NCT07012876

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 262 (estimated)
• Sponsor: Vilnius University · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Symptoms of Depression and Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2025-06-10
• Last updated: 2025-07-08

Locations

1 site across 1 country: Lithuania