View clinical trials related to Bipolar Disorder.
Filter by:This study evaluates the cultural and linguistic sensitivity and psychometric properties of a set of four adapted measurement instruments essential to determining the efficacy of group-psychoeducation for patients with bipolar disorder in Rwanda, and one screening tool for bipolar disorder. The four well-known instruments are; The Young Mania Rating Scale (YMRS), The Medical Adherence Scale (MARS), The Internalized Stigma of Mental Illness Scale-9 (ISMI-9), and the Mood disorder Questionnaire (MDQ). Each instrument will be culturally adapted and validated using a forward-backward translation, consensus conference, and cognitive interviews.
Bipolar disorder (BD) is a serious mental disorder characterized by episodes of mania/hypomania and/or depression. Compared to the general population, these individuals present functional impairment, and life interference subclinical symptoms even between mood episodes, and higher mood instability and suicide rates with a lower quality of life. Given the chronic and phasic course of this disorder, patients are great consumers of health services and in Portugal there is no specialised psychotherapeutic approach to Bipolar Disorder, having pharmacological treatment alone as the main therapeutic response, and a considerable number of patients are not fully stabilized with drug treatments, experiencing residual symptoms. Although studies suggest that certain psychological therapies can be helpful for people experiencing full mood disorder episodes, or to reduce risk of future episodes, there are no gold standard and evidence-based psychological therapies for BD, and recent systematic reviews on psychosocial interventions for BD identify Dialectical-Behavior Therapy (DBT) as promising. Our research is sustained in a recovery based perspective, which means we intend to develop a sense of hope, understanding, empowerment and work towards a meaningful and satisfying life, focusing on less clinical outcomes. Recovery is a concept that looks beyond the traditional clinical definitions which focus on reduced symptomatology, hospitalisation and medication compliance, and focuses on having a better sense of living even though you might have some clinical symptomatology. DBT was developed as an approach for highly emotionally and behaviourally dysregulated people, and it has been referred as promising in BD patients. DBT aims to give individuals who experience quick and intense shifts in mood, skills to manage and regulate their emotions. People with Bipolar Disorder can benefit from skills to regulate their emotions and interpersonal efficacy, which is frequently affected by mood changes, and therefore have a life worth living, feeling skillful and empowered to deal with challenges. Our study aimed to develop a 12 session DBT-skills group adapting the sessions and skills to be used with this client group (Bi-REAL - Respond Effectively and Live mindfully). This study aims to test acceptability, feasibility and efficacy of this 12 session DBT skills pilot randomized group intervention for patients with Bipolar Disorders.
The purpose of this study is to assess the impact of music on patients receiving a course of intravenous (IV) ketamine for treatment-resistant depression (TRD), both unipolar and bipolar. The primary outcome is changes in in systolic blood pressure throughout each 40-minute infusion. Secondary outcomes include repeated measures of mood, anxiety, suicidality, and psychological/physical pain. Aspects of the treatment experience, with and without music, will also be explored.
Background: Mental health- and neurological disorders constitute 13% of the global burden of disease. Alarmingly this burden has risen by 41% in the last 20 years. In low-and-middle-income countries as few as 10% of people living with bipolar disorder receive care. In western countries, the efficacy of psychoeducation, as an add-on treatment to pharmacotherapy in the treatment of symptoms and in relapse prevention initiatives with respect to bipolar disorder, is well documented. Yet, few studies on psychosocial interventions for bipolar disorder have been conducted in a low-income country. Aim: To determine the effect, feasibility and acceptability of psychoeducation for patients with bipolar disorder on all three levels of the health care system in Rwanda - at the community health centre, district- and university hospital. Methods: Patients will be randomized into either group A) group-psychoeducation at a referral hospital; or B) group-psychoeducation for both patients and relatives or C) waiting list. Moreover a district trial will test the impact and feasibility of psychoeducation at the district level. Outcomes: Reduction in symptom severity and incidence of relapse, improved quality of life, medical adherence and knowledge, as well as reduced self-stigmatization. Perspectives: If proven successful, this is of importance for closing the huge treatment gap in mental health particularly affecting low- and middle-income countries and may reduce the mortality and increase quality of life in the population suffering from bipolar disorder. Furthermore, potential positive outcomes may be implemented in similar low-resource settings elsewhere.
Involuntary mental health care is permitted because it is believed to make people with severe mental disorders (SMD) better and prevent them from getting worse or even dying In this study we will investigate whether low levels of coercion in an area is connected with poorer outcomes in Norway. It can be assumed that too little involuntary care might lead to the opposite outcomes to those intended by the Norwegian Mental Health Act. The same law applies all over Norway, but the rate of involuntary care varies: there is up to five-fold difference between the catchment areas of the 69 Community Mental Health Centers. The investigators will estimate rates of involuntary care and adjust for age, sex, urbanity and area deprivation. The data source is the Norwegian Patients Registry, and all patients in treatment for a severe mental disorder in 2015 and their use of mental health care until 2018 will be followed. Model 1 follows all patients who were treated for a severe mental disorder in 2015. The model will test whether the rates of involuntary care in the area they live can predict the length of time to death. Model 2 follows patients with treatment for severe mental disorders that had no episode of voluntary care in 2015. The model will test whether the rate of involuntary care in their area predicts their use of mental health inpatient care in 2016 and 2017. Model 3 tests how long time patients with severe mental disorders that received only voluntary care in 2015 remain without a period of involuntary care in 2016-17, as a function of the rate of involuntary care in their area. Model 4 estimates changing the total number of patients with severe mental disorders in the catchment area in 2016-17 as a function of time and the rate of involuntary in 2015. Model 5 tests whether suicide rates for a catchment area varies as a function of its rate of involuntary care. Because suicides are rare, we will observe the variables over longer time periods, using involuntary care rates from 2015 to 2018 and suicide rates for 2015-2019. The study was evaluated by the Research Ethics Committee (ref 2018/795), who approved use of registry data, and by the Privacy Ombudsman at Akershus University Hospital (ref 2018-090).
