Active clinical trials for "Mental Disorders"

Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.

This is a randomized pilot study of an intervention based on principles of Cognitive Behavioral Therapy (CBT). This intervention is the Health Dialogue Intervention (HDI) and will be compared to a traditional medical model of psychoeducation known as Team Solutions (TS) for first-episode schizophrenia patients. Outcomes include the acceptance of HDI and TS, compare adherence attitudes at the end of the treatment intervention, and to compare the time until the first episode of nonadherence.

The purpose of this study is to learn if patients being treated with second generation antipsychotics and with clinically meaningful elevations/levels in any metabolic syndrome elements will have better access to medical treatment more quickly if they are randomized to one of the following conditions: 1) a primary care provider located in the community mental health center where mental health treatment is provided (IMBED), 2) a medical care manager to help coordinate treatment with an outside primary care provider (Liaison) or 3) the standard practice of advising the patient to see a primary care doctor (Treatment as Usual).

Background: To improve employment prospects for people in the chronic stages of mental illness, the gold standard is a program called Individual Placement and Support (IPS). Little research on IPS has been done with clients in the early stages of mental illness. This project aims to assess the incremental effectiveness of the IPS model of employment support over treatment-as-usual in a representative sample of early-psychosis clients . Method: One hundred consenting clients from the Fraser Health Early Psychosis Intervention (EPI) program will be recruited and randomly assigned to receive either one year of IPS support or treatment as usual (i.e., no IPS support but no constraints on the clients to seek other employment or related support themselves). Our primary hypothesis is that the early-psychosis clients receiving the IPS intervention will obtain and maintain more paid employment compared to the TAU (treatment as usual) group. Secondary hypotheses pertain to employment success as a function of both fixed and dynamic factors and assessing the cost-effectiveness of IPS.

The main study intervention is the daily witnessing of participant self-administration of medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.

This is a school-based field experiment conducted in sixth grade classrooms to evaluate a multifaceted intervention designed to change attitudes and behaviors regarding mental illnesses. The research tests hypotheses as to whether alone or in combination interventions that are 1) a curriculum-based in-class presentations, 2) contact-based with a person who has experienced a mental illness, or 3) or based on educational materials distributed in classes improve knowledge/attitudes and encourage help seeking for mental health problems in a follow up study lasting two years.

Mindfulness-based interventions have gained increasing popularity in recent years as effective treatment for mental illness. Mindfulness is defined as paying attention in a particular way: on purpose, in the present moment, and non-judgmentally: "Being", rather than "Doing". Such mental states can improve emotional regulation through frontal cortex inhibition of otherwise dysregulated subcortical emotion-related circuits. Formal mindfulness approaches such as mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction, have been highly effective in a broad range of psychiatric disorders. Mindfulness-oriented interventions, are potentially useful in acute psychiatric hospitalizations, since they can be delivered as group therapies and are be both cost-effective and scalable. However, such interventions have rarely been provided to patients during psychiatric hospitalizations, where patients are treated for a variety of psychiatric diagnoses, and may have unpredictable lengths of stay. Additionally, there had been concerns that longer traditional mindfulness based interventions (e.g. 30 minute silent meditation) may exacerbate acute psychosis. However, strong evidence suggests that patients with psychotic symptoms appear to be largely unaffected by shorter interventions. Similarly, MBCT have been helpful to treat other major reasons for hospitalization such as: bipolar disorder, severe anxiety, substance use disorders, and major depressive disorder. Few studies have examined mindfulness-oriented treatments in inpatient settings, including two small studies involving mindfulness groups on an acute psychiatric inpatient ward (n<10) . Another study (n=23) offered inpatients with a diagnosis of major depressive disorder mindfulness-based activities. All studies concluded that mindfulness-oriented approaches in inpatient settings were feasible, although these needed to be brief interventions, given the risks and lack of efficacy of longer MBI (e.g. 40-minute silent meditation) in severe mental illness. A cross-sectional study conducted by our team (n=40) demonstrated that brief group mindfulness-oriented lasting 10 minutes were very well tolerated by 92.5% of psychiatric inpatients. The remaining 7.5% of patients left the session before 10-minutes, but had no symptomatic exacerbations or adverse effects. Moreover, the 50% of patients self- reported improvements in general well-being and mood after a single 10-minute session. Having been recently admitted to the psychiatric inpatient or having a diagnosis of acute psychosis (75% of inpatients) did not affect patients' capacity to tolerate and benefit from the intervention. In this inpatient psychiatric population, we found that mindfulness-oriented interventions that were brief and involved physical movement (e.g. seated Tai Chi) were better enjoyed compared to other interventions. Despite the growing literature in this field, data is needed on the effectiveness and health service implications of brief group mindfulness-oriented interventions in inpatient psychiatry settings. Outcome studies conducted so far cannot be interpreted reliably due to methodological flaws, including inadequate control groups, very small sample sizes (often n<10), and lack of randomization. In Canada, the direct cost of treatment for mental illness is estimated as 42.3 billion. Much of these costs are driven by psychiatric admissions. Thus, if brief mindfulness-oriented interventions are effective at lowering psychiatric symptom severity and shortening psychiatric hospitalizations, this could lead to significant cost-savings.

