Tag: Anxiety

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Pathway-Matched Resilience-Oriented Therapy in Rwanda

Conditions: Mental Health; Psychological Trauma; Stress Disorders, Post-Traumatic; Depression; Anxiety; Aggression; Substance-related Disorders; Psychosocial Functioning

Interventions: Behavioral: Resilience-Oriented Therapy – Emotion-Regulation Variant; Behavioral: Resilience-Oriented Therapy – Identity-Development Variant; Behavioral: Resilience-Oriented Therapy – Behavioural Self-Management Variant

Sponsors: Alexandros Lordos, PhD; Centre for Sustainable Peace and Democratic Development; University of Rwanda; Interpeace

Completed
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Feasibility and Preliminary Effectiveness of the ChulaCancer Mobile Chatbot for Supportive Care of Patients With Breast or Colorectal Cancer Receiving Chemotherapy: Pilot Randomized Controlled Trial

<strong>Background:</strong> Chemotherapy-related toxicities often lead to unscheduled health care use and diminished quality of life. Digital health interventions, such as chatbots, offer a scalable solution for supportive care; however, evidence regarding their effectiveness in resource-limited, low- and middle-income settings remains limited. <strong>Objective:</strong> This study aimed to evaluate the feasibility, use, and preliminary effectiveness of a closed-loop chatbot (ChulaCancer Chatbot) in reducing unscheduled hospital visits and stabilizing quality of life among patients receiving chemotherapy for breast or colorectal cancer. <strong>Methods:</strong> This pilot randomized controlled trial enrolled 40 patients at a single academic center in Thailand, randomized 1:1 to either ChulaCancer chatbot plus usual care or usual care alone. The primary end point was the proportion of unscheduled hospital visits due to chemotherapy-related toxicities within 12 weeks of treatment initiation. Secondary end points included longitudinal quality of life changes (30-item EORTC Quality of Life Questionnaire) measured at baseline, following chemotherapy cycle 2, and following cycle 4. Use metrics were extracted from the chatbot platform. Data were analyzed using the Fisher exact test and linear mixed-effects models. <strong>Results:</strong> The platform recorded 2393 total messages with a 70.5% (503/713) successful response rate for user-initiated queries. Unscheduled hospital visits occurred in 15% (3/20) of the chatbot group compared to 35% (7/20) of the usual care group (<i>P</i>=.24). While infection-related visits were similar between groups, the usual care group recorded multiple visits for low-acuity symptoms (eg, anxiety, headache, and edema) that were absent in the chatbot group. Regarding quality of life, the chatbot group demonstrated a significant mitigation of cancer-related fatigue following cycle 4 compared with the usual care group (<i>P</i>=.02 between groups). Additionally, the chatbot group significantly improved in global health status (<i>P</i>=.04) and avoided the decline in physical functioning observed in the control arm (<i>P</i>=.04). <strong>Conclusions:</strong> The integration of a closed-loop chatbot into oncology care is feasible and provides a potential secure triage mechanism that may reduce acute care use for low-acuity concerns. Future large-scale trials incorporating agentic artificial intelligence are warranted to further validate clinical and economic benefits. <strong>Trial Registration:</strong> Thai Clinical Trials Registry TCTR20251220014; https://tinyurl.com/5b6k3e63
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Predictive value of antioxidant and thyroid function indicators for non-suicidal self-injury in adolescents with major depressive disorder

BackgroundNon-suicidal self-injury (NSSI) is highly prevalent in adolescents with major depressive disorder (MDD); however, its underlying pathophysiological mechanisms remain incompletely elucidated. Emerging evidence suggests a potential association between antioxidant markers, thyroid function parameters, and the occurrence of NSSI, although research in this domain remains limited. Accordingly, this study aimed to investigate the predictive efficacy of combining antioxidant and thyroid biomarkers with clinical symptoms for NSSI in adolescents with MDD.MethodsThis study recruited 162 adolescents with MDD between September 2022 and January 2026. Participants were stratified into groups based on the presence or absence of NSSI, in accordance with DSM-5 diagnostic criteria. Multidimensional scales were employed to assess the severity of depression, anxiety, perceived stress, and internet addiction (IA). Concurrently, blood samples were collected to measure bilirubin levels and thyroid function parameters. Stepwise logistic regression analysis was subsequently performed to identify independent risk factors associated with NSSI. Finally, receiver operating characteristic (ROC) curves were constructed to quantify the predictive performance of these identified independent factors.ResultsThe prevalence of NSSI in adolescents with MDD was 57.4%. Multivariate logistic regression analysis identified females (OR = 2.246, 95% CI = 1.032-4.888, P = 0.041), HAMD-17 score (OR = 1.183, 95% CI = 1.088-1.286, P < 0.001), indirect bilirubin (OR = 0.890, 95% CI = 0.797-0.995, P = 0.040), and TSH (OR = 2.060, 95% CI = 1.254-3.385, P = 0.004) as independent predictors of NSSI. Furthermore, ROC curve analysis further demonstrated that the four-item combination of sex, HAMD-17 score, indirect bilirubin, and TSH (AUC = 0.776, 95% CI = 0.701-0.850, P < 0.001) had a better ability to identify NSSI.ConclusionAdolescents with MDD, particularly females, represent a high-risk population for NSSI. Reduced levels of indirect bilirubin coupled with elevated TSH levels may constitute the underlying pathophysiological basis of NSSI and demonstrate significant clinical predictive value. In the future, targeted intervention strategies focusing on the antioxidant defense system and thyroid function may offer novel therapeutic avenues for the management of NSSI.
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Wearable low-level laser therapy (laser acupuncture) versus manual acupuncture for chronic insomnia: protocol for a randomized, assessor-blinded, superiority trial

BackgroundChronic insomnia is a prevalent and disabling condition associated with impaired daytime functioning, psychiatric comorbidity, and autonomic dysregulation. Although cognitive behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment, access is limited. Acupuncture has demonstrated therapeutic benefits for insomnia but requires trained practitioners and repeated clinic visits. Low-level laser therapy (LLLT), an acupoint-targeted form of photobiomodulation that is also referred to as laser acupuncture when applied to acupuncture points, offers a non-invasive and standardized modality that may serve as a practical alternative.MethodsThis single-center, parallel-group, assessor-blinded, superiority randomized controlled trial will compare wearable LLLT with manual acupuncture in 106 adults with chronic insomnia. Participants aged 18–65 years who meet DSM-5 criteria for chronic insomnia and have an Insomnia Severity Index (ISI) score between 8 and 21 will be randomly allocated (1:1) to the LLLT group or acupuncture group. Both interventions will target bilateral HT7, PC6 and SP6 (six acupoints in total) for 30 minutes per session, three times per week, over two weeks (six sessions total). In the LLLT group, 650-nm laser irradiation will be delivered simultaneously to all six acupoints. The primary outcome is the change in ISI score from baseline to week 2. Secondary outcomes include sleep quality (Pittsburgh Sleep Quality Index, PSQI), fatigue (Fatigue Severity Scale, FSS), depressive symptoms (Patient Health Questionnaire-9, PHQ-9), anxiety (Generalized Anxiety Disorder-7, GAD-7) and heart rate variability (HRV) indices. The ISI will be assessed at baseline, post-treatment (week 2), and follow-up (week 6). Secondary outcomes, including PSQI, FSS, PHQ-9, GAD-7, and HRV indices, will be assessed at baseline and week 2. Analyses will follow the intention-to-treat principle using analysis of covariance and prespecified longitudinal or repeated-measures models where appropriate.DiscussionThis trial will provide comparative evidence on the short-term efficacy and safety of wearable LLLT versus manual acupuncture for chronic insomnia. By directly comparing an established acupuncture protocol with a non-invasive intervention that has potential for future home-based implementation, the study aims to clarify the clinical value of LLLT as a less invasive alternative within the framework of complementary and integrative sleep medicine.Clinical trial registrationhttps://itmctr.ccebtcm.org.cn/Home/ProjectView?pid=d0e46c39-0647-4cbd-ba40-e2b02830fd28, identifier ITMCTR2025000977.
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Group-based ACT for Psychological Distress of Young People

Conditions: Depression – Major Depressive Disorder; Depression Anxiety Disorder; Anxiety; Anxiety Depression

Interventions: Other: Group-based Acceptance and Commitment Therapy; Other: TAU

Sponsors: Sorlandet Hospital HF; University of Oslo; Helse Sor-Ost; Karolinska Institutet; Australian Catholic University

Recruiting
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Student Precarity and Psychiatry

Conditions: Depressive Disorder, Major; Generalized Anxiety Disorder; Suicidal Ideation; Loneliness

Interventions: Other: Questionnaires

Sponsors: Assistance Publique – Hôpitaux de Paris; Institut de Psychiatrie et Neurosciences de Paris (INSERM)

Not yet recruiting
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<![CDATA[DT-120, an optimized LSD formulation, shows lasting anxiety relief and high remission at 12 weeks, as researchers share detailed phase 2b safety insights.]]>
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Real-World Implementation of EndoConnect in Brazilian Primary Care: Formative Study of Usability, Engagement, and Equity in Digital Endometriosis Care

Background: Endometriosis is a chronic gynecological condition affecting approximately 10% of women of reproductive age worldwide and is associated with chronic pelvic pain, infertility, and reduced quality of life. In Brazil’s Unified Health System (Sistema Único de Saúde [SUS]), diagnostic delays frequently range from 7 to 10 years and disproportionately affect socially vulnerable populations, including rural, low-income, Black, and Indigenous women. Digital health interventions have been proposed as scalable solutions; however, most available applications are developed in high-income settings and do not align with the structural and operational realities of low- and middle-income countries (LMICs). Objective: This study aimed to evaluate feasibility, usability, acceptability, and user engagement associated with the real-world implementation of EndoConnect Alpha in primary health care settings, and to explore preliminary patterns of change in symptom burden, knowledge, and care navigation. Methods: A single-arm, prospective, formative implementation study was conducted in 10 primary health care units in Ceará, Brazil. A convenience sample of 60 participants, including women with suspected or confirmed endometriosis and primary care professionals, used the platform over an 8-week period under real-world conditions. Usability (assessed using the System Usability Scale), acceptability (assessed using the Technology Acceptance Model), engagement metrics, and exploratory outcomes were assessed. All analyses were exploratory, with no control group and no causal inference. Results: High usability and acceptability were observed, with strong user engagement, including a 79% completion rate of educational modules and consistent platform use. Observed decreases in pelvic pain and anxiety were identified, alongside increases in disease-related knowledge, self-reported therapy adherence, and reported gynecological referrals. A positive association between usability and acceptability was also observed. These findings should be interpreted as exploratory signals given the study design. Descriptive subgroup analyses suggested more pronounced trends among rural participants and those with a lower education level. Conclusions: The real-world implementation of EndoConnect Alpha demonstrated high feasibility, usability, and acceptability within a public primary care setting in a middle-income country. Observed trends suggest potential benefits, particularly among underserved populations; however, causal inference cannot be established. These findings support further controlled evaluation and highlight the relevance of equity-oriented digital health strategies tailored to LMIC contexts.
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