A Problem Solving Intervention Involving Employees at Risk of Sick Leave Due to Common Mental Disorders...
Mental DisordersThe 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.
Goals in Focus: CBT for Motivational Negative Symptoms of Psychosis
PsychosisSchizophrenia1 moreThis pilot feasibility trial aims to evaluate the "Goals in Focus" intervention for motivational negative symptoms in people with psychosis. Goals in Focus interventions translate findings of basic clinical research on psychological mechanisms of motivational negative symptoms into a tailored and comprehensive novel psychological treatment program. The current single-blind randomized-controlled study aims to test feasibility and to examine first estimates of the expected effect size of Goals in Focus to inform a subsequent fully-powered RCT. The feasibility data will be used to improve on the trial design and the provision of the "Goals in Focus" intervention where necessary.
Pilot Testing a Digital Intervention to Improve Smoking Cessation in Persons With Serious Mental...
Tobacco CessationAll patients with serious mental illness are abstinent while in the hospital for a psychiatric admission yet almost all return to smoking after discharge. The investigators propose to adapt a digital intervention both to the needs of SMI smokers and to being introduced in the inpatient psychiatric setting through a collaboration between experts in SMI and the Truth Initiative, a pre-eminent tobacco control organization. The investigators believe this will bridge the inpatient to outpatient gap in cessation services and will help people remain abstinent following hospital discharge.
Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis
PsychosisSchizophrenia1 moreSingle-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.
Terazosin Effect on Cardiac Changes in Early Parkinson's Disease
REM Sleep Behavior DisorderPre-motor Parkinson's Disease1 moreParkinson's disease (PD) is characterized by many non-motor symptoms that occur several years before the diagnosis, in particular idiopathic REM behavior disorder (iRBD), which is associated with autonomic impairment. The purpose of this study is to investigate the effect of treatment with the selective post-synaptic a1-adrenergic blocker terazosin on 123I-MIBG myocardial uptake in a population of subjects with defined pre-motor PD risks (i.e. hyposmia and RBD) and abnormal baseline 123I-MIBG uptake, with or without 123I-Ioflupane uptake abnormality or PD motor symptoms. Scintigraphic changes will be correlated to motor and non-motor severity of PD, measured by validated clinical scales and cardiac autonomic function tests.
Cognitive Training for Emotion Regulation in Psychotic Disorders
SchizophreniaSchizo Affective DisorderThe current study examines the efficacy of a cognitive training intervention for improving emotion regulation in psychotic disorders. it is hypothesized that the cognitive training program will enhance prefrontal activation, leading to enhanced emotion regulation.
Addressing Depression and Positive Parenting Techniques (ADAPT)
DepressionEmotional Problem5 moreChildren with emotional and behavioural difficulties (EBD) experience disproportionate social, family and academic impairment and have between two to five times increased likelihood of developing an anxiety disorder, mood disorder or other severe mental illness in adolescence and adulthood. There is a close association between parental depression and the emergence and maintenance of childhood EBD that is likely bidirectional. Parents of children with EBD experience disproportionate stress, increasing their risk for depression; yet chronic and untreated parental depression is associated with the emergence of child EBD in the first place. Therefore, designing targeted and effective assessment and treatment for parents of children with EBD that take into account parents' depression is necessary. Of pressing concern, first-line Behavioral Parent Training (BPT) treatments for parents of children with EBD are not tailored to parent's mental health needs, which may be why upwards of 40 percent of parents and children treated in these programs fail to sufficiently benefit. Existing research highlights emotional and cognitive factors that may differentiate depressed parents from non-depressed parents that may be treatment targets to improve outcomes for depressed parents and children. The main aim of the proposed project is to evaluate the feasibility and acceptability of a novel targeted treatment for depressed parents of children with EBD, along with adherence to study protocol. The investigators will use the results of the pilot study to make key modifications to study procedures and the treatment itself to increase the success of a future randomized controlled trial (RCT) to test treatment efficacy. The investigators hypothesize that: Recruitment will be feasible. The intervention will be acceptable, and there will be a high rate of adherence to study protocol.
Adapting and Examining Collaborative Decision Skills Training Among Veterans With Serious Mental...
