Anxiety DisordersREMOTENCT03991650

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

An observational study of Anxiety Disorders and Alcohol Use Disorder, run by humanITcare at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety Disorders, Alcohol Use Disorder, Depressive Disorder
What is being tested?: Monitoring with a device
Type of treatment: Lifestyle or therapy programme
How many people: 44 participants
Where: 1 siteSpain
Study dates: 1 Feb 2019to 5 Nov 2019
How long will I take part?: 1 Month
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospitcal Clínic de Barcelona
Barcelona, 08036

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions: Anxiety Disorders, Alcohol Use Disorder, Depressive Disorder
Being tested: Monitoring with a device
Keywords: wearable, sensor, anxiety, monitoring, ehealth, Alcohol Use Disorder, depression
Medical subject headings: Anxiety Disorders, Alcoholism, Depressive Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Monitoring with a deviceBehavioural
Participants will be monitored by an App.

Study groups in NCT03991650
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Monitoring with a device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: One month, questionnaire taken 4 times (1/week)
Sleep pattern
Monitoring of circadian rhythm using a motion sensor Fitbit and cardiac activity sensor
Measured: One month
REM sleep time
monitoring of REM sleep patterns using a motion sensor Fitbit and cardiac activity sensor
Measured: One month
Heart Rate
monitoring of heart rate using Fitbit sensor
Measured: One month
Step count
Monitoring of daily step count using motion sensor FitBit
Measured: One month
Distance travelled
Monitoring of distance travelled using GPS phone
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: One month, questionnaire taken 4 times (1/week)

Secondary outcomes (2)

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.
Measured: 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.
Measured: One month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20195 Nov 2019

First posted19 Jun 2019
Study start1 Feb 2019
Primary completion5 Nov 2019
Study completion5 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Anxiety DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 44 participants (actual)
Target duration: 1 Month

IDs, dates and publications

ClinicalTrials.gov ID: NCT03991650
Sponsor's protocol ID: humanITcare: Remote
Acronym: REMOTE
Status last verified: Jan 2023
First submitted: 17 Jun 2019
Last updated: 25 Jan 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data sets that underlie results in the final study report will be available for sharing.

