Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder
NCT ID: NCT03991650
Last Updated: 2023-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2019-02-01
2019-11-05
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Monitoring with a device
Participants will be monitored by an App.
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.
Monitoring with a device
Participants will be monitored by an App.
Interventions
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Monitoring with a device
Participants will be monitored by an App.
Eligibility Criteria
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Inclusion Criteria
* 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
* Cognitive deficits that prevent the participation.
* Active intake of other substances (except for nicotine).
18 Years
65 Years
ALL
Yes
Sponsors
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Hospital Clinic of Barcelona
OTHER
European Institute of Innovation and Technology
UNKNOWN
humanITcare
NETWORK
Responsible Party
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Principal Investigators
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Antoni Gual, MD
Role: PRINCIPAL_INVESTIGATOR
Director of Addictions Unit. Hospital Clínic de Barcelona
Elsa Caballeria
Role: STUDY_CHAIR
Clinic Foundation for Biomedical Research
Hugo Lopez-Pelayo, MD
Role: STUDY_CHAIR
Addictions Unit, Hospital Clínic de Barcelona
Nuria Pastor Hernandez, MSc
Role: STUDY_DIRECTOR
humanITcare, FollowHealth SL
Unai Sanchez Luque, MSc
Role: STUDY_DIRECTOR
humanITcare, FollowHealth SL
Elizabeth Katayoun Khalilian
Role: STUDY_CHAIR
humanITcare, University of Texas at Austin
Locations
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Hospitcal Clínic de Barcelona
Barcelona, , Spain
Countries
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References
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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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Trautmann S, Rehm J, Wittchen HU. The economic costs of mental disorders: Do our societies react appropriately to the burden of mental disorders? EMBO Rep. 2016 Sep;17(9):1245-9. doi: 10.15252/embr.201642951. Epub 2016 Aug 4.
Ghandeharioun, A., Fedor, S., Sangermano, L., Ionescu, D., Alpert, J., Dale, C., ... & Picard, R. (2017, October). Objective assessment of depressive symptoms with machine learning and wearable sensors data. In Affective Computing and Intelligent Interaction (ACII), 2017 Seventh International Conference on (pp. 325-332). IEEE.
Related Links
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World Health Organization. Global Status Report on Alcohol and Health (2018).
World Health Organization. Mental depression and other common disorders: Global health estimates (2017).
Other Identifiers
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humanITcare: Remote
Identifier Type: -
Identifier Source: org_study_id
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