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Proveditelnost intervence pro zvládání stresu založeného na Chatbotu STARS pro mládež v Litvě

3. listopadu 2026 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

80

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Vilnius, Litva, 01131
        • Vilnius University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 25 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.

Jiný: Control group

The control group will get basic psychoeducation.

Basic psychoeducation includes basic information on stress management.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in The Patient Health Questionnaire-9
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in Kessler-6
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Immediately after the intervention

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

Immediately after the intervention

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spolupracovníci

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

30. října 2024

Primární dokončení (Aktuální)

30. června 2025

Dokončení studie (Aktuální)

30. června 2025

Termíny zápisu do studia

První předloženo

17. října 2024

První předloženo, které splnilo kritéria kontroly kvality

17. října 2024

První zveřejněno (Aktuální)

21. října 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. listopadu 2026

Naposledy ověřeno

1. října 2024

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • (1.13E)250000-KT-67/ERC0004137

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Individual participant data can be shared upon a reasonable request.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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