Bipolar Disorder

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.

SAMPLE Inward patients at Klinikum rechts der Isar, Munich, Germany diagnosed with schizophrenia (F20) or a schizoaffective disorder (F25) will be recruited. Treating physicians will screen and pre-select patients who are primarily affected by negative symptoms and on stable medication and/or psychotherapy (treatment as usual) throughout the study period. The target sample size for this pilot is at least N = 10 patients who undergo the experimental study protocol, and an equal number of patients who only complete the scales as a treatment-as-usual control group. PROTOCOL - EXPERIMENTAL GROUP The protocol for the experimental group will be as follows. After written informed consent was obtained by their treating physician, patients will undergo session 0 for pre-tests five to one day(s) before the first stimulation session. For a fair comparison with the post-tests in the last session, patients will be asked not to drink coffee in the three hours beforehand, to rest at the lab for one hour, and then to complete the mood and cognition scales (PANAS and THINC-IT). The psychiatric symptom assessment (PANSS) will be carried out by their treating physician before the first stimulation in session 1. The stimulation protocol will take place the week after, from Monday to Friday, at approximately the same time of day as session 0. Patients should again avoid consuming coffee three hours before each session start, to facilitate sleep. In session 1 (Monday), the EEG will first be set up. The session will start with a five-minute resting-state EEG recording; then, patients will lay down and undergo the visual stimulation protocol with their eyes closed for one hour. They will be encouraged to relax and fall asleep during this time. Afterward, we will inquire about adverse events and the EEG will be removed. In sessions 2 to 4 (Tuesday to Thursday), no EEG will be recorded. Patients will undergo one hour of visual stimulation and subsequently be asked about adverse events in the same way as in session 1. In the last session 5, the protocol will be the same as in session 1, including EEG, five minutes of resting-state recording, and one hour of visual stimulation. Afterward, as in session 0, patients will also complete the mood and cognition scales (PANAS and THINC-IT). The psychiatric symptom assessment (PANSS) will be carried out by their treating physician zero to three days after the last stimulation session. PROTOCOL - CONTROL GROUP As for the control group, after written informed consent was obtained by their treating physician, patients will undergo session 0 analogously to the experimental group for the pre-tests. This procedure will be repeated 7-10 days later for the post-tests. VISUAL STIMULATION Visual stimulation parameters will be analogous to a previous study (Hainke et al., 2025). A customized sleep mask with inbuilt LEDs externally linked to a microcontroller will be used to deliver visual stimuli. Its high-wavelength LEDs with a narrow spectral peak at 605 nm and an illuminance of 80 lux will flicker at 40 Hz in a square wave pattern at a 50 % duty cycle. Light will be faded in at the beginning and out at the end for 10 seconds, respectively. Patients will be asked to keep their eyes closed and encouraged to fall asleep for the full stimulation duration of 60 minutes. After every stimulation session, the experimenter will verbally inquire about adverse events, by asking the patient: "Have you experienced any undesired effects during or after the stimulation?". If the patient answers yes, they will be asked to describe the adverse event and then rate its severity as mild, moderate or severe and whether it was unlikely, likely or certainly related to the stimulation. For the resting-state measurement, the LEDs will be flickering at 40 Hz as during the stimulation, but they will be covered with black tape ("blackout"). This controls for the possibility of electrical interference from the mask on EEG data (Hainke et al., 2025). Here, patients will remain awake. EEG SETUP EEG will be measured in the experimental group at sessions 1 and 5 using the Neurofax system at the clinic's sleep laboratory, supported by Polaris.One software (Nihon Kohden Europe GmbH, Rosbach v.d.H., Germany). The sampling rate will be 1000 Hz. Gold cup electrodes will be positioned at A1, A2 (mastoids reference), FpZ (ground), left EOG, left EMG, C3, C4, O1, Oz, O2, PO3, POz, and PO4. Sleep scoring will be performed automatedly and offline using the Python library YASA based on the C4, EOG, and EMG electrodes, and participants' sex and age (Vallat \& Walker, 2021). EEG PROCESSING Data will be pre-processed using MNE Python as in Hainke et al. (2025): Band-pass filtering (0.16-300 Hz) Bad channel rejection by visual inspection Electrode averaging by Region of Interest: central (C3, C4) and occipital (O1, Oz, O2, PO3, POz, PO4) Re-referencing to the mastoid average (A1, A2) Dividing data into 30-second epochs Bad epoch rejection (\<50% sleep scoring algorithm certainty or stimulation duration \<25 seconds) For frequency domain analyses, epochs with a peak to peak amplitude \> 1 mV will be rejected. All 30-s epochs will be subjected to a Fast-Fourier Transform using a Hamming window to obtain the Power Spectral Density per epoch. For time domain analyses, data will be further divided into 25 ms segments length of one cycle of a 40 Hz oscillation); segments with a peak-to-peak amplitude \>100 μV will be rejected. 30-s epochs and 25-ms segments will be averaged by region of interest (central / occipital), condition (blackout / stimulation), session (1 / 5), and state (awake / light sleep / deep sleep). Light sleep is defined as NREM1 and NREM2; deep sleep is defined as NREM3. EEG OUTCOMES The two resulting EEG outcomes describe the Steady-State Visually Evoked Potentials (SSVEPs), i.e., the magnitude of the neuronal response to 40 Hz visual stimulation, from complementary perspectives. EEG signals can be interpreted in the time domain or the frequency domain; analysing both allows for maximal information gain about underlying neuronal processes (Hainke et al., 2025). In the time domain, SSVEP magnitude is quantified as the peak-to-peak amplitude of the 25-ms segment average in microvolts. In the frequency domain, SSVEP magnitude is quantified as the signal-to-noise ratio of power at 40 Hz, i.e., the power spectral density value at 40 Hz in dB divided by the surrounding values \[38 to 39.5 Hz\] + \[40.5 to 42 Hz\] in dB. COGNITIVE \& PSYCHIATRIC OUTCOMES The following scales will be completed by both the experimental and control group patients, in the respective first and last session. Cognition will be assessed with the THINC-integrated tool test battery (THINC-IT; Harrison et al., 2018), presented on a Windows laptop. It has previously been used to assess cognition in schizophrenia (Szmyd et al., 2023) and has five components: Spotter (Choice Reaction Time), Symbol Check (1-back test), Trails (Trails Making Test B), Codebreaker (Digit Symbol Substitution Test), and a self-reported cognitive function questionnaire (5-item Perceived Deficit Questionnaire). Mood will be measured with the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988). The Positive and Negative Syndrome Scale (PANSS; Kay et al., 1987) will be administered by a trained physician to quantify schizophrenia-related psychiatric symptoms. An interim analysis will be conducted when a sample of 10 patients in the experimental group has been reached.

