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Mental Disorders clinical trials

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NCT ID: NCT05034523 Not yet recruiting - Clinical trials for Psychotic Depression

Voxel Based Morphometry In Patients With Psychotic Versus Non Psychotic Depression

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

1. To examine structural brain changes in patients with depression measured using voxel based morphometry(VBM) in comparison with healthy subjects. 2. Relation between grey mater volume (GMV) and other structural changes, and the severity of clinical symptoms. 3. To study if there is structural brain difference between psychotic and non-psychotic depression

NCT ID: NCT05031416 Not yet recruiting - Smoking Cessation Clinical Trials

Developing and Pilot Testing a Remote Smoking Cessation Digital Therapeutic for Individuals With Serious Mental Illness

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

This is a pilot randomized clinical trial testing an implementation intervention to support delivery of a smoking cessation app tailored to the needs of those individuals with SMI who at community mental health programs.

NCT ID: NCT05025566 Not yet recruiting - Clinical trials for Severe Psychiatric Disorders

Cognitive Phenotyping of Severe Psychiatric Disorders (PSYCOG)

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

The identification of transnosographic dimensions constituted by cognitive disorders constitutes a particularly promising avenue for classifying psychiatric disorders in a more precise and personalized manner. However, despite interesting preliminary data, there is no exhaustive phenotyping of the different cognitive disorders in large samples where all severe psychiatric disorders are represented. Moreover, the brain mechanisms underlying cognitive disorders remain poorly understood, whereas their identification would allow a better understanding of the pathophysiology of these disorders as well as the identification of potential therapeutic targets. Here, the investigators will compare cognitive-behavioral performance in patients with different types of severe psychiatric disorders (psychotic disorders, depressive disorders, bipolar disorder, anxiety disorders, autism spectrum disorders and eating disorders) and healthy volunteers to identify specific and shared cognitive alterations between the different severe psychiatric disorders. In addition, the investigators will compare neurophysiological cognitive data in to identify alterations in neurophysiological cognitive mechanisms that are specific to and shared between the different severe psychiatric disorders. The investigators will include 180 patients suffering from a severe psychiatric disorder (psychotic disorder, mood disorder (depressive and bipolar disorders), anxiety disorder, autism spectrum disorder and eating disorder) and benefiting from cognitive phenotyping (neuropsychological assessment and possibly EEG) as part of the initial assessment for a severe psychiatric disorder. In parallel, the investigators will include 180 healthy volunteers The different variables corresponding to the judgment criteria will be compared between the groups by being included as dependent variables in mixed linear regression models (ANOVA; or KRUSKAL-WALLIS if non-parametric) with the group as independent factor, time (before, after treatment) and type of treatment. This study will allow the constitution of a transnosographic atlas of neuro-cognitive deficits in different psychiatric pathologies.

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: NCT04909203 Not yet recruiting - Clinical trials for Suicide and Self-harm

iKinnect2.0 for Juvenile Justice Involved Youth at Risk for Suicide

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

This study is a 16-week intent-to-treat randomized controlled trial (RCT) with 120 suicidal juvenile justice (JJ)-involved transition-age (TA) youth (age 15-21 years) and a primary caregiver (dyads). Dyads will be randomly assigned to iKinnect2.0 (n=60 dyads) or Life360 (control app) plus an electronic suicide resources brochure (n=60 dyads). This design will test iKinnect2.0's new features for suicide prevention against TA youth awareness of and access to high-quality suicide prevention resources, while simultaneously testing features relating to conduct problems and parent management against parents knowing the TA youth's whereabouts in real-time and controlling for dyad member engagement in technology (Life360). Participants will be assessed at baseline, 4, 8 and 16 weeks. Primary youth-reported outcomes relating to suicide risk include: Suicidal behaviors (ideation, planning, attempts), non-suicidal self-injurious behaviors, self-efficacy in coping with distress, and use of imminent distress coping strategies (behavioral skills, use of crisis stabilization plan). Youth will also report on their criminal behavior. Primary caregiver-reported outcome variables relating to youth suicide include: Self-efficacy in applying family-based suicide-prevention strategies and reported use of those strategies; caregivers will also report on their own functioning (efficacy/confidence in parenting skills, life stress), TA youth functioning (internalizing and externalizing symptoms), parental management behaviors (expectation clarity, parental monitoring, discipline effectiveness/consistency, use of rewards), and parent-youth relationship quality (communication, conflict, support). App satisfaction and use of technology outcomes (i.e., degree of app usage, features used) will be examined and reported descriptively.

