Clinical Research Directory

Theta- and Alpha-Tuned Meditation for Negative Symptoms in Schizophrenia

This study done at the psychiatrics hospital of the cross Lebanon examined whether guided meditation combined with special sound stimulation (binaural beats) could help reduce negative symptoms of schizophrenia, such as low motivation and social withdrawal. Ninety inpatients participated in a six-week program and were assigned to meditation alone or meditation combined with either alpha- or theta-frequency sound stimulation. Results showed that patients who received meditation with binaural beats improved more than those who had meditation alone. The greatest improvement was seen in the theta-frequency group. Although not all differences were statistically significant, the findings suggest that this simple, low-cost, non-medication approach may help reduce persistent negative symptoms. Larger studies are needed to confirm these results.

Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness

Severe mental illness (SMI), including schizophrenia spectrum disorders and bipolar disorder, is associated with significant impairments in psychosocial functioning, daily life participation, self-efficacy, and social functioning. Despite pharmacological treatment, many individuals continue to experience limitations in social relationships, occupational roles, independent living activities, and overall functioning. Psychosocial rehabilitation interventions are therefore important components of comprehensive mental health care. Occupational therapy aims to improve individuals' participation in meaningful daily activities, enhance occupational performance, strengthen social roles, and support recovery. However, evidence regarding the effects of occupational therapy interventions on internalized stigma, self-efficacy, and personal and social functioning among individuals with SMI remains limited. This randomized controlled trial aims to investigate the effects of a structured occupational therapy group intervention on internalized stigma, self-efficacy, personal and social functioning, occupational performance, and instrumental activities of daily living in individuals with SMI receiving services at a Community Mental Health Center. Eligible participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in a seven-session occupational therapy group program, with one 60-90-minute session per week, while the control group will continue to receive routine Community Mental Health Center services. The intervention addresses self-awareness and identity, internalized stigma, personal strengths and self-efficacy, daily life roles, role performance, goal setting, and social participation through structured group activities and psychoeducational components. Outcomes will be assessed before the intervention and after the seven-week intervention period using validated measures of internalized stigma, self-efficacy, personal and social functioning, occupational performance and satisfaction, and instrumental activities of daily living. It is hypothesized that participants receiving the occupational therapy intervention will demonstrate reduced internalized stigma and improved self-efficacy and personal and social functioning compared with participants receiving routine services alone.

Motivational Intervention for Patients With Schizophrenia

The goal of this clinical trial is to learn if a group therapy called the Positive Emotions Program for Schizophrenia (PEPS) can reduce apathy in adults aged 18 to 60 who have schizophrenia or a related psychotic disorder. Apathy means having little motivation or drive and getting less pleasure from daily life. The trial will also look at how the brain responds to this therapy. The main questions it aims to answer are: Do people who take part in PEPS have less apathy after the therapy than people who continue with their usual care? Does PEPS increase activity in a brain areas important for motivation? Are changes in brain activity linked to changes in apathy? Researchers will compare PEPS with usual care (regular visits with the treating psychiatrist and nurse, without PEPS) to see if PEPS reduces apathy. They will also compare brain scans of people with schizophrenia to those of healthy volunteers, to see whether brain activity after PEPS becomes more similar to that of people without the illness. Participants with schizophrenia will: * Be placed by chance into one of two groups: PEPS or usual care * Have an interview and questionnaires about their symptoms * Have an MRI brain scan while doing computer tasks * In the PEPS group, attend 8 weekly group sessions of 1 hour led by a psychologist. They will learn skills to notice, enjoy and look forward to pleasant moments, to question discouraging thoughts, and to share positive feelings with others. They will also do short exercises at home. * In the usual-care group, continue their usual care for 8 weeks. They will be offered PEPS after the study ends. * Repeat the interview and the brain scan within 2 weeks after the 8-week period

A Clinical Trial to Compare the Efficacy and Safety of WAS123 Versus Daily Aripiprazole in the Maintenance Treatment of Patients With Schizophrenia.

A phase II, proof-of-concept, national, multicenter, randomized, double-blind clinical trial to compare the efficacy and safety of WAS123 in the maintenance treatment of patients with schizophrenia, with a parallel design between 2 groups and controlled by an active comparator (Aripiprazole). A total of 121 participants were randomized and assigned to either 1 of 2 treatment groups in a 1:1 ratio.

Biomarkers to Enhance Early Schizophrenia Treatment

This study is recruiting participants who are experiencing a first episode of psychosis and who have certain genetic factors that may make them respond better to certain medications that are used to treat people with psychosis.

Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections: Translating Epidemiology to Deep-phenotyping.

The study protocol was submitted to ERA-NET NEURON for funding on 28/06/2023. Description of the Israeli responsibilities was extracted from the full submitted research protocol. The protocol includes two studies (CHS1 and CHS2). At the time of the study registration CHS1 was partially analyzed whereas CHS2 has not been initiated. See below the full description of the two studies' protocols. To explore the probability of mental illness (MI) onset or psychiatric relapse following infections, we will utilize two databases from the CHS registries from Israel (n=50,000, n=69,594). Participants with a high load of past infections (cohort 1, n=50,000) will be identified and matched in a 1:1 ratio to controls by age and sex. Probability of MI onset across a broad range of psychiatric disorders, including depression, bipolar disorder, anxiety and psychotic disorders will be explored. The probability of psychiatric relapse among individuals with pre-existing mental disorder following infection will be investigated in a second cohort of 34,797 individuals with schizophrenia matched randomly to age and sex controls with no diagnosis of schizophrenia (n = 34,797) (cohort 2, total n=69,594, 5). Socio and sociodemographic factors which might serve as vulnerability or resilience factors will be assessed across both cohorts, and will include environmental factors such as socioeconomic status, familial status, healthcare utilization information and demographic factors. In addition, The CHS databases (n=50,000, n=69,594) will be utilized to study outcomes of infections in SMI. From the CHS databases in Israel, outcome of infections will be assessed in the two previously described cohorts. Severe outcomes will be defined as hospital admission \~two weeks after a diagnosis of an infection, among individuals with pre-existing anxiety, depression, bipolar diagnosis (n=50,000), and among patients with schizophrenia (n=69,594), as well as all-cause mortality. The following infections will be considered: Epstein Barr Virus, Cytomegalovirus, Toxoplasma Gondii, COVID-19, and Herpes viruses. Environmental protective and risk factors and their moderating role in the association between infection and outcome will include marital status, number of siblings, and sociodemographic factors. Vulnerability factors such as smoking, obesity, and comorbid physical illness will also be examined. The presence of pre-existing viral infections will be assessed as a potential vulnerability factor.

Exercise and Olanzapine-samidorphan

This is a single site trial in 30 patients with schizophrenia, schizoaffective, or bipolar I/II/NOS disorder in which all participants will receive eight weeks of olanzapine and samidorphan (Olz/Sam) plus four weeks of aerobic exercise.

Reduction of Anticholinergic Medications Among Persons With Schizophrenia or Other Psychiatric Disorders

The goal of this study is to reduce Anticholinergic Medication (ACM) in persons with psychoses or serious mental illness, when these medications are no longer needed.

Prospective Observational Study of the Relationship Between Sociodemographic Factors, Blood-based Biomarkers and Psychiatric Symptoms in Neurodegenerative Diseases and Mental Disorders

This is a prospective observational study to identify sociodemographic factors that predict mental health outcomes in the European population and provide evidence linking common, modifiable sociodemographic risk factors for psychiatric symptoms with biological changes in patients suffering from a mental disorder (MD) or a neurodegenerative disease (ND).

A Novel Blood Test as a Biomarker in Mental Health

This longitudinal, observational study aims to assess whether the characteristics of a novel blood peripheral biomarker can serve as indicators for depression and schizophrenia in patients at the Royal Columbian Hospital Psychiatric Clinics. The study will evaluate whether changes in these biomarker characteristics can help distinguish between depressed patients who do or do not respond to treatment and between individuals experiencing a single psychotic episode and those at risk of progressing to schizophrenia. To achieve this, blood samples and standardized mental health assessments will be collected across three study visits from up to 500 participants, grouped into two study arms based on their diagnosis: Depression (DEP) or Psychosis/Schizophrenia (PSY).

Effects of Smoking on Network Connectivity in Patients With Schizophrenia Symptoms in Scz Patients

The prevalence of smoking among people with schizophrenia (SCZ) is substantially higher at 54% to 90% (McClave et al., 2010). About half of all deaths amongst people with scz are attributed to smoking-related diseases and cancer involving the lung, the cardiovascular system, and the liver (Kely et al., 2011; WHO, 2019). Acceptance and commitment therapy (ACT) is effective for treating psychotic symptoms and addictive behaviours. In a local randomised controlled trial comparing individual ACT to social support for smoking cessation in adult scz smokers, the self-reported quit rates in ACT group were higher than in the social support group (6 months: 12.3% vs. 7.7%, p=0.56 ; 12 months: 10.8% vs. 7.7%, p=0.76; Mak, Loke, and Leung, 2021). In this study, functional neuroimaging (fMRI) will be combined with symptoms assessment in order to ascertain whether group-based ACT is effective in modifying the brain's responses in general and specifically to tobacco craving cues and resting-state functional connectivity in three time points (pre-, post-intervention, and 6-month follow-up) among people with schizophrenia.

Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)

This randomized clinical trial will test a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social engagement in consumers with serious mental illness.

Retrospective Observational Study of Blood-based Biomarkers in the Diagnosis and Monitoring of Patients With a Neurodegenerative Disease or Mental Disorder

This is a retrospective observational study to evaluate the clinical utility of blood-based biomarkers in the diagnosis and management of patients with a neurodegenerative disease (ND) or mental disorder (MD).