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.

Bipolar disorder (BD) is a serious, complicated, familial aggregation onset of mental illness, which has the characteristics of five-low and one-high, namely high prevalence, high recurrence rate, high morbidity and mortality, high comorbidity rate and younger age characteristics. This situation will seriously influence one's behaviour or thinking, cognitive, emotional, social and occupational function, causing the heavy burden of disease. But, early recognition and early diagnosis are difficult to achieve at present. Based on the preliminary research results of the project team, it is found that BD can be identified early through specific dimensions, and early recognition is crucial for the prognosis of patients. The earlier the intervention for BD is implemented, the better the prognosis, especially the functional prognosis, but the difficulty lies in how to implement it. Establishing a high-quality clinical cohort of BD high-risk population is a necessary prerequisite. This study intends to establish a high-quality, large-sample cohort through multi-center, long-term and prospective cohort design and enroll 100 BD high-risk patients every year, a total of 400 cases in 4 years. The electronic mental health service platform will be used for ten years of intensive follow-up. Multi-modal data including clinical characteristics, genetic, cognitive, neuroimaging, sleep monitoring, eeg, eye movement, speech, facial expression and movement were collected to construct the database. On this basis, the interaction of biological factors, clinical risk factors, and environmental risk factors in the onset of BD is discussed to establish a big data prediction model for BD onset in high-risk populations. The effective subgroups of early intervention were analyzed and screened. An ethical and individualized prediction model of the effectiveness and safety of early intervention for the BD high-risk population was constructed. It is hoped that the smooth implementation of this project can provide empirical evidence for the early identification, prevention and intervention of BD. To provide clinicians with real data-driven decision-making guidance to assist in selecting personalized and precise treatment; Ultimately promote the prognosis and functional recovery of BD patients.

