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Active, Not Recruiting

NCT Number: NCT06651411

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vilnius University

Vilnius, 01131, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STARS (Scalable Technology for Adolescents and youth to Reduce Stress)

Behavioral

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

Behavioral

Basic psychoeducation includes basic information on stress management.

Primary outcomes

  1. Changes in The Patient Health Questionnaire-9

    Time frame: 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.

  2. Changes in The Generalized Anxiety Disorder-7

    Time frame: 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 outcomes

  1. Changes in Kessler-6

    Time frame: 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.

  2. Changes in The Brief Adjustment Disorder Measure-8

    Time frame: 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.

  3. Changes in The SIDAS

    Time frame: 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.

  4. Changes in The WHODAS 2.0

    Time frame: 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.

  5. Changes in The World Health Organization Well-being Index-5

    Time frame: 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.

  6. Changes in The International Trauma Questionnaire

    Time frame: 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.

  7. Changes in The Resilience scale

    Time frame: 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.

  8. Changes in The Client Services Receipt Inventory

    Time frame: 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.

  9. Changes in The EQ-5D-5L

    Time frame: 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.

  10. Recruitment rate

    Time frame: Before the intervention

    Recruitment rate recorded as the number of eligible participants who consent to participate in the study will be assessed.

  11. Drop-out rates

    Time frame: 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.

  12. Number of adverse events and serious adverse events

    Time frame: Immediately after the intervention

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

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Collaborators

  • World Health Organization

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 21, 2024
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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