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Mental Disorders clinical trials

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NCT ID: NCT03970005 Enrolling by invitation - Clinical trials for Prodromal Schizophrenia

Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis

Start date: April 19, 2019
Phase:
Study type: Observational [Patient Registry]

The Ohio State University Early Psychosis Intervention Center is implementing a specialized clinical program to serve individuals who meet clinical high risk criteria for a psychosis. The purpose of this study is to evaluate the long-term outcomes among individuals participating in this clinical service.

NCT ID: NCT03969589 Completed - Clinical trials for Stress Disorders, Post-Traumatic

Reproductive Life Planning for Women With Mental Illness

RLP-MH
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Women represent the fastest growing population within the VHA. Many are of reproductive age and experience mental health concerns. Women with mental illness are at greater risk for unplanned pregnancy and poor pregnancy outcomes due to factors related to mental health and mental health treatment. Similarly, mental health concerns (e.g., impact of pregnancy on mental illness, psychiatric medications and pregnancy) can affect reproductive life goals and plans. Reproductive life planning (RLP) interventions that include considerations and concerns women Veterans with mental illness face are needed. The investigators adapted existing RLP materials to create an interactive, individualized, client-centered RLP intervention designed to help women Veterans with mental illness develop a mental health-informed reproductive life plan and reproductive life goals (RLP-MH). The current study aims to determine if the RLP-MH intervention is feasible and acceptable to women Veterans and if it increases engagement in behaviors to address RLP goals.

NCT ID: NCT03967509 Completed - Clinical trials for Attention Deficit Disorder With Hyperactivity

Effectiveness of Behavioral Preschool Teacher Training for Externalizing

BPTT
Start date: August 18, 2008
Phase: N/A
Study type: Interventional

A cluster randomized controlled pre-post effectiveness trial of behavioral preschool teacher training (BPTT) delivered in a practitioner assisted group format for children with externalizing behavior problems. Preschools were randomized to either intervention in 25 preschools or as 22 waiting list control preschools, where teachers in preschool classes with the target child or children were program receivers. Participants were 100 target children 3-5 years old together with 72 enrolled preschool teachers and 83 parents as informants of behavioral outcomes after a five months period of implementation (at six months). The intervention was part of the Swedish evidence-based parent and teacher training programs (Comet) for children and youth with elevated externalizing behavior, and here an adapted version was tried in preschool for the first time. Also investigated was eventual generalized effects to the children's homes and improved social competence as an intermediate mechanism for reduced problem behavior. Effects of implementation fidelity in addition to social acceptability and relevance, such as reliable change, was investigated as well.

NCT ID: NCT03966872 Recruiting - Chronic Disease Clinical Trials

Comparative Effectiveness of IIMR Versus CDSMP

Start date: September 2, 2019
Phase: N/A
Study type: Interventional

The study will enroll 600 people with serious mental illness who receive services at Centerstone in KY or TN and will compare two different evidence-based self-management interventions: Integrated Illness Management and Recovery (I-IMR), a program developed by the study team at Dartmouth that trains people with serious mental illness on physical and mental health self-management, and the Stanford Chronic Disease Self-Management Program (CDSMP), a program largely focused on physical health self-management that has been used widely in the general population.

NCT ID: NCT03965598 Recruiting - Schizophrenia Clinical Trials

Study on Predictiors and Mechanism of Conversion to Psychosis in Individuals at Ultra-high Risk Group

Start date: November 1, 2016
Phase:
Study type: Observational

Considering the complex pathological mechanism and the poor treatment outcomes of schizophrenia, early detection and intervention gradually become the key work for the foundational and clinical research in schizophrenia. Ultra-high risk for psychosis (UHP) is defined as individuals at the prodromal stage of schizophrenia. Early intervention in individual at UHP can effectively delay or even prevent the development of the illness. Long-term longitudinal studies suggested that there are clinical outcomes in people at UHP. Nearly 1/3 of individuals at UHP may be naturally relieved without any intervention, about 1/3 of individuals at UHP will remain at the prodromal stage of schizophrenia, and only 1/3 individuals at UHP will eventually develop schizophrenia. In this regard, it will cause adverse effects on false positive individuals if they accept clinical intervention. Unfortunately, it is difficult to accurately predict which individuals at UHP will make a transition to frank illness. To solve this issue, we explore the association between baseline brain structural and functional networks, methylation modifications, gene expression, neurocognitive function and the clinical outcomes of UHP individuals, and to identify the potential biological and clinical predictors for the long-term outcomes in the individuals at UHP. In addition, we also detect the changes of brain structure and function, methylation status and gene expression in individuals at UHP during follow-up, and further to investigate the etiology and pathogenesis of schizophrenia.