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.

BACKGROUND Population surveys indicate that people generally hold distorted views and negative stereotypes about individuals suffering from mental disorders. For example, 60% of the population believes that patients with mental disorders are aggressive or violent, and 50% believe they are incapable of working. Research has also found that most individuals with mental disorders are aware of the presence of these stereotypes in society, and over 70% expect to be treated unjustly by others because of their condition. Additionally, 60-70% of patients with mental disorders believe that most people would refuse to have someone with a mental disorder as a friend, neighbor, colleague, or partner. While some individuals with mental disorders may react to these stereotypes with indifference or anger, most end up accepting these stereotypes as true, internalizing them and attributing them to themselves; this phenomenon is known as internalized stigma or self-stigma. One of the largest studies in this field estimated that 41% of individuals with schizophrenia spectrum disorders experience high levels of self-stigma. Other studies have reported similar rates. The literature has found that self-stigma is associated with worse recovery outcomes. A recent meta-analysis reports significant correlations between self-stigma and a lack of hope, self-esteem, and self-efficacy, poorer subjective quality of life, greater symptom severity, and lower treatment adherence. Self-stigma can be both a consequence and a cause of negative outcomes. When self-stigma plays a causal role, it can become a target for treatment. Yanos and colleagues proposed the illness identity model which provides a set of detailed and testable hypotheses regarding the potential causal role that self-stigma plays in influencing recovery outcomes in individuals with mental disorders. This model suggests that when identity is influenced by self-stigma, individuals believe that recovery is not possible, reducing hope (i.e., expectations about one future) and self-esteem. Despair and low self-esteem, in turn, increase the risk of suicide, reduce social interaction, lead to the use of passive coping strategies for symptoms, and reduce treatment adherence. As patients use avoidant coping strategies, they may also lose their jobs. Finally, avoidant coping, social isolation, and reduced social functioning can increase the severity of psychotic symptoms. Empirical support for this model comes from the findings of two studies conducted by different research groups. Building on the evidence of the role that self-stigma plays in recovery processes, Narrative Enhancement and Cognitive Therapy (NECT) was developed as a treatment protocol aimed at reducing self-stigma in individuals with mental disorders. NECT is a structured group treatment that combines psychoeducation (to help participants challenge stigmatizing beliefs about mental illness and recovery with empirical and scientific data), cognitive restructuring (aimed at teaching skills to modify negative beliefs about oneself related to stigma), and narrative enhancement (designed to help participants improve their ability to integrate themes like trust and self-worth into their narratives). To date, five studies have tested the effectiveness of NECT. The first, conducted in the United States with a small group of 39 patients, failed to highlight significant effects of NECT on self-stigma, likely due to the small sample size; however, the intervention was found to be feasible and well-tolerated by participants. A study conducted in Israel with 119 patients showed that participation in the NECT program was associated with significant improvements in self-esteem, quality of life, and hope. Similarly, a randomized controlled trial with a 6-month follow-up conducted in Gothenburg, Sweden, found that the NECT intervention was associated with significant improvements in self-esteem and self-stigma, and that these improvements were maintained at six months. A subsequent randomized controlled study conducted in the United States with 170 patients with schizophrenia spectrum disorders demonstrated that NECT could produce significant improvements in self-stigma and other variables, including avoidant coping, compared to the supportive control intervention. Finally, a randomized controlled trial implemented in Taiwan showed more significant results from NECT in improving self-esteem and reducing perceived