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Mental Disorders clinical trials

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NCT ID: NCT05505578 Completed - Clinical trials for Psychiatric Diagnosis

A Digital Intervention to Improve Physical Activity and Sleep Behaviors in Youth With Psychiatric Diagnoses

GamerFit
Start date: January 19, 2023
Phase: N/A
Study type: Interventional

The goal of "GamerFit" is to test the delivery of a theory-based mHealth app that utilizes social support, exergaming, and telehealth coaching to improve PA levels, sleep, and psychiatric symptoms among youth participants (ages 13-17 y) with PD. In order to aid future intervention optimization, up to 65 participants with at least one PD will be randomized, with 30-35 using the GamerFit app with weekly telehealth coaching sessions and 30-35 using a commercial healthy habits app as a comparator group

NCT ID: NCT05501405 Recruiting - Autism Clinical Trials

Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits

FERmarkers
Start date: March 30, 2022
Phase: N/A
Study type: Interventional

Disorders in the recognition of emotional facial expressions are part of the social cognition disorders described in several diseases. They are notably present in a quasi-systematic way in diseases associated with socio-emotional behavior disorders, such as schizophrenia and autism. They are also found in some genetic syndromes with atypical neurodevelopment. In previous studies, the investigators adopted the FPVS-EEG approach to investigate facial emotion discrimination abilities in typical and atypical developing populations. the investigatorshave shown that, in typical adults, the neural response to facial expressions emerges as emotional intensity parametrically increases. A time-domain analysis revealed three components, with the first two increasing linearly with expressive intensity, and the third (beyond 300 ms) showing categorical sensitivity to increasing expressive intensity. The investigators have already successfully extended this approach to the investigation of patients, such as those with 22q11.2 syndrome. The brain response to facial expression was reduced by approximately 36% in these patients, revealing impaired visual coding of emotional facial signals. In this study, response amplitude was associated with positive symptom severity, indicating a potential endophenotype for psychosis risk. Here, the investigators study the implementation of high-level processes and the top-down effect it should have on the response of occipitotemporal regions to identify altered brain markers in schizophrenic patients, but also in other populations with expression recognition deficits (autistic, 22q11.2, in particular). The implementation of compensatory strategies that should result in an increased exploration of the lower part of the face at the oculometric level will also be studied.

NCT ID: NCT05500001 Recruiting - Psychotic Disorders Clinical Trials

Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Background: A lack of education, resources, and support for family carers of young adults with psychotic illnesses leaves them ill-equipped to support their loved one. Although family support groups exist, few groups offer evidence-based, skills-focused, psychoeducation taught by certified professionals and provided on a public-health level. By equipping families with skills and knowledge, public healthcare harnesses a powerful ally to maintain community stabilization. Aims: The primary study goal is to implement a psychoeducation intervention for family carers supporting young adults with psychosis to reduce family burden and foster community stabilization of service users. Methods: A longitudinal pre-post design will be used to assess the long-term effectiveness of the psychoeducation intervention for family carers supporting a young adult with psychosis on service utilization and functional indexes. Nine expert-reviewed, and family peer-informed psychoeducation modules are administered in 2-hour sessions over 9 weeks to family carers. Conclusion: Presenting the novel approach of an expert-reviewed, peer-informed psychoeducation intervention for family carers, with a focus on knowledge and skill development, the researchers contribute to literature and best practice in patient and family-centered care.

NCT ID: NCT05496907 Active, not recruiting - Type 2 Diabetes Clinical Trials

Psychosis and Type 2 Diabetes Study (PODS)

Start date: July 22, 2022
Phase: N/A
Study type: Interventional

People with severe mental illness (SMI), defined as psychotic and bipolar disorders, die 17-20 years earlier than the general population, the most common cause of death being cardiovascular diseases (CVD). The major contributor to CVD mortality in SMI is the increased prevalence of type 2 diabetes (T2D) compared to the general population. T2D is a paradigm of a single condition that progresses to multiple conditions. T2D requires annual reviews of 9 diabetes care processes and for patients to adopt multiple self-care tasks to prevent diabetes complications. The 9 diabetes care processes outlined by the NICE guidelines include: 3-6 monthly blood glucose measurement (HbA1c) with targets; blood pressure measurements and targets; annual blood cholesterol measurement; kidney function testing with urinary albumin; kidney function testing with serum creatinine; weight check; smoking status; diabetes annual eye screening; and annual foot examination. Previous research has focused on upskilling mental health professionals or link workers in diabetes care, however, a primary care led focus to support individuals with T2D and SMI has not been investigated. This is an interventional study in Lambeth south London testing a new model of care for people with SMI and T2D that is led by the community DSN in collaboration with the PN and mental health team within the Hills Brook and Dales Primary Care Network (PCN). StockWELL PCN participants will act as controls. Participants will complete 7 validated questionnaires, a physical examination including a blood test and urine sample and a brief interview either face to face in their GP surgery. The intervention group will be invited to a clinic run by a DSN. Baseline measures will be repeated after 6 months in both groups. An exit interview will be conducted to determine participants thoughts on the intervention. This project has been funded by the Burdett Trust for Nursing.

