Proveditelnost intervence pro zvládání stresu založeného na Chatbotu STARS pro mládež v Litvě
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
Postavení
Podmínky
Podmínky
Intervence / Léčba
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
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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-
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Vilnius, Litva, 01131
- Vilnius University
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
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
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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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. |
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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
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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
|
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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
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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
|
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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
|
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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
|
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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
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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
|
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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
|
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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
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Changes in The EQ-5D-5L
Časové okno: Before the intervention, immediately after the intervention, 3-months after the intervention
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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
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Recruitment rate
Časové okno: Before the intervention
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Recruitment rate recorded as the number of eligible participants who consent to participate in the study will be assessed. |
Before the intervention
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Drop-out rates
Časové okno: Immediately after the intervention, 3-months after the intervention
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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
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Number of adverse events and serious adverse events
Časové okno: Immediately after the intervention
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Number of adverse events and serious adverse events will be assessed. |
Immediately after the intervention
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- (1.13E)250000-KT-67/ERC0004137
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Individual participant data can be shared upon a reasonable request.
Informace o lécích a zařízeních, studijní dokumenty
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