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

NCT ID: NCT07012876

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Symptoms of Depression and Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Control group

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.

Group Type OTHER

Basic psychoeducation

Intervention Type 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.

Interventions

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

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 Type BEHAVIORAL

Basic psychoeducation

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Exclusion Criteria

* People at imminent risk of suicide
* People currently experiencing a psychotic episode
* People currently experiencing interpersonal violence
* Current dependency on alcohol/drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Health Organization

OTHER

Sponsor Role collaborator

Vilnius University

OTHER

Sponsor Role lead

Responsible Party

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Evaldas Kazlauskas

Professor in clinical psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evaldas Kazlauskas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vilnius University

Locations

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Vilnius University

Vilnius, Vilnius County, Lithuania

Site Status

Countries

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Lithuania

Central Contacts

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Austeja Dumarkaite, Ph.D.

Role: CONTACT

+37062306422

Kenneth Carswell, Ph.D.

Role: CONTACT

+41789401512

Facility Contacts

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Austeja Dumarkaite, Ph.D.

Role: primary

+37062306422

Other Identifiers

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(1.13E)250000-KT-56/ERC0004137

Identifier Type: -

Identifier Source: org_study_id

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