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Psychosis clinical trials

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NCT ID: NCT05808244 Not yet recruiting - Schizophrenia Clinical Trials

Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families

Start date: April 2023
Phase: N/A
Study type: Interventional

This mixed-method study aims to examine the feasibility of delivering tgCBFI programme to dyads of people with schizophrenia and their family caregivers, and generate preliminary evidence on the effectiveness of tgCBFI in reducing expressed emotion. The research questions are as follows. 1. What are the feasibility, acceptability, and safety of conducting a tele-group CBFI programme for people with schizophrenia and their family caregivers? 2. What effect does tgCBFI have on the expressed emotion experienced by adults with schizophrenia and the caregiving experience of their family caregivers at posttreatment and 12-week after completion of the programme? 3. What effect does tgCBFI have on the positive and negative symptoms of adults with schizophrenia and the perceived care burden and level of mood disturbance of their family caregivers at posttreatment, and 12-week after completion of the programme?

NCT ID: NCT05796401 Not yet recruiting - Psychosis Clinical Trials

Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis

PSYCARE
Start date: June 15, 2023
Phase: Phase 3
Study type: Interventional

Chronic psychosis, including schizophrenia is now viewed as a progressive disorder where cognitive deficits predate the clinical onset. Early intervention programs improve the general outcome with staged care strategies, supporting the view that the period before and around the first episode of psychosis is a window of opportunity for improving its functional recovery. Pioneering epigenetic analyses indicate that psychosis onset involves oxidative stress and inflammation suggesting that neuroprotective strategies could limit or even prevent the onset of or the transition into a chronic disorder. Several biological factors associated with the emergence of psychosis can all be rectified by using safe and easily accepted supplements including alterations folate deficiency/hyperhomocysteinemia; redox imbalance and deficit in polyunsaturated fatty acids (PUFA). The prevalence of these anomalies (20-30%) justifies a systematic detection and could guide personalised add-on strategy. Cognitive remediation improves quality of life (QoL) and functional outcome in patients with chronic psychosis. It would even be more efficacious in the early phase of psychosis by tackling the negative impact of psychosis on education achievement and employment. However, cognitive dysfunctions are often overlooked in patients at ultra-high risk (UHR) for psychosis and patient with a first episode of psychosis (FEP) and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatising tools, such as applications with cognitive strategies, motivational tools and functioning guidance personalised according to the need of each individual. Patients can have access to it, wherever they live. Early psychosis can be associated with inflammation, metabolic deficiency, as well as early structural brain anomalies that reflect brain plasticity abilities and could influence the prognosis and response to cognitive training. The study hypothesis is that promoting neuroplasticity by cognitive training and personalised virtual psychoeducation guidance could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients UHR or FEP and that this effect is modulated by individual brain plasticity abilities. The overall objective of PsyCARE_trial is to improve early intervention in psychosis by providing a composite personalised care (CPC) that will enable personalised cognitive training and psychoeducation guidance, adapted to individuals' needs, cognitive abilities and biological background.

NCT ID: NCT05769933 Recruiting - Healthy Clinical Trials

Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging

Start date: September 21, 2022
Phase:
Study type: Observational

The human brain presents outstanding challenges to science and medicine. Brain function and structure span broad spatial scales (from single neurons to brain-wide networks) as well as temporal scales (from milliseconds to years). Currently, none of the tools available for studying the brain can fully capture its structure and function across these diverse scales - "the neuroimaging puzzle". This poses crucial limitations to understanding how the brain works, and how it is affected by numerous diseases. The central goal of this project is to expand currently available tools for non-invasive human brain imaging, to bridge critical gaps in the neuroimaging puzzle. New methodologies will be developed, focused on ultra-high field magnetic resonance imaging (UHF MRI) and its combination with electroencephalography (EEG). New contrast mechanisms and technological advances enabled by UHF MRI and EEG will be explored to allow unprecedented views into the microstructure of brain regions like the thalamus, and to capture the activity of large-scale neuronal networks in the brain with high sensitivity, temporal and spatial specificity. These advances will be directly applied to address open questions in the diagnosis and treatment of essential tremor, and psychosis. In general, improved brain imaging techniques are critical for a deeper understanding of how the brain works, and to detect and characterize diseases more effectively, thereby improving clinical management and leading to a healthier population. The non-invasive characterization and treatment of neurodegenerative diseases like tremor is particularly relevant to aging modern societies.

NCT ID: NCT05766007 Recruiting - Schizophrenia Clinical Trials

Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum

LAMP
Start date: August 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about how long-acting injectable antipsychotic (LAIA) medications are affected by the changes that take place in the body during pregnancy, and how much an unborn baby is exposed to. The investigators are also interested in the amount of these drugs that enters into breastmilk and taken by babies during breastfeeding. In addition to their regular clinic visits to receive long-acting mental health medicine injection, participants will be invited for up to four study visits between day 2 and 14 after the injection. This will happen only once during pregnancy, and once during the breastfeeding period to collect a few drops of blood on special filter paper card from the finger using safety lancet. A few drops of breastmilk will also be collected. Immediately after delivery, a few drops of blood will be collected from the mother, umbilical cord and the baby heel. The investigators will use these samples to determine the amount of the drug in the body during pregnancy and compare this to the amount during the breastfeeding period. Additionally, every month during the third trimester, and during the first 3 months postpartum, participants will complete a questionnaire (using the Liverpool University Neuroleptic Side Effect Scale) to document how they are feeling. Clinical improvement will be documented by the primary care provider using the Clinical Global Impressions Scale. Findings from this study are expected to help healthcare providers to understand these drugs better so that they can make informed decisions about if and how to use these drugs in women who become pregnant or are breastfeeding.

