Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Die Machbarkeit einer Chatbot-basierten Stressbewältigungsintervention STARS für Jugendliche in Litauen

3. November 2026 aktualisiert von: Evaldas Kazlauskas, Vilnius University

The Feasibility of Chatbot-based Stress Management Intervention STARS for Youth in Lithuania: A Pilot Randomized Controlled Trial

The study aims to assess the feasibility of a chatbot-based stress management intervention among youth in Lithuania.

Studienübersicht

Detaillierte Beschreibung

The intervention is a chatbot-based stress management intervention developed by the World Health Organization (WHO). It consists of 10 sessions which include: Introduction (1), Psychoeducation (2), Emotion Regulation (3, 4), Behavior Activation (5, 6), Managing Problems (7), Thought Challenging (8, 9), and Relapse Prevention (10). Each session consists of psychoeducation and exercise parts. Trained e-helpers contact participants to support them individually on a weekly basis.

The effect of the intervention will be compared against a control group which gets basic psychoeducation. The intervention is provided in Lithuanian.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Vilnius, Litauen, 01131
        • Vilnius University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 25 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Age of 18-25 years
  • Understanding the Lithuanian language
  • Having access to a device for intervention delivery
  • Experiencing moderate levels of psychological distress

Exclusion Criteria:

  • People at imminent risk of suicide
  • People currently experiencing a psychotic episode
  • People currently experiencing interpersonal violence
  • Current dependency on alcohol/drugs

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intervention group

The intervention group will get a 10-session chatbot-based stress management intervention.

The intervention is a chatbot-based stress management intervention developed by the World Health Organization (WHO). It consists of 10 sessions, which include: Introduction (1), Psychoeducation (2), Emotion Regulation (3, 4), Behavior Activation (5, 6), Managing Problems (7), Thought Challenging (8, 9), and Relapse Prevention (10). Each session consists of psychoeducation and exercise parts. Trained e-helpers contact participants to support them individually weekly.

The effect of the intervention will be compared against a control group that receives basic psychoeducation. The intervention is provided in Lithuanian.

Sonstiges: Control group

The control group will get basic psychoeducation.

Basic psychoeducation includes basic information on stress management.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in The Patient Health Questionnaire-9
Zeitfenster: Before the intervention, immediately after the intervention, 3-months after the intervention

Changes in symptoms of depression are measured. The Patient Health Questionnaire-9 (PHQ-9, Kroenke et al., 2001) is a self-report measure comprising 9 items about symptoms of depression. All items are answered on a 4-point Likert scale that ranges from 0 (not at all) to 3 (nearly every day). A higher score indicates more pronounced symptoms.

Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The Generalized Anxiety Disorder-7
Zeitfenster: Before the intervention, immediately after the intervention, 3-months after the intervention

Changes in symptoms of anxiety are measured. The Generalized Anxiety Disorder-7 (GAD-7, Spitzer et al., 2006) is a self-report measure comprising 7 items about symptoms of anxiety. All items are answered on a 4-point Likert scale that ranges from 0 (not at all) to 3 (nearly every day). A higher score indicates more pronounced symptoms.

Before the intervention, immediately after the intervention, 3-months after the intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in Kessler-6
Zeitfenster: Before the intervention, immediately after the intervention, 3-months after the intervention

Changes in psychological distress are measured. Kessler-6 (K6, Kessler et al., 2002) is a self-report measure comprising 6 questions about psychological distress. All items are answered on a 5-point Likert scale that ranges from 0 (none of the time) to 4 (all of the time). A higher score indicates more pronounced symptoms.

Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The Brief Adjustment Disorder Measure-8
Zeitfenster: Before the intervention, immediately after the intervention, 3-months after the intervention

Changes in symptoms of adjustment disorder are measured. The Brief Adjustment Disorder Measure-8 (ADNM-8, Kazlauskas et al., 2018) is a self-report measure comprising 8 items about symptoms of adjustment disorder. All items are answered on a 4-point Likert scale that ranges from 1 (never) to 4 (often). A higher score indicates more pronounced symptoms.

Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The SIDAS
Zeitfenster: Before the intervention, immediately after the intervention, 3-months after the intervention

Changes in suicidal ideation are measured. The SIDAS (Van Spijker et al., 2014) is a self-report measure comprising 5 questions about suicidal ideation. All items are answered on a 10-point Likert scale that ranges from 0 (never, no control, not close at all, not at all) to 10 (always, full control, made an attempt, extremely). A higher score indicates more pronounced symptoms.

Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The WHODAS 2.0
Zeitfenster: Before the intervention, immediately after the intervention, 3-months after the intervention

Changes in functioning are measured. The WHODAS 2.0 (Ustun et al., 2010) is a self-report measure comprising 12 questions about functioning. All items are answered on a 5-point Likert scale that ranges from 0 (none) to 4 (extreme or cannot do). A higher score indicates more pronounced symptoms.

Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The World Health Organization Well-being Index-5
Zeitfenster: Before the intervention, immediately after the intervention, 3-months after the intervention

Changes in psychological well-being are measured. The World Health Organization Well-being Index-5 (WHO-5, Bech, 2004) is a self-report measure comprising 5 items about psychological well-being. All items are answered on a 5-point Likert scale that ranges from 0 (at no time) to 4 (all of the time). A higher score indicates more pronounced psychological well-being.

Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The International Trauma Questionnaire
Zeitfenster: Before the intervention, immediately after the intervention, 3-months after the intervention

Changes in symptoms of post-traumatic stress disorders are measured. International Trauma Questionnaire (ITQ, Cloitre et al., 2018) is a self-report measure comprising 18 items. All items are answered on a 5-point Likert scale that ranges from 0 (not at all) to 4 (extremely). A higher score indicates more pronounced symptoms.

Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The Resilience scale
Zeitfenster: Before the intervention, immediately after the intervention, 3-months after the intervention

Changes in resilience are measured. The Resilience scale (RS-14, Wagnild, 2011) is a self-report measure comprising 14 items about resilience. All items are answered on a 7-point Likert scale that ranges from 1 (strongly disagree) to 7 (strongly agree). A higher score indicates more pronounced resilience.

Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The Client Services Receipt Inventory
Zeitfenster: Before the intervention, 3-months after the intervention

Changes in client service are measured. The Client Services Receipt Inventory (CSRI, Beeacham and Knapp, 2001) is a self-report measure comprising questions about client service. The CSRI covers a broad range of services that may be utilized, including primary and secondary care services, other services, and informal care.

Before the intervention, 3-months after the intervention
Changes in The EQ-5D-5L
Zeitfenster: Before the intervention, immediately after the intervention, 3-months after the intervention

Changes in health are measured. The EQ-5D-5L (EuroQol Research Foundation, 2019) is a self-report measure comprising 5 items about health. All items are answered on a 5-point Likert scale that ranges from 1 (I have no problems or similar) to 5 (I am unable or similar). A higher score indicates more pronounced symptoms.

Before the intervention, immediately after the intervention, 3-months after the intervention
Recruitment rate
Zeitfenster: Before the intervention

Recruitment rate recorded as the number of eligible participants who consent to participate in the study will be assessed.

Before the intervention
Drop-out rates
Zeitfenster: Immediately after the intervention, 3-months after the intervention

Drop-out rates recorded as the number of randomized participants who do not complete the intervention, the post-test assessment, and three-month follow-up assessment will be assessed.

Immediately after the intervention, 3-months after the intervention
Number of adverse events and serious adverse events
Zeitfenster: Immediately after the intervention

Number of adverse events and serious adverse events will be assessed.

Immediately after the intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. Oktober 2024

Primärer Abschluss (Tatsächlich)

30. Juni 2025

Studienabschluss (Tatsächlich)

30. Juni 2025

Studienanmeldedaten

Zuerst eingereicht

17. Oktober 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Oktober 2024

Zuerst gepostet (Tatsächlich)

21. Oktober 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. November 2026

Zuletzt verifiziert

1. Oktober 2024

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • (1.13E)250000-KT-67/ERC0004137

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Individual participant data can be shared upon a reasonable request.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren