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Psychosis clinical trials

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NCT ID: NCT05127278 Recruiting - Psychosis Clinical Trials

E-Detection Tool for Emerging Mental Disorders

ENTER
Start date: April 20, 2022
Phase:
Study type: Observational

Psychosis is a severe mental disorder that involves abnormal experiences and altered behaviour. Although the onset of psychosis occurs in young people, most cases will only be identified later in the course of illness. The delayed detection is the main cause of significant negative long-term outcomes. The current proposal will develop an innovative E-mental health detection tool to effectively improve the identification of young people with emerging psychosis. This tool will be implemented on digital platforms including websites, tablets and mobile phones. Young people will be asked to complete an online questionnaire and two short online-exercises and will then be invited for face-to-face assessments to further confirm whether they are experiencing an emerging psychosis. This digital approach leverages previous expertise by the research team and it is expected to provide novel avenues to enable the identification of young people with emerging psychosis.

NCT ID: NCT05112432 Recruiting - Psychosis Clinical Trials

EPI-MINN: Targeting Cognition and Motivation

Start date: August 12, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to perform a practice-based research project designed to assess whether cognition and motivated behavior in early psychosis can be addressed as key treatment goals within real-world settings by using a 12-week mobile intervention program. Participants who are enrolled in a chart review study of measurement-based care will be recruited to participate in this study. In the measurement-based care study, participants are enrolled in coordinated specialty care programs for early psychosis that provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, work or education support, and measurement-based care. Participants will complete a set of well-defined measures every 6 months that assess symptoms, functioning, cognition and motivation as standard of care. The current study will utilize the data acquired in the measurement-based care study. The aim of this study is to investigate a well-defined 12-week mobile intervention program specifically designed to target cognitive functioning and motivated behavior for individuals with early psychosis. The investigators will test for differences in the clinical trajectories over 18 months in those who receive the intervention vs. those who do not. This study will be conducted jointly with a sister protocol under a separate NCT listing. This iteration will be conducted locally within the EPI-MINN Network, while the other project will be conducted on a national scale.

NCT ID: NCT05100875 Recruiting - Trauma Clinical Trials

Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis

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

This study will investigate if the SSERT (Social Skills and Emotion Regulation Training) intervention is feasible and acceptable in individual with psychotic disorder and a history of trauma.

NCT ID: NCT05074732 Recruiting - Obesity Clinical Trials

Dundrum Forensic Redevelopment Evaluation Study: D-FOREST Study.

D-FOREST
Start date: December 1, 2019
Phase:
Study type: Observational

The DUNDRUM Forensic Redevelopment Evaluation study (D-FOREST study) is a multi-site comprehensive evaluation of a complete National Forensic Mental Health Service. The study will have a prospective, observational, longitudinal design which will permit the evaluation of benefit over time for individual patients, groups of patients and the evaluation of the benefit in terms of service based outcomes of the redevelopment of a complete National Forensic Mental Health Service e.g. effects on waiting list times, length of stay. The study will systematically evaluate multiple domains of recovery in a complete National Forensic Service, including patients' physical health, mental health, offending behaviours and social and occupational functioning.

NCT ID: NCT05056415 Recruiting - Autism Clinical Trials

Effect and Cost-effectiveness of the Everyday Life Rehabilitation Intervention

ELR
Start date: September 15, 2021
Phase: N/A
Study type: Interventional

The person-centered, motivational, recovery-, and activity-based intervention model 'Everyday Life Rehabilitation´ (ELR), integrated in sheltered and supported housing facilities for people with severe psychiatric disabilities, has shown significant outcomes in feasibility studies, and thus a RCT is required, for the purpose of establishing the effectiveness and cost-effectiveness of ELR. All municipalities in northern and middle Sweden will be invited. Residents who meet the inclusion criteria, will be invited to participate. Housing-units, with associated residents giving consent, will be randomized to either receive intervention with ELR plus treatment as usual (TAU), or TAU alone for control group. Hence, the present study is a cluster RCT. The control group will, after control-period, be offered ELR. Professionals involved in the ELR intervention group; that is occupational therapists, housing staff and housing managers, will receive an educational package. It is hypothesized that the intervention-group will improve in personal and social recovery as well as quality of life. The primary outcome is recovering quality of life assessed by ReQoL, and secondary outcomes are self-perceived recovery, everyday functioning, and goal-attainment at 6 months, assessed using RAS-DS, and GAS, respectively. ReQoL will be transformed into QALY´s for calculation of cost-effectiveness. The study has an adaptive design, including an internal pilot year one and two, in order to determine required sample sizes before continuing with the full scale RCT.

