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Mental Disorders clinical trials

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NCT ID: NCT03603561 Recruiting - Depression Clinical Trials

Continuous Theta Burst Stimulation as an add-on Treatment for Bipolar Depression

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC as an add-on treatment in bipolar depression. The study consists of three phases. Phase 1: Bipolar depressed patients will be selected by a certified psychiatrist, who will administer (semi-)structured clinical interviews (M.I.N.I.-Plus 5.0.0, HRSD-17). The presence of exclusion criteria will be evaluated. Eligible patients will undergo MRI brain imaging for TMS neuronavigation Phase 2: Baseline clinical, cognitive and psychomotor assessments will take place. Patients will also undergo blood samples for laboratory and research assessments. TBS involves applying triple-pulse 50 Hz bursts given at a rate of 5 Hz uninterrupted trains (1). Patients will be treated with in total 20 continuous Theta Burst Stimulation (cTBS) session (900 pulses per session) over the right dorsolateral prefrontal cortex, which will be spread over 4 days. A stimulation intensity of 100% of the subject's resting motor threshold (rMT) of the right abductor pollicis brevis muscle will used. Patients will be randomized to receive either the real cTBS or sham treatment. Sham stimulation will be applied with a sham coil. The sham coil produces identical sounds but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS. The investigators expect that real cTBS treatment and not sham will result in a significant and clinical meaningful response. Phase 3: Two post-treatment assessment moments will take place respectively 3 (max. 4) days and 10 (max. 11) days after the last treatment day. The assessments are the same clinical, cognitive and psychomotor assessments as in phase 2.

NCT ID: NCT03601026 Recruiting - Schizophrenia Clinical Trials

Genetic Counselling in the Prevention of Mental Health Consequences of Cannabis Use

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

Severe mental illness (SMI) refers to the most burdensome psychiatric conditions. The need to pre-empt the onset of SMI is pressing because once SMI develops, quality of life is poor and available treatments have limited efficacy. Most risk factors for SMI are either unchangeable (e.g., genetics) or difficult to alter (e.g., low socio-economic status). In contrast, cannabis use is one specific risk factor that could be avoided. Certain individuals are more vulnerable to the harmful effects of cannabis. Genetic factors can help us identify these high-risk individuals. One in three individuals are carriers of a higher-risk genetic variant, and cannabis users with this genotype are at up to 7-fold increased risk of developing schizophrenia. In our study, genetic counselling will be provided to participants by a board-certified genetic counsellor. During the genetic counselling session, participants will have the option to receive their genotype. Participants will be counselled regarding their individualized risk of developing and of not developing SMI based on family history, whether or not they choose to use cannabis, and genotype (if the participants accept the genetic test results). The investigators hypothesize that this intervention will reduce exposure to cannabis compared to the youth who are not offered the intervention.

NCT ID: NCT03597789 Completed - Child Behavior Clinical Trials

Tantrum Tamers 2.0: The Role of Emotion

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

This study aims to better understand how to best help parents of young children with problem behavior. Problem behaviors vary between and within children, but can include inattention/hyperactivity, tantrums, and/or noncompliance.

NCT ID: NCT03597048 Completed - Mental Illness Clinical Trials

A School-Based Intervention to Reduce Stigma & Promote Mental-Health Service Use

Start date: July 1, 2011
Phase: N/A
Study type: Interventional

This is a school-based field experiment conducted in sixth grade classrooms to evaluate a multifaceted intervention designed to change attitudes and behaviors regarding mental illnesses. The research tests hypotheses as to whether alone or in combination interventions that are 1) a curriculum-based in-class presentations, 2) contact-based with a person who has experienced a mental illness, or 3) or based on educational materials distributed in classes improve knowledge/attitudes and encourage help seeking for mental health problems in a follow up study lasting two years.

