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Anxiety clinical trials

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NCT ID: NCT06391216 Active, not recruiting - Healthy Clinical Trials

The Effect of Probiotic Supplementation on Mental Health in Healthy Volunteers

ProBeMent
Start date: May 6, 2024
Phase: N/A
Study type: Interventional

Probiotics are "live microorganisms which when administered in adequate amounts confer a health benefit on the host". Accumulating evidence indicates their effect in mental health restoration. Beneficial neuropsychological and psychobiological effects are particularly well substantiated in clinical samples. However, it is not clearly documented whether probiotic supplementation reduces depressive and anxiety symptoms in healthy volunteers experiencing temporal deterioration in mental functioning while facing a stressful event. The combination of Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 is particularly well studied in terms of its central nervous system action with significantly deciphered mechanism. As a result, this combination is particularly promising to study the effect of mental health improvement in healthy volunteers facing a stressful event. The aim of this project is to assess the impact of a 8-week supplementation with probiotic combination of Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 strains in the daily dose of 3 × 10^9 colony forming units on mental health measures and oral microbiota composition and metabolome in healthy young adults facing a psychologically stressful event. The aim will be achieved by comparing the probiotic combination supplement to placebo in a randomized triple-blind controlled trial settings with a participant allocation ratio of 1:1. The summer academic examination session and the upcoming first take of the final exam in pharmacology at third year of medical studies will be a model of a stressful event. The participants will supplement their diets with probiotic/placebo for 8 weeks before the exam. After giving written informed consent, before the supplementation (relatively stress-free time period in terms of academic activities) the participants will provide background sociodemographic, anthropometric and psychometric data. At that time, participants will also give samples of saliva to assess cortisol and selected cytokines concentrations as well as salivary microbiome and metabolome. At the end of supplementation, a day before the final exam, participants will donate salivary samples and do psychometric tests for the second time to assess the same parameters as at the beginning of the study. Participants will also do a pre-exam test in pharmacology (not considered a formal academic assessment) as a comparator for the results of the formal examination held a day after.

NCT ID: NCT06348862 Active, not recruiting - Anxiety Clinical Trials

Assessment of Stress and Anxiety for Patients Undergoing MRI Using, Holy Quran, Music, and Natural Sounds

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

The aim of the current study is to analyze the effect of listening to Quran or music or natural sounds on anxiety and stress level among patients undergoing MRI.

NCT ID: NCT06271824 Active, not recruiting - Anxiety Clinical Trials

Self-Compassion to Enhance the Well-Being of Caregivers of Children With Physical Disabilities

Start date: March 21, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the feasibility, acceptability and preliminary social/emotional well-being outcomes of a tailored, online self-compassion-based resilience course for caregivers of children with physical disabilities. The main questions it aims to answer are: 1. Is the online resilience course feasible and acceptable to caregivers of children with physical disabilities? 2. Is participation in the resilience course associated with improvements in caregiver stress, anxiety, depression, burden, caregiver uplifts, self-compassion, emotion regulation and/or resilience? Participants will complete a screening, a verbal consent process and an electronic pre-course survey. Then, they will participate in a 6-session weekly online course with other caregivers and led by a certified Mindful Self-Compassion instructor. The course has been created with feedback from caregivers and includes skills for recognizing and coping with difficult emotions while connecting with others who have similar caregiving experiences. After the course, participants will repeat the electronic survey and will provide feedback on the course during a live, online feedback session.

NCT ID: NCT06265701 Active, not recruiting - Depression Clinical Trials

Does a Novel Intervention Targeting Derailment Decrease Depressive Symptoms?

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to explore the efficacy of a reflective journaling intervention-"Me Through Time"- in decreasing levels of derailment, and its impact on downstream depressive symptoms.

NCT ID: NCT06264050 Active, not recruiting - Anxiety Clinical Trials

Psychological Support Group and Its Effects on Mood, Anxiety and Coping

SUPPORT
Start date: January 8, 2004
Phase: N/A
Study type: Interventional

The aim of this study is to verify the influence that participation in a Psychological Support Group has on anxiety, depression and coping skills in patients admitted to the IRCCS San Camillo Hospital. It is therefore an observational study with a pre-post design on a cohort of patients hospitalized at San Camillo IRCCS who attend the Psychological Support Group. The study consists of verifying whether the therapeutic activity of the Psychological Support Group (GSP) has an influence on the levels of anxiety, mood and coping skills in the patients who attend it. These purposes will be pursued through the administration to each patient at the beginning (pre) and at the end (post) of the period of attendance at the GSP, of validated scales: Stay Y2 (anxiety), BDI II(depressive symptoms), COPE NVD 25 (coping strategies) and the CORE-OM (outcomes of psychological activity).

NCT ID: NCT06216626 Active, not recruiting - Anxiety Clinical Trials

PRebiotic Intervention for Metabolic and MEntal Health (PRIME)

PRIME
Start date: June 19, 2023
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether a daily prebiotic fibre blend can reduce systemic inflammation, dyslipidemia, and self-report measures of mental health in individuals with metabolic syndrome. This study will help shape a larger randomised controlled study (RCT) powered to assess efficacy in a bigger cohort of patients. Primary outcome measures will explore the efficacy of a prebiotic fibre blend on systemic inflammation. Secondary and exploratory outcomes measures will explore the efficacy of the prebiotic blend on clinical biomarkers associated with cardiometabolic risk factors, microbiota features, and mental health. Using these data, we will also estimate in-year savings for the NHS in the metabolic syndrome population on a per participant basis.

