Clinical Research Directory

Cost-effectiveness and Implementation of a Transdiagnostic Internet-based Intervention for Emotional Disorders in Community Care.

Emotional disorders (ED) are one of the leading causes of disability. They are highly prevalent and have an impact on quality of life. Addressing them places an overload on the National Health System (NHS), generating waiting lists and limiting appropriate care. The need for cost-effective solutions has led to the consideration of the transdiagnostic approach and the use of digital solutions. Both perspectives have demonstrated efficacy in a large number of randomized clinical trials. As a result, investment in digital health interventions is on the rise to improve access to care in overburdened healthcare systems. However, their integration and implementation in health systems remains limited. Implementation Science emerges to facilitate the integration of interventions into clinical practice through specific strategies that overcome barriers and optimize their sustainability. The objective of this project is to examine the effectiveness, economic costs and feasibility of implementing an online psychological treatment program for emotional disorders in mental health services. The Mutua and UJI teams have already carried out the transfer of the online program. In order to facilitate the adoption and sustainability of this program and that it can be used by mental health professionals in daily practice, a hybrid design 1 study will be carried out in which not only the efficacy but also the possibility of adoption and the analysis of economic costs in comparison with the usual treatment will be evaluated.

Impact of an Artificial Intelligence-Based Management Model on Psychological and Behavioral Outcomes in Breast Cancer Patients Undergoing Home CDK4/6 Inhibitor Therapy

This version uses full terminology and flows well for a research proposal or paper. Primary Objective: To compare the intervention effects of an "AI-based management model," a "customized active follow-up model," and a "conventional patient education and follow-up model" on anxiety and depression in patients. Secondary Objectives: To evaluate the impact of these models on patients' quality of life (QoL), patient-reported adverse events, medication adherence, serological markers, progression-free survival (PFS), and overall survival (OS).

Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer

The diagnosis of cancer can be a major trigger for new sleep problems, especially insomnia, in people who did not have sleep issues before. Insomnia may appear early in the care pathway and can continue over time, often interacting with other physical or emotional symptoms. The main goal of this preliminary study is to describe how insomnia develops during the first months after a cancer diagnosis in patients who had no sleep problems at the time of diagnosis. This will be done through regular follow-up over time. A secondary aim is to identify the factors that may contribute to the onset or persistence of insomnia, such as the cancer treatments patients receive, as well as any medical or non-medical therapies used to manage sleep difficulties. The study will also look at whether patients who develop sleep problems are referred to psychologists trained in specific therapies for insomnia, and how well they follow and adhere to these treatments.

Efficacy and Safety Evaluation of Remote Ischemic Adaptation ( Intermittent Pressure Stimulation ) in the Treatment of Insomnia After Stroke

The incidence of post-stroke depression is high, which will affect the rehabilitation of neurological function, damage cognitive function, and increase the risk of subsequent stroke recurrence. The guidelines recommend that in addition to antiplatelet, blood pressure control, lipid-lowering and other treatments, secondary prevention of post-stroke depression should also be strengthened. Moreover, after the occurrence of post-stroke depression, methods such as medication and psychotherapy have their own limitations, such as potential adverse drug reactions and limited psychotherapy. Therefore, it is necessary to pay attention to the prevention of post-stroke depression. The remote ischemic adaptation therapy applied in our study is a safe, non-invasive and convenient physical therapy. By transiently and repeatedly applying ischemia-reperfusion stimulation to both upper arms, it induces a systemic protective response, improves the brain 's tolerance to ischemia and hypoxia, and exerts a protective effect on multiple organs such as the brain and heart. The RIC therapeutic instrument has been national patented and has been maturely applied to the prevention and treatment of acute cerebral infarction, which can promote the rehabilitation of neurological function. In addition, it also has certain curative effect in the treatment of cerebrovascular stenosis, refractory hypertension, depression, insomnia, anxiety and so on.

Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups

Mental conditions and disorders (e.g. distress, depressive, anxiety, and eating disorders) are more prevalent in people with diabetes (PWD) and associated with reduced quality of life and impaired glycaemic outcomes. Evidence supports a complex network between psychosocial factors and glycaemic control that can be highly variable between persons. It is assumed that subgroups exist that show different trajectories of glycaemia and mental health. Belonging to a particular subgroup may be linked with a higher risk of developing mental health problems compared to others. This suggests that it is possible to treat individuals in different subgroups in a manner that optimizes their treatment and can improve health outcomes. Accurate characterisation can inform more individualized care. This calls for a more personalised approach considering the idiosyncrasies of different subgroups. Over 3 years, the investigators have established the basis of a precision mental health approach for diabetes using n-of-1 analyses. By utilizing combined ecological momentary assessment (EMA: repeated daily sampling of psychosocial factors in everyday life) and continuous glucose monitoring (CGM), intensive longitudinal data per person could be collected. This enables the analysis of individual associations between glycaemic parameters and psychosocial variables and identification of individual sources of diabetes distress in each person. The objective of the present study is to use of the n-of-1 approach to identify subgroups of PWD who share common characteristics in the associations between glucose and psychosocial variables. The identified subgroups shall be used to develop a digital twin for precision mental health in diabetes. The digital twin serves as representation of a real person, allowing to make simulations and predictions of the course of mental health and glycaemia. These predictions can inform diabetes care and lead to more precise, personalised treatment decisions. To achieve this, a longitudinal panel including over 1,400 PWD who continuously complete EMA and questionnaire surveys and measure glucose levels using CGM was developed. Over 1000 clinical interviews to diagnose mental disorders have been conducted to identify major mental health conditions and map mental outcomes. To identify subgroups and develop the digital twin, the sampling will be expanded aiming at a total of 1,809 PWD. Incidence and remission of mental disorders will be determined via repeated interviews. The complex networks between clinical, metabolic, and psychosocial data will be analysed using machine learning, leading to new insights with the potential to shape future guidelines. These results will be used by the digital twin to predict courses of glycaemic control and mental health, translating the individual evidence into direct treatment suggestions.

CULTURALLY ADAPTED DIALECTICAL BEHAVIOR THERAPY FOR LOW-MIDDLE-INCOME COUNTRIES

The study aims to assess the efficacy of culturally adapted dialectical behaviour therapy (DBT) for addressing emotional dysregulation in a low- and middle-income country, as well as to evaluate the impact of DBT on secondary outcomes such as borderline personality traits, self-harm or suicide, depression, anxiety, and individuals' functioning and disability. Through a rigorous Randomised Controlled Trial (RCT), the research seeks to assess how cultural adaptations of dialectical behaviour therapy improve its applicability, engagement, and outcomes in diverse socio-cultural settings, contributing to more accessible and effective mental health interventions in resource-limited regions.

Mental Health CPR for Cancer Survivors

This is a parallel, two-arm interventional study comparing the Mental Health CPR behavioral intervention to standard community health education. The goal of this clinical trial is to learn if Mental Health CPR program, a culturally and linguistically adapted behavioral intervention, helps improve emotional well-being and access to mental health services among Hispanic/Latino cancer survivors in Puerto Rico. The main questions it aims to answer are: * Does Mental Health CPR help more people complete psychological distress screening? * Does it help more participants connect with psycho-oncology services? Researchers will compare the Mental Health CPR program to standard community health education to determine whether it improves emotional well-being, enhances communication between patients and caregivers, reduces negative attitudes toward mental health care, and lowers emotional distress levels. Participants will: * Attend community sessions led by trained Community Mental Health Workers (CMHWs) * Receive printed materials and educational resources * Take part in brief follow-ups over about 36 weeks

Effect of Probiotics "Psychobiotics" on Depression and Metabolic Syndrome in Saudi Arabia

The goal of this clinical trial is to assess the effect of commercial multi-strains psychobiotics supplementation as an ad-on therapy on depressive symptoms and metabolic syndrome components (HDL-C, FPG, TGs, WC, BP) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. The second goal is to explore the effect of commercial multi-strains psychobiotics supplementation on the anthropometric measurement (weight, body mass index (BMI)) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. The main questions they aim to answer are: * Will commercial multi-strains psychobiotics supplementation help to ease depressive symptoms as an ad-on therapy in patients with pre-metabolic syndrome and metabolic syndrome? * Will commercial multi-strains psychobiotics supplementation improve anthropometric measurements and metabolic syndrome components (WC, FPG, BP, TGs, HDL-C) in depressed patients? Researchers will compare psychobiotics to a placebo (a look-alike substance that contains no drug) to see if psychobiotics work to improve depression and metabolic syndrome components. Participants will: * Be examined for depression, anxiety, and metabolic syndrome components (waist circumference, diabetes, blood pressure, triglycerides, and high-density lipoprotein). * Be asked to conduct laboratory tests to determine the inclusion and exclusion criteria. * Be given probiotics/ placebo to consume every day for 3 months (12 weeks). * Repeat the examination and laboratory tests to determine the results. * Be followed up weekly for adverse events and to insure their compliance with the study instructions. * Be followed up after 4 weeks as an end-visit and will conduct the examination and the laboratory blood tests.

Digital Silence and Mental Health

Social media use has been linked to negative mental health outcomes, including increased anxiety, depression, stress, poor sleep quality, and difficulties in emotion regulation. Digital detox interventions, which involve reducing or temporarily eliminating digital engagement, have emerged as a strategy to mitigate these effects. However, current evidence regarding their effectiveness is mixed and limited by short-term follow-ups and methodological variability. This study aims to examine the impact of a digital detox intervention on depression, anxiety, stress, sleep quality, and emotion regulation in young adults.

