Acceptance and Commitment Therapy (ACT) in Early Psychosis Patients
Acceptance and Commitment TherapyPsychotic Disorders1 moreThis study is to examine the effect of Acceptance and Commitment Therapy applied to patients in early psychosis patients on psychotic symptoms and functionality levels.
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder...
SchizophreniaPsychotic Disorders10 moreThis is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 80 eligible patients will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups.
Cognitive and Balance Dual Task Training for People With Schizophrenia
SchizophreniaCognition5 moreAfter developing and pilot testing the training program, including the CogBals software, a 3-arm, single-blinded, randomized controlled trial is used to recruit 81 participants and then randomly allocated to the cognitive and balance dual task training group (COG&BAL), the balance training group (BAL), and the treatment as usual group. The first two training groups (COG&BAL, BAL) receive training for 60 minutes in a group format, 2 times weekly, for 12 weeks. All participants will be assessed at baseline and posttest. The primary outcome is balance function and secondary outcomes are cognitive functions and the muscular endurance of lower extremities.
Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis
Family MembersInvestigators aim to develop and evaluate a culturally informed family motivational engagement strategy (FAMES) and implementation toolkit for coordinated specialty care (CSC) programs for first episode psychosis. First, 5 family member participants will be recruited into a three-month trial of FAMES and implementation toolkit. The investigators will then conduct a 16-month non-randomized, stepped-wedge trial with 50 family members from 5 CSC programs in community-based mental health clinics.
Acceptance and Commitment Therapy-based Lifestyle Counselling Programme for Early Psychosis on Physical...
Schizophrenia Spectrum and Other Psychotic DisordersThis pilot randomized controlled trial aims to determine the feasibility, acceptability and preliminary effects of an Acceptance and Commitment Therapy-based Lifestyle Counselling Programme (ACT-LCP) on the physical and psychosocial health outcomes of patients with early psychosis over a 12-week follow-up.
Integrated Care in Psychotic Disorders With Severe Mental Illness
SchizophreniaSchizophreniform Disorder5 moreThe study examine the effectiveness of an integrated care program including therapeutic assertive community treatment (ACT) for people with psychotic disorders fulfilling severe and persistent mental illness (SPMI, ACCESS-II study).
Building Regulation in Dual Generations 2022-2025
Maternal DepressionSelf-Regulation3 moreThis randomized control trial aims to investigate whether a novel intervention, the "Building Regulation in Dual Generations (BRIDGE)" program, improves mental wellness and parenting practices among mothers of 3 to 5-year-old children who have elevated symptoms of depression. The main two questions this study aims to answer are: Does participation in the BRIDGE program reduce maternal depression symptoms? Does participation in the BRIDGE program improve children's mental health? Researchers will compare the BRIDGE intervention to an established mental health intervention (i.e., Dialectical Behaviour Therapy skills group) and to a services-as-usual control group to see if participation in BRIDGE leads to greater improvements than either the general mental health treatment or community services as usual. Participants will: Complete a set of questionnaires pre- and post-intervention, and at 6-month follow-up. Complete a virtual assessment with their child at pre- and post-intervention. Be randomized to BRIDGE, Dialectical Behavioural Therapy(DBT) skills group, or a services-as-usual control group. Participate in the 16-week BRIDGE or DBT Skills only group, if randomized to either of these groups. If they are randomized to services-as-usual they will receive a list of community resources they can access. Complete weekly symptom monitoring via questionnaires, if randomized to BRIDGE or DBT Skills Wear a Fitbit device during pre- and post-intervention, as well as throughout the 16-week intervention period.
Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis
Clinical High Risk for Psychosis (CHR)This study aims to evaluate the feasibility and effectiveness of telehealth interventions for individuals at clinical high risk for psychosis (CHR). Psychosis typically emerges during late adolescence or early adulthood, significantly impacting long-term functioning. While CHR programs have the potential to reduce illness severity, individuals often face barriers such as stigma and limited access to services. Telehealth interventions could address these barriers and improve treatment accessibility and engagement. The study will focus on Group and Family-Based Cognitive Behavioral Therapy, Family-Based CBT, and individual CBT, adapted for telehealth delivery (GF-CBT-TH, F-CBT-TH, and I-CBT-TH). Participants aged 14-25 who meet CHR criteria will be randomly assigned to one of these interventions. Feasibility will be measured by recruitment rate, attendance, and retention. The study will assess the impact of the interventions on cognitive biases, social connectedness, family emotional climate, and proficiency in CBT skills. The three intervention groups will be compared in terms of psychosocial functioning, symptom severity, rates of remission from CHR, and rates of transition to psychosis. Additionally, factors like patient treatment preference, family emotional climate, and sociodemographic factors will be explored as potential moderators of treatment outcomes. Qualitative interviews will be conducted with participants and clinicians to inform dissemination efforts.
Interactive Obesity Treatment Approach for Obesity Prevention in Adults With Early Serious Mental...
ObesityOverweight1 moreUsing a design-for-dissemination approach, this application proposes to use combined methods to adapt and pilot test an interactive obesity treatment approach (iOTA) for obesity prevention in early serious mental illness (eSMI) that uses text messaging to provide between-visit support. Derived from the lifestyle intervention used in the Diabetes Prevention Program, the parent iOTA targets diet, activity and adherence using web-based and health coach support.
Adrenergic Blockers for Cardiac Changes in Early Parkinson's Disease (Protocol 53136)
REM Sleep Behavior DisorderPre-motor Parkinson Disease1 moreREM Behavior Sleep Disorder (RBD) is a sleep disorder causing people to 'act out' their dreams. A high percentage of individuals with idiopathic RBD (iRBD) are known to develop conditions affecting the neurons in the brain such as Parkinson's disease (PD). Based on the increased risk to develop PD, individuals with iRBD are currently considered ideal candidates for therapies that can possibly protects brain cells, due to the critical window of opportunity to intervene early before brain cell loss progresses significantly. Early changes of PD are associated with a number of symptoms including loss of smell, constipation, anxiety and depression. In addition, early heart and brain abnormalities can be visualized using specialized imaging techniques called 123I-MIBG myocardial scintigraphy (MIBG) and dopamine transporter (DAT) single photon emission computerized tomography (SPECT) respectively. The combined presence of certain symptoms and the use of these imaging techniques are considered early markers of PD in individuals with iRBD. In other conditions, like heart failure, MIBG abnormalities are reversed by drugs able to block excessive adrenergic stimulation, known as beta-blockers. In this study the investigators want to learn about the effect of treatment with the beta-blocker carvedilol on MIBG abnormalities found in iRBD patients at risk to develop PD. The investigators believe that reversing the MIBG abnormality might prelude to a slowing of the neurodegenerative process. This drug is approved by the U.S. Food and Drug Administration (FDA) for congestive heart failure, hypertension and left ventricular dysfunction after myocardial infarction. However, carvedilol is not approved by the FDA in patients with iRBD at risk for PD. The available doses for this drug oral formulations are 3.125mg, 6.25mg, 12.5mg and 25mg. Changes visualized with the MIBG imaging technique will be correlated to the presence and severity of neurological (i.e. tremors, stiffness, slow movements, walking difficulties) and other symptoms associated with PD (i.e. abnormal smell, constipation, depression, color vision abnormalities), as measured by specific clinical scales and exams.