Publications

Alonso J, Liu Z, Evans-Lacko S, Sadikova E, Sampson N, Chatterji S, Abdulmalik J, Aguilar-Gaxiola S, Al-Hamzawi A, Andrade LH, Bruffaerts R, Cardoso G, Cia A, Florescu S, de Girolamo G, Gureje O, Haro JM, He Y, de Jonge P, Karam EG, Kawakami N, Kovess-Masfety V, Lee S, Levinson D, Medina-Mora ME, Navarro-Mateu F, Pennell BE, Piazza M, Posada-Villa J, Ten Have M, Zarkov Z, Kessler RC, Thornicroft G; WHO World Mental Health Survey Collaborators. Treatment gap for anxiety disorders is global: Results of the World Mental Health Surveys in 21 countries. Depress Anxiety. 2018 Mar;35(3):195-208. doi: 10.1002/da.22711. Epub 2018 Jan 22.
PubMed 29356216
Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jonsson B, Olesen J, Allgulander C, Alonso J, Faravelli C, Fratiglioni L, Jennum P, Lieb R, Maercker A, van Os J, Preisig M, Salvador-Carulla L, Simon R, Steinhausen HC. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011 Sep;21(9):655-79. doi: 10.1016/j.euroneuro.2011.07.018.
PubMed 21896369
Barrio P, Ortega L, Lopez H, Gual A. Self-management and Shared Decision-Making in Alcohol Dependence via a Mobile App: a Pilot Study. Int J Behav Med. 2017 Oct;24(5):722-727. doi: 10.1007/s12529-017-9643-6.
PubMed 28236288
Gustafson DH, McTavish FM, Chih MY, Atwood AK, Johnson RA, Boyle MG, Levy MS, Driscoll H, Chisholm SM, Dillenburg L, Isham A, Shah D. A smartphone application to support recovery from alcoholism: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):566-72. doi: 10.1001/jamapsychiatry.2013.4642.
PubMed 24671165
Reddy MS. Depression: the disorder and the burden. Indian J Psychol Med. 2010 Jan;32(1):1-2. doi: 10.4103/0253-7176.70510. No abstract available.
PubMed 21799550
Menger V, Spruit M, Hagoort K, Scheepers F. Transitioning to a Data Driven Mental Health Practice: Collaborative Expert Sessions for Knowledge and Hypothesis Finding. Comput Math Methods Med. 2016;2016:9089321. doi: 10.1155/2016/9089321. Epub 2016 Aug 17.
PubMed 27630736
Hsin H, Torous J, Roberts L. An Adjuvant Role for Mobile Health in Psychiatry. JAMA Psychiatry. 2016 Feb;73(2):103-4. doi: 10.1001/jamapsychiatry.2015.2839. No abstract available.
PubMed 26747695
Insel TR. Digital Phenotyping: Technology for a New Science of Behavior. JAMA. 2017 Oct 3;318(13):1215-1216. doi: 10.1001/jama.2017.11295. No abstract available.
PubMed 28973224
Bernert RA, Hom MA, Iwata NG, Joiner TE. Objectively Assessed Sleep Variability as an Acute Warning Sign of Suicidal Ideation in a Longitudinal Evaluation of Young Adults at High Suicide Risk. J Clin Psychiatry. 2017 Jun;78(6):e678-e687. doi: 10.4088/JCP.16m11193.
PubMed 28682534
Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015 Sep;17(3):327-35. doi: 10.31887/DCNS.2015.17.3/bbandelow.
PubMed 26487813
Saeb S, Zhang M, Karr CJ, Schueller SM, Corden ME, Kording KP, Mohr DC. Mobile Phone Sensor Correlates of Depressive Symptom Severity in Daily-Life Behavior: An Exploratory Study. J Med Internet Res. 2015 Jul 15;17(7):e175. doi: 10.2196/jmir.4273.
PubMed 26180009
Saeb S, Lattie EG, Kording KP, Mohr DC. Mobile Phone Detection of Semantic Location and Its Relationship to Depression and Anxiety. JMIR Mhealth Uhealth. 2017 Aug 10;5(8):e112. doi: 10.2196/mhealth.7297.
PubMed 28798010
Sano A, Taylor S, McHill AW, Phillips AJ, Barger LK, Klerman E, Picard R. Identifying Objective Physiological Markers and Modifiable Behaviors for Self-Reported Stress and Mental Health Status Using Wearable Sensors and Mobile Phones: Observational Study. J Med Internet Res. 2018 Jun 8;20(6):e210. doi: 10.2196/jmir.9410.
PubMed 29884610
Torous J, Staples P, Shanahan M, Lin C, Peck P, Keshavan M, Onnela JP. Utilizing a Personal Smartphone Custom App to Assess the Patient Health Questionnaire-9 (PHQ-9) Depressive Symptoms in Patients With Major Depressive Disorder. JMIR Ment Health. 2015 Mar 24;2(1):e8. doi: 10.2196/mental.3889. eCollection 2015 Jan-Mar.
PubMed 26543914
Onnela JP, Rauch SL. Harnessing Smartphone-Based Digital Phenotyping to Enhance Behavioral and Mental Health. Neuropsychopharmacology. 2016 Jun;41(7):1691-6. doi: 10.1038/npp.2016.7. Epub 2016 Jan 28. No abstract available.
PubMed 26818126

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REMOTE: Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder: Smartphone and Wearable Sensors
ClinicalTrials.gov ID: NCT03991650
Acronym / sponsor ID: REMOTE / humanITcare: Remote
Conditions: Anxiety Disorders, Alcohol Use Disorder, Depressive Disorder
Keywords: wearable, sensor, anxiety, monitoring, ehealth, Alcohol Use Disorder, depression
Study type: Observational
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: humanITcareResearch network
Collaborators: Hospital Clinic of Barcelona, European Institute of Innovation and Technology
Study start: 1 Feb 2019 (actual)
Primary completion: 5 Nov 2019 (actual)
Study completion: 5 Nov 2019 (actual)
First posted: 19 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 1 Month
Number of arms: 2

Arm	Type	Receives
Control	–	Behavioral: Monitoring with a devicen=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.
Experimental	–	Behavioral: Monitoring with a deviceThe 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: There will be a sample n = 60, with 30 healthy control subjects and 30 afflicted experimental subjects.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Monitoring with a deviceParticipants will be monitored by an App.	Behavioural	Control, Experimental

Primary outcome

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.