NCT ID: NCT05757128 Recruiting - Psychosis Clinical Trials

Optimizing Mental Health for Young People at Clinical High Risk for Psychosis (CHR)

Start date: August 24, 2023
Phase: N/A
Study type: Interventional

This proposal aims to adapt an evidence-based comprehensive psychosocial and mental health support program, the Optimal Health Program (OHP), to improve functioning, reduce distress, and build resiliency in youth who are at clinical risk of developing psychosis (CHR). The main aims of the studies are 1). To adapt an existing, effective, validated psychological intervention for use in young people with CHR; 2). To evaluate the acceptability of OHP and the feasibility of conducting a clinical trial of OHP in individuals with CHR; 3). To assess the preliminary efficacy of OHP in enhancing resiliency, reducing depression and anxiety, and improving functioning in individuals with CHR in a single-arm exploratory clinical trial. Participants will be delivered OHP intervention over 12-weeks. Measures will be completed at study entry and repeated immediately post-treatment at 12-weeks.

NCT ID: NCT05731414 Not yet recruiting - Schizophrenia Clinical Trials

Outcomes From Remediation and Behavioural Intervention Techniques

ORBIT
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

It is currently unknown what factors predict response to Cognitive Behavioural Therapy for Psychosis (CBTp) or Cognitive Remediation Therapy (CR) among individuals with schizophrenia-spectrum disorders, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy.

NCT ID: NCT05719116 Recruiting - Psychosis Clinical Trials

A Combined Aerobic and Resistance Training Program for Adults With Psychotic Disorders

TREPP
Start date: November 23, 2022
Phase: N/A
Study type: Interventional

The study is a feasibility study of a combined high intensity aerobic and strenght exercise program for persons with psychotic disorders. The feasibility of the protocol will be investigated, in addition to the participants subjective experience with the participation.

NCT ID: NCT05703711 Active, not recruiting - Depression Clinical Trials

Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa

Start date: June 30, 2023
Phase: N/A
Study type: Interventional

In West Africa, most people with serious mental illness receive care from traditional or faith healers at prayer camps. The stepped-wedge cluster randomized trial aims to evaluate the effectiveness of a dual-pronged intervention package comprised of a mobile health program designed to train healers to deliver evidence-based psychosocial interventions combined with pharmacotherapy delivered directly to the patients at their prayer camps via a visiting nurse in Ghana.

NCT ID: NCT05670197 Recruiting - Schizophrenia Clinical Trials

Service User and Staff Views on Digital Remote Monitoring for Psychosis

Start date: November 1, 2022
Phase:
Study type: Observational

Psychosis is a severe mental health problem. Symptoms of psychosis include hallucinations (e.g. hearing voices that others cannot hear) and delusions (unusual, often troubling beliefs). People who experience psychosis often have times when their symptoms are relatively stable. At other times, their symptoms may increase and become much more problematic (a 'relapse'). Helping people with psychosis to stay well (preventing relapses) is an important and time-consuming challenge for mental health services. Smartphones and other digital technologies are now widespread. This offers a solution to help tackle the overwhelming demand on services and to enable people with psychosis to access mental health support when they need it most (e.g. when relapsing). Research shows that people with psychosis are often willing to report their symptoms using a smartphone app. Apps like this can alert health professionals when someone needs extra support, but can be burdensome to use long-term. The investigators want to make a system that is less burdensome and is personalised to users' needs and experiences (a 'complex digital remote monitoring system'). Recent research shows that information gathered routinely by individuals' smartphones (e.g. GPS, step count) might help predict relapses of psychosis. The investigators want to use this method in a complex digital remote monitoring system. First, the investigators need to know what people with psychosis and mental health staff think about this idea. The investigators will interview around sixty adults with psychosis and around forty staff, recruited from UK mental health services (Manchester, Glasgow, Edinburgh, Cardiff, London, Sussex). These one-off, audio-recorded interviews will last up to 60 minutes. The interviewer will ask about participants' views on complex digital remote monitoring. The investigators will then systematically analyse the interviews. Findings will inform the design of the investigators' own complex digital remote monitoring system and future digital tools designed by other researchers. NIHR and Wellcome are funding this study.

NCT ID: NCT05664594 Recruiting - Schizophrenia Clinical Trials

State Representation in Early Psychosis - Project 4

STEP (P4)
Start date: July 31, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to examine state representation in individuals aged 15-45 who have been diagnosed with a psychotic illness, as well as young adults who do not have a psychiatric diagnosis. State Representation is our ability to process information about our surroundings. The investigators will complete a clinical trial examining two paradigms of cognitive training.