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

The Feasibility of Chatbot-based Stress Management Intervention STARS for Youth in Lithuania: a Pilot Randomized Controlled Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Symptoms of Depression and Anxiety
• Intervention / Treatment: Behavioral: STARS (Scalable Technology for Adolescents and youth to Reduce Stress); Behavioral: Basic psychoeducation

Detailed Description

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 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 01131
    • Vilnius University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group will get a 10-session chatbot-based stress management intervention.	Behavioral: STARS (Scalable Technology for Adolescents and youth to Reduce Stress); 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.
Other: Control group; The control group will get basic psychoeducation.	Behavioral: Basic psychoeducation; Basic psychoeducation includes basic information on stress management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Kessler-6	Changes in psychological distress are measured. Kessler-6 (K6, Kessler et al., 2002) is a self-report measure comprising 6 questions about psychological distress. All items are answered on a 5-point Likert scale that ranges from 0 (none of the time) to 4 (all of the time). A higher score indicates more pronounced symptoms.	Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The Brief Adjustment Disorder Measure-8	Changes in symptoms of adjustment disorder are measured. The Brief Adjustment Disorder Measure-8 (ADNM-8, Kazlauskas et al., 2018) is a self-report measure comprising 8 items about symptoms of adjustment disorder. All items are answered on a 4-point Likert scale that ranges from 1 (never) to 4 (often). A higher score indicates more pronounced symptoms.	Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The SIDAS	Changes in suicidal ideation are measured. The SIDAS (Van Spijker et al., 2014) is a self-report measure comprising 5 questions about suicidal ideation. All items are answered on a 10-point Likert scale that ranges from 0 (never, no control, not close at all, not at all) to 10 (always, full control, made an attempt, extremely). A higher score indicates more pronounced symptoms.	Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The WHODAS 2.0	Changes in functioning are measured. The WHODAS 2.0 (Ustun et al., 2010) is a self-report measure comprising 12 questions about functioning. All items are answered on a 5-point Likert scale that ranges from 0 (none) to 4 (extreme or cannot do). A higher score indicates more pronounced symptoms.	Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The World Health Organization Well-being Index-5	Changes in psychological well-being are measured. The World Health Organization Well-being Index-5 (WHO-5, Bech, 2004) is a self-report measure comprising 5 items about psychological well-being. All items are answered on a 5-point Likert scale that ranges from 0 (at no time) to 4 (all of the time). A higher score indicates more pronounced psychological well-being.	Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The International Trauma Questionnaire	Changes in symptoms of post-traumatic stress disorders are measured. International Trauma Questionnaire (ITQ, Cloitre et al., 2018) is a self-report measure comprising 18 items. All items are answered on a 5-point Likert scale that ranges from 0 (not at all) to 4 (extremely). A higher score indicates more pronounced symptoms.	Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The Resilience scale	Changes in resilience are measured. The Resilience scale (RS-14, Wagnild, 2011) is a self-report measure comprising 14 items about resilience. All items are answered on a 7-point Likert scale that ranges from 1 (strongly disagree) to 7 (strongly agree). A higher score indicates more pronounced resilience.	Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in The Client Services Receipt Inventory	Changes in client service are measured. The Client Services Receipt Inventory (CSRI, Beeacham and Knapp, 2001) is a self-report measure comprising questions about client service. The CSRI covers a broad range of services that may be utilized, including primary and secondary care services, other services, and informal care.	Before the intervention, 3-months after the intervention
Changes in The EQ-5D-5L	Changes in health are measured. The EQ-5D-5L (EuroQol Research Foundation, 2019) is a self-report measure comprising 5 items about health. All items are answered on a 5-point Likert scale that ranges from 1 (I have no problems or similar) to 5 (I am unable or similar). A higher score indicates more pronounced symptoms.	Before the intervention, immediately after the intervention, 3-months after the intervention
Recruitment rate	Recruitment rate recorded as the number of eligible participants who consent to participate in the study will be assessed.	Before the intervention
Drop-out rates	Drop-out rates recorded as the number of randomized participants who do not complete the intervention, the post-test assessment, and three-month follow-up assessment will be assessed.	Immediately after the intervention, 3-months after the intervention
Number of adverse events and serious adverse events	Number of adverse events and serious adverse events will be assessed.	Immediately after the intervention

Collaborators and Investigators

• Sponsor: Vilnius University
• Collaborators: World Health Organization

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Feasibility; Intervention; youth; Chatbot; STARS; Stress management
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: (1.13E)250000-KT-67/ERC0004137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data can be shared upon a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No