NCT ID: NCT05050201 Recruiting - Insomnia Clinical Trials

Implementation of Digital CBT for Insomnia in First Episode Psychosis

Start date: April 20, 2021
Phase: N/A
Study type: Interventional

This study uses mixed methods to investigate the implementation of digital cognitive behavioural therapy for insomnia (Sleepio) in a first episode of psychosis service (FEP). Interviews will be conducted with keyworker clinicians and service users to consider their expectations for digital sleep intervention. The rates of recruitment into the study, eligibility, completion of baseline measures, completion of the intervention sessions, attrition from the intervention and completion of follow up measures will be recorded. Interviews will be conducted with keyworker clinicians and service users to consider their experiences of digital sleep intervention. The primary outcome will be a logic model describing factors acting upon the implementation of Sleepio in this population. The investigators will provide signal data in relation to changes in insomnia severity, psychosis symptomatology, and general mental health.

NCT ID: NCT05046912 Recruiting - Psychosis Clinical Trials

Online Yoga and the Impact on Psychosis

Start date: November 11, 2021
Phase: N/A
Study type: Interventional

Yoga and mindfulness are considered complementary and alternative healthcare options that involve breathing techniques, relaxation, and bodily postures (yoga only). Research has shown a positive effect of these on depression, quality of life, and other symptoms of psychosis. As an 8-week pilot study, the goal is to offer yoga and/or mindfulness online and to explore the effect on recovery and quality of life for people with psychosis.

NCT ID: NCT05017532 Recruiting - Schizophrenia Clinical Trials

Cognitive Remediation for Social Cognition in Schizophrenia and Related Disorders

RC2S
Start date: January 6, 2022
Phase: N/A
Study type: Interventional

This study will investigate whether the remote administration of the cognitive remediation program RC2S+ acceptable and feasible in people with schizophrenia and related disorders.

NCT ID: NCT04940663 Recruiting - Schizophrenia Clinical Trials

Neurobehavioral Mechanisms of Social Isolation and Loneliness in Serious Mental Illness

Start date: July 13, 2022
Phase: N/A
Study type: Interventional

The proposed research will test the hypothesis that objective social isolation and loneliness are linked to neurobehavioral mechanisms involved in social perception and motivation in individuals with and without serious mental illness. Moreover, it will investigate the specific dynamic interactions among these experiences in daily life and how they, and their neurobehavioral predictors, are linked to day-to-day functioning. The findings of this project could provide novel targets for therapeutics aimed at improving functioning and overall quality of life in individuals with serious mental illnesses, as well as quantitative phenotypes for use in early detection efforts.

NCT ID: NCT04929938 Recruiting - Psychosis Clinical Trials

Application of UP for Transdiagnostic Treatment of Emotional Disorders for UHR for Psychosis Patients

Start date: September 6, 2021
Phase: N/A
Study type: Interventional

The principal aim of the study is to assess the efficacy of the Unified Protocol (UP) for the treatment of the comorbid symptomatology of patients with Ultra High Risk (UHR) for psychosis. The secondary aims would be to assess the effects of the intervention with the UP on the subthreshold positive symptoms and the transition to psychosis rates at 3 months follow-up, insight, positive and negative emotions, emotion regulation skills, personality, quality of life, cognitive distortions, psychosocial functioning and the maintenance of the effects at the 3 months of follow-up. The study is a randomised controlled trial in which a group will receive inmediate UP plus standard intervention and the other one will be in a waiting list plus standard care at our Early Psychosis Program (PIPPEP). The evaluator will be blind to the group that owns every patients. The sample will be 42 patients with UHR for psychosis with comorbid emotional symptoms and are visited at the PIPPEP of the CSMA Ripollet (PSSJD). The assessment will be performed at baseline, at the end of treatment and at three months follow-up and will include: general psychopathology (SCID), anxiety and depression (BDI-II, BAI), positive and negative emotions (PANAS), emotional disregulation (DERS), personality (NEO-FFI), functionality (EEASL, MI), quality of life (QLI-sp), cognitive distortions (CBQ), insight (BCIS) and a scale of satisfaction created ad-hoc. At the end of each session with the UP we will assess depression and anxiety during the last week (ODSIS, OASIS). Treatment with the UP will consist in 15 group sessions of 8 patients, 120 minutes in addition to the treatment as usual.