Effectiveness of a Guided Mental Health Chatbot for Youth Living in Lithuania

NCT07012876 | Active Not Recruiting

• 1 other identifier: (1.13E)250000-KT-56/ERC0004137
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Symptoms of Depression and Anxiety

Keywords

Intervention; Chatbot; Mental health; Youth; STARS; Effectiveness

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline, eight weeks after baseline, three months after baseline

• 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).

  Baseline, eight weeks after baseline, three months after baseline

Secondary Outcomes (9)

• Changes in Kessler-6

  Baseline, eight weeks after baseline, three months after baseline

• Changes in The Brief Adjustment Disorder Measure-8

  Baseline, eight weeks after baseline, three months after baseline

• Changes in The SIDAS

  Baseline, eight weeks after baseline, three months after baseline

• Changes in The WHODAS 2.0

  Baseline, eight weeks after baseline, three months after baseline

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

  Baseline, eight weeks after baseline, three months after baseline

Other Outcomes (4)

• International Trauma Exposure Measure before intervention

  Baseline

• The International Trauma Questionnaire before intervention

  Baseline

• The Resilience scale before intervention

  Baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will get a guided mental health chatbot STARS.

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

Control group

OTHER

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.

Behavioral: Basic psychoeducation

Interventions

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

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.

Intervention group

Basic psychoeducation BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Vilnius University: lead
• World Health Organization: collaborator

Study Sites (1)

Vilnius University

Vilnius, Vilnius County, 01131, Lithuania

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Evaldas Kazlauskas, Ph.D.

  Vilnius University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in clinical psychology

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 10, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

LI (1)