Background: Depression and anxiety are a leading cause of disability worldwide and often start during adolescence and young adulthood. The majority of young people live in low- and middle-income countries where there is a lack of mental health services. The World Health Organization (WHO) developed a guided, nonartificial intelligence chatbot intervention called Scalable Technology for Adolescents and youth to Reduce Stress (STARS) to reduce symptoms of depression and anxiety among young people affected by adversity. Objective: The objective of this study was to evaluate the feasibility of the STARS intervention and study procedures among young people in Jordan. Methods: A 2-arm, single-blind, feasibility randomized controlled trial was conducted among 60 young people aged 18 years to 21 years living in Jordan with self-reported elevated levels of psychological distress. Immediately after baseline, participants were randomized 1:1 into the STARS intervention or enhanced care as usual (ECAU). STARS consisted of 10 lessons in which participants interacted with a chatbot and learned several cognitive behavioral therapy strategies, with optional guidance by a trained e-helper through 5 weekly phone calls. ECAU consisted of a static web page providing basic psychoeducation. Online questionnaires were administered at baseline (week 0) and postassessment (week 8) to assess depression (Hopkins Symptom Checklist-25 [HSCL-25]), anxiety (HSCL-25), functional impairment (WHO Disability Assessment Schedule [WHODAS] 2.0), psychological well-being (WHO-Five Well-Being Index [WHO-5]), and agency (State Hope Scale). Process evaluation interviews with stakeholders were conducted after the postassessment. Results: Participants were recruited in December 2022 and January 2023. Of 700 screening website visits, 160 participants were eligible, and 60 participants (mean age 19.7, SD 1.16 years; 49/60, 82% female) continued to baseline and were randomized into STARS (n=30) or ECAU (n=30). Of those who received STARS, 37% (11/30) completed at least 8 chatbot lessons, and 13% (4/30) completed all 5 support calls. The research protocol functioned well in terms of balanced randomization, high retention at postassessment (48/60, 80%), and good psychometric properties of the online questionnaires. Process evaluation interviews with STARS participants, ECAU participants, e-helpers, and the clinical supervisor indicated the acceptability of the study procedures and the STARS and ECAU conditions and highlighted several aspects that could be improved, including the e-helper support and features of the STARS chatbot. Conclusions: This study demonstrated the feasibility and acceptability of the STARS intervention and research procedures. A fully powered, definitive randomized controlled trial will be conducted to evaluate the effectiveness of STARS. Trial Registration: ISRCTN ISRCTN19217696; https://doi.org/10.1186/ISRCTN19217696

Background: Young people in low- and middle-income countries encounter significant barriers to accessing mental health support due to various factors, including a substantial treatment gap and limited health care budgets allocated to mental health. Using innovative strategies, such as scalable digital self-help psychological interventions, offers a potential solution for improving access to mental health support. However, digital mental health interventions come with their own set of challenges, including issues related to low user engagement. Chatbots, with their interactive and engaging nature, may present a promising avenue for the delivery of these interventions. Objective: This study aims to explore the effectiveness of a newly developed World Health Organization (WHO) digital mental health intervention, titled Scalable Technology for Adolescents and Youth to Reduce Stress (STARS). Methods: A single-blind, 2-arm randomized controlled trial will be conducted nationally across Jordan. Participants will include 344 young adults, aged 18-21 years, currently residing in Jordan. Inclusion criteria are heightened levels of psychological distress as determined through the 10-item Kessler Psychological Distress Scale (≥20). Assessment measures will be conducted at baseline, 1-week post intervention, and 3-month follow-up. Following baseline assessments, eligible participants will be randomized to receive STARS or enhanced usual care. The primary outcomes are the reduction of symptoms of depression and anxiety (Hopkins Symptom Checklist, 25 subscales) at 3-month follow-up. Secondary outcomes include general functioning (WHO Disability Assessment Schedule 2.0), well-being (WHO-5 Well-Being Index), personal problems (Psychological Outcomes Profile), and agency (State Hope Scale subscale). Results: The study was funded in January 2020 by the Research for Health in Humanitarian Crises Programme (Elhra) and recruitment for the trial started on July 16, 2023. As of November 15, 2023, we randomized 228 participants. Conclusions: This trial intends to contribute to the growing digital mental health evidence base by exploring technological solutions to address global public health challenges. Given the widespread use of technology globally, even in resource-constrained settings, and the high adoption rates among adolescents and young individuals, digital initiatives such as STARS present promising opportunities for the future of mental health care in low- and middle-income countries. Trial Registration: ISRCTN Registry ISRCTN10152961; https://www.isrctn.com/ISRCTN10152961 International Registered Report Identifier (IRRID): DERR1-10.2196/54585