NCT ID: NCT03595475 Completed - Clinical trials for REM Sleep Behavior Disorder

Prodromal Markers of First-degree Relatives of Patients With Psychiatric Disorders Comorbid With RBD

Start date: October 1, 2017
Phase:
Study type: Observational

REM sleep behavior disorder (typical or 'idiopathic' RBD, iRBD) is a novel and distinct parasomnia characterized by recurrent dream enactment behaviours and polysomnographic features of loss of normal REM-sleep related muscle atonia, with a male predominance commonly occurring at the age of 60's. A majority of the patients with iRBD will eventually develop α-synucleinopathy (e.g., Parkinson's disease). On the other hand, growing evidence reveals a specific group of psychiatric patients demonstrating comparable clinical RBD features (pRBD) (e.g., abnormal REM-related electromyographic (EMG) activities) as found in typical iRBD, but with less male predominance occurring at the age of mid 40's to early 50's. Although recent findings from both cross-sectional and prospective studies have suggested that pRBD is likely to be a persistent parasomnia with close association with clinical and neuroimaging biomarkers related to neurodegeneration, the nosology of the development of RBD symptoms among patients with psychiatric disorders, notably major depressive disorder, remains unclear as to whether they are simply antidepressants related, or represent a part of the early phase of α-synucleinopathy neurodegeneration. Family studies on iRBD have confirmed a significant familial aggregation of iRBD with a higher rate of RBD cases and presence of prodromal neurodegenerative biomarkers (e.g. tonic EMG activity during REM sleep, constipation, and motor function impairments) of α-synucleinopathy neurodegeneration among first-degree relatives (FDRs) of patients with iRBD. Thus, the investigators propose this family study to examine the following hypotheses: 1) FDRs of patients with pRBD have a higher rate of RBD symptoms and its core features when compared to FDRs of controls with and without psychiatric disorders; 2) FDRs of pRBD are more likely to exhibit the features associated with prodromal markers of α-synucleinopathy neurodegeneration when compared with FDRs of controls with and without psychiatric disorders; 3) FDRs of patients with pRBD have a higher rate of α-synucleinopathy neurodegeneration when compared with FDRs of controls with and without psychiatric disorders. A total of 176 FDRs from each group (e.g., pRBD cases, psychiatric controls, and healthy controls) will be recruited to undergo a face-to-face clinical interview and a series of assessments on prodromal markers of Parkinson's diseases (as according to the International Parkinson and Movement Disorder Society research criteria) respectively. All FDRs with possible RBD and a subset of FDRs without possible RBD will be invited to undergo one-night video-polysomnographic assessment to confirm the clinical diagnosis of RBD and to assess the abnormal REM-related EMG muscle activities.

NCT ID: NCT03583203 Completed - COPD Clinical Trials

Tobacco Intensive Motivational and Estimate Risk

Start date: July 12, 2018
Phase: N/A
Study type: Interventional

Randomized, open label, prospective study with a 12-month follow-up period. The primary objective evaluates the effectiveness of an intensive anti-smoking programme that informs patients of their individual risk of lung damages and the possibilities of prevention. The main measurement will be having given up smoking in month 12, measurement of self-reported abstinence on the 7 previous days and confirmed by a CO-oximeter test< 10 ppm, between the intervention and control group. A total of 9 urban and rural mental health centres will participate in the study. The intervention group will undergo spirometry and presence and the degree of respiratory obstruction will be assessed. Participants will be given individual information to generate a motivational message about the possibilities of prevention and the information will be maintained for three months by sending text messages (SMS) to their mobile phones. The efficacy of the method and the pulmonary damage variables will be evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the COPD diagnosis and the severity of the staging for disease will be assessed

NCT ID: NCT03583073 Completed - Psychotic Disorders Clinical Trials

Psychosis Screening in Juvenile Justice

JJ-Psychosis
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

This study will investigate the occurrence of psychosis-spectrum disorders among youth in the Juvenile Justice System and track mental health referrals for these youth in Phase 1, a standard care condition. Then, in Phase 2, an enhanced referral and linkage to care model will be employed, with the aim of bolstering motivation for and engagement in mental health treatment. It is hypothesized that the enhanced referral protocol will promote completion of mental health care referrals.