NCT ID: NCT04897295 Not yet recruiting - Clinical trials for Substance Use Disorders

Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder

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

Background: Alcohol Use Disorder (AUD) is a complex psychiatric disorder, involving several brain areas and neurocircuits. Transcranial Direct Current Stimulation (tDCS) allows to stimulate superficial areas of brain using a weak electrical current. Preliminary data suggest that tDCS may reduce alcohol craving and consumption. Objectives: The main outcome is to test if tDCS can reduce alcohol craving and use and to assess the changes in BDNF and pro-BDNF levels. Secondary outcomes are the assessment of other psychiatric dimensions (mood, behavioral and cognitive alterations) associated with prolonged alcohol use. Eligibility: Healthy, right-handed adults ages 18-65 who do have AUD (moderate to severe). Design: This is a randomized, double-blind, sham-controlled study with three phases: 1) a tDCS intensive treatment phase; 2) follow-up with weekly tDCS stimulation; 3) follow-up without tDCS stimulation. Participants will be screened with: - Psychometric Scales - Medical history - Physical exam - Urine tests and breathalyzer - After being enrolled, baseline behavioral and laboratory data will be collected. In particular, participants will undergo: - Psychometric Scales - Venous blood sample (BDNF/proBDNF levels) Participants will be randomized to real or sham tDCS arm. The stimulation will be delivered daily for five days during the first week (intensive treatment phase) and then weekly for 3 months (follow-up with stimulation). During this period patient will be tested with a behavioral and psychometric evaluation.Therefore, participants will receive 3 follow-up monthly visits without tDCS stimulation, in which behavioral and psychometric data will be collected. Treatment includes: - tDCS: The tDCS will be delivered with a stimulator connected to two sponge electrodes, soaked in a saline solution. The stimulation will be administered at a current intensity of approximately 1 mA, for the duration of 20 minutes. The anode will be placed on the right DLPFC, the cathode on the contralateral cortical area. - BDNF/proBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first week). The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis. - Repeat of screening tests and questionnaires - Urine toxicological screen and breathalyzer

NCT ID: NCT04814576 Not yet recruiting - Clinical trials for Mental Health Wellness 1

Collaborative Nursing Care-based Intervention in Mental Health Day Hospital Users

Start date: March 26, 2021
Phase: N/A
Study type: Interventional

OBJECTIVES: 1. To evaluate the impact of an intervention based on collaborative nursing care in terms of the changes produced in the recovery process, in positive mental health and in the nurse-patient therapeutic relationship among users of mental health day hospitals. To explore the changes produced in the recovery process of users who receive collaborative nursing care through the co-design and implementation of group activities. DESIGN: A sequential and transformative mixed methods design is proposed. METHODS. The study is structured in three phases. In phase one (baseline) and phase three (follow-up), quantitative data will be collected from patients at a mental health day hospitals based on a two-armed, parallel-design, non-randomized trial. In phase two, two groups will be established: an intervention group (GI) in which the intervention based on collaborative nursing care will be carried out through the co-design and implementation of activities through Participatory Action Research, and a control group (CG) in which the usual care dynamics will be continued. All the users of three mental health day hospitals who agree to participate in the study will be studied consecutively until the necessary sample size is reached. The outcomes used to evaluate the impact of the intervention will be the stage of the recovery process, the quality of the therapeutic relationship and the patient's level of positive mental health. DISCUSSION: Very few collaborative nursing care interventions have been studied and shown to be effective in the context of the paradigm shift toward recovery in mental health nursing. IMPACT: Understanding the changes produced in the recovery process, as well as in the quality of the therapeutic relationship and in the maintenance and/or increase of the levels of positive mental health of people with mental health problems, can contribute to the design and implementation of new methodologies to offer effective and person- centered care.