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Depression and anxiety are a leading cause of disability worldwide and often start during adolescence and young adulthood. The majority of young people live in low- and middle-income countries where there is a lack of mental health services. The World Health Organization (WHO) developed a guided, nonartificial intelligence chatbot intervention called Scalable Technology for Adolescents and youth to Reduce Stress (STARS) to reduce symptoms of depression and anxiety among young people affected by adversity. Objective: The objective of this study was to evaluate the feasibility of the STARS intervention and study procedures among young people in Jordan. Methods: A 2-arm, single-blind, feasibility randomized controlled trial was conducted among 60 young people aged 18 years to 21 years living in Jordan with self-reported elevated levels of psychological distress. Immediately after baseline, participants were randomized 1:1 into the STARS intervention or enhanced care as usual (ECAU). STARS consisted of 10 lessons in which participants interacted with a chatbot and learned several cognitive behavioral therapy strategies, with optional guidance by a trained e-helper through 5 weekly phone calls. ECAU consisted of a static web page providing basic psychoeducation. Online questionnaires were administered at baseline (week 0) and postassessment (week 8) to assess depression (Hopkins Symptom Checklist-25 [HSCL-25]), anxiety (HSCL-25), functional impairment (WHO Disability Assessment Schedule [WHODAS] 2.0), psychological well-being (WHO-Five Well-Being Index [WHO-5]), and agency (State Hope Scale). Process evaluation interviews with stakeholders were conducted after the postassessment. Results: Participants were recruited in December 2022 and January 2023. Of 700 screening website visits, 160 participants were eligible, and 60 participants (mean age 19.7, SD 1.16 years; 49/60, 82% female) continued to baseline and were randomized into STARS (n=30) or ECAU (n=30). Of those who received STARS, 37% (11/30) completed at least 8 chatbot lessons, and 13% (4/30) completed all 5 support calls. The research protocol functioned well in terms of balanced randomization, high retention at postassessment (48/60, 80%), and good psychometric properties of the online questionnaires. Process evaluation interviews with STARS participants, ECAU participants, e-helpers, and the clinical supervisor indicated the acceptability of the study procedures and the STARS and ECAU conditions and highlighted several aspects that could be improved, including the e-helper support and features of the STARS chatbot. Conclusions: This study demonstrated the feasibility and acceptability of the STARS intervention and research procedures. A fully powered, definitive randomized controlled trial will be conducted to evaluate the effectiveness of STARS. Trial Registration: ISRCTN ISRCTN19217696; https://doi.org/10.1186/ISRCTN19217696

BACKGROUND Young people in low- and middle-income countries encounter significant barriers to accessing mental health support due to various factors, including a substantial treatment gap and limited health care budgets allocated to mental health. Using innovative strategies, such as scalable digital self-help psychological interventions, offers a potential solution for improving access to mental health support. However, digital mental health interventions come with their own set of challenges, including issues related to low user engagement. Chatbots, with their interactive and engaging nature, may present a promising avenue for the delivery of these interventions. OBJECTIVE This study aims to explore the effectiveness of a newly developed World Health Organization (WHO) digital mental health intervention, titled Scalable Technology for Adolescents and Youth to Reduce Stress (STARS). METHODS A single-blind, 2-arm randomized controlled trial will be conducted nationally across Jordan. Participants will include 344 young adults, aged 18-21 years, currently residing in Jordan. Inclusion criteria are heightened levels of psychological distress as determined through the 10-item Kessler Psychological Distress Scale (≥20). Assessment measures will be conducted at baseline, 1-week post intervention, and 3-month follow-up. Following baseline assessments, eligible participants will be randomized to receive STARS or enhanced usual care. The primary outcomes are the reduction of symptoms of depression and anxiety (Hopkins Symptom Checklist, 25 subscales) at 3-month follow-up. Secondary outcomes include general functioning (WHO Disability Assessment Schedule 2.0), well-being (WHO-5 Well-Being Index), personal problems (Psychological Outcomes Profile), and agency (State Hope Scale subscale). RESULTS The study was funded in January 2020 by the Research for Health in Humanitarian Crises Programme (Elhra) and recruitment for the trial started on July 16, 2023. As of November 15, 2023, we randomized 228 participants. CONCLUSIONS This trial intends to contribute to the growing digital mental health evidence base by exploring technological solutions to address global public health challenges. Given the widespread use of technology globally, even in resource-constrained settings, and the high adoption rates among adolescents and young individuals, digital initiatives such as STARS present promising opportunities for the future of mental health care in low- and middle-income countries. CLINICALTRIAL ISRCTN Registry ISRCTN10152961; https://www.isrctn.com/ISRCTN10152961 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/54585

Background: Adolescents and young adults in Jordan experience high levels of psychological distress amid persistent stigma, limited mental health literacy, and shortages of specialist services. Although task-shared interventions have expanded access, their dependence on in-person delivery and sustained human resources constrains scalability. Guided digital interventions may extend reach, but evidence regarding their system integration and sustainability in low- and middle-income countries remains limited. Purpose: This study explored how the WHO-developed Scalable Technology for Adolescents and youth to Reduce Stress (STARS), a non-generative, rule-based chatbot intervention supported by trained e-helpers, was experienced and implemented in Jordan. It also examined the system-level tensions shaping its potential for sustainable scale-up. Methods: We conducted a qualitative multiple-case study nested within a randomized controlled trial of STARS in Jordan. Semi-structured interviews were conducted with 21 individuals, including STARS completers and non-completers, trained non-specialist e-helpers, a clinical supervisor, and policy and implementation stakeholders. Data were analyzed using a hybrid approach combining inductive thematic analysis with deductive coding informed by a system-innovation perspective and the culture–structure–practice framework. Results: Participants described STARS as culturally resonant, accessible, and adaptable to everyday life. Four recurring system-level tensions emerged: individualized support versus standardized protocols; privacy and anonymity versus institutional and parental trust; non-specialist support versus expectations for professionally qualified providers; and innovation within research settings versus integration into routine service systems. These tensions reflected competing priorities shaping implementation and perceptions of sustainable scale-up. Conclusions: STARS shows promise as a scalable guided digital mental health intervention for young people in Jordan. However, scale-up will require navigating recurring tensions across cultural, structural, and practice domains rather than addressing implementation barriers in isolation. This will require policy alignment, sustained investment in digital infrastructure and supervision, and cross-sector collaboration.