NCT ID: NCT03582839 Active, not recruiting - Mental Disorder Clinical Trials

Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program

PROTECT+
Start date: April 14, 2016
Phase: N/A
Study type: Interventional

Background. In the last two decades Internet usage has grown vastly. Pathological Internet usage (IUD; Internet Use Disorder) is associated with severe mental health problems affecting social, academic and daily life functioning. Internet Gaming Disorder (IGD) has been already included in the DSM-V. Recently, the WHO declared to include Gaming Disorder (GD) in the upcoming ICD-11. Despite the increasing rates of adolescents with IUD and (I)GD, affected people are treated unsystematically and there is a lack of evidence based treatment programs. PROTECT+ is a low-threshold, cognitive behavioral short-term group intervention. Methods. 54 patients, aged 9-19 years, received PROTECT+ intervention in Heidelberg, Germany. The PROTECT+ intervention group underwent a cognitive-behavioral 4-session group therapy. Follow-up data were collected at 1, 4, and 12 months after admission. Primary outcome was the change in (I)GD and IUD related symptoms at the 12-months follow-up. Secondary outcomes were changes in comorbid symptoms as well as in problem solving, cognitive restructuring and emotion regulation skills Discussion. Treatment of IUD and IGD is still in its early stages. Recent reviews report increasing research on treatment but also a lack of well-designed studies and evidence based treatment programs. The PROTECT+ intervention is a theory driven and evidence based therapy program which is based on the PROTECT preventive intervention in school settings. In the intervention group a reduction of (I)GD and IUD symptom severity is expected over 12 months.

NCT ID: NCT03582813 Completed - Clinical trials for Mental Illness Persistent

Efficacy of Mental Health Self-Directed Care Financing

SDC-RCT
Start date: March 1, 2009
Phase: N/A
Study type: Interventional

Self-directed care (SDC) programs give people with disabilities control over public funds to purchase traditional behavioral health and non-traditional services in order to remain outside of institutional settings. The purpose of this study is to determine the effects of this model on participant outcomes, service costs, and user satisfaction among people with serious mental illness.

NCT ID: NCT03575442 Active, not recruiting - Schizophrenia Clinical Trials

"Art Therapy" in Acute Psychiatry

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

Background: Given the complexity of this problem, psychiatric in-patients in the acute stage of their disease need different types of therapeutic programs to recover they mental health state. Usually they're submitted to systematic biological programs (namely psychopharmaceuticals), often considered a priority when compared to psychosocial programs. Among the different therapies that have been introduced in this context "art therapy", also named creative therapy, can constitute a treatment that complements the allopathic treatments, providing improvements in self-esteem and self-efficiency, distraction and relief from concerns and negative thoughts. Scientific evidence on the effects of psychosocial programs in the context of hospitalization of acute cases is scarce. Aims: a) evaluate the effectiveness of a 3 session program of "art therapy" in changing emotional indicators, namely depression, anxiety, stress, and psychological well-being, in individuals with mental illness; b) analyze the meanings a person attributes to his creative self-expression. Method: This is a pre-experimental, prospective study, with a pre test-post test design without control group, with a mixed approach (quantitative and qualitative). The study was performed in the psychiatry unit (Psiquiatria B), in the Centro Hospitalar e Universitário de Coimbra - Portugal. The target population was composed by men (older than 18), hospitalized in this ward. The exclusion criteria were: individuals with active psychotic symptomology, in manic phase and/or refusing to participate. The instruments used to collect information were: Depression, Anxiety and Stress Scale [DASS-21]; Ryff Scales of Psychological Well-Being (SPWB - 18 item version) and a semi-structured interview. Data collection and the development of this study occurred in the following manner: - Initial evaluation to verify the sample selection criteria in the first 48 hours after patient hospitalization; - Obtain informed consent for the application of instruments and participation in the "art therapy" intervention program; - Application of instruments (DASS-21 and SPWB-18 item version) before intervention; - Development of the program applied as a group, during three weeks, one session a week, each lasting approximately 90 minutes and assisted by a specialist in plastic expression. Each session was held in an occupational therapy room, including all the material deemed necessary for the execution of some of the techniques introduced by the technician. After each session, a semi-structured interview was conducted with each participant in order to analyze the meanings attributed. - In the end of the program, the same instruments were reapplied.