Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Целесообразность вмешательства STARS по управлению стрессом с помощью чат-бота для молодежи в Литве

3 ноября 2026 г. обновлено: 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.

Обзор исследования

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

80

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

      • Vilnius, Литва, 01131
        • Vilnius University

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 25 лет (Взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.

Другой: Control group

The control group will get basic psychoeducation.

Basic psychoeducation includes basic information on stress management.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Changes in The Patient Health Questionnaire-9
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Changes in Kessler-6
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Immediately after the intervention

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

Immediately after the intervention

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Соавторы

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

30 октября 2024 г.

Первичное завершение (Действительный)

30 июня 2025 г.

Завершение исследования (Действительный)

30 июня 2025 г.

Даты регистрации исследования

Первый отправленный

17 октября 2024 г.

Впервые представлено, что соответствует критериям контроля качества

17 октября 2024 г.

Первый опубликованный (Действительный)

21 октября 2024 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

6 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

3 ноября 2026 г.

Последняя проверка

1 октября 2024 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • (1.13E)250000-KT-67/ERC0004137

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Individual participant data can be shared upon a reasonable request.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться