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

NCT03991650 | Completed DMC

• 1 other identifier: humanITcare: Remote
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Alcohol Use Disorder; Depressive Disorder

Keywords

wearable; sensor; anxiety; monitoring; ehealth; Alcohol Use Disorder; depression

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (2)

• Usability of the mobile application

  One month

• Satisfaction with the application

  One month

Study Arms (2)

Control

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

Experimental

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

Interventions

Monitoring with a device BEHAVIORAL

Participants will be monitored by an App.

Control; Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There will be a sample n = 60, with 30 healthy control subjects and 30 afflicted experimental subjects.

You may qualify if:

• 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.

You may not qualify if:

• Mood disorder diagnoses (DSM5).
• Cognitive deficits that prevent the participation.
• Active intake of other substances (except for nicotine).

Sponsors & Collaborators

• humanITcare: lead
• Hospital Clinic of Barcelona: collaborator
• European Institute of Innovation and Technology: collaborator

Study Sites (1)

Hospitcal Clínic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (17)

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  BACKGROUND

Related Links

• World Health Organization. Global Status Report on Alcohol and Health (2018).
• World Health Organization. Mental depression and other common disorders: Global health estimates (2017).

MeSH Terms

Conditions

Anxiety Disorders; Alcoholism; Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Antoni Gual, MD

  Director of Addictions Unit. Hospital Clínic de Barcelona

  PRINCIPAL INVESTIGATOR

• Elsa Caballeria

  Clinic Foundation for Biomedical Research

  STUDY CHAIR

• Hugo Lopez-Pelayo, MD

  Addictions Unit, Hospital Clínic de Barcelona

  STUDY CHAIR

• Nuria Pastor Hernandez, MSc

  humanITcare, FollowHealth SL

  STUDY DIRECTOR

• Unai Sanchez Luque, MSc

  humanITcare, FollowHealth SL

  STUDY DIRECTOR

• Elizabeth Katayoun Khalilian

  humanITcare, University of Texas at Austin

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: February 1, 2019
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be available by the estimated date of September 2019, when study results are expected to be published
• Access Criteria: Participants can access their own individual data records, only hospital researchers can access the aggregated data sets.

Locations

ES (1)