- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05991713
Geolocation Positional System (GPS) Erfaring
Individuelle forskelle i følelsesmæssige og adfærdsmæssige mønstre og deres forhold til kognition
The purpose of this study is to use smartphone technology to capture individual location emotional and cognitive data, to examine how real-world behaviors thoughts, emotions, and brain activity are related to one another.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The observational portion of this study was initially approved in 2015, this is a subset of the initially approved study and it is a clinical trial of 100 participants.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Isabella C D'Ottone, BA
- Telefonnummer: 3052849555
- E-mail: icd30@miami.edu
Studiesteder
-
-
Florida
-
Coral Gables, Florida, Forenede Stater, 33146
- Rekruttering
- University of Miami
-
Ledende efterforsker:
- Aaron S Heller, PhD
-
Kontakt:
- Isabella C D'Ottone, BA
- Telefonnummer: 3052849555
- E-mail: icd30@miami.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Must agree to give informed consent
- Must be willing to have an functional Magnetic Resonance Imaging (FMRI) scan
- Must be able to receive and respond to daily text messages assessing current emotion
- Must be willing to download and run a GPS tracking application (FollowMee) onto their smartphone for a four-month period
Exclusion Criteria:
- history of head trauma, seizures, or neurological disorders
- severe/unstable medical conditions
- conditions that interfere with MRI
- pregnancy
- lifetime psychotic/bipolar disorder
- chronic/severe substance or alcohol abuse/dependence
- antipsychotic medication
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Modifying Exploration
Individuals will be asked on certain days to increase their levels of exploration, and some days be asked to decrease their levels of exploration. Participants will do this for up to six months. |
Participants in this group will use a mobile phone sensor data application that uses an accelerometer, Wireless Fidelity (WiFi) and/or GPS designed for smartphone devices. This technology allows the phones to capture information automatically and passively on the participant's activity. The application will be collecting participants' data 24 hours a day, 7 days a week. Participants will be asked to make alterations to their exploration levels approximately 20 days of their participation in the study. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in positive emotional response as measured by ecological momentary assessment
Tidsramme: Baseline, up to 6 months
|
Emotional response will be measured by computing a total mean score of "happy", "excited", "content", "attentive", "relaxed". The total mean score ranges from 0 to 100, with higher scores indicating greater positive emotional response. |
Baseline, up to 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in negative emotional response as measured by ecological momentary assessment
Tidsramme: Baseline, up to 6 months
|
Emotional response will be measured by computing a total mean score of "sad", "tired", "upset", "irritable", "anxious". The total mean score ranges from 0 to 100, with higher scores indicating greater negative emotional response. |
Baseline, up to 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Aaron S Heller, PhD, University of Miami
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20150678
- R01MH133693 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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