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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
262
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.
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.
Vilnius University
Vilnius, Vilnius County, Lithuania
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. In the Lithuanian sample, the PHQ-9 had a good internal consistency with Cronbach's α of 0.85 (Nomeikaite et al., 2023).
Time frame: Baseline, eight weeks after baseline, three months after baseline
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. In the Lithuanian sample, the GAD-7 had a good internal consistency with Cronbach's α of 0.91 (Nomeikaite et al., 2023).
Time frame: Baseline, eight weeks after baseline, three months after baseline
Changes in Kessler-6
Kessler-6 is used as a screener with a cut-off score of 8, which is commonly used to indicate moderate levels of psychological distress. Also, 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. Previous studies have shown good psychometric properties of the Kessler-6 (Cronbach α = 0.86) (Ferro, 2019).
Time frame: Baseline, eight weeks after baseline, three months after baseline
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. In the Lithuanian sample, the ADNM-8 had a good internal consistency with Cronbach's α of 0.93 (Kazlauskas et al., 2023).
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Time frame: Baseline, eight weeks after baseline, three months after baseline
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. In the Lithuanian sample, the SIDAS had a good internal consistency with Cronbach's α of 0.93 (Skruibis et al., 2022).
Time frame: Baseline, eight weeks after baseline, three months after baseline
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. Previous studies have shown good psychometric properties of the WHODAS 2.0 (Cronbach α = 0.96) (Saltychev et al., 2021).
Time frame: Baseline, eight weeks after baseline, three months after baseline
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. In the Lithuanian sample, the WHO-5 had a good internal consistency with Cronbach's α of 0.87 (Nomeikaite et al., 2023).
Time frame: Baseline, eight weeks after baseline, three months after baseline
Changes in Internalized Stigma of Mental Illness
Changes in internalized stigma of psychological difficulties (the term of psychological difficulties instead of mental illness is used in this study) are measured. The Internalized Stigma of Mental Illness-Brief Version (ISMI-10, Boyd et al., 2014) is a self-report measure comprising 10 items about internalized stigma of psychological difficulties. All items are answered on a 4-point Likert scale that ranges from 1 (strongly disagree) to 4 (strongly agree). A higher score indicates more pronounced internalized stigma of psychological difficulties. Previous studies have shown good psychometric properties of the ISMI-10 (Cronbach's α = .75-.81) (Boyd et al., 2014).
Time frame: Baseline, eight weeks after baseline, three months after baseline
Changes in Self-Stigma of Seeking Help
Changes in stigma of self-stigma of seeking help are measured. The Self-Stigma of Seeking Help-Ultra-Brief Version (SSOSH-3, Brenner et al., 2021) is a self-report measure comprising 3 items about self-stigma of seeking help. All items are answered on a 5-point Likert scale that ranges from 1 (strongly disagree) to 5 (strongly agree). A higher score indicates more pronounced self-stigma of seeking help. Previous studies have shown good psychometric properties of the SSOSH-3 (Cronbach's α = .82-.87) (Brenner et al., 2021).
Time frame: Baseline, eight weeks after baseline, three months after baseline
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.
Time frame: Baseline, three months after baseline
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. Convergent validity was demonstrated by a correlation between EQ-5D-5L and the WHO-5, (r = .43, P \< .001) (Janssen et al. 2013).
Time frame: Baseline, eight weeks after baseline, three months after baseline