View clinical trials related to Psychotic Disorders.
Filter by:Adults with psychiatric disabilities get sick and die 20 to 30 years younger than same-age peers, with even greater disparities occurring when the person is from a low SES or of color. Factors explaining this difference are complex and include genetic comorbidity, iatrogenic effects of medication, life choices, and life consequences. These factors are worsened by service disparities which are often fragmented in the public health system. Peer navigators are part of a program in which providers escort people with psychiatric disabilities around the fragmented system to meet their health and wellness goals, often a demanding task for the person who has needs addressed at clinics, labs, and pharmacies spread across an urban area. Navigators are peers because they have lived experience of recovery and are often from similar ethnic groups. A community-based participatory research program supported by NIMHD and PCORI developed a peer navigator program specific to the needs of people with psychiatric disabilities. Results of two small pilots funded by NIMHD and PCORI showed the Peer Navigator Program (PNP) led to significant improved service engagement which corresponded with better health, recovery, and quality of life. The studies included fidelity measurement which showed peer navigators conducting the intervention at high levels of fidelity. The current research is an efficacy study with a more fully powered test of PNP versus treatment as usual, which is integrated care (TAU-IC). The investigators aim to recruit 300 adults with psychiatric disability who wish to improve physical health/wellness through peer health navigation randomized to TAU-IC or TAU-IC plus PNP. Individuals will participate in assigned interventions as part of 8-month cohorts with data being obtained at baseline, 4, 8, and 12 months. Data will include personal descriptors (demographics, diagnosis, life consequences report), outcomes (service engagement, physical symptoms, blood pressure, recovery, and quality of life), mediators (personal empowerment, self-determination, and perceived relationship for recovery), and process measures (fidelity, feasibility, and acceptability). Investigators hypothesize that those in PNP intervention will have improved outcomes over the integrated care as usual. A cost-benefit analysis will seek to model impact based on quality-adjusted life years. Larger effect sizes will permit post hoc identification of how PNP effects vary by participant characteristics such as ethnicity and gender.
Design: This parallel randomized controlled trial (RCT) was conducted according to the Consolidated Standards of Reporting Trials (CONSORT). Methods: In total, 90 patients were randomly assigned to either the intervention or the control group. After a 2-week washout period, the intervention group was reassigned to the control and vice versa. The CONSORT checklist for RCT was reported. Psychotic symptoms, emotional reactions, behavioral relaxation responses and heart rates were assessed at 6 time points.
The aim of this study is to test the feasibility of an application for smartphones based on Acceptance and Commitment Therapy (ACT) that was designed to increase treatment adaptation (i.e. learning therapy skills) and treatment utility (i.e. feedback for the patient). The use of this avatar- led application will be tested by patients with mental disorders adjunctive to their therapy. Patients will be given a smartphone for one week with the application developed specifically for this purpose. The study will be a single group design and patients will be assessed two times: before and after having tested the application. Measurements will include acceptability (adherence, utilization, utility, satisfaction) of the application, as well as patients characteristics, such as diagnostic interviews, questionnaires about symptomatology, well-being, social interactions, and an exit questionnaire when leaving the study to assess what was learned.
The study "DigiPuR" (Digitally Supported Psychotherapy and Reintegration) examines the effectiveness of a new, digital aftercare program for children and adolescents after a psychiatric hospitalization in the intervention group compared to regular aftercare in the control group. Thereby, the randomized controlled trial with a naturalistic parallel group study design provides longitudinal data on the reintegration phase with a pre-post follow-up assessment and a daily ambulatory assessment from the point of view of patients, parents, and teachers. The aim of the new aftercare program is to facilitate reintegration after an inpatient hospital stay for children and adolescents as well as their attachment figures, to reduce readmissions and, if necessary, to ensure a good transition to outpatient structures. For this purpose, regular video calls without travel time between the children and adolescents as well as their attachment figures such as parents and teachers and, if necessary, external support systems are conducted with the clinic. Beyond these appointments, a smartphone-based secure messenger will allow all participants to communicate directly with the therapist. It is expected that the aftercare program in the intervention group will lead to improvements in health-related quality of life and treatment satisfaction, as well as reduce symptom severity and readmissions.
Peripheral inflammation and microvascular dysfunction are central to the pathophysiology of schizophrenia (SZ). Retinal imaging allows for the accurate quantitative assessment of the condition of retinal microvessels, and early studies implicate microvascular dysfunction in SZ, but the specific pathophysiological mechanisms underlying greater length, density, capillary network and diameter are not yet entirely understood. Anti-inflammatory drug trials in SZ suggest that Early Course Schizophrenia (ECS) individuals with elevated peripheral inflammation show the greatest benefit to adjunctive anti inflammatory treatments. Also, there is a growing interest in the use of Sodium Nitroprusside (SNP) in SZ but further studies are needed as results are inconsistent. This study will determine the effectiveness of SNP on psychosis symptoms, cognition, and retinal measures in symptomatic ECS.
The overall aim of this randomized controlled trial is to evaluate the effectiveness of a problem-solving intervention for the prevention of sick leave among employees with early signs of CMDs. The intervention is delivered by first-line managers and a 30% reduction in sick leave days is expected in the experimental condition compared to treatment-as-usual, during the 12- months follow-up.
Cannabis users who experienced a psychosis are particularly vulnerable to cannabis-related harms, which can include worse psychotic symptoms and more hospitalizations. Unfortunately, few psychosocial interventions exist that aim to decrease these harms. Instead, most focus on ceasing cannabis use which is rarely appealing to cannabis users. Furthermore, face-to-face psychotherapy often remains inaccessible to people with psychosis mostly due to lack of trained clinicians. Alternatives such as e-interventions have the potential to increase access to treatment and decrease clinicians' workload. Among cannabis harm reduction approaches are the protective behavioural strategies. These strategies do not encourage nor discourage cannabis use. Instead, they recommend behaviours for safer cannabis use. For example, these strategies include: 1) avoid driving a car under the influence of cannabis, 2) avoid mixing cannabis with other drugs and 3) purchase cannabis only from a trusted source. In the present pan-Canadian study, we will test the first e-intervention called CHAMPS (Cannabis Harm-reducing App for Managing Practices Safely) for cannabis harm reduction adapted for young adult cannabis users who experienced a psychosis. CHAMPS is a smartphone application that includes 17 strategies for safer cannabis use, a personalized consumption goal and a consumption journal. The goals of this study are 1) to confirm whether CHAMPS is acceptable to participants and 2) to test whether it works, notably by positively impacting participants' health and cannabis consumption habits.
The proposed research project aims to develop and test a mobile health intervention designed to improve caregivers' illness knowledge and caregiving skills through interactive cognitive-behavioral modules, and through these improvements, reduce distress, improve coping, improve family communication, increase caregiver treatment facilitation and reduce duration of untreated psychosis. This clinical trial will involve a remote pilot randomized controlled trial comparing this new intervention to existing online caregiving support resources. Analyses will determine whether this approach is acceptable and feasible, as well as explore its effectiveness and impact on key components of the cognitive model of caregiving.
The main objective of this study is to establish whether there are differences in self-recognition and self/other distinction in subjects with psychological vulnerability compared to healthy volunteer controls.
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.