NCT ID: NCT05491486 Recruiting - Clinical trials for Schizophrenia Spectrum and Other Psychotic Disorders

Mindfulness, Empathy and the Oxytocinergic System in Persons With Schizophrenia

OXYGEN
Start date: June 15, 2022
Phase: N/A
Study type: Interventional

Recent studies indicated positive effects of mindfulness-based interventions (MBI) for schizophrenia (SCZ), but also on oxytocin (OXT) levels in healthy persons. It was also shown that response to MBI could be shaped by genetic factors. However, the interplay between mindfulness and empathy and genetic factors with the oxytocinergic system has not yet been examined in SCZ. The aim of the current explorative study is to (1) explore the effect of mindfulness-based group therapy (MBGT) on OXT levels as well as empathy in persons with SCZ; (2) investigate whether polygenic risk scores (PRS) for empathy can predict empathy levels in persons with SCZ; (3) investigate whether PRS for empathy and specific genetic configurations in the oxytocin receptors are associated with MBGT outcomes and OXT levels; 4) examine changes in positive- and negative symptoms, depression, anxiety, social functioning, and mindfulness at a within-group level and between both conditions. A parallel-group, proof-of-concept randomized controlled trial with 30 participants allocated to each trial arm (N = 60) will be conducted. Participants will be randomly assigned to MBGT alongside treatment as usual (MBGT+TAU) or treatment as usual (TAU). For a treatment period of four weeks, participants will receive weekly MBGT sessions. Four weeks after baseline assessments (T0), post-intervention assessments (T1) will take place. As a pilot study, effect sizes will be estimated for within- and between-group effects with corresponding confidence intervals. Outcomes of our proof-of-concept study can provide insight into potential biological mechanisms underlying mindfulness in SCZ, determine a valid biomarker associated with empathy and negative symptoms and pave the way for a personalized treatment approach for individuals with SCZ.

NCT ID: NCT05491174 Completed - Clinical trials for Severe Mental Illness

Mental Health Intervention for Transdiagnostic Groups in the Community

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The investigators propose to evaluate a new protocol-based intervention that is informed by Dialectical Behaviour Therapy (DBT), known as a DBT-informed intervention, delivered in routine mental health settings within South London and Maudsley NHS foundation trust. The intervention is delivered to a group of transdiagnostic service users with a severe mental illness (SMI). It is delivered by a junior workforce who will be referred to as Protocol-Based Intervention Facilitators (P-BIFs). Successful delivery by a less expert workforce has potential to increase routine implementation, compared to delivery by expert staff, where costs of both salary and training are higher. Dialectical Behaviour Therapy (DBT) is a type of psychological treatment recommended for people with a diagnosis of emotionally unstable personality disorder (EUPD). Individuals with a diagnosis of EUPD commonly experience difficulties with managing and responding to their emotions. This is known as emotion dysregulation. Difficulties with emotion dysregulation are thought to play a role in many mental health difficulties. The evidence base for using interventions that are informed by DBT, known of as DBT informed interventions with other mental health diagnoses, is emerging. The current research aims to investigate whether it is possible (feasible) to conduct a randomised control trial evaluating the transdiagnostic DBT-informed skills group for individuals representative of SMI presentations seen within community mental health settings. The study will also examine whether it is possible for junior staff to deliver the manualised group intervention. Service user participants will be randomised to either a 10-week DBT-informed intervention delivered by the P-BIFs, or a waitlist. Those on the waitlist will access the intervention once their involvement in the study has ended. The study will last for up to 1 year. The maximum duration to complete trial participation from consent to completion will be 18 weeks. It is hypothesized that the DBT informed intervention, delivered by junior staff, will be feasible and acceptable with this client population.