NCT ID: NCT04810325 Not yet recruiting - Parkinson Disease Clinical Trials

Brain Sensing in Neurological and Psychiatric Disorders

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

High-frequency deep brain stimulation (DBS) is an effective treatment strategy for a variety of movement disorders including Parkinson's disease, dystonia and tremor1-5, as well as for other neurological and psychiatric disorders e.g. obsessive compulsive disorder, depression, cluster headache, Tourette syndrome, epilepsy and eating disorders6-11. It is currently applied in a continuous fashion, using parameters set by the treating clinician. This approach is non-physiological, as it applies a constant, unchanging therapy to a dysfunctional neuronal system that would normally fluctuate markedly on a moment-by moment basis, depending on external stressors, cognitive load, physical activity and the timing of medication administration. Fluctuations in physical symptoms reflect fluctuations in brain activity. Tracking and responding in real-time to these would allow personalised approaches to DBS through stimulating at appropriate intensities and only when necessary, thereby improving therapeutic efficacy, preserving battery life and potentially limiting side-effects12. Critical to the development of such adaptive/closed-loop DBS technologies is the identification of robust signals on which to base the delivery of variable high-frequency deep brain stimulation. Local field potentials (LFPs), which are recordable through standard DBS electrodes, represent synchronous neuronal discharges within the basal ganglia. Different LFP signatures have been identified in different disorders, as well as in different clinical states within individual disorders. For example, low frequency LFPs in the Alpha/Theta ranges (4-12Hz) are frequently encountered in patients with Dystonia13,14, while both beta (12-30Hz) gamma (60-90Hz) band frequencies may be seen in Parkinson's disease, when the patient is OFF and dyskinetic, respectively15,16. Equally, suppression of these abnormal basal ganglia signals through medication administration or high-frequency DBS correlates with clinical improvement. As such, they represent attractive electrophysiologic biomarkers on which to base adaptive DBS approaches. Until recently, neurophysiological assessments were purely a research tool, as they could only be recorded either intra-operatively or for a short period of time post-operatively using externalised DBS electrodes. However, advances in DBS technology now allow real-time LFP recordings to be simply and seamlessly obtained from fully implanted DBS systems e.g. Medtronic Percept PC. In this study, we will evaluate a cohort of patients with movement disorders and other disorders of basal ganglia circuitry who have implanted DBS systems. Recordings of LFPs and/or non-invasive data such as EEG, limb muscle activation and movement (surface EMG and motion tracking) under various conditions (e.g. voluntary movement, ON/OFF medications, ON/OFF stimulation) will allow us to evaluate their utility as markers of underlying disease phenotype and severity and to assess their potential for use as electrophysiological biomarkers in adaptive DBS approaches. These evaluations in patients with DBS systems with and without LFP-sensing capabilities will take place during a single or multi-day evaluation (depending on patient preference and researcher availability). This study will advance not only the understanding of subcortical physiology in various disorders, but will also provide information about how neurophysiological and behavioural biomarkers can be used to inform personalised, precision closed-loop DBS approaches.

NCT ID: NCT04792671 Not yet recruiting - Wolman Disease Clinical Trials

Prevalence and Risk Factors of Women Mental Health Disorders

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

Perinatal major depressive disorder affects 20% of women, while perinatal anxiety affects 10% of women. Although pharmacological treatment has shown effectiveness, many pregnant women are concerned about potential adverse effects on the fetus, maternal-infant bonding, and child development.. On the other hand, Depressive disorder in women mainly occurs during the first year after childbirth. It takes many forms according to the onset, severity, and duration of the symptoms including; Postpartum blues (PPB), Postpartum depression (PPD), and Postpartum psychosis (PPP). Lack of access to mental health services during the perinatal period is a significant public health concern that may worse outcome. So, we aimed to study prevalence of women mental health in Assiut governorate and evaluate possible risk factor for it

NCT ID: NCT04792658 Not yet recruiting - Clinical trials for Psychiatric Disorder

Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation

Start date: March 10, 2021
Phase:
Study type: Observational

Benzodiazepines are usually a secondary drug of abuse-used mainly to augment the high received from another drug or to offset the adverse effects of other drugs. Few cases of addiction arise from legitimate use of benzodiazepines. Pharmacologic dependence, a predictable and natural adaptation of a body system long accustomed to the presence of a drug, may occur in patients taking therapeutic doses of benzodiazepines. However, this dependence, which generally manifests itself in withdrawal symptoms upon the abrupt discontinuation of the medication, may be controlled and ended through dose tapering, medication switching, and/or medication augmentation. Due to the chronic nature of anxiety, long-term low-dose benzodiazepine treatment may be necessary for some patients; this continuation of treatment should not be considered abuse or addiction. previous study reported that The results of the study are important in that they corroborate the mounting evidence that a range of neuropsychological functions are impaired as a result of long-term benzodiazepine use, and that these are likely to persist even following withdrawal. The findings highlight the residual neurocognitive compromise associated with long-term benzodiazepine therapy as well as the important clinical implications of these results.