NCT ID: NCT03963245 Completed - Mental Illness Clinical Trials

Project Meaningful Activities and Recovery

MA&R
Start date: September 19, 2018
Phase: N/A
Study type: Interventional

Occupational therapy interventions are often part of the treatment and rehabilitation services offered to people with mental illnesses. Occupational therapy can be an important contribution when the purpose is to promote participation in everyday activities that are meaningful for the individual. (1-3) There is limited evidence to support whether occupational therapy interventions for people with mental illnesses have an effect. (2,3) Based on principles from Lifestyle Redesign®, which is an evidence-based occupational therapy intervention for older people, a comparative qualitative study with participant experiences from various psychosocial rehabilitation efforts, and a dialogue-based collaboration with experienced occupational therapists and peer staff from community mental health centers, we developed a new recovery oriented occupational therapy intervention to people with disabilities due to mental illness. The intervention "Meaningful activities and recovery" (MA&R) - is an eight-month rehabilitation program. The aim of MA&R is to enable participation in activities that are meaningful to the individual. Project Meaningful Activities and Recovery (MA&R) is a clinical trial where the purpose is to compare the effects of: 1) "Meaningful activities and Recovery" (MA&R) in addition to standard care and 2) standard care as it is now offered to people with psychiatric disabilities. The design is a randomized clinical trial with self-reported assessments. Based on sample size calculation, 128 participants will be included in the trials. The primary endpoint is activity engagement, and the secondary effect goals are personal recovery, functioning and quality of life. Participants are followed up at the end of the intervention, after eight months.

NCT ID: NCT03962426 Recruiting - Psychosis Clinical Trials

Efficacy of Social Cognitive Training (SCT) in Recent-onset Psychosis

Start date: May 2016
Phase: N/A
Study type: Interventional

Participants with recent onset psychosis (ROP) experience delusions, hallucinations, and impairment in social, cognitive and emotional functioning. Although symptoms often improve following pharmacological intervention, the marked cognitive deficits, that often precede the onset of symptoms, continue to persist despite current treatment methods. Computerized neurocognitive interventions (NCI) are a promising therapeutic approach in participants with chronic schizophrenia and individuals at risk for psychosis. Specifically, focus has shifted to social cognitive training (SCT) as treating social cognition have been shown to provide improvements not only in general cognitive deficits but is also related to improvements in functional outcome (occupational and social). NCIs include non-invasive computerized tasks that are done on a tablet. This intervention can be conducted in a clinical setting, as well as out of the comfort of one's home. Additionally, research has shown that NCIs have the potential to elicit neuroplastic effects on the brain. The purpose of this study is to explore the efficacy of a 10-hour SCT in improving the primary outcome measure, global cognition, and secondary outcome measure, global functioning, in ROP participants. It is hypothesized that participants receiving the intervention will show gains in global cognition, as well as the subdomains of social cognition, processing speed, and working memory. Additionally, participants undergoing active intervention are expected to show gains in functional connectivity primarily between the prefrontal cortex and amygdala and other brain areas, that are engaged in social cognition. Furthermore, machine learning approach will be used(support vector classification) to investigate how the decision scores of the resting state classifier, indicating health vs. disease proneness, change in response to the training. In this randomized controlled trial, participants with a ROP receive a 4-6-week treatment with 10 hours of SCT, with 30-minute sessions 4-5 times per week or treatment as usual (TAU) control condition. Baseline and follow-up (6 weeks after the baseline assessment) assessments include clinical diagnostic and symptom assessment, standard neuropsychological testing, and structural and functional imaging. The already recruited part of the ROP sample counts 27 participants in SCT and 27 in the TAU arm. The power analysis recommends to recruit at least 6 more participants in both study arms. For the purpose of machine learning part of the analysis an independent psychosis (ROP)-healthy population (HC) classifier will be used, which takes the data from the naturalistic multi-center european study, Personalized Prognostic Tools for Early Psychosis Management, in order to be able to track the decision scores of the intervention SCT sample without risk of overfitting.

