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Completed

NCT Number: NCT03991650

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

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.

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Key information

Conditions

Anxiety Disorders Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Depressive Disorder Mental Disorders Mood Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospitcal Clínic de Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Monitoring with a device

Behavioral

Participants will be monitored by an App.

Primary outcomes

  1. 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.

  2. Sleep pattern

    Time frame: One month

    Monitoring of circadian rhythm using a motion sensor Fitbit and cardiac activity sensor

  3. REM sleep time

    Time frame: One month

    monitoring of REM sleep patterns using a motion sensor Fitbit and cardiac activity sensor

  4. Heart Rate

    Time frame: One month

    monitoring of heart rate using Fitbit sensor

  5. Step count

    Time frame: One month

    Monitoring of daily step count using motion sensor FitBit

  6. Distance travelled

    Time frame: One month

    Monitoring of distance travelled using GPS phone

  7. 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

  8. 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

  9. 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.

  10. 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

  1. Usability of the mobile application

    Time frame: 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.

  2. Satisfaction with the application

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

humanITcare

Network

Collaborators

  • European Institute of Innovation and Technology
  • Hospital Clinic of Barcelona

Registry information

Official study title

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

Acronym: REMOTE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2019
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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