SchizophreniaSchizoaffective Disorder2 moreRecovery-oriented care is an imperative for the VA, particularly in mental health programming for Veterans with serious mental illness (SMI). Collaborative decision-making (CDM) is a recovery-oriented approach to treatment decision-making that assigns equal participation and obligation to patients and providers across all aspects of decision-making, thereby empowering patients and facilitating better decision-making based on patient values and preferences. CDM is associated with several important outcomes including improved treatment engagement, treatment satisfaction, and social functioning. However, current levels of CDM among Veterans with SMI are low, and there is not yet an evidence-based method to improve CDM. Improving Veteran skill sets associated with engaging in CDM is a potential intervention strategy. Collaborative Decision Skills Training (CDST) is a promising new intervention that was previously developed by the applicant for use in adult civilians with SMI and found to improve relevant skills and improve sense of personal recovery. The proposed study has two primary stages. First, a small, one-armed, open label trial will establish CDST's feasibility will evaluate CDST among 12 Veterans with SMI receiving services at the VA San Diego Psychosocial Rehabilitation and Recovery Center (PRRC) and identify and complete any needed adaptations to CDST. Stakeholder feedback from Veterans, VA clinicians, and VA administrators will be collected to assess Veteran needs and service context to identify any needed adaptations to the CDST manual or the delivery of CDST to maximize its impact and feasibility. The developers of CDST will review all feedback and make final decisions about adaptations to ensure that CDST retains its essential components to protect against loss of efficacy. For example, a recommendation to adjust role-play topics to better reflect the needs of Veterans would be accepted because it would increase CDST's relevance without impairing its integrity, but a recommendation to remove all role-plays would not be accepted because it would cause loss of a key component. Second, CDST will be compared to active control (AC) using a randomized clinical trial of 72 Veterans. The primary outcome measure will be functioning within the rehabilitation context, operationalized as frequency of Veteran CDM behaviors during Veteran-provider interactions. Secondary outcomes are treatment attendance, engagement, satisfaction, and motivation, along with treatment outcomes (i.e., rehabilitation goal attainment, sense of personal recovery, symptom severity, and social functioning). Three exploratory outcomes will be assessed: Veteran-initiated collaborative behaviors, acute service use and provider attitudes and behavior. Veterans will be randomly assigned to CDST or AC conditions. Veterans in the both groups will attend eight hour-long group sessions held over eight weeks. All Veterans will complete an assessment battery at baseline, post-intervention, and at three-month post-intervention follow-up. Following the trial and adaptation phase, the findings will be used to develop a CDST service delivery manual and design a logical subsequent study. The results of the proposed study will inform the potential for larger trials of CDST and the utility of providing CDST broadly to Veterans with SMI. The results of this study will expand current understanding of CDM among Veterans with SMI by providing data that will: 1) identify adaptations needed to optimize CDST for Veterans receiving services in PRRCs; 2) identify possible benefits of CDST; 3) inform development of alternate interventions or methods to improve CDM; and 4) further elucidate CDM and associated treatment processes among Veterans with SMI receiving VA rehabilitation services.
Hjernegym - Effects of Exergaming in Psychosis: a Clinical Intervention Study
Schizophrenia; PsychosisCognitive ImpairmentThe goal of this clinical intervention study is to investigate the effects of exergaming on cognition and other clinical symptoms in outpatient individuals with schizophrenia. The main questions it aims to answer are: Will an exergaming intervention contribute to improved cognition and reduced clinical symptoms, as well as enhanced physical health/self-efficacy/quality of life, in individuals with schizophrenia? Will the gaming component strengthen motivation for a physically more intensive component, so that attendance will be at least as high as in comparable exercise studies despite the current study being implemented in a resource-limited, regular clinical outpatient setting? Participants will be asked to engage in two 45 minutes exergaming sessions with a designated personal trainer for 12 weeks. Results pre- and post intervention will be compared, and comparisons will also be made with a former randomized controlled trial conducted at the same site, in which the currently combined activities were investigated separately (high-intensity interval training and low-intensity video gaming), both yielding positive but different effects.
RCT Comparing Avatar Intervention to Supportive Intervention to Reduce Cannabis Use in Patients...
Psychotic DisordersCannabis Use Disorder1 moreThe goal of this clinical trial is to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacy over supportive intervention to reduce cannabis use in patients with psychotic disorders.