Clinical Research Directory

Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

The goal of this clinical trial is to evaluate the feasibility and preliminary effectiveness of auricular acupressure (ear seeds) combined with nicotine replacement therapy (NRT) in psychiatric inpatients (both male and female, aged 18-65) who are forced to abstain from smoking due to the smoke-free environment of the inpatient ward. The main questions it aims to answer are: * Does auricular acupressure significantly reduce the severity of nicotine withdrawal symptoms compared to standard care? * Can auricular acupressure effectively lower nicotine craving and anxiety levels in patients during their mandatory abstinence? Researchers will compare the experimental group (NRT plus active auricular acupressure) to a control group (NRT plus sham auricular acupressure) to see if the addition of ear point stimulation provides better relief for withdrawal distress. Participants will: * Receive standard nicotine replacement therapy (NRT) as prescribed by their physician. * Be randomly assigned to receive either Vaccaria segetalis seeds or sham materials on specific ear acupuncture points. * Be instructed to press the beads 3 times daily to stimulate the points for a period of 4 weeks. * Complete standardized assessments (MNWS, HAMA, and craving scales) at baseline and multiple time points during the intervention.

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

Stimulation-Induced Changes in Fronto-Limbic Network

The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to assess different aspects of emotion processing. Stimulation pulses during pre and post-test periods will assess the effects of stimulation before and after conditioning, the results of which will be combined with results from the activity of each electrode during the emotion tasks to inform us of the nature of emotion processing in the brain and allow us to devise brain modulation protocols in the future.

Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)

Among youth, the prevalence of mental health and addiction (MHA) disorders is roughly 20%, yet youth are challenged to access services in a timely fashion. To address MHA system gaps, this study will test the benefits of an Integrated Collaborative Care Team (ICCT) model for at-risk youth with MHA challenges. In partnership with community agencies, adolescent psychiatry hospital departments, and family health teams, investigators have developed an innovative model of service provision involving rapid access to MHA services. This model will be implemented and compared to the usual treatment youth receive in hospital-based, outpatient, mental health clinics in Toronto. A rapid, systematic, approach to MHA services geared to need in a youth-friendly environment is expected to result in better MHA outcomes for youth. Moreover, the ICCT approach is expected to decrease service wait-times, be more youth- and family-centred, and be more cost-effective.

Psychiatric Multi-omics and Neuroimaging Project

This study focuses on the structure and function of the brain and gene expression in peripheral blood of patients with schizophrenia, to explore the interaction and influence between the three. Patients with mental disorders who have been recruited will take their medication regularly for 1 year and participate in baseline and follow-up assessments.

Pharmacist-led Interventions in Psychiatric Patients

The goal of this intervention study is to examine the impact of pharmacist-led interventions in psychiatric patients initiating second-generation antipsychotic treatment. The primary purpose is to assess the impact of intervention on antipsychotic induced metabolic outcomes, such as weight gain and other cardiometabolic risk markers, in patients aged 18 to 60 years who have been diagnosed with chronic mental disorder. Participants will be assigned to either the intervention or the control group. The intervention group will receive educational interventions from the pharmacist at baseline, after 4 weeks, 8 weeks, and 12 weeks along with the standard therapy prescribed by the psychiatrist. On the other hand, the control group will receive only the standard therapy with no intervention from the pharmacist.

Psychosocial Factors in Dual Diagnosis in a General Hospital

Dual diagnosis, defined as the co-occurrence of a mental disorder and a substance use disorder, is frequently associated with increased clinical severity, functional impairment, and poorer health outcomes. Identifying psychosocial protective factors related to better clinical and functional outcomes is essential to improve patient care and treatment planning. The aim of this observational, cross-sectional, single-center study is to analyze psychosocial protective factors and their association with clinical-functional outcomes in hospitalized patients with dual diagnosis. The study will be conducted in a general hospital setting and will include adult inpatients diagnosed with dual diagnosis according to clinical criteria. Sociodemographic, clinical, and psychosocial variables will be collected using standardized assessment tools and clinical records. The results of this study are expected to contribute to a better understanding of psychosocial factors associated with clinical severity and functional outcomes in patients with dual diagnosis, supporting more comprehensive and patient-centered care approaches.