NCT ID: NCT03962348 Completed - Clinical trials for First-Episode Psychosis

Clinical Interviews With Detainees With Early Psychosis

Interview
Start date: January 8, 2020
Phase: N/A
Study type: Interventional

The investigators are studying a jail-based intervention to reduce the duration of untreated psychosis (DUP) among young adults with previously undetected first-episode psychosis who are detained in jail. Longer DUP (or treatment delay) is linked to poorer outcomes in first-episode psychosis and there is evidence that justice-involved young adults with first-episode psychosis have an alarmingly long DUP. Thus, despite the expansion of Coordinated Specialty Care (CSC) programs that improve outcomes through early, multi-component care, there is a need to establish early detection services in the criminal justice system and create pathways from justice involvement to CSC. This intervention offers a novel and potentially high impact approach for reducing DUP in jail settings: a jail-based Specialized Early Engagement Support Service that receives referrals, engages detainees, and serves as a bridge to community-based CSC. The study team will design and implement the intervention, thoroughly study its feasibility and acceptability, and prepare an intervention manual for broader use in diverse jails and future formal research.

NCT ID: NCT03959735 Completed - Schizophrenia Clinical Trials

High Intensity Interval Training in Severe Mental Illness

Start date: October 10, 2019
Phase: N/A
Study type: Interventional

People experiencing severe mental illnesses (SMI), including schizophrenia, psychosis, bipolar disorder and major depressive disorder, are prone to poorer physical health and increased incidences of premature mortality when compared to the general population (De Hert et al., 2009; Hert et al., 2011; Hennekens et al., 2005; Tiihonen et al., 2009 . High-intensity-interval-training (HIIT) is a type of exercise involving alternating short bursts of high intensity exercise with recovery periods of rest/ light exercise (Weston, Wisløff & Coombes, 2014). HIIT improves physical health, quality of life and cognition in the general population and in those with physical health disorders (Gomes-Neto et al., 2017; Hwang, Wu & Chou, 2011; Wen et al., 2019). It has been proposed that HIIT may improve symptoms, physical health and time to discharge among inpatients with SMI. The research will involve three stages: 1) Focus groups, 2) A pilot study, 3) Follow-up qualitative interviews and focus groups. Firstly, a series of focus groups with inpatients with SMI, carers of individuals with SMI and clinical staff will be conducted. The focus groups will scope perceptions of attitudes, and practicalities of a pilot RCT. The information gained will be used to inform a pilot HIIT trial which will evaluate whether HIIT is acceptable and feasible amongst this population group. Each focus group will run for ≈2 hours and will involve an open discussion about the benefits and barriers of conducting HIIT exercise sessions in a population with SMI. Secondly, the HIIT pilot study will be trialed. The final protocol will be developed with feedback from the focus group but will involve an RCT where 12 weeks of HIIT will be compared to 12 weeks of treatment-as-usual (TAU). HIIT will be conducted, twice a week, in a supervised environment using a stationary bike. Inpatients with a diagnosis of SMI will be eligible to participate. Thirdly, follow-up qualitative interviews, with pilot study participants, those that withdrew and those that did not want to take part, and focus groups with clinical staff will address the acceptability and feasibility of HIIT.

NCT ID: NCT03955549 Completed - Clinical trials for Schizophrenia Spectrum and Other Psychotic Disorders

Insight Enhancement Program vs. Metacognitive Training for Psychosis in Patients With Schizophrenia: A Three-Armed Comparative Randomized Controlled Trial

Start date: May 1, 2019
Phase: Phase 3
Study type: Interventional

The aim of this study is to explore new safe effective psychotherapeutic interventions for schizophrenia through assessing the efficacy and acceptability of complementary "Insight Enhancement Program" (IEP) and "Metacognitive Training for Psychosis" (MCT), in relation to each other, and in relation to "Treatment As Usual" (TAU). It is hypothesized that at the end of therapy, compared to "Treatment As Usual", patients undergoing whether (IEP) or (MCT) will display a significant reduction in psychopathology particularly positive symptoms and delusional ideation, and a significant improvement in Insight and metacognitive capacity. Additionally, it is hypothesized that the acceptance of (IEP) and (MCT) will be higher than acceptance of (TAU). This study also aims to examine whether metacognition is associated with insight even after controlling for the effects of psychiatric symptomatology.