Effect of Exercise on Tapering Antipsychotics in Patients With Psycho-cardiological Disease(EXTRA-study)

Psycho-Cardiological Disease studies the complex links between the cardiovascular system and emotions. The two diseases are now the focus of public health organizations, forming a vicious circle of mutual influence. Anxiety and depressive symptoms are three to four times more common in patients with cardiovascular disease than in the general population, and about 15 to 18 percent of patients with coronary heart disease also have major depression, while 25 to 30 percent show significant depressive symptoms. At least 20% of patients with chronic heart failure have some degree of depression. In addition, the probability of cardiovascular events is 2.5 times higher in patients with two hearts, the risk of recurrence of cardiovascular events is heightened, and is strongly associated with higher mortality. At present, the common treatment methods show different advantages and disadvantages, for example, Antipsychotics treatment is a common means of depression/anxiety symptoms, with rapid onset, significant efficacy, wide application and other advantages. However, medications often struggle to fully relieve symptoms, have a high recurrence rate, and can have side effects. Psychotherapy as a traditional intervention method for mental disorders. Its advantages are long-lasting efficacy and no Antipsychotics dependence, but the effect is slower, and patients need to invest more time, energy and financial resources, and the psychological burden is also heavier. In recent years, exercise therapy, as a safe intervention without significant side effects, has been gradually included in a number of international clinical guidelines, and is regarded as the first-line recommended treatment for mild to moderate depression. Research has shown that exercise can effectively relieve anxiety and depression symptoms through a variety of mechanisms, such as lowering cortisol levels, regulating autonomic nervous system function, and reducing stress responses. A study of aerobic exercise in patients with Psycho-Cardiological Disease showed that a 16-week exercise intervention significantly reduced patients' depression scores and significantly improved mood and cognitive function. In addition, it has been validated in multiple studies that exercise can significantly reduce anxiety and depression symptoms by enhancing neuroplasticity, promoting neurogenesis and synaptic remodeling, improving cognitive and emotional regulation. These findings provide a strong theoretical and practical basis for the application of exercise therapy in the comprehensive management of Psycho-Cardiological Disease. The above studies provide important theoretical support for the treatment of biheart disease with exercise, but most studies focus on scale scores, biomarkers, and changes in social behavior. It is well known that antidepressant or anti-anxiety drugs can have many side effects due to their dosage, duration and long-term use, which in turn poses a potential risk to the overall health and quality of life of patients. Therefore, it is of significant clinical significance and research value to explore whether exercise as an adjunct therapy can effectively reduce the use of Antipsychotics and shorten the withdrawal period. This will not only help optimize personalized treatment plans, provide scientific basis for clinical decision-making, but also promote the development of Psycho-Cardiological Disease treatment to the direction of precision and integration.

Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients

People with severe kidney failure who need regular hemodialysis treatment often experience several health problems. These include anemia (low red blood cell count), issues with their bone health (sometimes called mineral and bone disease), and mental health challenges like depression and anxiety. They may also have problems with their nerves and muscles. Roxadustat is a newer medicine, taken as a pill, used to treat anemia caused by kidney disease. It works differently than the standard injectable medications often used. This study aims to investigate if Roxadustat has effects beyond treating anemia in hemodialysis patients. Specifically, researchers want to see if taking Roxadustat affects patients' bone health (measured by bone density scans and blood tests) and their psychological well-being (looking at symptoms of depression and anxiety using questionnaires). The study will also use ultrasound to look at potential changes in nerves and muscles. The study will enroll 46 patients on hemodialysis. Patients will be randomly assigned (like flipping a coin) into two groups. One group (23 patients) will receive Roxadustat three times a week, while the other group (23 patients) will continue receiving their usual conventional treatment for anemia. All patients will be followed for 6 months. During this time, they will have regular blood tests, bone density scans (using a technique called QCT), nerve and muscle ultrasound examinations, and will complete questionnaires about their mood. Researchers will compare the results between the two groups to understand the effects of Roxadustat on bone, mood, anxiety, and neuromuscular aspects in patients undergoing hemodialysis

Hybrid Type 2 Implementation-Effectiveness Trial of a Third Wave Virtual Reality Treatment for Youth Depression/Anxiety

This research will evaluate a new virtual reality (VR) intervention to support youth with depression and anxiety. While VR has shown promise for adult mental health, little is known about its use in youth or routine clinical care. The VR intervention is based on Acceptance and Commitment Therapy (ACT) and immerses young people in fun, engaging environments to teach practical coping skills for managing distress. Clinicians within youth mental health services will use the VR intervention within their routine treatment of young people. The study will evaluate both the preliminary effectiveness of the VR intervention for improving youth mental health, as well as real-world implementation outcomes to understand how it can be successfully adopted in clinical settings. The trial will use a single-group, pre-post design, with treating clinicians delivering the intervention to up to 75 young people seeking treatment for depression and anxiety over a 12-week period. Assessments will be conducted at baseline, immediately after the intervention (12 weeks), and four weeks post-intervention (16 weeks).