Exergames in Mental Health

Mental health and stress-related disorders have a growing impact on physical functioning, motivation, and participation in daily activities. Several studies indicate that integrating physical therapy into mental health programs improves functional status, reduces associated physical symptoms (fatigue, muscle tension, somatization), and promotes emotional regulation through movement. However, its implementation in clinical services remains limited. This project proposes to evaluate the effectiveness of an innovative mental health-oriented physical therapy program using active video games (exergames) on the Nintendo Switch platform, an accessible, motivating tool that can be adapted to each patient's functional level. Objective: To determine whether a structured physiotherapy program based on exergames promotes physical exercise, improves quality of life, and increases therapeutic adherence in patients with mental illness. Methods: An experimental pilot study will be conducted, implementing an intervention over 4 weeks, with 2 sessions per week lasting 40 minutes. Participants (n=12) will be assigned to an intervention group (exergames with Nintendo Switch) or a control group (usual routine). Quality of life, motivation, and therapeutic adherence will be assessed using the World Health Organization Quality of Life - BREF (WHOQOL-BREF) questionnaire, the Intrinsic Motivation Inventory, and a satisfaction questionnaire. Expected results: The intervention group is expected to show better quality of life, greater motivation to exercise, and greater adherence to treatment. It is also expected to demonstrate that exergames are a viable tool, accepted by patients and incorporable into mental health physical therapy programs.

Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits

The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy.

Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry

The goal of this clinical trial is to compare Braining, a physical exercise lifestyle intervention in psychiatric care, with structured advice on physical exercise. The main questions are: * does Braining lead to increased physical exercise compared to structured advice on physical exercise? * what effect does Braining have on mental and physical health, quality of life and functional level compared to structured advice on physical exercise? The participants will join a twelve weeks long study period with clinician led exercise classes up to three times per week. Before and after the study period they will leave blood tests, take part in a mental and physical examination and fill in assessment scales. To measure physical activity, the participants will carry an accelerometer, a device that measures steps and acceleration. After six and twelve months, the participants take part in the same measurements. The control group takes parts in the same measurements and follow up, but instead of having clinician led exercise classes, they will exercise on their own during the twelve weeks study period.

Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression

Background: Major depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD. Objective: To test a study drug (HNK) in people with MDD. Eligibility: People aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254. Design: Participants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity. HNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule: They will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study. They will receive no drugs for 2 to 3 weeks. They will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study. One set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo. ...

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated. However, many patients have persistent memory impairment for weeks to months after surgery. Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital stay and loss of independence. The investigators propose to investigate the role of Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early postoperative recovery. It is anticipated that DEX will be the first effective preventative therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will be enrolled per addendum. The study will last approximately 91 weeks and include up to 26 visits in the main study.

Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms

Breast Cancer is the most common cancer in women. After completion of successful therapy, may behavioral symptoms persist with over 20% of breast cancer survivors reporting chronic insomnia of greater than 6 months duration that fulfils clinical diagnostic criteria with associated functional limitations, decreased quality of life, and possible effects on long-term survival. Behavioral interventions are highly efficacious in the treatment of insomnia and preferred over hypnotic medication when insomnia is chronic. However, insomnia studies conducted in cancer are scarce. The proposed research builds upon program of study that has examined the efficacy of mind-body intervention, Tai Chi Chih (TCC), on health outcomes including sleep impairments. Preliminary studies show that TTC, a slow moving meditation, contributes to improvement in subjective sleep quality, sleep amounts and sleep efficiency. The investigators have further found that sleep, fatigue and proinflammatory cytokine activity are reciprocally related and that TCC decreases the mechanism through TCC carries its effects on sleep outcomes.