People with a severe mental illness (SMI) have an increased risk for premature mortality, predominantly due somatic health conditions. Evidence indicates that prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility and acceptability of a coordinated co-produced care programme (SOFIA model) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. The primary outcomes are description of study feasibility (recruitment and retention) and acceptability. The SOFIA trial is designed as cluster randomized controlled trial targeting general practices in two regions in Denmark. 12 practices will each recruit 15 community-dwelling patients aged 18 and older with severe mental illness (SMI). Practices will be randomized in a ratio 2:1 to deliver a coordinated care program or care-as-usual during a 6 month period. An online randomized algorithm is used to perform randomization. The coordinated care program comprises enhanced educational training of general practitioners and their clinical staff, and prolonged consultations focusing on individual needs and preferences of the patient with SMI. Assessments are administered at baseline, and at end of study period. If delivery of the intervention in the general practice setting proves feasible, a future definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place.
Insufficient community-based support after inpatient discharge for persons with serious mental illnesses (SMI) may lead to re-hospitalization, excessive criminal justice involvement, homelessness, and an inability to embrace recovery. In fact, many of these especially vulnerable persons find themselves in a cycle of repeated hospital stays, arrests, and even homelessness, with little support for real recovery. Public mental health systems are struggling to address these problems. Evidence-based, comparatively inexpensive, time-limited community support models are needed to reduce institutional recidivism and facilitate recovery. The Georgia chapter of the National Alliance on Mental Illness (NAMI-GA) developed Opening Doors to Recovery (ODR), and we have collected extensive preliminary data on it. ODR is now being tested in a randomized controlled trial (RCT) taking place in southeast Georgia where ODR was first developed. The primary goals of ODR are to prevent institutional recidivism (i.e., going back into the hospital) and to promote recovery among persons with SMI like schizophrenia and bipolar disorder. The ODR intervention is comprised of several components that work together to address barriers to successful integration into the community among individuals with SMI and repeated inpatient hospitalizations. A team of 3 specially trained "Community Navigation Specialists" (CNSs, also called Navigators) provides intensive, mobile, community support to persons with SMI with a defined history of inpatient recidivism (i.e., repeated hospital stays). We are carrying out a fully powered trial of ODR in a 7-county catchment area in southeast Georgia, which is an ideal real-world location to carry out the study. During the 5-year study period, we will randomize 240 persons with SMI and a history of ≥2 inpatient stays in the past 12 months to ODR (n=120, followed for 12 months, with a maximum CNS caseload of 40) versus community care in traditional intensive case management or case management (ICM/CM, n=120). Assessments are conducted at baseline (just before hospital discharge), and at 4, 8, 12, and 18 months.
People with schizophrenia and bipolar disorder display alterations in cognition and metacognition. These alterations may have an impact on learning during therapeutic education programs.
The study team will use components of the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to compare Cognitive Adaptation Training (CAT) to Remotely delivered Cognitive Adaptation Training (R-CAT) 1-9 within a managed care organization (MCO), targeting members with serious mental illness (SMI) needing assistance with the regular taking of medication.
Adults with serious mental illness (SMI) are disproportionately affected by medical comorbidity, earlier onset of disease, and 10 to 25 years reduced life expectancy compared to the general population. These high rates of morbidity and early mortality are associated with inadequately managed medical and psychiatric illnesses. A recent systematic review found nine effective self-management interventions that address medical and psychiatric illnesses in adults with SMI. However, there has been limited adoption of these interventions due to both provider and consumer-based factors. Provider-based barriers consist of the lack of an adequate workforce with the capacity, time, and knowledge of effective approaches to self-management support for adults with SMI and chronic health conditions. Consumer-based barriers associated with limited participation in self-management programs include lack of access, engagement, and ongoing community-based support for persons with SMI. Peer support specialists have the potential to address these barriers as they comprise one of the fastest growing sectors of the mental health workforce, have "lived experience" in self-management practices, and offer access to support in the community. However, challenges need to be resolved for peers to be effective providers of evidence-based interventions. For example, peers are frequently trained to provide "peer support" described as "giving and receiving help founded on key principles of respect, shared responsibility, and mutual agreement of what is helpful". Peer support has been associated with increased sense of control, ability to make changes, and decreased psychiatric symptoms. Despite benefits, peer support does not adhere to evidence-based practices for psychiatric and medical self-management and does not follow protocols that ensure fidelity and systematically monitor outcomes. The investigators hypothesize that mobile technology has the potential to overcome these limitations of peer support by providing real-time guidance in fidelity adherent delivery of a peer-delivered, technology-assisted evidence-based self-management intervention (PDTA-IIMR). The investigator will build the necessary expertise to pursue a career developing and testing novel approaches to peer-delivered evidence-based self-management interventions. Training will include: development of peer-delivered interventions; development and design of mobile health-supported interventions; and intervention clinical trials research. Concurrently, this study includes refinement of the intervention protocol with input from peers and consumers and conducting a pilot study evaluating the feasibility and potential effectiveness of PDTA-IIMR compared to routine peer support for N=6 peers and N=40 adults with SMI and chronic health conditions. Outcomes include feasibility, medical and psychiatric self-management skills, functional ability, and mortality risk factors and examine self-efficacy and social support as mechanisms on outcomes.