A Cannabis Harm Reduction e-Intervention for Young Cannabis Users With Early Psychosis
Psychotic DisorderMarijuana Use1 moreCannabis 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.
Melatonin Metabolism Abnormality in Patients With Schizophrenia or Schizoaffective Disorder Treated...
SchizophreniaSchizoaffective Disorder3 moreAtypical antipsychotic medications, such as olanzapine, cause metabolic side effects, including weight gain, extra fat around the middle of the body, high blood sugar, and high cholesterol. One of the mechanisms by which these medications may cause these effects is by reducing plasma melatonin. This study is a pilot project to evaluate 1) the effect of olanzapine on melatonin secretion levels and 2) the effect of melatonin on olanzapine-induced changes in melatonin secretion in patients with schizophrenia, schizoaffective, or bipolar disorder.
Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)...
SchizophreniaSchizoaffective DisorderThe investigators propose a cluster randomized effectiveness trial comparing Cognitive Adaptation Training (CAT; a psychosocial treatment using environmental supports such as signs, alarms, pill containers, checklists, technology and the organization of belongings established in a person's home or work environment to bypass the cognitive and motivational difficulties associated with schizophrenia ) to existing community treatment (CT) for individuals with schizophrenia in 8 community mental health centers across multiple states including 400 participants. Mechanisms of action will be examined. Participants will be assessed at baseline and 6 and 12 months on measures of functional and community outcome, medication adherence, symptoms, habit formation and automaticity, cognition and motivation.
Illness Management and Recovery- a Cluster Randomized Controlled Trial Within a Forensic Mental...
Psychotic DisordersForensic Psychology3 moreThe purpose of the study is to investigate the effects of a psychoeducational intervention program, Illness Management and Recovery (henceforth abbreviated as IMR), when administered to inpatient forensic mental health patients. IMR is a treatment program that can be administered in both a group and an individual format. It is designed for persons suffering from severe mental health problems and has two principal aims: 1. promoting participants´ capacity to manage and alleviate symptoms and functional impairment and 2. helping participants in formulating and attaining subjectively meaningful recovery goals. Forensic mental health inpatients receiving this treatment will be compared to patients who receive treatment as usual on a variety of outcome measures, such as clinician and self-rated levels of symptoms, function and perceived levels of hope. Furthermore, clinicians' experiences of working with the intervention will be investigated using a structured questionnaire regarding implementation processes and through an interview protocol. The study has 3 objectives: Investigating the effects of the treatment on the chosen outcome measures. Investigating the effects of potential moderators on treatment outcome. These moderators include: pre-treatment functional status measured by self and informant report, neuropsychological performance and pre-admission indicators of presence of criminogenic risk factors and everyday functioning. Investigating the experiences of staff working with the intervention, through the lense of Normalization Process Theory.
Efficacy of Personalizing Cognitive Remediation for Schizophrenia by Targeting Impairments in Early...
SchizophreniaSchizoaffective DisorderThe primary aim of this study is to provide confirmation that Cognitive Remediation (CR) for schizophrenia, when personalized based on pre-treatment assessment of early auditory processing ability, facilitates improved cognitive and functional outcomes. Additional aims of this study address the mechanisms of treatment effect. The study uses a repeated-measures randomized trial design. Enrollment will be by invitation, open to individuals receiving services at select community behavioral health facilities where CR is offered. Clients who are eligible for the service, who agree to participate in research and who meet inclusion/exclusion criteria will be assessed on outcome measures and categorized via performance on the Tone Matching (TM) test, as EAP impaired (EAP-) or EAP intact (EAP+). Subsequently, EAP- and EAP+ subgroups will be randomized to either (1) Brain Basics (BB; n = 100), an EAP-enhanced CR approach or (2) Brain Training (BT; n = 100), a routine CR approach. Participants will be invited to participate in a second pre-treatment assessment to measure electrophysiologic responses to auditory stimuli. All participants will be scheduled to repeat outcome measure assessments after treatment and after a follow-up period. The EAP- group receiving BB will be invited to repeat electrophysiological paradigms post-treatment to investigate mechanisms of change related to the CR intervention. Verbal learning will be the primary outcome with functional capacity the secondary outcome. EEG is exploratory and will examine neurophysiologic markers of need for and response to EAP training.
DigiPuR: Digitally Supported Psychotherapy and Reintegration
Mental Disorder in ChildhoodThe 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.
