- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05343039
Technology Enhanced Adolescent Mental Health (TEAM) (TEAM)
Gebruikmaken van biomarkers en nieuwe technologieën om het risico op zelfverwonding en middelenmisbruik bij zeer kwetsbare adolescenten te verminderen
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
De overkoepelende doelstellingen van het voorgestelde project zijn drieledig. DOEL 1: Evalueer de klinische werkzaamheid van tVNS bij het terugdringen van NSSI en alcoholmisbruik bij kwetsbare adolescenten. We veronderstellen dat zelf-gerapporteerde tVNS, toegediend in sessies van 25 minuten, zelfgerapporteerd NSSI- en alcoholgebruik zal verminderen, de zelfgerapporteerde emotieregulatie van adolescenten zal verbeteren en verbeteringen zal opleveren in sympathische en parasympathische zenuwstelselmarkers van emotieregulatie en kwetsbaarheid voor NSSI en alcoholmisbruik. DOEL 2: therapietrouw evalueren in vergelijking met traditionele psychosociale interventies van vergelijkbare duur. We veronderstellen dat adolescenten meer therapietrouw zullen laten zien dan waargenomen bij traditionele psychosociale interventies van vergelijkbare duur, en beoordelen tVNS als acceptabel, onopvallend en gunstig voor face-to-face behandeling. DOEL 3: Evalueer de effecten van mishandeling op TVNS. We veronderstellen dat TVNS effectief zal zijn voor mensen met een geschiedenis van mishandeling.
Hoewel tVNS tot nu toe zelden wordt gebruikt bij adolescenten, verandert het de neurale en emotionele reacties op droevige prikkels en vermindert het bij volwassenen het risico op zelfmoord tot vijf jaar later. Momenteel wordt het geëvalueerd als een behandeling voor alcoholmisbruik in een door de NIH gefinancierd klinisch onderzoek. Dit suggereert potentieel voor de behandeling van NSSI, alcoholmisbruik, posttraumatische stresssymptomen (PTSS) en andere aandoeningen van emotie-ontregeling. Zoals hierboven geschetst, zullen we de werkzaamheid van tVNS testen bij het veranderen van gedrags-, emotioneel en autonoom zenuwstelselrisico voor NSSI en alcoholmisbruik, de therapietrouw en aanvaardbaarheid van tVNS bij adolescenten evalueren en bepalen of de geschiedenis van mishandeling de respons op de behandeling matigt.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Indiana
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South Bend, Indiana, Verenigde Staten, 46617
- University of Notre Dame
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
Inclusiecriteria:
- Heb alcohol gebruikt
- ≥ 3 episodes van NSSI hebben gehad in de afgelopen 6 maanden of ≥ 5 in het hele leven (1 van deze 5 moet in het afgelopen jaar zijn geweest)
- Bezit een smartphone (iPhone of Android)
Uitsluitingscriteria:
- Autisme
- Schizofrenie
- Een pacemaker, een geïmplanteerde defibrillator of een geïmplanteerd of metalen elektronisch apparaat hebben
- Zwanger of borstvoeding
- Heb een voorgeschiedenis van epileptische aanvallen of epilepsie
- Temperomandibulair gewrichtsaandoening
- Bell's verlamming
- Verminderde hersenzenuwfunctie of aangezichtspijn
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Behandelingsgroep
Deelnemers ontvangen een tvNS-apparaat.
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Deelnemers zullen gedurende 30 dagen elke dag 25 minuten durende tvNS-sessies volgen.
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Experimenteel: Niet-behandelde groep
Deelnemers ontvangen geen tvNS-apparaat.
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Deelnemers krijgen geen tussenkomst.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Verandering ten opzichte van de uitgangswaarde in niet-suïcidaal zelfverwonding en alcoholmisbruik op dag 30
Tijdsspanne: 30 dagen
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Deelnemers zullen dagelijks deelnemen aan 25 minuten durende tvNS-sessies.
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30 dagen
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Behoud van behandelingseffecten tot 3 maanden na de interventie
Tijdsspanne: 3 maanden
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Deelnemers zullen worden beoordeeld op het behoud van dergelijke behandelingseffecten 3 maanden na de interventie.
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3 maanden
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Verandering ten opzichte van baseline in emotieregulatie op dag 30
Tijdsspanne: 30 dagen
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Deelnemers vullen dagelijks een enquête van 2-3 minuten in waarin ze verschillende gevoelens en emoties moeten rapporteren, zoals geluk, verdriet en woede.
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30 dagen
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Naleving van tVNS-interventie vanaf baseline tot dag 30
Tijdsspanne: 30 dagen
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De therapietrouw van de zelfbeheerde dagelijkse 25 minuten durende tvNS-sessies van de deelnemers wordt gemeten via de tvNS-telefoonapp van de deelnemers.
Ze zullen ook rapporteren over de aanvaardbaarheid, opdringerigheid en voorkeur van TVNS.
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30 dagen
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Theodore P Beauchaine, PhD, University of Notre Dame
- Hoofdonderzoeker: Brooke A Ammerman, PhD, University of Notre Dame
- Hoofdonderzoeker: Kristin Valentino, PhD, University of Notre Dame
Publicaties en nuttige links
Algemene publicaties
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