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Symptoms of Depression and AnxietyNCT06651411

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

A study testing STARS (Scalable Technology for Adolescents and youth to Reduce Stress) and Basic psychoeducation in people with Symptoms of Depression and Anxiety, run by Vilnius University at 1 site in Lithuania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Symptoms of Depression and Anxiety
What is being tested?
STARS (Scalable Technology for Adolescents and youth to Reduce Stress) and Basic psychoeducation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteLithuania
Study dates
30 Oct 2024to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age of 18-25 years
  • Understanding the Lithuanian language
  • Having access to a device for intervention delivery
  • Experiencing moderate levels of psychological distress

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Lithuania1 site
  • Vilnius University

    Vilnius, 01131

Other trials in Lithuania

About this study

Official title: 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.

Read the 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.

Being tested
STARS (Scalable Technology for Adolescents and youth to Reduce Stress), Basic psychoeducation
Keywords
Intervention, Chatbot, Stress management, youth, STARS, Feasibility
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 psychoeducationBehavioural

    Basic psychoeducation includes basic information on stress management.

Study groups in NCT06651411
Study groupRoleWhat they receive
Intervention groupExperimentalThe intervention group will get a 10-session chatbot-based stress management intervention.
Receives: Behavioral: STARS (Scalable Technology for Adolescents and youth to Reduce Stress)
Control groupOtherThe control group will get basic psychoeducation.
Receives: Behavioral: Basic psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in The Patient Health Questionnaire-9

    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.

    Measured: Before the intervention, immediately after the intervention, 3-months after the intervention

  2. Changes in The Generalized Anxiety Disorder-7

    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.

    Measured: Before the intervention, immediately after the intervention, 3-months after the intervention

Secondary outcomes (12)
  1. Changes in Kessler-6

    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.

    Measured: Before the intervention, immediately after the intervention, 3-months after the intervention

  2. Changes in The Brief Adjustment Disorder Measure-8

    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.

    Measured: Before the intervention, immediately after the intervention, 3-months after the intervention

  3. Changes in The SIDAS

    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.

    Measured: Before the intervention, immediately after the intervention, 3-months after the intervention

  4. Changes in The WHODAS 2.0

    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.

    Measured: Before the intervention, immediately after the intervention, 3-months after the intervention

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

    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.

    Measured: Before the intervention, immediately after the intervention, 3-months after the intervention

  6. Changes in The International Trauma Questionnaire

    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.

    Measured: Before the intervention, immediately after the intervention, 3-months after the intervention

  7. Changes in The Resilience scale

    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.

    Measured: Before the intervention, immediately after the intervention, 3-months after the intervention

  8. Changes in The Client Services Receipt Inventory

    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.

    Measured: Before the intervention, 3-months after the intervention

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

    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.

    Measured: Before the intervention, immediately after the intervention, 3-months after the intervention

  10. Recruitment rate

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

    Measured: Before the intervention

  11. Drop-out rates

    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.

    Measured: Immediately after the intervention, 3-months after the intervention

  12. Number of adverse events and serious adverse events

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

    Measured: Immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2024
  2. Study start30 Oct 2024
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06651411
Sponsor's protocol ID
(1.13E)250000-KT-67/ERC0004137
Status last verified
Oct 2024
First submitted
17 Oct 2024
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data can be shared upon a reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing STARS (Scalable Technology for Adolescents and youth to Reduce Stress) and Basic psychoeducation in people with Symptoms of Depression and Anxiety, run by Vilnius University at 1 site in Lithuania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in The Patient Health Questionnaire-9 (time frame: Before the intervention, immediately after the intervention, 3-months after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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