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

The Feasibility of Chatbot-based Stress Management Intervention STARS for Youth in Lithuania: a Pilot Randomized Controlled Trial

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06651411
Enrollment
80
Registered
2024-10-21
Start date
2024-10-30
Completion date
2028-06-30
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptoms of Depression and Anxiety

Keywords

Intervention, Chatbot, Stress management, youth, STARS, Feasibility

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.

Interventions

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.

Basic psychoeducation includes basic information on stress management.

Sponsors

World Health Organization
CollaboratorOTHER
Vilnius University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in The Patient Health Questionnaire-9Before the intervention, immediately after the intervention, 3-months after the interventionChanges 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-7Before the intervention, immediately after the intervention, 3-months after the interventionChanges 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

MeasureTime frameDescription
Changes in The Brief Adjustment Disorder Measure-8Before the intervention, immediately after the intervention, 3-months after the interventionChanges 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 SIDASBefore the intervention, immediately after the intervention, 3-months after the interventionChanges 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 2.0Before the intervention, immediately after the intervention, 3-months after the interventionChanges 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-5Before the intervention, immediately after the intervention, 3-months after the interventionChanges 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 QuestionnaireBefore the intervention, immediately after the intervention, 3-months after the interventionChanges 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 Client Services Receipt InventoryBefore the intervention, 3-months after the interventionChanges 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-5LBefore the intervention, immediately after the intervention, 3-months after the interventionChanges 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 rateBefore the interventionRecruitment rate recorded as the number of eligible participants who consent to participate in the study will be assessed.
Drop-out ratesImmediately after the intervention, 3-months after the interventionDrop-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 eventsImmediately after the interventionNumber of adverse events and serious adverse events will be assessed.
Changes in The Resilience scaleBefore the intervention, immediately after the intervention, 3-months after the interventionChanges 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 Kessler-6Before the intervention, immediately after the intervention, 3-months after the interventionChanges 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.

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026