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Symptoms of Depression and AnxietyNCT07012876

Effectiveness of a Guided Mental Health Chatbot for Youth Living 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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The study aims to assess the effectiveness of a guided mental health chatbot called "Scalable Technology for Adolescents and youth to Reduce Stress (STARS)", adapted for youth living 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
262 participants
Where
1 siteLithuania
Study dates
8 Sep 2025to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 (a cut-off score of 8 as measured with Kessler-6)

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, Vilnius County, 01131

Other trials in Lithuania

About this study

Official title: Effectiveness of a Guided Mental Health Chatbot STARS for Youth Living in Lithuania: a Randomized Controlled Trial

The study aims to assess the effectiveness of a guided mental health chatbot called "Scalable Technology for Adolescents and youth to Reduce Stress (STARS)", adapted for youth living in Lithuania.

Read the detailed description

The intervention is a guided mental health chatbot STARS 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), Supportive Self-talk (8, 9), and Relapse Prevention (10). Each session consists of psychoeducation and exercise parts. Trained and supervised non-specialists (called e-helpers) provide weekly calls (five calls lasting approximately 15 minutes) to support participants individually.

The effect of the intervention will be compared against a control group which receives enhanced usual care.

Being tested
STARS (Scalable Technology for Adolescents and youth to Reduce Stress), Basic psychoeducation
Keywords
Intervention, Chatbot, Mental health, Youth, STARS, Effectiveness
Medical subject headings
Depression, Anxiety Disorders, Psychological Well-Being

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 guided mental health chatbot - STARS - 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), Supportive Self-talk (8, 9), and Relapse Prevention (10). Each session consists of psychoeducation and exercise parts. Trained and supervised non-specialists (called e-helpers) provide weekly calls (five calls lasting approximately 15 minutes) to support participants individually and increase motivation and adherence to the intervention.

  • Basic psychoeducationBehavioural

    The control group will receive basic psychoeducation. The content of the psychoeducation is very similar to the content of session 2 of the STARS chatbot and includes psychoeducation about emotions, a personal story about a fictional character who talks about her emotions, and information about where to access mental health support. It also includes a list of organizations and clinics providing mental health care in Lithuania.

Study groups in NCT07012876
Study groupRoleWhat they receive
Intervention groupExperimentalThe intervention group will get a guided mental health chatbot STARS.
Receives: Behavioral: STARS (Scalable Technology for Adolescents and youth to Reduce Stress)
Control groupOtherThe control group will receive basic psychoeducation. The content of the psychoeducation is very similar to the content of session 2 of the STARS chatbot and includes psychoeducation about emotions, a personal story about a fictional character who talks about her emotions, and information about where to access mental health support. It also includes a list of organizations and clinics providing mental health care in Lithuania.
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. In the Lithuanian sample, the PHQ-9 had a good internal consistency with Cronbach's α of 0.85 (Nomeikaite et al., 2023).

    Measured: Baseline, eight weeks after baseline, three months after baseline

  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. In the Lithuanian sample, the GAD-7 had a good internal consistency with Cronbach's α of 0.91 (Nomeikaite et al., 2023).

    Measured: Baseline, eight weeks after baseline, three months after baseline

Secondary outcomes (9)
  1. Changes in Kessler-6

    Kessler-6 is used as a screener with a cut-off score of 8, which is commonly used to indicate moderate levels of psychological distress. Also, 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. Previous studies have shown good psychometric properties of the Kessler-6 (Cronbach α = 0.86) (Ferro, 2019).

    Measured: Baseline, eight weeks after baseline, three months after baseline

  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. In the Lithuanian sample, the ADNM-8 had a good internal consistency with Cronbach's α of 0.93 (Kazlauskas et al., 2023).

    Measured: Baseline, eight weeks after baseline, three months after baseline

  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. In the Lithuanian sample, the SIDAS had a good internal consistency with Cronbach's α of 0.93 (Skruibis et al., 2022).

    Measured: Baseline, eight weeks after baseline, three months after baseline

  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. Previous studies have shown good psychometric properties of the WHODAS 2.0 (Cronbach α = 0.96) (Saltychev et al., 2021).

    Measured: Baseline, eight weeks after baseline, three months after baseline

  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. In the Lithuanian sample, the WHO-5 had a good internal consistency with Cronbach's α of 0.87 (Nomeikaite et al., 2023).

    Measured: Baseline, eight weeks after baseline, three months after baseline

  6. Changes in Internalized Stigma of Mental Illness

    Changes in internalized stigma of psychological difficulties (the term of psychological difficulties instead of mental illness is used in this study) are measured. The Internalized Stigma of Mental Illness-Brief Version (ISMI-10, Boyd et al., 2014) is a self-report measure comprising 10 items about internalized stigma of psychological difficulties. All items are answered on a 4-point Likert scale that ranges from 1 (strongly disagree) to 4 (strongly agree). A higher score indicates more pronounced internalized stigma of psychological difficulties. Previous studies have shown good psychometric properties of the ISMI-10 (Cronbach's α = .75-.81) (Boyd et al., 2014).

    Measured: Baseline, eight weeks after baseline, three months after baseline

  7. Changes in Self-Stigma of Seeking Help

    Changes in stigma of self-stigma of seeking help are measured. The Self-Stigma of Seeking Help-Ultra-Brief Version (SSOSH-3, Brenner et al., 2021) is a self-report measure comprising 3 items about self-stigma of seeking help. All items are answered on a 5-point Likert scale that ranges from 1 (strongly disagree) to 5 (strongly agree). A higher score indicates more pronounced self-stigma of seeking help. Previous studies have shown good psychometric properties of the SSOSH-3 (Cronbach's α = .82-.87) (Brenner et al., 2021).

    Measured: Baseline, eight weeks after baseline, three months after baseline

  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: Baseline, three months after baseline

  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. Convergent validity was demonstrated by a correlation between EQ-5D-5L and the WHO-5, (r = .43, P < .001) (Janssen et al. 2013).

    Measured: Baseline, eight weeks after baseline, three months after baseline

Timeline

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

  1. First posted10 Jun 2025
  2. Study start8 Sep 2025
  3. Primary completion6 Oct 2026
  4. Study completion30 Jun 2028 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
262 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07012876
Sponsor's protocol ID
(1.13E)250000-KT-56/ERC0004137
Status last verified
Apr 2026
First submitted
16 May 2025
Last updated
2 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: under way, not looking for participants, as of the sponsor's last update on 2 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?

This study is still under way. Results are not available in the source record yet.

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: Baseline, eight weeks after baseline, three months after baseline). 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 2 Nov 2026.

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