- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT06651411
Wykonalność interwencji w zakresie zarządzania stresem w oparciu o Chatbota STARS dla młodzieży na Litwie
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Vilnius, Litwa, 01131
- Vilnius University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Inny: Control group
The control group will get basic psychoeducation. |
Basic psychoeducation includes basic information on stress management. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes in The Patient Health Questionnaire-9
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes in Kessler-6
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
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Drop-out rates
Ramy czasowe: 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
Ramy czasowe: Immediately after the intervention
|
Number of adverse events and serious adverse events will be assessed. |
Immediately after the intervention
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- (1.13E)250000-KT-67/ERC0004137
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Individual participant data can be shared upon a reasonable request.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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