Online Access to Clinical Treatment Notes for Outpatients

This study investigates the feasibility and impact of patient access to clinical notes written by their healthcare providers-a concept known as Open Notes. While international research has already demonstrated positive effects of Open Notes on patient empowerment and treatment outcomes, there is a lack of corresponding evidence for the German healthcare context. The quasi-experimental study therefore combines quantitative and qualitative methods to evaluate the effects of Open Notes on patient-reported outcomes as well as clinical practice. The study is structured into five modules, each addressing specific research questions: Module A - Summative Outcome Evaluation in Patients: Does the use of Open Notes lead to a significant increase in patient-reported outcomes such as empowerment and self-efficacy? Module B - Formative Process Evaluation with Stakeholders: What experiences do patients, relatives and clinicians have with Open Notes and what challenges and barriers arise in their use? Module C - Changes in Clinical Documentation: How do language style and content of clinical notes change when they are shared with patients as Open Notes? Module D - Optimization through Artificial Intelligence: Can clinical notes be processed using artificial intelligence in a way that makes them easier for patients to understand compared to conventional medical documentation? Module E - Integration into National Data Infrastructure: What technical, organizational and legal requirements must be met to successfully integrate Open Notes into the national telematics infrastructure and the electronic health record or routine care? The overall goal is to identify both patient-related outcomes and structural conditions for the sustainable implementation of Open Notes in the German healthcare system. The use of artificial intelligence is intended to further enhance patient-centeredness while reducing the burden on clinical staff.

Studying the Health of Asians to Advance Knowledge, Treatments, and Interventions for Depression

SHAKTI (from the Sanskrit word for "power") is a 5-year natural history, longitudinal, prospective study of a cohort of 6,000 participants that will help uncover the socio-demographic, lifestyle, clinical, psychological, and neurobiological factors that contribute to antidepressant treatment response (remission, recurrence, relapse and individual outcomes in depressive disorders) and resilience. As this is an exploratory study, we will assess a comprehensive panel of carefully selected participant specific parameters - socio-demographic (age, sex, gender, race, ethnicity, economic); life habits (physical activity, substance use); clinical (medical history, anxious depression, early life trauma), biological (biomarkers in blood, saliva, urine, stool), behavioral (cognitive, emotional), neurophysiological (EEG), and neuroimaging (magnetic resonance imaging; MRI) with the goal of developing the most robust predictive models of depression treatment response and of outcomes.

Biobank and Brain Health in Bordeaux.

B cube is a new generation cohort to study the determinants and natural history of brain aging, using molecular epidemiology, in a representative sample (N=2000) of the general population from the age of 55 (the approximate age of onset of the first cognitive disorders and a target population particularly receptive to prevention messages). Special interest will be given to nutrition, a promising environmental exposure for prevention.

Improving Patient Mental Health With Psychotherapist Virtual Training

Several types of psychotherapy are equally effective to treat mental disorders. However, many patients remain symptomatic after treatment. The investigators demonstrated that a professional development training program to improve psychotherapists' skills at identifying and repairing therapeutic alliance tensions resulted in improved therapeutic alliance (an important therapeutic ingredient) and patient mental health outcomes. However, the investigators delivered this training program by conventional in-person workshops which limited access by psychotherapists living outside large urban centres. Further, post-study interviews with therapists suggested that cultural/diversity factors complicated the therapeutic alliance. In the current study, the investigators will test the effectiveness and acceptability of a virtually-delivered training program to psychotherapists in North America to improve their capacity to identify and repair problems in the therapeutic alliance, including tensions related to patient diversity. The investigators will also examine how acceptable the virtually-delivered training is to psychotherapists and whether they would use such training in their practice. Participants in the study will be community-based licensed psychotherapists and their patients engaging in therapy in North America. Patient mental health outcomes, therapeutic alliance, and diversity issues will be assessed by comparing outcome measures between three groups: 1) therapists complete a self-paced virtual course + consultation, 2) therapists complete synchronous workshop + consultation, 3) control: therapists do not complete training. The team of investigators developed Canada's largest psychotherapy practice-research network and has expertise in clinical trials, diversity, and education research of virtual training. State of the art training is often out of the reach of therapists who live outside of urban centres, and the effectiveness and acceptability of providing training virtually is not well-studied in mental health care. This study will improve psychotherapists' effectiveness at managing the therapeutic alliance and issues related to diversity, and will improve patient mental health outcomes thus promising to reduce the burden of mental illness.

A Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Acute Pediatric Mental Health and Addiction Care Bundle

The investigators will determine, in an 8-site, hybrid Type 1 cluster randomized effectiveness implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking emergency department care for mental health and substance use concerns.

Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care

This study evaluates the addition of a group based stabilization and skill-training intervention to individual out-patient treatment for long lasting post-traumatic reactions. Half of the participants will receive the combined treatment while the other half will receive individual treatment as usual.

Dynamics of Psychotherapy and Treatment Outcomes

The study is a 3-month controlled trial that aims to measure changes in patient's capacity (mindfulness, resilience, insight, working alliance) and intensity of neurotic symptoms. The following tools are used: the Freiburg Mindfulness Inventory, the Psychological Insight Questionnaire, the Connor-Davidson Resilience Scale - Short Version, the Working Alliance Inventory - Short Version and the "O" Symptom Questionnaire. During 12-week group intervention patients are asked to fill in the appropriate set of questionnaires four times (at the beginning, two times between and at the end of treatment). The study is conducted in the Psychotherapy Unit of University Hospital in Krakow.

Obstacles and Facilitators to the Treatment of Police Officers With Mental Health Disorders

Police officers are subject to various professional risk factors that can contribute to the occurrence of mental health difficulties such as depression, anxiety, and post-traumatic stress disorder. In previous work, low use of specialized care structures was noted. Added to this is the carrying of a weapon which represents an element facilitating the passage to self-aggressive action. The objective of the study is to identify and describe the barriers and facilitators to the treatment of police officers facing mental health difficulties.

Multimodal Imaging and Biospecimen Collection for Low Back Pain (LBPB)

This prospective cohort study investigates the neurobiological, genetic, and psychosocial mechanisms underlying acute and chronic low back pain (LBP). Core objectives include establishing a high-quality biobank to support future research in connectomics, genomics, and biomarker discovery, and identifying predictors of pain progression and treatment response. The study will also assess the impact of comorbid conditions such as anxiety, depression, and sleep disturbances on pain perception and clinical outcomes. Longitudinal analyses will explore the dynamic interplay between emotion, cognition, sleep, and pain to inform precision, mechanism-based interventions. Functional imaging will be used to examine brain responses to nociceptive modulation, aiming to identify neural circuits involved in pain chronification. By integrating multimodal data-including neuroimaging, neurophysiology, microbiota profiling, polysomnography, and molecular assays-the study will define LBP subtypes, with a particular focus on nociceptive, neuropathic, and nociplastic mechanisms. The ultimate goal is to establish prognostic biomarkers and advance personalized strategies for LBP prevention and treatment.

A Trial of Extended Reality Activities to Enhance Leisure Participation Among Inpatients With Persistent Mental Health Conditions

The goal of this clinical trial is to evaluate the effects of an extended reality (XR)-enhanced occupational therapy leisure intervention on motivation, emotional engagement, and therapeutic participation among inpatients with chronic psychiatric conditions. The main questions it aims to answer are: Can the XR intervention improve leisure motivation, leisure-related attitudes, and emotional coping strategies in long-term hospitalized individuals with mental illness? Does the XR intervention promote improvements in psychological health, volition, and occupational performance? Researchers will compare an XR-based leisure therapy group to a usual care group engaged in standard hospital leisure activities such as art, music, or reading. Participants will take part in weekly 40-minute sessions for 6 weeks. The XR group will use a custom-designed mobile VR program featuring immersive 360° leisure scenarios aligned with participants' interests and functional goals. Data collection includes standardized assessments (e.g., Interest Checklist, Volitional Questionnaire, COPM, PANSS) and semi-structured interviews to explore changes in motivation, coping, and perceived benefits.