NCT ID: NCT05485181 Completed - Addiction Clinical Trials

Validating Promoted Spiritual Experience

Start date: January 20, 2023
Phase: N/A
Study type: Interventional

This pilot study of 16 patients will demonstrate a specific psychologically focused intervention to affect a spiritual aspect of psychological health and will measure (1) its effects on general distress, depression, anxiety and well-being; (2) healing and psychological impact beyond that accounted by usual personality factors; (3) its effect in correlation to measures of spirituality; (4) with neuroimaging, possible biological changes associated with this intervention. A. Objectives 1. Pilot a psychological intervention that impacts a "spiritual" level. 2. Measure efficacy improving well-being beyond explanation by usual personality factors. 3. Identify biological changes with neuroimaging. B. Hypotheses / Research Question(s) Studies demonstrate a healing effect beyond usual psychological and medical health to include a "spiritual" aspect with added experience of wholeness and well-being. Benefits are beyond just symptom relief but methods to achieve this are not well-defined. This study will provide a specific intervention and measure psychological and neuroimaging effects of the intervention. Hypotheses of Specific Results (see Study Instruments below) 1. DASS-21-shows significant decrease in depression, anxiety and overall stress. 2. PCL-5 - shows decrease 5-10 points (5 points=response, 10 points=clinically meaningful). 3. NIH-HEALS - shows significant increase overall and in all 3 factors. 4. WEMWBS - shows increase of greater than 3 points, considered "meaningful change." 5. Contingencies of Self-Worth Scale-shows significant global increase, positively correlated with increase in Mysticism Scale scores with post-intervention total above standardized mean. 6. A relevant portion of outcome improvement on DASS-21, NIH-HEALS, and ASPIRES will NOT be accountable by personality factors measured by NEO-FFI-3. 7. ASPIRES-shows significant increase in transcendence, no change in religious sentiments. 8. Neuroimaging-shows reduced activity in SPL, TPJ, MPFC, and IPL (see Research Significance).

NCT ID: NCT05480826 Recruiting - Clinical trials for Psychiatric Disorder

Familial and Functional Study of Genetic Variants Identified in People With Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder or Resistant Depression

GENI
Start date: March 15, 2023
Phase: N/A
Study type: Interventional

Genetic analyses conducted on patient with psychiatric disorders assessed at the expert centres resulted in the identific action of genetic variants associated with psychiatric disorders (Courtois, 2020). These data require further genetic and functional analyses. The first objective of this study is to investigate the disease-related inheritance of genetic variants in the families of individuals in whom these variants have been identified. The second objective is to explore the functional consequences of disease-associated genetic variants in patients cells and those of their relatives with and without these variants. The present project aims to enrich existing biocollections with DNA from blood or saliva from relatives of patients identified with genetic variants. In addition, we wish to collect hair follicules from patients with identified genetic variants of interest and their family members who wish to participate in the study. These hair samples with SNA will be used to dedifferentiate the isolated cells into induced pluripotent stem cells (IPSCs), and then to differentiate them into cells expressing the gene of interest, such as neurons or astrocytes, or into more complex systems, such as brain organoids.

NCT ID: NCT05480709 Completed - Clinical trials for Cardiovascular Diseases

Evaluation of Immediate and Medium-term Health- and Work-related Effects Following Inpatient Psychocardiological Rehabilitation

EvalPsyKard
Start date: May 3, 2021
Phase:
Study type: Observational

Since May 2019, psychocardiological rehabilitation has been carried out at the Rehabilitation Center Felbring (RFE) in the form of a pilot project. The background is the mutual relationship of psychological and physical morbidity, which is of particular importance in cardiological rehabilitation. The present outcome evaluation study is designed as a quantitative longitudinal study with 4 repeated measures, in which at least 75 rehabilitation patients will be included. Three assessments are conducted at admission and discharge to/from inpatient rehabilitation, and an additional survey will be conducted by mail 6 months after the end of rehabilitation. Effects that become apparent as a result of rehabilitation will be recorded from a patient-centered perspective by means of "patient-reported outcomes". In this way, primarily psychological and work-related changes, but also changes in the physical quality of life are to be mapped, which can be determined immediately after completion of rehabilitation and continue in the medium term up to 6 months later.

NCT ID: NCT05478642 Completed - Chronic Pain Clinical Trials

Influence of Psychological Status on the Results of Pain Treatment in Patients With Gunshot and Mine-explosive Wounds

IPSRPTPGaM-EW
Start date: February 24, 2022
Phase:
Study type: Observational [Patient Registry]

82.1% of patients with gunshot and mine-explosive wounds and wounds during hostilities in Ukraine have negative results of pain treatment, which leads to its chronicity. Examining the effect of psychological status on pain management outcomes in these patients may improve their treatment outcomes.