discrimination compared to the control intervention. These studies demonstrate that NECT's effectiveness is supported by robust empirical evidence, qualifying it as an evidence-based intervention and suggesting its large-scale implementation. Unfortunately, in Italy, interventions against self-stigma in individuals with mental disorders are not regularly provided. Where anti-self-stigma interventions are offered, they are generally not based on solid evidence of effectiveness. This delay is due to the unavailability of manualized interventions, such as NECT, in our language. Moreover, the anti-self-stigma interventions published in the literature have so far been tested in geographical contexts and within healthcare organizations very different from those in our country. Therefore, it is unclear how these interventions, if made available in Italian, could be applicable within our healthcare settings. OBJECTIVES The objectives of this study are: (1) to evaluate the effectiveness of this approach in the clinical routine of mental health centers; (2) to test the feasibility of the new Italian version of the NECT treatment in patients who seek care at mental health centers in a large area of north-eastern Italy. Overall, this project will enhance knowledge of optimal treatments for patients with mental disorders burdened by high self-stigma, with the aim of improving their recovery outcomes. The study is a pragmatic, multicenter, randomized controlled trial with two parallel arms: intervention group and control group. INTERVENTIONS The intervention group will receive Narrative Enhancement and Cognitive Therapy (NECT), a structured group therapy aimed at reducing self-stigma in individuals with severe mental disorders. NECT, originally developed by Philip Yanos and colleagues, has been adapted into Italian for this study and consists of 20 sessions divided into five parts: orientation, psychoeducation, cognitive restructuring, narrative enhancement, and conclusion. Each part is designed to help participants reflect on their experiences, challenge self-stigmatizing beliefs, and foster a new, positive identity. The control group will continue with their usual care, which typically involves a combination of pharmacological treatment and psychosocial interventions provided by public mental health services. The study will systematically collect information about the care received by participants during the trial. STUDY DURATION AND RANDOMIZATION PROCEDURE NECT sessions during approximately one hour, structured into an introduction, a central discussion, and a conclusion. The NECT intervention is considered an add-on treatment, meaning participants will continue receiving their standard care in addition to the group therapy. The control group will continue with their usual treatment, which may include medication, symptom management, and psychiatric rehabilitation. Staff involved in delivering the NECT intervention will undergo specific training to ensure consistent and effective implementation. Treatment fidelity will be monitored through audio recordings of selected sessions, evaluated using the NECT Fidelity Scale. The study also includes a feasibility assessment, measuring participant engagement, session completion rates, and feedback from both participants and facilitators to identify factors that may impact the implementation of NECT in clinical settings. The study is designed to be completed over 12 months. It begins with protocol approval, followed by a two-month recruitment phase to enroll eligible participants. Once recruitment is complete, a five-month intervention phase will take place, during which participants will undergo the NECT treatment. The final five months are allocated for data entry, analysis, and the preparation of results for publication. The study involves 26 community mental health centers (CMHCs) across the Veneto region, the Trento province, and the city of Bolzano. The randomization process is crucial for ensuring the validity of the trial. Each CMHC will recruit 16 patients, for a total of 416 participants. They will be randomly assigned to either the NECT intervention group or a control group, maintaining a 1:1 allocation ratio. This stratified randomization by CMHC ensures that the unique characteristics of each center are accounted for, contributing to the robustness of the study's findings. The randomization will be carried out using specialized software to ensure fairness and consistency across all centers.