EFCT vs. BCT for Depression and Anxiety in Married Couples

This study compares the effectiveness of Emotion-Focused Couples Therapy (EFCT) and Behavioral Couples Therapy (BCT) in reducing depression and anxiety symptoms in married couples. A total of 150 married couples aged 18-65 will be screened, and 60 couples with high depression and anxiety levels will be selected. These couples will be randomly assigned to one of three groups: EFCT, BCT, or a control group. Therapy sessions will be conducted weekly for 12 weeks, with assessments before therapy, after the 6th and 12th sessions, and at a 3-month follow-up. The study aims to determine which therapy is more effective in improving mental health outcomes in couples.

High Intensity Training for Patients with Anxiety

The aim of the current project is to examine the effects of high intensity exercise (by using 1x4 intervals) to reduce symptoms of anxiety in patients in mental health care. The expected benefits for patients are positive health effects, by improving physical fitness and reducing psychological symptom burden. The patients will have the opportunity to learn to use physical activity as a specific measure to be used in their own lives and be a source of coping. Furthermore, knowledge about physical activity and mental health may be applicable in mental health care as a part of a treatment plan.

Evaluating the Effectiveness and Acceptability of a GPT-4o and RAG-Based Voice Chatbot for Depression Screening Using PHQ-9

This study aims to assess the feasibility and acceptability of a voice-based chatbot, powered by GPT-4o and Retrieval-Augmented Generation (RAG), for conducting depression screening using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a validated self-report instrument widely used to screen, diagnose, and monitor the severity of depression. It consists of nine questions that correspond to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder. Respondents rate the frequency of symptoms experienced over the past two weeks on a scale from 0 ("not at all") to 3 ("nearly every day"). The total score (ranging from 0 to 27) indicates the severity of depressive symptoms, categorized into minimal, mild, moderate, moderately severe, or severe depression. The PHQ-9 is also used to assess functional impairment and guide treatment decisions in clinical and research settings. The voice-based chatbot integrates GPT-4o, with RAG to enhance its ability to provide informed and contextualized responses during interactions. GPT-4o serves as the conversational engine, capable of generating human-like, empathetic, and contextually appropriate dialogue. RAG, on the other hand, enables the chatbot to retrieve and incorporate external, up-to-date knowledge from a curated database or knowledge repository, ensuring the accuracy and reliability of its responses.

Study on Music Intervention of Non-clinical College Students

The purpose of this trial is to understand whether a mindfulness-integrated volleyball team sports program can effectively intervene in the mental health of college students. The main questions it aims to answer is: Does the music group effectively intervene in the participants' mental health levels, including indicators such as anxiety and depression? Participants will: Attend a music group once a week for 1.5 hours each session, for a total of 6 weeks. Complete a psychological questionnaire every 3 weeks and a follow-up questionnaire every 2 weeks after the program concludes for twice.

Promoting Sustainable Return to Work Among Employees on Sick Leave Due to a Mental Health Condition: Evaluation of the HealthyMinds Online Group Intervention

The purpose of this clinical trial is to evaluate the impact of an online group intervention called Healthy Minds in facilitating a sustainable return to work for individuals with a mood disorder. The study aims to answer the following key questions : * Does receiving the Healthy Minds online intervention lead to a more sustainable return to work compared to not receiving the intervention? * Are the health outcomes (e.g., depressive symptoms) and work-related outcomes (e.g., work functioning) of individuals who receive the Healthy Minds online intervention better than those who do not receive the intervention in the year following the intervention? Both experimental and control participants will be recruited at baseline while on sick leave (expected to return to work in less than one month) or recently returned to work (less than one month). Participants will complete a series of online questionnaires at the following time points : * Baseline * First follow-up (2 months after baseline) * Second follow-up (6 months after baseline) * Third follow-up (12 months after baseline) The questionnaires will cover the following areas : * Sociodemographic and biopsychosocial factors * Symptoms associated with the primary mood disorder * Cognitive difficulties and biaises * Self-efficacy related to return to work * Work accommodations and natural supports * Relationship with immediate supervisor * Work functioning * Return to work time (number of days away from work) Experimental participants will participate in the 2-month online Healthy Minds group intervention (cohort of 5 participants) between the baseline assessment and the first follow-up. The intervention consists of 8 sessions (one per week for 8 weeks), with each session focusing on a specific aspect of the return-to-work process from a cognitive-behavioral perspective.