リトアニアの青少年向けチャットボットベースのストレス管理介入STARSの実現可能性
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Vilnius、リトアニア、01131
- Vilnius University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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. |
|
他の:Control group
The control group will get basic psychoeducation. |
Basic psychoeducation includes basic information on stress management. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in The Patient Health Questionnaire-9
時間枠:Before the intervention, immediately after the intervention, 3-months after the intervention
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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
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in Kessler-6
時間枠: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
|
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Changes in The Brief Adjustment Disorder Measure-8
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
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Recruitment rate
時間枠: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
時間枠: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
時間枠:Immediately after the intervention
|
Number of adverse events and serious adverse events will be assessed. |
Immediately after the intervention
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- (1.13E)250000-KT-67/ERC0004137
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data can be shared upon a reasonable request.
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