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Mental Disorders, Severe clinical trials

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NCT ID: NCT05834309 Recruiting - Metabolic Syndrome Clinical Trials

Exercise Effects on Health Status in Patients With Severe Mental Illness

SMI01
Start date: December 5, 2022
Phase: N/A
Study type: Interventional

People with severe mental disorders have a mortality rate 2 to 3 times higher than that of the general population, largely due to the presence of comorbidities, with a predominance of cardiovascular disease. This population has a higher risk of developing metabolic syndrome compared to the healthy population. Several factors are involved. The usual pharmacological treatment in people with severe mental disorder is a risk factor for the development of metabolic syndrome and deterioration of physical condition. This is generally compounded by poor health care, high-calorie diets, a sedentary lifestyle, difficulties in coping with life situations that generate emotional states (anxiety and/or depression) that result in unhealthy lifestyle habits related to food, activity, interpersonal relationships, sleep, consumption habits (tobacco, alcohol and drugs) and other environmental factors. Physical exercise has been proposed as one of the most effective treatments to reverse the negative consequences of low levels of physical activity in this population. However, the mechanism of action of exercise on health status and the optimal "dose" and intensity of exercise to achieve the greatest number of benefits with respect to cardiometabolic health in patients with severe mental disorder are unknown.The study will be carried out at the Mental Health Rehabilitation Unit of Navarra, a center under the Mental Health Management of Osasunbidea, where people between 18 and 65 years of age with a diagnosis of severe mental illness in a situation of clinical stability receive treatment.The sample will be composed of 100 participants from consecutive admissions to the Rehabilitation Unit. The subjects will be randomized into 2 groups; a control group that will receive the usual specialized care and an intervention group, which in addition to receiving the usual rehabilitation treatment, will undergo a 6-week multicomponent physical exercise program performed 2 days per week. The effects of exercise on the inflammatory profile, metabolic parameters, physical condition, cognitive function, vascular function, muscle strength, health-related quality of life, lifestyle habits (diet, activation, sleep, substance use) and mood will be evaluated.

NCT ID: NCT05647980 Recruiting - Clinical trials for Mental Disorders, Severe

Transmural Collaborative Care Model for CVRM and Medication Review for Patients Using Antipsychotics

TACTIC
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Currently, monitoring of usage and effects of antipsychotic treatment and cardiovascular risk screening in patients with severe mental illness or antipsychotic treatment is not sufficient. A transmural collaborative care model for cardiovascular risk management and medication review for patients using atypical antipsychotics in general practice (TACTIC) was developed. This trial aims to assess the effectiveness of TACTIC regarding predicted cardiovascular risk and mental quality of life.

NCT ID: NCT05564559 Completed - Clinical trials for Alcohol Use Disorder

Multifamily Group Psychoeducation for SUD's in Turkey

Start date: October 10, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of multi-family group psychoeducation (MFGP) on the families of people living with a diagnosis of substance abuse disorder on patients and their families. It has been reported that families are affected by substance-related disorders. Families that are the target of psychoeducational practices for families are defined as follows: "Family" is a relative, biological family member, partner, close friend, or any other support person or a person who sees herself/himself as the patient's family. In most studies, it has been stated that including family members in the patient's treatment provides additional benefits to substance use services and makes long-term recovery more likely. Studies have found that MFGP is associated with fewer relapses and hospitalizations, improved family well-being, increased participation in vocational rehabilitation, higher employment rates, and reduced costs of care. Multifamily psychoeducation aims to increase the family's knowledge about substance use disorders and to include them in the recovery process. Study Design:The intervention involves 8-week MFGP for families. During the 8 sessions, it was planned to conduct face-to-face psychoeducational group work, with each session lasting 75 minutes on average. The MFGP to be covered during 8 sessions was created by evaluating MFGP modules from 3 different sources. Intervention protocols included these subjects: First session: Psychoeducation on Substance-Abuse Disorders Second session: Effects of Addiction on the Family Third session: illness management Fourth session: Supporting Recovery Fifth session: Improving Stress Coping Skills/Stress Management Sixth session: Developing Problem-Solving Skills Seventh session: Strengthening the Family Eighth session: Working with Stigma Study population: Families of people suffering from substance abuse disorders were studied. Expected outcomes: An increase in general and social functionality, a decrease in depression, anxiety, and self-stigma, an increase in quality of life, and treatment compliance are expected for patients. For families, it is expected that depression, anxiety, self-stigma, and caregiving burnout decrease, funcitonalty and quality of life increases and people gain skills to cope with stress.

NCT ID: NCT05545228 Active, not recruiting - Clinical trials for Mental Disorders, Severe

The Mouth Matters in Mental Health Study

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

To investigate the feasibility and acceptability of a link work intervention to increase planned dental care visits for patients with severe mental illness, and through this to improve their oral health. 1. To understand what constitutes best practice when delivering link work around dental visiting. 2. To identify what training needs exist for support workers around link work. 3. To determine whether patients with SMI are willing to be randomised to a trial targeting dental visiting. 4. To understand whether it is feasible to collect clinical outcome and planned dental appointment data in this population. 5. To explore if, and how, patients with severe mental illness engage with a link work intervention. 6. To understand the potential factors impacting (e.g. facilitators and barriers) acceptability and delivery.

NCT ID: NCT05457179 Enrolling by invitation - Clinical trials for Mental Disorders, Severe

Physical Activity to Reduce Cardiometabolic Risk in Adults With Serious Mental Illness (PARCS) Study

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

The aim of this project is to trial the protocol of a park-based physical activity (PA) intervention in adults with serious mental illness (SMI) in a community mental health center's peer support program.

NCT ID: NCT05293587 Completed - Clinical trials for Mental Disorders, Severe

Physical Activity to Reduce Diabetes Risk in Serious Mental Illness

PARCS Pilot
Start date: September 13, 2021
Phase: N/A
Study type: Interventional

The aim of this project is to trial the protocol of a park-based physical activity (PA) intervention in adults with severe mental illness (SMI) in a community mental health center's peer support program.

NCT ID: NCT05160701 Recruiting - Clinical trials for Mental Disorders, Severe

Bringing Health Home

BHH
Start date: May 9, 2022
Phase: N/A
Study type: Interventional

Individuals suffering from Serious Mental Illnesses (SMI) are at risk for serious adverse health and social outcomes compared to the general population due to a high prevalence of chronic physical health disorders such as cardiovascular disease, hypertension, and Type II Diabetes, along with consequences of mental distress such as suicide, substance abuse, and acute stress.While pharmacological treatments exist for these conditions, they have limited effectiveness in SMI populations because: (1) up to 60% of individuals with SMI do not take their psychiatric or somatic medications as prescribed, (2) individuals with SMI have poorer clinical outcomes and experience high rates of hospitalizations, and (3) individuals with SMI experience worse care. Challenges in the management of these complex chronic health and mental health conditions have led to the development of intensive community-based service delivery programs. However, as currently structured these intensive in-person interventions have only had limited impact optimizing service delivery, and consequently on adherence to treatment and health outcomes. While in-person clinical contact in select situations is important, telehealth may serve as an effective and nimble intervention to help meet the high need for clinical intervention for SMI populations and particularly those with geographically limited-service access. Although research exists regarding the efficacy of telehealth with SMI populations, most of the existing interventions with this population have been designed for institutional settings, not community settings, because of barriers to adoption of telehealth such as limited access to digital technology, technical support difficulties and cost of necessary technology. The COVID-19 pandemic has underscored the need for developing effective telemedicine and telemonitoring technologies to serve the unique needs of this vulnerable population in community settings. This project builds on a successful Phase I SBIR project and ongoing Phase II clinical trial of the Medherent medication management platform. This study will test an expanded set of telehealth care-coordination services that can be used to address the broad health needs of individuals diagnosed with SMI living in community settings and supported by community mental health agencies. The study team will recruit 300 individuals, including 200 individuals currently using the device and 100 new users of the device. The study will test the existing Medherent platform and a set of extended services. Our key outcomes include acute service use, receipt of preventive and other health screenings, health outcomes and costs of services. The study will use a Stepped Wedge Design approach with a matched comparison group to identify potential benefits of the intervention.

NCT ID: NCT05004298 Active, not recruiting - Clinical trials for Mental Disorders, Severe

Evaluation of an Animal Assisted Therapy Program in People With Mental Illness, and Promotion of Positive Mental Health

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

Scientific literature reports that focusing interventions on people with mental health problems, from the threshold of Positive Mental Health, is effective and allows the person to promote positive mental health behaviors. The well-known Animal Assisted Therapy is a complementary intervention used for decades that has reported scientific evidence in the field of mental health in communication, socialization, anxiety and adherence to treatment of patients. This protocol aims to create and evaluate an Assisted Therapy program with dogs in relation to the development and promotion of Positive Mental Health behaviors in people with mental illness in a community rehabilitation service.

NCT ID: NCT04948853 Completed - Clinical trials for Mental Disorders, Severe

Improving Employment Outcomes for Probationers With Mental Illnesses

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Employment is a key protective factor against recidivism; however, the lack of job opportunities keeps justice-involved mentally ill individuals, especially young adults of color, unemployed and at risk for future justice involvement. To address these issues and grow the evidence for evidence-based practices for justice-involved adults with mental illnesses, the investigators will study the implementation and outcomes of individual placement support-supported employment (IPS-SE) combined with specialty mental health probation (SMHP) for probationers with mental illnesses.

NCT ID: NCT04917666 Completed - Clinical trials for Intellectual Disability

Process and Outcomes of Horticultural Therapy for People With Disabilities

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Horticultural therapy (HT) "is the engagement of a client in horticulture activities facilitated by a trained therapist to achieve specific and documented treatment goals" (American Horticultural Therapy Association, 2012). People's interactions with plants, through goal-orientated horticultural activities in the form of active gardening, as well as the passive appreciation of nature, could be therapeutic to people with mental or intellectual disabilities in many ways (Eling, 2006; Parkinson, Lowe, & Vecsey, 2011). This study aims to conduct evaluation studies of HT group programmes for care home residents with severe mental illness.