The Feasibility of Chatbot-based Stress Management Intervention STARS for Youth in Lithuania

NCT06651411 | Active Not Recruiting

• 1 other identifier: (1.13E)250000-KT-67/ERC0004137
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the feasibility of a chatbot-based stress management intervention among youth in Lithuania.

Conditions

Symptoms of Depression and Anxiety

Keywords

Intervention; Chatbot; Stress management; youth; STARS; Feasibility

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.

  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.

  Before the intervention, immediately after the intervention, 3-months after the intervention

Secondary Outcomes (12)

• Changes in Kessler-6

  Before the intervention, immediately after the intervention, 3-months after the intervention

• Changes in The Brief Adjustment Disorder Measure-8

  Before the intervention, immediately after the intervention, 3-months after the intervention

• Changes in The SIDAS

  Before the intervention, immediately after the intervention, 3-months after the intervention

• Changes in The WHODAS 2.0

  Before the intervention, immediately after the intervention, 3-months after the intervention

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

  Before the intervention, immediately after the intervention, 3-months after the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will get a 10-session chatbot-based stress management intervention.

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

Control group

OTHER

The control group will get basic psychoeducation.

Behavioral: Basic psychoeducation

Interventions

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

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.

Intervention group

Basic psychoeducation BEHAVIORAL

Basic psychoeducation includes basic information on stress management.

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

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, 01131, Lithuania

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 28, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

LI (1)