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Mental Disorders clinical trials

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NCT ID: NCT06458686 Not yet recruiting - Clinical trials for Psychiatric Disorder

Effect of Vitamin D Supplementation on Mental Health: An Exploratory Study on A University Students Suffering From Vitamin D Deficiency

Start date: June 30, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

University students are susceptible to psychological burdens such as depressive symptoms, anxiety, and stress which might have been linked to vitamin D deficiency. Low serum vitamin D level is well recognized around the world. Vitamin D has been reported to modulate several neurological pathways in the brain that control psychological function. As a result, the purpose of this study is to evaluate the effect of vitamin D supplementation on the presence of depressive symptoms, anxiety, and stress in university students. The study will include two phases. The first phase is a cross-sectional phase assessing the prevalence vitamin D deficiency in addition to psychological symptoms. The second phase is a randomized controlled clinical trial that aims to assess the effect of vitamin D supplementation on the prevalent psychological symptoms and its impact on the academic performance among university students. The study will look at the relationship between mental health and vitamin D deficiency, as well as how it will affect academic performance of university students.

NCT ID: NCT06453174 Active, not recruiting - Psychosis Clinical Trials

CLinical Utility of Early Intervention Including the 5-Step Precision Medicine (5SPM) Method in First-episode Psychosis: The CLUMP Project

CLUMP
Start date: January 1, 2024
Phase:
Study type: Observational

CLUMP is a project of translational research that intends to bridge the gap between what we already know about pharmacogenetics of antipsychotic drugs and what we still do to treat patients with first-episode psychosis (FEP). We aim to improve the adherence to antipsychotic drugs and, therefore, the outcomes of patients with FEP. To achieve this aim, our objectives are to: (1) Introduce a pioneering early intervention model of Personalised Precision Psychiatry, including pharmacogenetics, for patients with FEP; (2) ascertain whether such a model can reduce the elevated discontinuation rates of antipsychotic medications in this group; (3) assess the impact of this model on pragmatic efficacy and functional measures; (4) determine whether this innovation can bring cost benefit; and (5) establish a blueprint for implementing this precision model nationally and internationally. We shall compare all-cause discontinuation rates of the first prescribed antipsychotic medication (primary outcome), discontinuation rates by causes, pragmatic efficacy and tolerability measures, functional outcomes, and healthcare costs between two cohorts of patients with FEP followed for one year. One cohort will be comprised of patients treated before the implementation of the early intervention model of Personalised Precision Psychiatry, and the other of new patients treated under this model. Also, we shall compare pharmacogenetic information, and its implications for clinical management, between these patients and another national cohort of patients with either longer-term psychotic disorders or other mental health problems.

NCT ID: NCT06449521 Not yet recruiting - Clinical trials for Mental Health Disorder

BECOME COmbined Intervention for MH & NCD Delivered by Community Health Workers in Nepal

BECOME
Start date: July 2024
Phase: N/A
Study type: Interventional

Common mental health disorders (CMDs) and noncommunicable diseases (NCDs) pose significant public health challenges, especially in resource-limited settings like Nepal. The coexistence of CMDs and NCDs is prevalent, tied together by shared behavioral risk factors including stress, isolation, tobacco use, low physical activity, poor diet, and treatment non-adherence. Addressing these risk factors through behavioral interventions has the potential to positively impact both CMDs and NCDs. While the World Health Organization (WHO) recommends three behavioral interventions-evidence-based stress reduction (EBSR) for stress and anxiety, behavioral activation (BA) for depression, and motivational interviewing (MI) for healthy behaviors-availability remains scarce in low-resource settings. This research proposes a hybrid implementation-effectiveness study of the BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases (BECOME) in Nepal. BECOME, delivered by community health workers (CHWs), integrates EBSR, BA, and MI to improve mental health and address NCDs. The study employs a stepped-wedge cluster randomized trial, with 20 clusters randomly assigned to five steps, starting in the control condition. Transitioning every three months, clusters gradually adopt the intervention, minimizing logistical challenges during implementation. The study targets 600 patient participants (age 40 years and above with at least one CMD and NCD) from Bardibas and Chandragiri municipalities, involving 20 CHWs, five primary care providers (PCPs), and six health system leaders. CHWs identify potential participants, with research staff assessing eligibility, obtaining informed consent, and conducting baseline assessments using a digital REDCap tool. CHWs undergo BECOME intervention training, delivering it to consenting patient participants (30 per CHW). Quantitative data collected quarterly over 12 months will measure primary outcomes for CMDs and NCDs. Additionally, qualitative components, following the Reach Effectiveness-Adoption Implementation and Maintenance (RE-AIM) framework, include focus group discussions (FGDs) with CHWs and Key Informant Interviews (KIIs) with patient participants, PCPs, and health system leaders to assess implementation mechanisms, outcomes, and clinical impact. The study, if successful, aims to furnish evidence and a model for implementing behavioral interventions addressing CMDs and NCDs.

NCT ID: NCT06441864 Not yet recruiting - Clinical trials for REM Sleep Behavior Disorder

Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD). People with RBD will be enrolled in the study along with their romantic partners. All participants will receive the treatment via videoconference and will complete 2 assessments. Participants with RBD will attend 7 sessions, and their partners will attend 2 of those sessions with them.

NCT ID: NCT06440200 Enrolling by invitation - Schizophrenia Clinical Trials

Exploring the Health Effects of Group Game-based Activities on Individuals With Chronic Mental Illness

Start date: January 18, 2024
Phase: N/A
Study type: Interventional

This study aims to explore the health effects of group games for patients with chronic mental illness. The goal of this clinical intervention study is to compare the efficacy of group games in two ways (experimental group/ group game-based or control group) to improve the health of patients with chronic mental illness. The main questions it aims to answer are: The efficacy of applying group game-based activities to increase interest and improve the physical fitness of patients with chronic mental illness. Also, the goal of this clinical interventional study is to clarify the positive benefits of psychological and social aspects. Subjects will be asked to complete the questionnaire and physical ability examination after filling out the consent of this study. Participants will be randomly divided into two groups. Participants in the experimental group will accept the group game-based activities for 12 weeks (twice per week, 22 times). In contrast, Participants in the control group will accept the activities the psychiatric day wards and halfway house offer as usual. After 12 weeks of intervention, The Participants in both groups will be asked to fill out the questionnaire and physical ability examination. One month later, Participants in both groups will be asked to fill out the questionnaire and physical ability examination again. The study will last for 4 months. The time points for completing the questionnaire are listed following: Baseline/ pre-intervention test(T1), First post-intervention test (T2, 12 weeks later) and Second post-intervention test (T3, 4 weeks later). The researchers will compare the difference in effectiveness between the two groups.

NCT ID: NCT06434428 Completed - Clinical trials for Sedation Complication

Comparison Between Intranasal vs Intravenous Dexmedetomidine for EEG Sedation of Children With Behavior Disorders.

Start date: March 1, 2018
Phase:
Study type: Observational

The aim of the project was to compare the efficacy and safety of intranasal (IN) and intravenous (IV) dexmedetomidine (DEX) in procedural sedation for electroencephalogram (EEG) in pediatric patients with behavioural disorders. Single-centre comparative observational study in the tertiary care centre of Padua, regarding all consecutive pediatric patients affected by behavioural disorders, who needed sedation for EEG recording. A group of children received IV administration of DEX, the following year a second group of children received IN administration of the same drug. Target of sedation was level 2, according to the Paediatric Sedation State Scale (PSSS).

NCT ID: NCT06433583 Not yet recruiting - Clinical trials for Psychiatric Disorder

Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents

NEUROMUTE
Start date: June 18, 2024
Phase: N/A
Study type: Interventional

Non-suicidal self-injury (NSSI) are acts defined by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5) as intentional and deliberate, occurring outside a psychotic state and directly causing moderate injury. Their international prevalence is between 13 and 17% in adolescents and young adults, and has recently increased with the COVID-19 health crisis, with the prevalence of NSSI rising to 40% in adolescents. Access to psychiatrists is declining. Drug solutions, meanwhile, lack scientific proof in this indication. The autonomic nervous system and the hypothalamo-hypophyseal axis are involved in the human response to experimentally-induced pain, as well as in stress regulation, notably via control of cortisol secretion. Abnormally low levels of the latter hormone have been detected in persons with NSSI disorder. Transcutaneous neurostimulation of the atrial vagus nerve (taVNS) has been studied for some ten years. The afferent branches of the vagus nerve stimulate the hypothalamic-pituitary axis, leading to the production of cortisol by the adrenals. The hypothesis of this research is that stimulation of the vagus nerve by taVNS would improve the functioning of the hypothalamic-pituitary axis in patients with NSSI, and thus reduce the frequency of acting out. Although taVNS is an easy-to-access technique that patients can implement at home, the question of adherence to this treatment in adolescents has not yet been evaluated. The aim of this pilot study is to assess whether adolescents with NSSI will adhere to taVNS treatment.

NCT ID: NCT06433271 Not yet recruiting - Mental Disorder Clinical Trials

Transdiagnostic Behavior Therapy vs TAU for Adjustment Disorder Following Traumatic Event Exposure

Start date: July 2024
Phase: N/A
Study type: Interventional

Adjustment Disorder (AjD) is the most common mental health condition diagnosed in Active Duty personnel, and is diagnosed following an extreme stress event such as traumatic loss of a comrade, serious accident or injury, or other intense stress event. Despite its high prevalence, no evidence based treatment for AjD has been subjected to randomized controlled trials. This study seeks to build on the research team's pilot work across several disorders study to benefit service members and Veterans with AjD, a highly prevalent but frequently inadequately treated condition. The investigators will compare the effects of Transdiagnostic Behavior Therapy (TBT) vs treatment as usual which is Moving Forward Problem Solving Therapy (TAU-PST) on AjD symptom outcomes. The investigators hypothesize that TBT will result in greater overall symptom reduction compared to TAU-PST.

NCT ID: NCT06423651 Recruiting - Schizophrenia Clinical Trials

Benefits of Combining MCT With CR in the Recovery of Patients With Psychotic Spectrum Disorders

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

The goal of this clinical trial is to compare the efficacy of combined REHACOP + MCT alone in persons with nonaffective psychotic disorder in terms of recovery. The main questions it aims to answer are: - Does combined REHACOP + MCT therapy increase the clinical recovery in persons with nonaffective psychotic disorder (compared to MCT alone)? - What is the impact of combined REHACOP + MCT therapy compared to MCT therapy alone on personal/psychological recovery, cognitive biases, and social cognition, taking gender differences into account? - What is the durability of the effects of combined REHACOP + MCT therapy compared to MCT therapy alone on clinical recovery, personal recovery, cognitive biases, and social cognition in the long term? Researchers will compare REHACOP+MCT therapy to MCT alone to see if there are differences in personal/psychological recovery. Participants will: - Participate in Metacognitive Training or in combined REHACOP + Metacognitive training therapy. - Do 8 weekly sessions of 45-60 minutes (MCT group). - Do 12 weekly sessions of 45-60 minutes (RECHACOP+MCT group). - Visit the clinic for checkups and tests. - Answer self-administered tests.

NCT ID: NCT06417918 Not yet recruiting - Parenting Clinical Trials

An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya: a Pilot Randomized Controlled Trial

C0058 (4C)
Start date: May 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a family counseling intervention, entitled "Tuko Pamoja" (Translation "We are Together" in Kiswahili). The intervention, delivered by lay counselors and through existing community social structures, is expected to improve family functioning and individual mental health among members. The sample includes highly distressed families with a child or adolescent (ages 8-17) exhibiting emotional or behavioral concerns; as such, particular emphasis is placed on adolescent-focused outcomes, including mental health and well-being.