The Feasibility of Chatbot-based Stress Management Intervention STARS for Youth in Lithuania

Not Applicable

Not yet recruiting

• Conditions: Symptoms of Depression and Anxiety

• Registration Number: NCT06651411
• Lead Sponsor: Vilnius University

Brief Summary

The study aims to assess the feasibility of a chatbot-based stress management intervention among youth in Lithuania.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-17
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-21
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-24
• Study Start: 2024-10-30
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• People at imminent risk of suicide
• People currently experiencing a psychotic episode
• People currently experiencing interpersonal violence
• Current dependency on alcohol/drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in The Patient Health Questionnaire-9	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.
Changes in The Generalized Anxiety Disorder-7	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Kessler-6	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.
Changes in The Brief Adjustment Disorder Measure-8	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.
Changes in The SIDAS	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.
Changes in The WHODAS 2.0	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.
Changes in The World Health Organization Well-being Index-5	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.
Changes in The International Trauma Questionnaire	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.
Changes in The Resilience scale	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.
Changes in The Client Services Receipt Inventory	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.
Changes in The EQ-5D-5L	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.
Recruitment rate	Before the intervention	Recruitment rate recorded as the number of eligible participants who consent to participate in the study will be assessed.
Drop-out rates	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.
Number of adverse events and serious adverse events	Immediately after the intervention	Number of adverse events and serious adverse events will be assessed.

Trial Locations

Locations (1)

Vilnius University; 🇱🇹 Vilnius, Lithuania