Clinical trial NCT07012876: Effectiveness of a Guided Mental Health Chatbot STARS for Youth Living in Lithuania
Official title: Effectiveness of a Guided Mental Health Chatbot STARS for Youth Living in Lithuania: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Symptoms of Depression and Anxiety
Keywords: Intervention
Chatbot
Mental health
Youth
STARS
Effectiveness
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2025-06-10
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to assess the effectiveness of a guided mental health chatbot STARS 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), 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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in The Patient Health Questionnaire-9
timeFrame: Baseline, eight weeks after baseline, three months after baseline
measure: Changes in The Generalized Anxiety Disorder-7
timeFrame: Baseline, eight weeks after baseline, three months after baseline
Secondary outcomes:
measure: Changes in Kessler-6
timeFrame: Baseline, eight weeks after baseline, three months after baseline
measure: Changes in The Brief Adjustment Disorder Measure-8
timeFrame: Baseline, eight weeks after baseline, three months after baseline
measure: Changes in The SIDAS
timeFrame: Baseline, eight weeks after baseline, three months after baseline
measure: Changes in The WHODAS 2.0
timeFrame: Baseline, eight weeks after baseline, three months after baseline
measure: Changes in The World Health Organization Well-being Index-5
timeFrame: Baseline, eight weeks after baseline, three months after baseline
measure: Changes in Internalized Stigma of Mental Illness
timeFrame: Baseline, eight weeks after baseline, three months after baseline
measure: Changes in Self-Stigma of Seeking Help
timeFrame: Baseline, eight weeks after baseline, three months after baseline
measure: Changes in The Client Services Receipt Inventory
timeFrame: Baseline, three months after baseline
measure: Changes in The EQ-5D-5L
timeFrame: Baseline, eight weeks after baseline, three months after baseline
Other outcomes:
measure: International Trauma Exposure Measure before intervention
timeFrame: Baseline
measure: The International Trauma Questionnaire before intervention
timeFrame: Baseline
measure: The Resilience scale before intervention
timeFrame: Baseline
measure: User satisfaction after intervention
timeFrame: Eight weeks after baseline
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University
Study officials:
References: