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NCT ID: NCT05841823 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Virtual Reality Exposure Therapy in the Treatment of Alcohol Use Disorder

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

This study aims to compare the efficacy of two types of interventions, which are acceptance and commitment therapy (ACT) as compared with virtual reality exposure therapy (VRET) for alleviating psychological dependence on alcohol and preventing relapse. It also assesses the changes of EEG in patients with alcohol use disorder after completion of the above related interventions. In this study 120 subjects with alcohol use disorder who have completed 2 weeks of in-patient detoxification will be randomized into three groups (VRET, ACT and treatment-as-usual control groups) and undergo respective interventions. Then assessment will be performed at four timelines (baseline, 4 weeks after baseline which is immediately after completion of intervention, 12 weeks after baseline, and 24 weeks after baseline assessment).

NCT ID: NCT05830708 Not yet recruiting - Clinical trials for Alcohol Use Disorder

The Efficacy of Probiotics for the Treatment of Alcohol Use Disorder Among Adult Males

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

This three-armed, parallel-group, single-blind, multi-center randomized control trial (RCT) aims to evaluate the efficacy of probiotic supplement compared with that of acceptance and commitment therapy (ACT) in ameliorating alcohol craving and severity of alcohol use disorder (AUD) in patients diagnosed with AUD after 2 weeks of in-patient detoxification. In addition, this study also compares the efficacy of probiotic supplement and ACT to mitigate common comorbid of AUD (such as depression and anxiety symptoms); changes in event-related potential (ERP) on electroencephalogram (EEG) monitoring which indicate reduce alcohol craving; and depreciate the serum level of pro-inflammatory cytokines, such as interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) indicating lowering of systemic inflammation. In phase I of the study, 120 patients diagnosed with AUD (using Diagnostic and Statistical Manual for Mental Disorders 5th Edition or DSM-5) and 120 healthy controls will be recruited. The measured outcomes to be compared between patients with AUD and healthy non-AUD controls include ERP on EEG monitoring, serum levels of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α), and the fecal microbiota content. Then, in phase II of the study, 120 AUD patients will be randomized into three groups of intervention in a 1:1:1 ratio (Lactobacillus sp. probiotic, ACT and placebo group; n = 40 per group). The participants in probiotic and placebo groups will then consumed the Lactobacillus sp. Probiotic and placebo 1 sachet once a day of probiotic and placebo, respectively for 12 weeks. While participants in ACT group will undergo training for ACT one session per week for 8 weeks. Outcome assessments will be performed across four time points, such as t0 = before intervention began, t1 = 8 weeks after intervention began, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began. The primary outcomes to be measured are the degree of alcohol craving, alcohol withdrawal, and severity of alcohol use disorder. While the secondary outcomes to be assessed are severity of comorbid depression and anxiety symptoms, serum levels of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α), changes in ERP on EEG monitoring, and fecal microbiota content.

NCT ID: NCT05821634 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Digital Phenotyping of Anxiety and Anxiety-Related Alcohol Co-occurrence: Pilot Study

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

Anxiety and anxiety-related disorders frequently co-occur with alcohol use problems resulting in an enormous humanitarian and economic cost to society. The proposed research will use digital technology to examine person-specific risk factors predicting problematic alcohol use in individuals vulnerable to anxiety and anxiety-related disorders and will use this information to design a personalized intervention for individuals seeking psychological treatment. Results from this research will integrate output from novel and innovative digital technology methods into psychotherapy, advancing research on personalized treatment and prevention efforts.

NCT ID: NCT05816304 Not yet recruiting - Depression Clinical Trials

Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Frontline Health Care Workers (The HCW-CBTi Study)

HCW-CBTi
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

The COVID-19 pandemic has resulted in increased workload and concerns about personal and family safety for frontline healthcare workers (HCWs), which can lead to decreased well-being and worsening mental health. Sleep disruption is particularly prevalent among HCWs providing frontline COVID-19 care. It can have direct consequences on their cognitive and emotional functioning, as well as on patient safety. Cognitive Behavioral Therapy for insomnia (CBTi) is a first-line treatment for insomnia. It has been shown to improve sleep health and wellbeing in the general population. However, there are significant barriers to delivering CBTi to frontline HCWs, including limited availability of trained sleep therapists and high costs. To address this, a Canada-wide randomized controlled trial is developed to determine the effectiveness of a digital CBTi program on the sleep health, mental health, wellness, and overall quality of life of frontline HCWs caring for COVID-19 patients. This study may provide an easily accessible and scalable sleep health intervention that can be included as part of a national and global response to the COVID-19 pandemic.

NCT ID: NCT05807295 Not yet recruiting - Clinical trials for Caregivers With a Child Followed up With a Cancer Diagnosis

The Effect of Relaxation Program on Coping With Stress and Anxiety Levels of Caregivers of Children With Cancer.

Start date: April 13, 2023
Phase: N/A
Study type: Interventional

This research will be carried out to determine the effect of the relaxation program applied to the caregivers of children followed by the diagnosis of cancer on the levels of caregivers' anxiety and coping with stress. The research will be conducted in a single-blind parallel-group randomized controlled trial design. A relaxation program including progressive muscle relaxation exercises will be applied to caregivers. The application will be carried out by sending muscle relaxation videos and videos for relaxation to mothers. The relaxation program is planned to last approximately 6 weeks

NCT ID: NCT05802446 Not yet recruiting - Bipolar Disorder Clinical Trials

Neurofeedback for Bipolar Disorder

NEUROFEED-BD
Start date: April 2023
Phase: N/A
Study type: Interventional

Bipolar Disorder (BD) is a severe mood disorder affecting between 1% and 3% of the general population. It is characterized by the succession of depressive and manic episodes, with periods of stabilization during which patients may present "residual" depressive or anxious symptoms, which are characterized by sadness and emotional hyper-reactivity. Although subthreshold, these residual symptoms are very disabling for their daily lives and are associated with the risk of recurrence and poor global functioning. The effect of pharmacological and psychotherapeutic treatments is demonstrated in the management of acute episodes but remains insufficient on residual symptoms. Therefore, there are so far few therapeutic options to target the inter-episode residual symptoms in BD. One novel approach is the real-time functional magnetic resonance imaging (fMRI) neurofeedback (NFB), which has already been shown to be an efficient method for self-regulating brain function, behavior and treating depression. Hypothesis/Objective : This study aims at assessing the efficacy of 3-weeks neurofeedback training with real-time fMRI on the treatment of residual mood symptoms in patients with BD. The investigators will specifically target depressive symptoms by training the patients to regulate the emotional network hemodynamic response to emotional stimuli. Method : The investigators will include 64 stabilized patients with BD. The investigators will recruit them in three French expert centers for BD and will randomly assign them to the experimental group, receiving feedback from the emotional brain network hemodynamic activity, or to the control group, receiving the signal from control brain areas not involved in emotion processing. Both groups will be trained to regulate their brain activity while they are presented with negatively valenced emotional pictures, based on the neurofeedback shown immediately after the trial. They will continue their usual treatment (as prescribed) throughout the duration of the study. Clinical scales and cognitive tests will enable us to evaluate the symptomatic, emotional, and cognitive changes after NFB training. The investigators will also measure resting-state functional connectivity and brain morphology before and after NFB to assess brain plasticity and to explore the neural mechanisms associated with successful regulation.

NCT ID: NCT05785312 Not yet recruiting - Clinical trials for Major Depressive Disorder

Development of Online EMDR Therapy System and Its Comparative Testing With Face-to-Face EMDR Therapy for Treatment of Anxiety and Depressive Disorders in Pakistan

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

This study aims at developing an online system for the remote delivery of EMDR therapy in Pakistan. Moreover, this study will compare the efficacy of online EMDR therapy with face-to-face EMDR therapy.

NCT ID: NCT05768308 Not yet recruiting - Clinical trials for Adjustment Disorders

Online CBT Intervention for Students With Adjustment Disorder

Online CBT
Start date: May 2023
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effectiveness of online cognitive-behavioral intervention based on Unified Protocol and mediators of obtained changes among polish students with adjustment disorder. The intervention is fully self-helped and based on Unified Protocol principles. Control conditions contain of online progressive muscle relaxation group and waiting list.

NCT ID: NCT05756218 Not yet recruiting - Motivation Clinical Trials

Motivation of Nursing Students and Perception Levels of the Taboo Game Adapted for Nursing Diagnoses

Start date: February 27, 2023
Phase: N/A
Study type: Interventional

The goal of this To determine the effect of the taboo game adapted for nursing diagnoses in the professional practice course on the motivation and perception levels of nursing diagnoses in nursing students. Type of Research: It was designed as a parallel group randomized controlled trial. The reporting of the study was planned in accordance with the PEER criteria] in [describe participant population/health conditions]. The main question[s] it aims to answer are:The Research Hypothesis: H1: The taboo game organized for nursing diagnoses in the professional practice course has an effect on the motivation of nursing students. H2: The taboo game organized for nursing diagnoses in the professional practice course has an effect on nursing students' perception of nursing diagnoses. Participants will [The Universe of her Research: The universe of her research Necmettin Erbakan University Faculty of Nursing 4. Class (Quota: 145) and Necmettin Erbakan University Seydişehir Kamil Akkanat SBF Nursing department 4. The class (Quota: 42) students will be formed]. If there is a comparison group: It was increased by 10% for possible records, the research was planned to be completed with 80 people, with an error of 0.05, a power of 0.80 and an effect size of 0.600; 40 experiments, 40 control groups.

NCT ID: NCT05749224 Not yet recruiting - Clinical trials for Temporomandibular Disorder

Turkish Validity and Reliability of The Helkimo Index for Diagnosis of Temporomandibular Disorders

Start date: March 15, 2023
Phase: N/A
Study type: Interventional

Helkimo Index evaluates movement, joint function, pain and musculature, providing a quick general overview that could be very useful at different levels of care. The aim of this study is to investigate the validity and reliability of the Turkish version of the Helkimo index. Registration of subjective symptoms applying for the Helkimo Index required a questionnaire-based survey. Questionnaire comprised two parts: Anamnestic component which includes answers to questions in "yes" or "no". Clinical dysfunction part comprised clinical examination. Method: Turkish translation of Helkimo index will be made. The sample will consist of 100 subjects, 50 TMD patients and 50 healthy controls. the patients will be selected, demographic data were recorded: age, sex, height, weight, body mass index (BMI), educational level, work situation, smoking status, alcoholic habits and physical activity. Helkimo Index is comprised of five items, with each assessment having three possible answers, scored as 0, 1 or 5. The first item is related to the limitation in the range of jaw movement. The second item evaluates the alterations of joint function that produce deviations, sounds and/or joint locks or blockages; the third item evaluates the presence of pain when performing some movements; the fourth item evaluates muscular pain in the masticatory muscles; and the fifth item evaluates the presence of discomfort or pain in the prearticular area of the temporomandibular joint (TMJ) through palpation. From the sum of the 5 items, we identify no TMJ involvement if the score is 0, mild TMJ involvement when the score ranges from 1 to 9, moderate TMJ involvement if the score ranges between 10 and 19 and severe TMJ involvement for a score between 20 and 25. The Numerical Pain-Rating Scale (NPRS) test, disability, the Neck Disability Index test, the Dizziness Handicap Inventory (DHI), the Headache Impact Test (HIT-6) and 12-item Short-Form Health Survey (SF-12) will be assessed. Correlation will be made between the Helkimo index and these rating scales.