Clinical trial NCT06651411: The Feasibility of Chatbot-based Stress Management Intervention STARS for Youth in Lithuania
Official title: The Feasibility of Chatbot-based Stress Management Intervention STARS for Youth in Lithuania: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Symptoms of Depression and Anxiety
Keywords: Intervention
Chatbot
Stress management
youth
STARS
Feasibility
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2024-10-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

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: Before the intervention, immediately after the intervention, 3-months after the intervention
measure: Changes in The Generalized Anxiety Disorder-7
timeFrame: Before the intervention, immediately after the intervention, 3-months after the intervention
Secondary outcomes:
measure: Changes in Kessler-6
timeFrame: Before the intervention, immediately after the intervention, 3-months after the intervention
measure: Changes in The Brief Adjustment Disorder Measure-8
timeFrame: Before the intervention, immediately after the intervention, 3-months after the intervention
measure: Changes in The SIDAS
timeFrame: Before the intervention, immediately after the intervention, 3-months after the intervention
measure: Changes in The WHODAS 2.0
timeFrame: Before the intervention, immediately after the intervention, 3-months after the intervention
measure: Changes in The World Health Organization Well-being Index-5
timeFrame: Before the intervention, immediately after the intervention, 3-months after the intervention
measure: Changes in The International Trauma Questionnaire
timeFrame: Before the intervention, immediately after the intervention, 3-months after the intervention
measure: Changes in The Resilience scale
timeFrame: Before the intervention, immediately after the intervention, 3-months after the intervention
measure: Changes in The Client Services Receipt Inventory
timeFrame: Before the intervention, 3-months after the intervention
measure: Changes in The EQ-5D-5L
timeFrame: Before the intervention, immediately after the intervention, 3-months after the intervention
measure: Recruitment rate
timeFrame: Before the intervention
measure: Drop-out rates
timeFrame: Immediately after the intervention, 3-months after the intervention
measure: Number of adverse events and serious adverse events
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University
Study officials:
References: