Social Anxiety Disorder
Explore social anxiety research studies currently enrolling. All trials follow HIPAA and IRB compliance standards.
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Found 735 Actively Recruiting clinical trials
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In Thıs study, we aım to evaluate the erectile status of male patients undergoing percutaneous coronary intervention after both heart attack ( group 1) and stable angina ( Group 2). The primary aim is to assess any possible predictive effect of erectile function status on cardiac events. The secondary aim is to assess the direct effect of myocardial infarction on ED status by comparing the two groups. The secondary objective is to assess and analyse other determinants in the natural history survey of erectile status after the intervention. All male patients who undergo a successful PCI and survive will be evaluated. Patients who have had: Malignancy, underlying neurological diagnosis interfering with erectile status, uncontrolled diabetes, and more than two chronic medical conditions, on polifarmacy ( more than three medications a day), and no sexual relationship, who have not agreed to include the study, will not be included in the study. The follow-up period will be 0 (the time the patient recovered well after the intervention). Questinnaiere will examine the status over the last 3 months. 3 and 6-month follow-up. During the follow-up period, the interviews will be conducted face-to-face in the clinical environment, either by a responsible doctor or an educated nurse. The surveys include: IIEF (International Index of erectile function ) questionnaires BECK depression inventory questionnaires FCRP ( Fear of Cardiac Recurrence and Progression Scale ) The objective scale we use: Age SYNTAX score and residual SYNTAX score for evaluating the cardiac vessels occlusion status Cardiac Ejection Fraction status Laboratory values, including testosterone levels, Bodily measurements, including body mass index and waist circumference. Medications Medical conditions Intervention route ( trans radial or femoral ) The survey will take place in our institutions. The hypothesis is that erectile dysfunction is a preliminary condition of an upcoming cardiac event. Myocardial infarction causes significant changes in erectile function in a natural survey. The syntax score has a direct correlation with the baseline erectile function Residual syntax score has a direct relation with post-intervention erectile status.
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This prospective observational study investigates the correlation between lingual colorimetry, captured using readily available and standardized modern photographic tools (iPhone cameras), and anxiety-depression scores evaluated by the Montgomery-Åsberg Depression Rating Scale (MADRS) among patients attending routine acupuncture consultations. Participants will undergo a simple and non-invasive photographic recording of their tongue using an iPhone, ensuring consistent lighting and standardized positioning to minimize variability. Simultaneously, participants will complete the MADRS questionnaire, a widely validated instrument for assessing anxiety and depression severity. No invasive procedures or therapeutic interventions beyond their usual acupuncture care will be performed. The acquired photographic data will be analyzed using machine learning algorithms to identify potential predictive relationships between distinct colorimetric characteristics of the tongue and the MADRS scores. The objective is to determine whether lingual imaging could serve as a reliable, non-invasive biomarker or complementary diagnostic tool for assessing psychological status in clinical practice. This approach leverages everyday technology (smartphones), promoting ease of replication and broader accessibility in clinical environments. Ultimately, findings from this study could facilitate early detection and monitoring of anxiety-depressive disorders, thus enhancing individualized patient care in complementary and integrative medicine.
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Introduction Post-secondary students report alarming rates of feeling overwhelmed, hopeless, anxious, and depressed. To better support student mental health, there is a well-documented need to improve the range and quality of mental health services available to students. Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed. Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses. Despite the growing evidence supporting physical activity for student mental health, there are significant knowledge gaps in the literature. First, research to date has predominantly been single-group designs with a lack of a control group and randomization. This contributes to limitations in the confidence and quality of the implications drawn from the synthesized studies. Indeed, within a post-secondary context, most studies are noted as poor quality and lack critical information regarding how they are designed, delivered, and made accessible to students. Second, there is a paucity of research exploring the effects of different delivery styles (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology reduction) and secondary (i.e., social support, social connectedness) outcomes. Importantly, group-based physical activity, in comparison to 1:1 delivered physical activity, may provide a less costly and less resource intensive intervention option, and may have unique benefits associated with exercising with others and peer-to-peer support (e.g., social support, a sense of belonging, expanded social networks). Third, the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown. As such, conclusions concerning achieving lasting change to mental health and sustained physical activity involvement are not possible. Lastly, limited research has explored contextual factors (e.g., intervention reach, adherence, and program satisfaction) that may influence the sustainability and scale-up of such programming opportunities. Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice. Objectives and Hypotheses This randomized controlled trial study will assess the immediate (post-intervention, 6 weeks) and follow-up (4 weeks after post-intervention) maintenance effects of 1:1 supervised physical activity and group-based physical activity in comparison to a 10-week waitlist control group in reducing symptoms of poor mental health, supporting social well-being outcomes, and facilitating physical activity behaviour among post-secondary students experiencing poor mental health. The primary outcomes will be the immediate change in symptoms of poor mental health (anxiety symptoms, depression symptoms, psychological distress). The secondary outcomes will include follow-up change in symptoms of poor mental health (anxiety symptoms, depression symptoms, psychological distress) as well as the immediate and follow-up change in social well-being outcomes (social connectedness, social support), and physical activity behaviour. The aims of the study include: (1) examining group differences between 1:1 physical activity delivery, group-based physical activity delivery, and the 10-week waitlist control group on the primary and secondary outcomes; and (2) grounded in process evaluation recommendations, to explore contextual factors (e.g., intervention reach, adherence, and program satisfaction) that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination. It is hypothesized that there will be no group differences between 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes. Lastly, it is hypothesized that in comparison to the control group, 1:1 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes. Study Setting The trial will be delivered in the post-secondary setting of a large metropolitan university. Importantly, post-secondary contexts offer natural advantages for large-scale implementation of physical activity programs for student mental health because they offer essential infrastructure (e.g., an integrated setting with access to sport and recreation facilities and mental health services) and practical support (e.g., experts in diverse fields) to develop, evaluate, and disseminate sustainable and scalable programs. Aligning with this perspective, the current study will employ a collaborative implementation approach, whereby the research team will work with on-campus sport and recreation professionals (i.e., for the provision of certified coaches with standard training in behavior change coaching and physical activity delivery) and mental health professionals in the post-secondary community (i.e., for program design, recruitment and implementation, and evaluation). In addition, purposeful efforts (e.g., through advocating for targeted referrals to the program and delivering targeted information sessions) will be made to promote the program among professionals (e.g., accessibility services, student-life services, health and wellness services) involved with providing mental health support or referrals to on-campus support services- an important approach for facilitating collaboration across disciplines and sectors in the campus community. Participant Timeline The university research ethics board (REB) has approved this study (protocol # 00045228). Students who meet eligibility and who have provided informed consent will be contacted to schedule an intake session with a program coordinator for the trial. Students who do not meet eligibility will be notified via email by the program coordinator and will be provided with a mental health resource sheet outlining alternative health and wellness programs and resources available to participate in. Intake sessions will be scheduled in-person in a private research space conveniently located in the campus athletics and recreation centre. During the intake session, participants will complete the baseline assessment (T1), and randomization will be conducted. Following completion of the intake session, participants in the experimental arms will complete the 6-week physical activity program (either 1:1 physical activity delivery or group-based physical activity delivery). In the experimental arms and control condition, study outcomes will be assessed at baseline (T1), 6-weeks post baseline (T2), and at 1-month follow-up (T3). Sample Size A 3 (group, individual, control) by 3 (T1, T2, T3) repeated measures design would require 25 participants per group assuming a moderate effect size of .30, a power level of .80, an alpha of .05, and expected correlations between timepoints of r = .50. To account for a loss to follow-up rate of 25%, the final targeted sample size is 93 post-secondary students. Participants will be randomly assigned to equal groups of approximately 31 students. Recruitment Purposive and snowball sampling procedures will be used to recruit post-secondary students who are physically inactive and experiencing poor mental health. Post-secondary students will be recruited and referred to the intervention through the team's research and professional networks (e.g., health and wellness and student support services; student life listservs; campus mental health listservs; the research team's social media platforms including Twitter and Instagram). Digital recruitment materials (including email scripts and poster advertisements) outlining the purpose of the intervention, intervention procedures, eligibility criteria, and a link to the screening questionnaire will be shared. The screening questionnaire will be administered through REDCap and allow participants to "sign up" up for the intervention through providing their email address and completing several screening questions to confirm eligibility. The program coordinator will contact eligible participants through their provided email address to confirm involvement in the study and to schedule an intake meeting. Data Collection Methods Statistical Methods Preliminary analyses will include descriptive statistics (including mean scores for study variables, standard deviations, frequency counts for categorical variables and bivariate correlations) to examine the relationships between study variables and to describe participant characteristics. A 3 (group, individual, control) by 3 (T1, T2, T3) repeated measures ANOVA will be used to examine whether there are group differences between 1:1 physical activity delivery, group-based physical activity delivery, and the 10-week waitlist control group on the primary and secondary outcomes. Lastly, the implementation process evaluation outcomes will be assessed analyzing the responses to the closed-ended and open-ended questions. Closed-ended questions will be analyzed using descriptive statistics and open-ended questions will be analyzed using inductive thematic analysis. Methods Monitoring Harms There are minimal risks or harms associated with participating in the research trial. Nonetheless, the current sample represents a population with relevant group vulnerability due to self-reported mental health concerns. There are also inherent risks associated with engaging in physical activity. First, it is possible that the self-report assessments may provoke negative emotions or may elicit uncomfortable thoughts and/or feelings. To mitigate emotional risks, participants will be informed of their right to not answer questions they feel uncomfortable answering, and all participants will be provided with a mental health resource sheet following completion of the intake meeting. Participants will also be informed of their right to withdraw from the trial without any penalty to their involvement in the 6-week physical activity intervention. Second, physical risks are rare but include cardiac events and musculoskeletal injuries. To reduce the risk of injury, the physical activity sessions will be delivered by certified sport and recreation coaches who have received standard training in behaviour change coaching and physical activity program delivery. Participants will also receive clearance for physical activity engagement using the PAR-Q+ and will be informed to refrain from engaging in any physical activity causing sharp pain, nausea, dizziness, or light-headedness. Bi-weekly meetings with the research team and sport and recreation coaches to mitigate any risks or concerns for participant vulnerability throughout the duration of the study will be held. Ethics and Dissemination Protocol Amendments Protocol amendments, including but not limited to changes in the study objectives, the eligibility criteria, samples size, the outcomes, or statistical analyses will be submitted to appropriate REB review. Substantive changes will also be documented as amendments to the published study protocol and to the trial registry. Confidentiality All information collected for this trial will be kept strictly confidential. The information will be stored electronically in secure, password-protected folders only accessible to members of the research team. All data will be collected through a secure online data capture program (REDCap), where identifying information (i.e., email address, participant name) will be removed prior to data analysis. Data will be coded by participant ID and presented as aggregate-level data to maintain confidentiality and anonymity of the data.
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The investigators will conduct a pilot randomized controlled trial to evaluate the preliminary effectiveness of an adapted community health worker (CWH)-delivered positive affect counselling intervention delivered remotely via mHealth. The adapted intervention will include CHW-delivered positive affect skill-based counseling accessible through video call that will be accessible through the mHealth app. The CHW will conduct approximately 5 weekly individual 60-minute counseling sessions via a secure video call feature. If the participant does not have symptomatic improvement, the CHW will refer the participant to a licensed mental health professional. Participants will be randomized to receive access to the counselling intervention that also includes modified features of the mHealth app with increased mental health resources (intervention arm) or to current standard of mental health care that includes the unmodified version of the app (control arm). Participants allocated to the intervention arm will receive the counseling intervention approximately weekly for 5 weeks. The study will continue to abstract data from participants' EMR and mHealth app for approximately 6 months after enrollment. To assess preliminary effectiveness, the investigators will analyze differences by condition in anxiety and depression (primary outcome). Informed consent will be obtained prior to study participation.
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The GENESIS study is a multicenter, prospective, non-interventional, clinical study with a target of 12,000 subjects and an anticipated total duration of 36 months. The aim of study GENESIS is to provide a pilot map of HLA genetic variation in the Greek population in order to be used in medical research and for possible clinical applications (evaluation of possible correlations with selected underlying diseases). During the study, each subject will conduct one visit to the participating cite, in which they will provide: 1. Demographic information \[i.e. date of birth, gender, race, ancestry (including information about the subject's grandparents' birthplace), height, weight\], 2. Other information about smoking/vaping, alcohol consumption, arterial blood pressure, diagnosed diseases (if any), current treatments (if any), and 3. Recent (up to 12 months prior to sample collection) results if/when are available from clinical lab tests such as blood count (Hct, Hb, RBC, WBC, PLT count), including a metabolic panel, liver enzymes and biochemical parameters (Glu, HbA1c, TC, TG, LDL-C, HDL-C, ALT, AST, ALP, γGT, bilirubin, LDH, insulin, C-peptide). Upon completion of the data registry, two buccal swabs will be collected per subject and they will be stored at ALTP premises until their shipment to Galatea.Bio. All buccal swab samples will be subjected to genetic material (DNA) extraction. The DNA samples will be further proceeded for HLA genotyping analysis. A follow up analysis will be performed in selected DNA samples via full low-pass whole genome sequencing (LP-WGS), which aims to further investigate the association between the HLA region and autoimmune diseases. Upon completion of the analysis, an individualized ancestry report will be securely made available to all study subjects which they can access, as and if they elect to.
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A clinical study to evaluate Colistimethate Sodium for Injection combination with Meropenem versus Coly-Mycin® M Parenteral combined with Meropenem in the treatment of Carbapenem resistant gram-negative bacteria infection. A total of 80 patients will be enrolled in the study.
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This U.S. multicenter, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the efficacy, safety, and tolerability of a repeat intranasal (i.n.) dose of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PH94B-CL036 and choose to enter the distinct open-label extension phase of the study.
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Background and Significance: Anxiety is very common for autistic youth and can significantly limit functioning and full participation across settings. In school, anxiety may negatively impact students' attendance, school performance, peer relationships and extracurricular participation. Unfortunately, autistic youth have experienced long-standing difficulty accessing mental health care in community settings, and this difficulty is even more pronounced for youth from historically underserved racial and ethnic backgrounds. Cognitive-behavioral therapies (CBT) are evidence-based practices that are effective for anxious children with and without autism but have not yet been consistently available in schools. Schools may be the best location to equitably manage the mental health symptoms of autistic youth. In fact, youth from low-income households and/or other underserved communities are most likely to access services only in school settings. Thus, there is a critical need for evidence-based mental health interventions in schools for autistic students. The primary purpose of the current study is to compare two school-based curriculums: Facing Your Fears - Schools Based (FYF-SB) and Zones of Regulation (ZOR) on meaningful outcomes. The results of this study will not only fill a significant gap in the literature but will provide practical information about the strengths and weaknesses of each program so that school leaders and other stakeholders can make informed decisions about program selection for autistic students. Study Aims. Aim 1: Compare the effectiveness of FYF-SB and ZOR for 200 school-aged autistic students with interfering anxiety. Compare the effectiveness of FYF-SB and ZOR on: (a) symptoms of anxiety (primary) and emotion dysregulation (co-primary) as rated by caregivers, students, teachers, and masked research staff; and (b) functional outcomes of priority to stakeholders, including school attendance, disciplinary action, and academic participation (secondary). Hypothesis: Students who received FYF-SB will show greater reduction of anxiety compared to students who received ZOR. Aim 2. Compare the acceptability, appropriateness, and feasibility of FYF-SB and ZOR via a mixed methods approach with students, caregivers and school providers to aid in decision-making regarding program selection (Secondary). Following intervention completion, participants will complete measures on acceptability, appropriateness, and feasibility of either FYF-SB or ZOR. In addition, a purposive subset of participants will participate in exit interviews to understand outcomes of interest, including potential harms linked with either FYF-SB or ZOR. Aim 3. Examine autism symptom severity and anxiety symptoms severity as moderators of treatment response. This exploratory aim may help answer questions regarding which program could work best for which students. Study Description: This study is a multi-site cluster randomized controlled, type 1 hybrid comparative effectiveness-implementation trial designed to examine whether FYF-SB or ZOR is more effective in treating anxiety in autistic students. School administrators in Colorado and North Carolina will select schools with large numbers of students from historically underserved communities. Randomization will occur at the school level to either FYF-SB (50 schools) or ZOR (50 schools). Interdisciplinary school providers (ISPs) will be trained in one of the interventions and then nominate autistic students with anxiety for participation. ISPs will deliver the intervention programs to small groups (2-5 students) in their schools. Assessments will be conducted pre, post and 6 months following program completion. Independent evaluators masked to condition will complete post-assessments. Implementation outcomes (acceptability and feasibility) will also be examined via mixed-methods and reported by students, caregivers and ISPs. Main components of the intervention and comparator (s): The two school-based curriculums in this study are: Facing Your Fears- School Based (FYF-SB) and Zones of Regulation (ZOR). Both are rooted in CBT principles but manage anxiety in different ways. FYF-SB is based on disorder-specific CBT strategies tailored for reduction of anxiety symptoms and incorporates psychoeducation and graded exposure (facing fears a little at a time) to target anxiety. ZOR is an example of a transdiagnostic approach to intervention and targets emotion dysregulation by focusing on four different emotional states called zones. Students are taught strategies for managing emotions and how to stay in a certain zone. A transdiagnostic treatment approach posit that when emotion regulation improves so to will psychiatric symptoms related to those emotions (e.g., anxiety). Study Population: There are three groups of participants in the study: autistic students, caregivers and interdisciplinary school providers (ISPs). (1) 200 autistic students with interfering anxiety (8-14 years) from historically underserved communities attending elementary or middle schools in Colorado or North Carolina; (2) 200 caregivers of the eligible autistic students; and (3) 150 ISPs (e.g., school psychologists, special educators, speech/language pathologists, occupational and physical therapists) who work with autistic students Primary Outcomes: The primary outcome (s) for this study are: (1) Screening for Childhood Anxiety and Related Emotional Disorders - Child/Parent versions (SCARED; Birmaher et al. 1999). The SCARED is a 41-item inventory of statements that assesses five types of anxiety experienced by children and adolescents, to be completed separately by caregivers and students pre/post intervention and at 6 months follow-up. A total score, as well as cutoffs for specific domains of anxiety (e.g., social, generalized) are obtained. (2) Co-Primary Outcome: Pediatric Anxiety Rating Scale- Autism Spectrum Disorder (PARS-ASD) (Maddox et al. 2020). The PARS-ASD is a clinician-rated semi-structured interview assessing anxiety severity and impairment over the past week, modified for youth with ASD ages 5 to 17 from the original Pediatric Anxiety Rating Scale (PARS) (RUPP) (Walkup et al. 2013). The PARS-ASD will be administered by an independent evaluator (IE) masked to condition. It includes: a Symptom Checklist and five Severity Items. Secondary Outcomes: There are multiple secondary outcomes: (1) stakeholder (patient-centered) identified meaningful outcomes (e.g., tardies, school attendance, grades, number of elopements, classroom participation, use of coping strategies, increase in social initiations, number of phone calls home, visits to the principal, and number of expulsions/suspensions); (2) Emotion Dysregulation Inventory (EDI) (Mazefsky et al. 2018). The EDI is a parent report measure of emotion dysregulation in youth with ASD and will be completed pre/post intervention and at follow-up. The EDI can be used as a self-report measure and can also be completed by school providers); (3) The School Anxiety Scale-Teacher Report (SAS-TR) (Lyneham et al. 2008) is a 16-item teacher-reported measure of anxiety designed to assess the behavior of children at school from 5 to 12 years of age. Items are answered on a four-point scale. The measure provides a total score for anxiety (scores ranging from 0-48); (4) Strengths and Difficulties Questionnaire (SDQ) (Goodman et al. 2000) is a 25-item teacher, parent and student reported tool measuring prosocial behavior and psychopathology of youth 3-16 years old;(5) Emotion Regulation Index for Children and Adolescents (ERICA) (MacDermott et al. 2010) is a 16-item self-report measure of social competence and emotion regulation for children between the ages of 9-16. Implementation Outcomes: (1) CBT Program Use. This brief measure will be administered to ISPs to obtain information about their knowledge and perceptions related to school based interventions, including ZOR and FYF-SB. (2) Acceptability Questionnaire. A six-item acceptability questionnaire will be completed by students and caregivers asking them to respond to questions such as "How much did you enjoy participating in FYF-SB/ZOR?" or "My child is less anxious after participating in FYF-SB/ZOR?" A 5-point Likert scale will be used to rate their responses. (3) Implementation Survey: Brief evaluation forms using a 6-point Likert scale will be completed by ISPs post delivery of FYF-SB/ZOR to assess quality of the training, feasibility, acceptability, and appropriateness of each program including the likelihood that providers will continue to implement the interventions once the study has ended; (4) Semi-structured Exit Interviews: A purposive subset of participants (students, ISPs, caregivers) will be engaged in semi-structured exit interviews conducted by an independent member of the research team designed to understand the acceptability, appropriateness, feasibility and potential harms or negative aspects of either FYF-SB and ZOR. (5) FYF-SB/ZOR Treatment Fidelity Checklists (for internal use only). These checklists will assess ISPs' adherence to either core components of FYF-SB or ZOR, including the four ZOR key elements of preparation, provision of structure, quality of facilitation, and adult evaluation of student learning. The measures assesses the presence/absence of core treatment components as well as quality of intervention delivery. Timeframe: Assessments occur pre and post-intervention for primary and secondary outcomes. Selected measures will also be administered at 6 months follow-up, with the 6 month follow up as primary endpoint. Analytic Plan: General consideration of statistical modeling: Between-arm imbalance of baseline characteristics will be examined using t and chi-square tests and evaluated based on summary statistics. Intervention effect of FYF-SB as compared to ZOR will be assessed using Linear mixed effect model (LMM) for continuous outcomes and non-linear mixed effect model (NLMM) for categorical outcome such as school attendance. To account for design effect of clustering trials, random school (cluster) effect will be in the models for outcome without repeated measures while appropriate covariance structure of LMM/NLMM accounting for both the design effect and the correlation of repeated measures will be used for outcome with repeated measures. Transformation of outcome (ie. Square root or log) will be used if normality assumption is violated. Any imbalanced potential confounding variables will be adjusted for modeling. Primary analysis will be conducted on intent-to-treat basis (ITT). LMM and NLMM will the primary method for dealing with missing value without data imputation since missing pattern would most likely be of the missing at random (MAR) pattern. The change score from baseline to the end of intervention is considered to the primary effectiveness endpoint. No type I error adjustment for multiple tests in a single model or multiple outcomes will be applied. P \< 0.05 is deemed statistically significant. No interim analysis will be performed. To examine the robustness of primary analyses, sensitivity analyses will be conducted, including the same analyses among completers and analyses after missing data were imputed using Markov chain Monte Carlo (MCMC) method.
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Objectives: 1. to develop a multi-domain digital active aging training program through Zoom to promote active aging; and 2. to evaluate whether adding a resilience-building module would enhance the active aging training efficacy to mitigate the lingering detrimental impacts of the pandemic Sample: For Study 1, the investigators will recruit 120 Mandarin-speaking healthy older Chinese immigrants (aged 60+, Chinese migrants) through WeChat(a popular instant messaging app among Chinese)/email/lab website social media channels (e.g., Facebook, Twitter) from the community partners (see a list attached). For Study 2, we will recruit 120 English-speaking healthy White Canadian older adults (aged 60+) through TMSPSS (the senior participant pool at Toronto Metropolitan University) or advertisements. Overall Design and Procedure: Informed consent will be collected. The proposed study will take a traditional pretest-intervention-posttest design including three phases of research activities. In Phase 1 (pretest), the investigators will administer a large battery of outcome measures including physical, psychological (emotional and cognitive), and social function measures to assess the baseline performance. The data collected at pretest also addresses the first sub-objective to identify sociodemographic risk predictors for the biopsychosocial functions and resilience among Chinese older immigrants in Canada. In Phase 2 (intervention), participants will be randomly assigned to an "active aging with resilience", an "active aging", and a "workshop" control condition. They will go through 4 weeks of 8 sessions of training/control treatment delivered virtually through Zoom/YouTube and 8 sessions of offline self-practice. In Phase 3 (posttest), all participants who completed the intervention programs will complete the same battery of the outcome measures as administered at the pretest session. Their performance on the outcome measures at posttest will be compared against pretest to evaluate the efficacy of the training programs. Intervention: The virtually-delivered intervention program will be developed based on previous studies and practices that proved to be effective in resilience-building and active. During the 4-week training period delivered through Zoom/YouTube, participants in the "active aging with resilience" group will complete 8 sessions (approximately 1.5 hours per session and 2 sessions per week) of active aging training program integrated with a resilience-building module. Each session will start with a 15-min session of resilience building activities modified from positive psychology resilience-building activities that promotes various resilience characters (e.g., gratitude, forgiveness, grit etc.). This will be followed by the 1-hour multi-dimensional active aging training activities, including progressive "aging in motion" physical and nutrition training (e.g., age-appropriate "Choose to move" physical workout on-line videos), cognitive training with executive function and speed based on a customized module on CogniFit website, socialization and social engagement (e.g., discussion on the topic and session, followed by homework on volunteering, calling friends/families, community activity participation etc.), and combined bio-psycho-social multi-component training (e.g., performing a cognitive tasks such as counting backwards or memorizing names while doing physical exercise in a virtual socialization setting). Participants in the "active aging" group will receive the same training except that the initial 15-min resilience-building activities will be replaced by warmup activities such as watching some pre-selected video on active aging and completing a quiz afterwards. Both the "active aging with resilience" and traditional "active aging" group will also engage in 8 offline practice sessions where they follow instructions to practice and repeat the last completed modules. Finally, participants in the receptive "workshop" control group will attend 8 virtual workshops or watching workshop videos (following the same 4-week schedule as the two training groups) on different aging-related topics such as physical health, mental health, cognitive wellbeing, emotional regulation, social engagement, and resilience. Each workshop will take approximately 1.5 hours (including 30 min for questions). They will also review and watch the replays of last workshops and take a short survey question after each review session. All these activities will be delivered virtually via Zoom/YouTube in groups of 10-15 individuals. Data Analysis Plan To identify active aging and resilience predictors, a set of explorative multivariate linear regression models will be conducted on the data collected at the pretest session, with all sociodemographic as predictors and outcome measure performance as dependent variables. To evaluate the relative efficacy of the active aging intervention programs, a 3 (condition) by 2 (session) mixed model analysis of variances (ANOVA) models will be conducted on each outcome variable, after controlling for potential sociodemographic covariates. For comparison and clarity purposes, if the outcome measures within each function domain demonstrates similar patterns, the investigators will calculate a composite outcome variable based on the z-scores of all involved measures to index the performance level of that specific functional domain. This composite score will be used as the outcome variable in the ANOVA. In light of the literature, the investigators hypothesized that the "active aging with resilience" training will produce larger and wider benefits relative to the "active aging" training, both compared against the receptive "workshop" control condition.
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Suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people. Specifically, it will conduct a pragmatic randomized controlled trial (RCT) based at the intensive outpatient services (Intensive Adolescent and Family DBT Program (Columbia Doctors)) to test the impact of using the Vira platform for patients versus treatment as usual control (TAU; i.e., not using Vira). This project will include adolescent patients (n = 200) aged 13-18-years-old randomized to: (a) Vira group (n = 100) and (b) treatment as usual control group (n = 100). Participants will include current patients receiving treatment in the intensive outpatient program, and all treatment decisions will be overseen by practitioners within the program. The overarching goal is to test whether using the Vira platform in the context of an intensive outpatient setting improves clinical outcomes.
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