Effects of Schizophrenia and Bipolar Disorder on Exercise Capacity, Pulmonary Function, and Quality of Life

This observational study aims to evaluate exercise capacity, pulmonary function, respiratory muscle strength, and quality of life in individuals diagnosed with schizophrenia and bipolar disorder. These psychiatric conditions are associated with sedentary lifestyles, metabolic side effects of psychotropic medications, and increased comorbidity risks, all of which may negatively impact physical fitness and respiratory health. By assessing cardiorespiratory endurance, pulmonary parameters (FVC, FEV₁), and respiratory muscle strength in this population, the study seeks to identify physiological limitations and contribute to the development of more effective rehabilitation strategies. The findings may support multidisciplinary approaches to improving physical health and overall quality of life in individuals with severe mental illness.

Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study

The project proposes to develop a digital product based on cognitive behavioral therapy for the assisted treatment of depression. The digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. The therapy is developed by psychotherapists, which is conducted for a total of 8 weeks, with weekly sessions including AI-guided course work and homework. This study aims to evaluate the therapeutic effects of CBT-based digital products for depression in patients through a real-world study, and to explore its genetic and neuroimaging mechanisms.

A Remote Life Balance Training Program for People With Schizophrenia

People living with schizophrenia often experience significant disruptions to their ability to maintain a balanced lifestyle and perform daily activities. These disruptions can hinder their ability to participate successfully in community life. In response to these challenges, a pilot study was planned to examine the feasibility and effectiveness of a telerehabilitation-based occupational therapy program aimed at promoting life balance and functional skills. The eight-week intervention is delivered remotely via videoconferencing and incorporates personalized goal setting, activity planning, skills training, and problem-solving strategies tailored to each participant. Clients diagnosed with schizophrenia who could engage in virtual sessions were invited to voluntarily participate, and pre- and post-intervention assessments were planned to measure outcomes related to instrumental activities of daily living and perceived life balance. This study aims to generate preliminary data on whether a remote, therapist-guided approach can positively impact daily functioning and quality of life. This information will guide the development of larger-scale trials in the future.

The Effectiveness of Combining AR/VR Technology in Virtual Clinical Auditory Hallucinations on the Comprehensive Auditory Hallucination Nursing Competency of Psychiatric Nurses

This study aims to develop and evaluate a Virtual Reality (VR) Auditory Hallucination Program to enhance psychiatric nurses' comprehensive care competence in managing auditory hallucinations among patients with schizophrenia. Given that 60-80% of patients on the schizophrenia spectrum experience auditory hallucinations, and many continue to do so despite medication, improving nurses' professional skills in this area is critical. The research is conducted in two phases across four psychiatric institutions. Phase one involves the development and validation of the VR program and an OSCE (Objective Structured Clinical Examination), piloted with five participants and evaluated by psychiatric nursing experts. Phase two is a formal interventional study with 200 psychiatric nurses, using block randomization and three data collection time points. Assessment tools include five instruments measuring nurses' confidence, knowledge, attitude, empathy, immersion, and care performance related to auditory hallucinations. The study expects to strengthen nurses' ability to assess and manage auditory hallucinations effectively, and proposes the VR program as a potential tool for nursing in-service education.

CRacking the HEterogeneity of Social Outcome Through Neuropsychophysiological Profiles

CRHESO aims at overcoming the considerable burden of mental disorders, which affects both psychosocial well-being and societal welfare, through a multidisciplinary and integrated approach to explore and remediate dimensions affecting social outcome.

Interventional Programs' Impact on Patients' Quality of Life and Functioning

The objective of the study is to investigate the effect of interventional program in improving the quality of life for individuals with chronic schizophrenia The design of the study will be an interventional study - Randomized Control Trial - taking place in the Psychiatric hospital of the Cross Lebanon. Six types of intervention will be done on the patients such as ping-pong, sport exercise, psychoeducation program, nutrition, art therapy and bibliotherapy. A 100 patients adhering to the inclusion and exclusion criteria will be randomized into two groups (50 patients in the intervention group and 50 patients in the control group) - Simple Randomization. A Baseline and follow-up assessments will take place at the beginning of the study and after three months through using Arabic Validated Scales. The scales that be used are the following Positive and negative symptoms scale (PANSS), to determine severity of symptoms in patients. WHO quality of life questionnaire WHOQOL- BREF Arabic version: physical, psychological, social and environmental and EQ-5D scale, to determine quality of life of patients. MOCA scale to determine cognitive function, Rosenberg self-esteem questionnaire, Social functioning questionnaire QFS and Birchwood Insight Scale.

Evaluating Pharmacogenomics-Based Pharmacotherapy in Real-World Settings for Schizophrenia

An 8-week, rater-blinded, real-world observational study to investigate the benefits of pharmacogenetics-based pharmacotherapy in patients suffering from schizophrenia.