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| Name | Class |
|---|---|
| World Health Organization | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention group will get a guided mental health chatbot STARS. |
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| Control group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STARS (Scalable Technology for Adolescents and youth to Reduce Stress) | Behavioral | 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. |
| 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. In the Lithuanian sample, the PHQ-9 had a good internal consistency with Cronbach's α of 0.85 (Nomeikaite et al., 2023). | 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). | Baseline, eight weeks after baseline, three months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| International Trauma Exposure Measure before intervention | Number and type of traumatic events before intervention are measured. International Trauma Exposure Measure (ITEM, Hyland et al., 2021) is a self-report measure comprising of 21 items. All items are answered on a dichotomous scale (yes/no). A higher score indicates higher number of traumatic events experienced. ITEM will be used as a predictor in the analysis. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evaldas Kazlauskas, Ph.D. | Vilnius University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vilnius University | Vilnius | Vilnius County | 01131 | Lithuania |
Individual participant data can be shared upon a reasonable request.
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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| Basic psychoeducation | Behavioral | 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. |
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| 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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). | Baseline, eight weeks after baseline, three months after baseline |
| Baseline |
| The International Trauma Questionnaire before intervention | Symptoms of post-traumatic stress disorders before intervention 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. ITQ will be used as a predictor in the analysis. In the Lithuanian sample, the ITQ had a good internal consistency with Cronbach's α of 0.86 (Dumarkaite et al., 2023). | Baseline |
| The Resilience scale before intervention | Resilience before intervention is 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. RS-14 will be used as a predictor in the analysis. The analysis of the psychometric properties of the RS-14 in the sample of Lithuanian adolescents demonstrated high reliability of the scale (Zelviene, 2020). | Baseline |
| User satisfaction after intervention | The usability of the intervention is measured. Participants are asked to evaluate the usability of the intervention by indicating how useful (from 1 "not useful at all" to 5 "very useful"), satisfactory (from 1 "I did not like it at all" to 5 "I liked it a lot"), easy to use (from 1 "it was not easy at all" to 5 "it was very easy"), etc., the program is. Participants are also asked to report their subjective impression regarding the improvement of mental well-being (from 1 "worsened a lot" to 5 "improved a lot"), physical health (from 1 "worsened a lot" to 5 "improved a lot"), general understanding of oneself and one's well-being (from 1 "not at all" to 5 "definitely improved"), recommending the program to others (from 1 "not at all" to 5 "definitely would recommend"), etc. | Eight weeks after baseline |