2 secondary outcomes

Usability of the mobile application
Time frame: One month
Satisfaction with the application
Time frame: One month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
Background: PubMed 29356216Alonso J, Liu Z, Evans-Lacko S, Sadikova E, Sampson N, Chatterji S, Abdulmalik J, Aguilar-Gaxiola S, Al-Hamzawi A, Andrade LH, Bruffaerts R, Cardoso G, Cia A, Florescu S, de Girolamo G, Gureje O, Haro JM, He Y, de Jonge P, Karam EG, Kawakami N, Kovess-Masfety V, Lee S, Levinson D, Medina-Mora ME, Navarro-Mateu F, Pennell BE, Piazza M, Posada-Villa J, Ten Have M, Zarkov Z, Kessler RC, Thornicroft G; WHO World Mental Health Survey Collaborators. Treatment gap for anxiety disorders is global: Results of the World Mental Health Surveys in 21 countries. Depress Anxiety. 2018 Mar;35(3):195-208. doi: 10.1002/da.22711. Epub 2018 Jan 22.
Background: PubMed 21896369Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jonsson B, Olesen J, Allgulander C, Alonso J, Faravelli C, Fratiglioni L, Jennum P, Lieb R, Maercker A, van Os J, Preisig M, Salvador-Carulla L, Simon R, Steinhausen HC. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011 Sep;21(9):655-79. doi: 10.1016/j.euroneuro.2011.07.018.
Background: PubMed 28236288Barrio P, Ortega L, Lopez H, Gual A. Self-management and Shared Decision-Making in Alcohol Dependence via a Mobile App: a Pilot Study. Int J Behav Med. 2017 Oct;24(5):722-727. doi: 10.1007/s12529-017-9643-6.
Background: PubMed 24671165Gustafson DH, McTavish FM, Chih MY, Atwood AK, Johnson RA, Boyle MG, Levy MS, Driscoll H, Chisholm SM, Dillenburg L, Isham A, Shah D. A smartphone application to support recovery from alcoholism: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):566-72. doi: 10.1001/jamapsychiatry.2013.4642.
Background: PubMed 21799550Reddy MS. Depression: the disorder and the burden. Indian J Psychol Med. 2010 Jan;32(1):1-2. doi: 10.4103/0253-7176.70510. No abstract available.
Background: PubMed 27630736Menger V, Spruit M, Hagoort K, Scheepers F. Transitioning to a Data Driven Mental Health Practice: Collaborative Expert Sessions for Knowledge and Hypothesis Finding. Comput Math Methods Med. 2016;2016:9089321. doi: 10.1155/2016/9089321. Epub 2016 Aug 17.
Background: PubMed 26747695Hsin H, Torous J, Roberts L. An Adjuvant Role for Mobile Health in Psychiatry. JAMA Psychiatry. 2016 Feb;73(2):103-4. doi: 10.1001/jamapsychiatry.2015.2839. No abstract available.
Background: PubMed 28973224Insel TR. Digital Phenotyping: Technology for a New Science of Behavior. JAMA. 2017 Oct 3;318(13):1215-1216. doi: 10.1001/jama.2017.11295. No abstract available.
Background: PubMed 28682534Bernert RA, Hom MA, Iwata NG, Joiner TE. Objectively Assessed Sleep Variability as an Acute Warning Sign of Suicidal Ideation in a Longitudinal Evaluation of Young Adults at High Suicide Risk. J Clin Psychiatry. 2017 Jun;78(6):e678-e687. doi: 10.4088/JCP.16m11193.
Background: PubMed 26487813Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015 Sep;17(3):327-35. doi: 10.31887/DCNS.2015.17.3/bbandelow.
Background: PubMed 26180009Saeb S, Zhang M, Karr CJ, Schueller SM, Corden ME, Kording KP, Mohr DC. Mobile Phone Sensor Correlates of Depressive Symptom Severity in Daily-Life Behavior: An Exploratory Study. J Med Internet Res. 2015 Jul 15;17(7):e175. doi: 10.2196/jmir.4273.
Background: PubMed 28798010Saeb S, Lattie EG, Kording KP, Mohr DC. Mobile Phone Detection of Semantic Location and Its Relationship to Depression and Anxiety. JMIR Mhealth Uhealth. 2017 Aug 10;5(8):e112. doi: 10.2196/mhealth.7297.
World Health Organization. Global Status Report on Alcohol and Health (2018).Link provided by the sponsor.
World Health Organization. Mental depression and other common disorders: Global health estimates (2017).Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Individual participant data sets that underlie results in the final study report will be available for sharing.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antoni Gual, MD principal investigator

Director of Addictions Unit. Hospital Clínic de Barcelona

Elsa Caballeria study chair

Clinic Foundation for Biomedical Research

Hugo Lopez-Pelayo, MD study chair

Addictions Unit, Hospital Clínic de Barcelona

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Anxiety Disorders and Alcohol Use Disorder, run by humanITcare at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Self-reported Anxiety symptoms assessed with the State-Trait Anxiety Inventory (STAI) (time frame: One month, questionnaire taken 4 times (1/week)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03991650, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.