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-reported Alcohol Abuse Symptoms assesed with the Alcohol Use Disorders Identification Test (AUDIT) | 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. |
| Sociability (number of incoming an outgoing calls and text messages) | 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) | 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 Anxiety symptoms assessed with the State-Trait Anxiety Inventory (STAI) | 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 | One month | Monitoring of circadian rhythm using a motion sensor Fitbit and cardiac activity sensor |
| REM sleep time | One month | monitoring of REM sleep patterns using a motion sensor Fitbit and cardiac activity sensor |
| Heart Rate | One month | monitoring of heart rate using Fitbit sensor |
| Step count | One month | Monitoring of daily step count using motion sensor FitBit |
| Distance travelled | One month | Monitoring of distance travelled using GPS phone |
| Mobile device usage | One month | Monitoring how often the patient's mobile device is used, determined by tracking the presence of a signal from their device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with the application | One month | 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. |
| Usability of the mobile application | One month | 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. |
Countries
Spain
Outcome results
None listed