Cognitive Remediation for Coordinated Specialty Care
SchizophreniaSchizoaffective DisorderCognitive remediation (CR) is an evidence-based behavioral skills intervention that targets the cognitive processes underlying functioning in everyday life. It can be used as part of early intervention to reduce cognitive deficits evident at the first episode of psychosis, and has the potential to impact recovery and quality of life. Across Coordinated Specialty Care (CSC) programs, about half of early psychosis participants do not achieve sustained vocational, educational, and/or social recovery; adding CR to CS programs could improve these outcomes. However, models of CR need to be adapted to meet the developmental needs of a younger population and to better fit the CSC model of service delivery. This study of CR implementation will be conducted within the context of OnTrackNY, a network of first-episode psychosis programs that currently offers basic cognitive health evaluation and supportive treatment but not CR. Intervention content will be designed and refined based on input from multiple stakeholders. The study will assess two delivery approaches to CR, one that delivers CR exclusively "in-clinic/clinician-led" and the other that is "partial-remote/independent" with one in-clinic/clinician-led session per week plus out-of-clinic independent cognitive practice. Nine OnTrackNY programs will be selected and OnTrackNY clinicians will be trained to conduct a cognitive assessment battery and CR. Three programs will be randomly assigned to provide treatment as usual (TAU) and six programs will be randomly assigned to provide both TAU and CR (either "in-clinic/clinician-led" or "partial-remote/independent"). Using de-identified data collected routinely by OnTrackNY for quality improvement/program evaluation, the investigators will examine whether the addition of CR improves functional outcomes for clients with first-episode psychosis, compare the effectiveness of CR delivery methods, and explore whether cognitive improvement is associated with improvement in functioning.
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS...
SchizophreniaSchizophreniform Disorder1 moreThis study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder
Multiomic Diagnostics in Youth With Psychosis
PsychosisRady Children's Institute for Genomic Medicine seeks to understand the genomes and immune systems in 15 children and adolescents who are admitted to Rady Children's Hospital Child and Adolescent Psychiatry Service with psychotic symptoms or schizophrenia. Cutting-edge genome and protein sequencing technology will be used to better understand how immunological and genetic assessments may improve our ability to identify the cause of psychosis and impact care. The investigator also hopes to identify new genetic and/or autoimmune causes of psychosis that may inform new treatment for future patients.
Evaluation of Membrane Phospholipid and Energy Metabolism in Subjects at High Risk of Psychotic...
Patients With Ultra High Risk of Psychotic TransitionThe management of schizophrenia is a major public health issue, due to its particularly disabling psychotic symptoms and their onset at an early age, typically in adolescents or young adults. The physiopathological hypothesis of an anomaly relating to the renewal of cell membranes and energy metabolism in schizophrenia was proposed as early as the 1930s. This is based on anomalies at certain times in the development of the balance between phosphomonesters, precursors of membrane phospholipids, and phosphodiesters, catabolites of membrane phospholipids. Alterations of these different balances sign neurodevelopmental disorders, and can be objectified by specific techniques such as phosphorus-31 magnetic resonance spectroscopy (SMR-31P). This is used in particular to characterize the energy metabolism of the brain and allows in vivo quantification of phosphorus metabolites. The application of SMR-31P techniques to assess the metabolism of membrane phospholipids and cellular energy metabolism in subjects at high risk of psychotic transition could make it possible to objectify a difference between subjects subsequently suffering from a psychotic transition compared to those who do not suffer from it. Alterations in the metabolism of membrane phospholipids could thus represent a biomarker of psychotic transition. Secondarily, this approach would make it possible to provide elements as to the validity as a diagnosis of this category, which is very heterogeneous in its future. Among the Ultra High Risk (UHR) group, subjects with a psychotic transition (UHR-T) are compared to subjects without this transition (UHR-NT) during the two years of follow-up. The UHR group is compared to the control group. At T0, UHR patients and healthy volunteers will perform brain MRI with Phosphorus 31 magnetic resonance spectroscopy. UHR patients will then be reviewed: at T+1 year for a clinical assessment medical interview to assess the patient's functioning and the appearance of symptoms; at T+2 years for the realization of a follow-up interview with passing of the scales CAARMS (Comprehensive Assessment of At Risk Mental State) and SOFAS (scale of evaluation of the social and professional functioning) in order to determine if the subject belongs to the UHR-T or UHR-NT group.