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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Symptoms of Depression and Anxiety
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The 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 group | Other | The 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.
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
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted21 Oct 2024
- Study start30 Oct 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptoms of Depression and AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Evaldas Kazlauskas, Vilnius University
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Chatbot-based Stress Management Intervention STARS for Youth in Lithuania: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06651411
- Acronym / sponsor ID
- (1.13E)250000-KT-67/ERC0004137
- Conditions
- Symptoms of Depression and Anxiety
- Keywords
- Intervention, Chatbot, Stress management, youth, STARS, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: STARS (Scalable Technology for Adolescents and youth to Reduce Stress)The intervention group will get a 10-session chatbot-based stress management intervention. |
| Control group | Other | Behavioral: Basic psychoeducationThe control group will get basic psychoeducation. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age of 18-25 years
- Understanding the Lithuanian language
- Having access to a device for intervention delivery
- Experiencing moderate levels of psychological distress
Key exclusion criteria (4 listed)
- People at imminent risk of suicide
- People currently experiencing a psychotic episode
- People currently experiencing interpersonal violence
- Current dependency on alcohol/drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STARS (Scalable Technology for Adolescents and youth to Reduce Stress)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. | Behavioural | Intervention group |
| Basic psychoeducationBasic psychoeducation includes basic information on stress management. | Behavioural | Control group |
Primary outcome
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.
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.
12 secondary outcomes
Changes in Kessler-6
Time frame: Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The Brief Adjustment Disorder Measure-8
Time frame: Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The SIDAS
Time frame: Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The WHODAS 2.0
Time frame: Before the intervention, immediately after the intervention, 3-months after the intervention
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 The International Trauma Questionnaire
Time frame: Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The Resilience scale
Time frame: Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The Client Services Receipt Inventory
Time frame: Before the intervention, 3-months after the intervention
Changes in The EQ-5D-5L
Time frame: Before the intervention, immediately after the intervention, 3-months after the intervention
Recruitment rate
Time frame: Before the intervention
Drop-out rates
Time frame: Immediately after the intervention, 3-months after the intervention
Number of adverse events and serious adverse events
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual participant data can be shared upon a reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.