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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: 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: NCT05558332 Not yet recruiting - Suicide Clinical Trials

Youth Nominated Support Team

YST
Start date: September 2024
Phase: N/A
Study type: Interventional

This study aims to adapt the current Youth-Nominated Support Team (YST) manual used to treat suicide risk for people at clinical high risk for psychosis.

NCT ID: NCT05358457 Not yet recruiting - Psychosis Clinical Trials

Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)

MCTf
Start date: September 2022
Phase: N/A
Study type: Interventional

The objective of this study is to adapt and evaluate the efficacy of Familiar Metacognitive Training (MCTf) in mothers and adolescent children in a group context with the main purpose of improving family relationships, cognitive awareness and symptoms of women with psychosis and the knowledge of the disease by the children. Secondary objectives: to evaluate the improvement in metacognition and social cognition, symptoms, protective factors and self-perception of stigma.

NCT ID: NCT04631952 Not yet recruiting - Psychosis Clinical Trials

Online Exercise Intervention for Psychosis Patients Receiving Residential Care

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

The main objective of this randomised controlled trial (RCT) is to investigate the immediate and long-term effectiveness of 8-week online exercise intervention for people with psychosis receiving residential care.

NCT ID: NCT04602585 Not yet recruiting - Psychosis Clinical Trials

The Effect of Psycho-education on Clinical Outcomes Among Patients With a First Episode Psychosis in Central Uganda

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Background: Psychotic disorders which the investigators have operationally defined as any of schizophrenia or schizophrenia spectrum disorder, brief psychotic episode, or bipolar affective disorders are severe forms of mental illness that contribute to significant morbidity and mortality primarily due to high rates of relapse. Delivering psycho-education messages about disease etiology, their signs and symptoms, as well as the benefits of adhering to treatment have been shown to reduce relapse among individuals with psychoses in high income countries. However, little has been done to examine the efficacy of this intervention in low resourced settings like Uganda. Objective: The study objective is to examine the efficacy of psycho-education on symptom severity, stigma and retention in care. Methods: The Investigators will recruit 80 adult patients (aged ≥18 years) who have been diagnosed with a First Episode Psychosis (FEP) and received antipsychotic medication at Butabika Hospital. Participants should be ready for discharge and reside within a 21km radius from Kampala city. The investigators will use a simple random technique to randomize the 80 participants to either receive 6 sessions of psycho-education from village health team members (VHTs) with a family member (n=40) or routine care (n=40). The investigators will collect symptom severity, stigma and retention in care data over 24 weeks. Data analysis plans: The investigators will conduct an intention to treat analysis and compare the groups at baseline, weeks 4, 12 and 24. We will assess the effects of the intervention on symptom severity. The investigators will assess for potential confounders, mediators and effect modifiers using generalized linear estimates. Between-subject analysis at week 24 will be used to assess if there is a significant difference in the mean severity scores between the 2 arms. Conclusion: Findings from this research will throw more light with regards to the preliminary efficacy of the use of psycho-education for individuals with psychosis.

NCT ID: NCT04060498 Not yet recruiting - Psychosis Clinical Trials

Mindfulness Intervention and Relapse in Psychosis

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Practicing mindfulness is popular and well-accepted for its benefits in improving mental and physical health. In particular, its benefits in promoting resilience to stress and well-being have been shown in studies involving different psychiatric conditions, as well as preventing relapse in patients with depressive disorders. However, its role in relapse prevention among patients with psychosis has not been tested. The investigators therefore propose a multi-site, single-blind, 12-month randomized controlled trial in Hong Kong to examine the effectiveness of mindfulness intervention in prevention of relapse among 152 remitted psychosis patients.

NCT ID: NCT04038112 Not yet recruiting - Psychosis Clinical Trials

Method of Level (MOL) Therapy for Psychosis

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

The study is a systematic case replication series of a new psychological therapy Method of Levels (MOL) for people who experience psychosis. Between 6 and 8 people with psychosis who receive services from CMHT will be recruited. Participants will complete baseline questionnaires measuring their symptoms and distress and will be offered up to 12 sessions of MOL. Following the completion of therapy they will complete the questionnaires measuring symptoms and distress again.

NCT ID: NCT03974620 Not yet recruiting - Schizophrenia Clinical Trials

Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia

Start date: December 1, 2024
Phase: N/A
Study type: Interventional

This study aims to test the hypothesis that addition of Individual Placement and Support (IPS) and/or Cognitive Remediation Therapy (CRT) in addition to treatment as usual in patients with early psychosis will be feasible and acceptable in patients with early schizophrenia.