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Mental Disorders clinical trials

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NCT ID: NCT05018351 Recruiting - Mental Disorder Clinical Trials

Peer Navigators for the Health and Wellness of People With Psychiatric Disabilities

DRRRP-PHN
Start date: May 17, 2021
Phase: N/A
Study type: Interventional

Adults with psychiatric disabilities get sick and die 20 to 30 years younger than same-age peers, with even greater disparities occurring when the person is from a low SES or of color. Factors explaining this difference are complex and include genetic comorbidity, iatrogenic effects of medication, life choices, and life consequences. These factors are worsened by service disparities which are often fragmented in the public health system. Peer navigators are part of a program in which providers escort people with psychiatric disabilities around the fragmented system to meet their health and wellness goals, often a demanding task for the person who has needs addressed at clinics, labs, and pharmacies spread across an urban area. Navigators are peers because they have lived experience of recovery and are often from similar ethnic groups. A community-based participatory research program supported by NIMHD and PCORI developed a peer navigator program specific to the needs of people with psychiatric disabilities. Results of two small pilots funded by NIMHD and PCORI showed the Peer Navigator Program (PNP) led to significant improved service engagement which corresponded with better health, recovery, and quality of life. The studies included fidelity measurement which showed peer navigators conducting the intervention at high levels of fidelity. The current research is an efficacy study with a more fully powered test of PNP versus treatment as usual, which is integrated care (TAU-IC). The investigators aim to recruit 300 adults with psychiatric disability who wish to improve physical health/wellness through peer health navigation randomized to TAU-IC or TAU-IC plus PNP. Individuals will participate in assigned interventions as part of 8-month cohorts with data being obtained at baseline, 4, 8, and 12 months. Data will include personal descriptors (demographics, diagnosis, life consequences report), outcomes (service engagement, physical symptoms, blood pressure, recovery, and quality of life), mediators (personal empowerment, self-determination, and perceived relationship for recovery), and process measures (fidelity, feasibility, and acceptability). Investigators hypothesize that those in PNP intervention will have improved outcomes over the integrated care as usual. A cost-benefit analysis will seek to model impact based on quality-adjusted life years. Larger effect sizes will permit post hoc identification of how PNP effects vary by participant characteristics such as ethnicity and gender.

NCT ID: NCT05018039 Recruiting - Mental Disorder Clinical Trials

Feasibility and Acceptability of Collaborative Care for People With Musculoskeletal and Mental Problems

CCOPER
Start date: January 30, 2022
Phase: N/A
Study type: Interventional

This study aims to implement a feasibility Randomised Controlled Trial to support patients with musculoskeletal problems and a co-existing mental condition, which the intervention will be the implementation of a Collaborative Care Model. In England, one in six adults suffers from a mental health condition, such as anxiety or depression. Despite these high numbers, mental health conditions are often unrecognised in physical healthcare settings, including patients with musculoskeletal (MSK) conditions. Patients with both a physical and mental health diagnosis are likely more difficult to treat in comparison to those with just a physical health condition. The Collaborative Care Model offers an alternative way of improving musculoskeletal rehabilitation as it takes into consideration both physical and mental health needs. This model involves physical and mental healthcare professionals working together to better identify and manage people with both conditions. Patients are then further supported by a Case Manager who coordinates access to relevant professionals/services following an assessment of both physical and mental health needs. The investigators propose a feasibility study to assess whether the collaborative care model is beneficial to orthopaedic patients in addressing both physical and mental health needs. Patients over 18 years old, with an MSK condition attending therapy services at the Royal National Orthopaedic Hospital with a moderate to severe anxiety or depression score, may be eligible. Following informed consent, they will be randomly allocated to either treatment as usual or the intervention group (the collaborative care model with input from a Case Manager). All participants will participate for 6 months with a follow-up on months 3 and 6.

NCT ID: NCT05012709 Completed - Anxiety Clinical Trials

A Study of Dose-response Relationship and the Evidence Based Multisensory Stimulation Intervention

Start date: March 15, 2012
Phase: N/A
Study type: Interventional

Design: This parallel randomized controlled trial (RCT) was conducted according to the Consolidated Standards of Reporting Trials (CONSORT). Methods: In total, 90 patients were randomly assigned to either the intervention or the control group. After a 2-week washout period, the intervention group was reassigned to the control and vice versa. The CONSORT checklist for RCT was reported. Psychotic symptoms, emotional reactions, behavioral relaxation responses and heart rates were assessed at 6 time points.

NCT ID: NCT05010447 Not yet recruiting - Mental Disorder Clinical Trials

Feasibility of an Avatar-Led and ACT-Based App for Adjunctive Psychotherapy in In- and Outpatients: Virtual Coach App

Start date: August 15, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to test the feasibility of an application for smartphones based on Acceptance and Commitment Therapy (ACT) that was designed to increase treatment adaptation (i.e. learning therapy skills) and treatment utility (i.e. feedback for the patient). The use of this avatar- led application will be tested by patients with mental disorders adjunctive to their therapy. Patients will be given a smartphone for one week with the application developed specifically for this purpose. The study will be a single group design and patients will be assessed two times: before and after having tested the application. Measurements will include acceptability (adherence, utilization, utility, satisfaction) of the application, as well as patients characteristics, such as diagnostic interviews, questionnaires about symptomatology, well-being, social interactions, and an exit questionnaire when leaving the study to assess what was learned.

NCT ID: NCT05008120 Recruiting - Gut Microbiota Clinical Trials

Gut Microbiota in Major Depressive Disorders With and Without Rapid Eye Movement Behavior Disorder

Start date: October 1, 2021
Phase:
Study type: Observational

The purpose of this study is to identify the variations in gut microbiota compositions between two subtypes of major depressive disorder.

NCT ID: NCT05007353 Recruiting - Alzheimer Disease Clinical Trials

The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study

SINGER
Start date: August 23, 2021
Phase: N/A
Study type: Interventional

A study in Finland found that a multidomain intervention of physical activity, nutritional guidance, cognitive training, social activities and management of vascular risk factors slowed cognitive decline in healthy older adults at increased risk of cognitive decline. A 6-month pilot study was initiated in Singapore, which demonstrated the cultural feasibility and practicality of the FINGER interventions and a set of locally adapted interventions in an Asian population. The SINGER study is a 2-year randomized controlled trial that aims to test the efficacy and safety of these lifestyle changes, including diet and cardiovascular risk factor management, cognitive and physical exercises, in delaying cognitive decline in older adults at risk of dementia.

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: NCT04990674 Completed - Mental Disorder Clinical Trials

Acute-REMOTION: REMOTION in Acute Psychiatric Care

Acute-REMOTION
Start date: August 9, 2021
Phase: N/A
Study type: Interventional

This study aims to examine REMOTION, an internet-based intervention aimed at reducing symptom severity and improving emotion regulation in an acute psychiatric inpatient care setting. REMOTION is currently being studied in an outpatient psychotherapy setting. This study aims to investigate feasibility and first effects of this intervention in inpatient psychiatric care.

NCT ID: NCT04989842 Completed - Mental Disorder Clinical Trials

Effectiveness and Equivalence of an Internet-based Virtual Classroom Intervention for Psychosomatic Aftercare

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Outpatient psychosomatic aftercare after inpatient rehabilitation pursues the goal of helping patients to transfer the achieved rehabilitation result in everyday life and professional life. The Hanover Curriculum has been established as a treatment programme for psychosomatic aftercare. This comprises 25 weekly group sessions and two single therapies at the beginning and at the end of the therapy. In Germany a vast majority of rehabilitants in a psychosomatic rehabilitation clinic has an indication for psychosomatic aftercare, but it is used only by less than half of the patients due to a lack of aftercare therapists. If there is a therapist in the patient's vicinity, there are often long travelling times to the therapist or the patients might feel stigmatized participating in a face-to-face therapy. Thus, the expansion of internet-based aftercare services is recommended. Advantages are that they can be carried out at home, possible cost and time savings and improvement of the care situation. Several meta-analyses provide high evidence for the effectiveness of internet-based therapy offers in depressive and anxiety disorders that are frequent among psychosomatic rehabilitation patients. First randomised controlled studies show that internet-based aftercare services can lead to a symptomatic improvement and to a reduction of relapses. It is currently not clear whether established aftercare concepts, such as the Curriculum Hannover, are also effective in an internet-based format (Curriculum Hannover Online). The present project consists of a superiority study, examining whether participation in Curriculum- Hannover-Online leads to a stronger adoption and maintenance of the health improvements achieved in inpatient rehabilitation in comparison to care as usual, and an equivalnece study, examining, wether the Curriculum Hannover Online is an equivalent treatment option to the existing face-to-face aftercare therapy.

NCT ID: NCT04988477 Completed - Mental Illness Clinical Trials

Proactive Outreach for Smoking Treatment

POST
Start date: July 14, 2021
Phase: Phase 3
Study type: Interventional

Tobacco use disorder is a chronic disease. This is particularly true for people living with mental illness, who are more likely to smoke and make more unsuccessful quit attempts than those without. The current study is designed to test a package of two chronic disease management strategies to treatment tobacco in community mental health centers: regular provider interventions during routine mental healthcare visits, and proactive outreach by community mental health center staff to offer connections to tobacco cessation treatment. 50 patients at a community mental health center will receive provider intervention at their regular visits as well as 3 outreach calls over 9 months from trained staff to offer to connect them with stop smoking treatment. The investigators will measure the effect of these interventions on tobacco use over the next year.