Research has shown that mental health care (MHC) providers differ significantly in their ability to help patients. In addition, providers demonstrate different patterns of effectiveness across symptom and functioning domains. For example, some providers are reliably effective in treating numerous patients and problem domains, others are reliably effective in some domains (e.g., depression, substance abuse) yet appear to struggle in others (e.g., anxiety, social functioning), and some are reliably ineffective, or even harmful, across patients and domains. Knowledge of these provider differences is based largely on patient-reported outcomes collected in routine MHC settings. Unfortunately, provider performance information is not systematically used to refer or assign a particular patient to a scientifically based best-matched provider. MHC systems continue to rely on random or purely pragmatic case assignment and referral, which significantly "waters down" the odds of a patient being assigned/referred to a high performing provider in the patient's area(s) of need, and increases the risk of being assigned/referred to a provider who may have a track record of ineffectiveness. This research aims to solve the existing non-patient-centered provider-matching problem. Specifically, the investigators aim to demonstrate the comparative effectiveness of a scientifically-based patient-provider match system compared to status quo pragmatic case assignment. The investigators expect in the scientific match group significantly better treatment outcomes (e.g., symptoms, quality of life) and higher patient satisfaction with treatment. The investigators also expect to demonstrate feasibility of implementing a scientific match process in a community MHC system and broad dissemination of the easily replicated scientific match technology in diverse health care settings. The importance of this work for patients cannot be understated. Far too many patients struggle to find the right provider, which unnecessarily prolongs suffering and promotes health care system inefficiency. A scientific match system based on routine outcome data uses patient-generated information to direct this patient to this provider in this setting. In addition, when based on multidimensional assessment, it allows a wide variety of patient-centered outcomes to be represented (e.g., symptom domains, functioning domains, quality of life).

This study will test the effects of the Leadership and Organizational Change for Implementation (LOCI) intervention in facilitating evidence-based practice (EBP) implementation in substance use disorder (SUD) and HIV services settings. LOCI improves implementation leadership and organizational support to develop strategic climate for EBP implementation. Greater efficiency and effectiveness of EBP implementation will improve the public health impact of evidence-based health and allied healthcare innovations and lead to greater effectiveness of SUD and HIV services. Project Terms:

In order to establish target engagement and identify an effective dose the investigators will conduct a placebo-controlled single-dose parallel group trial of levetiracetam 185 mg and 500 mg in 24 medication-naïve early psychosis (EP) patients, measuring hippocampal activity by pulsed arterial spin labelling (ASL) pre-dose and 2 hours post-dose. The lower dose is calculated to achieve blood levels within the range that were associated with reduced hippocampal activity and improved cognition in patients with mild cognitive impairment; the higher dose is a typical antiepileptic dose. Successful demonstration of target engagement will be defined by an effect size of 0.5 or greater compared to placebo in reduction by levetiracetam of hippocampal blood flow measured by ASL. The optimal dose will be defined by maximal reduction of hippocampal perfusion in the absence of clinically-significant adverse effects. The investigators will also study 8 healthy control subjects to verify that baseline hippocampal blood flow is elevated in the sample of EP subjects.