The study objective is to assess the feasibility and acceptability of three new culturally-responsive components added to the brief young adult engagement intervention called Just Do You. The new components incorporate techniques from the DSM-5 Cultural Formulation Interview (CFI) and creative arts therapy to increase culturally-responsive content in Just Do You, which demonstrated evidence of keeping young adults connected to their treatment in a prior trial. Components are designed to elicit relevant cultural characteristics, experiences, and perspectives of diverse young adults enrolled in psychiatric rehabilitation as part of the Just Do You orientation program. The investigators will examine whether the new culturally-responsive components improve engagement in mental health services and increase service utilization. A total of 80 young adults enrolled in an outpatient psychiatric rehabilitation program in New York will be recruited over 24 months to take part in a randomized full factorial pilot trial. Participants will be given a baseline assessment and randomly assigned to one of eight combinations of intervention components. Just Do You will be delivered first to all participants, with the assigned combination of new components to follow. The intervention will be delivered at the psychiatric rehabilitation program and will last up to five weeks for each participant, depending on the experimental condition. Outcome measures will be assessed at baseline, post-intervention, and 3-month follow up.

The effectiveness of a multidomain lifestyle intervention on the prevention of cognitive decline and dementia have not been studied in Asian elderly at high risk of dementia conversion. Dementia is caused by both nonmodifiable genetic variables, and modifiable lifestyle risk factors. While neuroimaging biomarkers have been well documented in the neurophysiology of ageing and age-associated cognitive decline, their role as surrogate endpoints and intermediate variables between multi-domain lifestyle intervention and cognitive benefits has not been studied. The current study aims to understand brain functional and structural changes that may result from a multi-domain lifestyle intervention and whether the changes correlate with improvement in cognitive function. At risk elderly aged 60-80 years will be randomly allocated to either the control arm (self-guided management) or the intervention (multi-domain lifestyle) arm, which consists of nutritional guidance, physical exercise, cognitive training and the monitoring and management of vascular and metabolic risk factors. We hypothesize that the multi-domain lifestyle intervention will promote favorable changes in cognitive function. Moreover, such intervention will slow down the progression of cerebrovascular disease and neurodegeneration in participants in the intervention arm. Findings from the present study will shed light on the biological mechanisms of age-related cognitive decline and neurodegenerative disease. Insight obtained from the study could be translated into new targets of nonpharmacological interventions which aim at the potential causal molecular pathways implicated in ageing and age-related cognitive decline. Adaption and implementation of our findings into clinical and public health practice will further promote healthy and confident ageing among Chinese elderly, to eventually expand their health span.

The goal of this cluster randomized controlled trial is to evaluate the effects of a smartphone-based Healthy Lifestyle (HLS) intervention on firefighters' mental and physical health in firefighters in Tainan, Taiwan. The main questions it aims to answer are: * Does the Traditional Chinese version of the HLS mobile App improve firefighters' mental and physical health compared to usual care? * Can the intervention effectively promote a healthy lifestyle and reduce the risk of chronic non-communicable diseases among firefighters? Researchers will compare firefighters receiving the smartphone-based HLS intervention to those receiving usual care to determine whether the intervention leads to improved health and fitness outcomes over 3 to 6 months. Participants will: * Use the Traditional Chinese version of the HLS mobile App, originally developed at Cambridge Health Alliance, Harvard Medical School, and adapted for firefighters in Taiwan. * Be randomly assigned to either the intervention group (HLS App) or the control group (usual care). * Undergo health and fitness assessments at baseline and at 3 to 6 months post-intervention. Anticipated outcomes are improvements in mental and physical health among firefighters receiving the intervention compared to the control group.

This 5-year study aims to refine and pilot a peer-delivered intervention to improve functional and social recovery to decrease suicide risk; the study consists of two phases. Phase 1 employs a user-centered design approach to refine SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT) aided by scientific and consumer advisory board stakeholders as well as training Peer Specialists to fidelity on pilot cases in an open trial. SUPPORT is a flexibly delivered intervention intended to augment safety planning by addressing functional and social goals personalized to each Veteran's recovery following a suicidal crisis while including cognitive learning strategies to enhance recall and salience of intervention material. Following adaptations from Phase 1, Phase 2 includes a pilot randomized controlled trial of SUPPORT compared to an enhanced standard care condition. Veteran participants in both phases will be quantitatively assessed at baseline, mid-treatment, post-treatment, and 3-months post-treatment (and qualitatively interviewed at post-treatment). Peer Specialists delivering the intervention will also be qualitatively interviewed post-treatment. The primary outcomes to be evaluated is improvement in personal recovery and reduction in suicidal ideation severity. Secondary outcomes concern changes in various domains of personal and social functioning.