NCT ID: NCT06187428 Active, not recruiting - Pain Clinical Trials

The PainSMART Research Program: Evaluating a Pain Education Strategy for Patients Seeking Primary Care Physiotherapy

PainSMART
Start date: January 22, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the PainSMART-strategy in a population of patients seeking primary care physiotherapy for pain related to muscles, joints and bones, so called musculoskeletal pain. The PainSMART-strategy consists of a digital educational film (entitled Be PainSMART:er) and a discussion based on the film at the initial physiotherapy consultation. The main questions this clinical trial aims to answer are: 1. Can the PainSMART-strategy update knowledge and beliefs about pain and aid early stage self-management of pain for participants seeking primary care physiotherapy with benign musculoskeletal pain? 2. Can the PainSMART-strategy improve evaluations of the initial physiotherapy consultation for both the patient and physiotherapist? Participating patients will be randomised into two groups. One group (intervention group) will receive the PainSMART-strategy as an adjunct to the current physiotherapy care pathway for musculoskeletal pain. The other group (control group) will follow the current physiotherapy care pathway. The two groups will be followed and compared over three months. Self-report questionnaires will be collected during the three-month period to analyse what effects the PainSMART-strategy can have on the following health outcomes: - Pain levels - Beliefs that one can remain active despite pain - Knowledge about pain - Worry about the seriousness of the pain - Expectations regarding recovery - Use of pain self-management strategies - Levels of physical activity - Absence from work due to pain - Number of referrals made for scans or x-rays, or to a specialist, for pain - Number of healthcare visits for pain during the trial period. Participating patients (both groups) and physiotherapists will also complete questionnaires to evaluate the effect of the PainSMART-strategy on the initial physiotherapy consultation.

NCT ID: NCT06146517 Active, not recruiting - Anxiety Clinical Trials

A Single-Arm, Virtual Clinical Trial to Evaluate the Effects of a Sleep Supporting Beverage and Two Coffee Substitute Products

Start date: August 31, 2023
Phase: N/A
Study type: Interventional

This is a virtual, single-arm clinical trial that will last 12 weeks. Participants will trial three different products, each for 4 weeks. Participants will trial Clevr Blends Sleeptime during weeks 1-4, Clevr Matcha for weeks 5-8, and Clevr Blends Chai for weeks 9-12. Participants will complete questionnaires at Baseline and Week 2, 4, 6, 8, 10, and 12. In addition to data will be collected from participants' sleep tracking devices at Baseline, Week 2, and Week 4.

NCT ID: NCT06119854 Active, not recruiting - Depression Clinical Trials

Brief Digital Intervention to Increase COVID-19 Vaccination Among Individuals With Anxiety or Depression

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The COVID-19 pandemic has led to a mis/disinformation ecosystem that promotes divergent views of vaccine efficacy, as well as the legitimacy of science and medicine. Individuals are confronted with vaccine-related information from a multitude of sources, posing a challenge to identifying inaccurate information. COVID-19 vaccine uptake is lower among people with anxiety and depression than in the general population, due in part to higher levels of vaccine hesitancy. The prevalence of anxiety and depressive symptoms among US adults increased significantly during the COVID pandemic and has remained elevated. Interventions capable of mitigating the impact of vaccine hesitancy and mis/disinformation among undervaccinated people with anxiety or depression are therefore an urgent priority. Emerging evidence suggests that reasons for vaccine hesitancy and the impact of conventional vaccination messaging differ between those with and without mental health symptoms. There may also be added challenges overcoming logistical barriers to vaccination for people with anxiety or depressive symptoms. The investigators aim to determine the effectiveness of two different brief digital intervention strategies compared with conventional public health messaging for increasing vaccine uptake in undervaccinated adults with and without anxiety or depressive symptoms. Attitudinal inoculation is a brief, scalable strategy that leverages the power of narrative, values, and emotion to strengthen resistance to mis/disinformation and reduce hesitancy. Though this approach has been shown to decrease COVID-19 vaccine hesitancy among US adults, the extent to which this approach increases COVID-19 vaccination remains unknown. Cognitive-behavioral therapy (CBT) is an evidence-based intervention for anxiety and depression. However, the efficacy of incorporating CBT-informed messaging in a vaccine promotion intervention has not been tested. The investigators hypothesize that both attitudinal inoculation and CBT-style communication will be more effective than conventional public health messaging to increase COVID-19 vaccination. The investigators also hypothesize that the CBT-informed intervention will be more effective than the attitudinal inoculation intervention for increasing COVID-19 vaccination among participants with symptoms of anxiety or depression.

NCT ID: NCT06063265 Active, not recruiting - Anxiety Clinical Trials

Effect of a Six-week Integrated Attention Training Program on the Cognitive Functions of Older Adults With Co-occurring Anxiety Symptoms and Subjective Cognitive Complaints

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

The goal of this single-blind randomized control trial is to compare a 6-week Integrated Attention Training Program (IATP) and health education in older people with co-occurrence of anxiety symptoms and subjective cognitive decline (SCC). The study aims to answer if a 6-week Integrated Attention Training Program (IATP) will improve cognitive, anxiety, and level of pro-inflammatory biomarkers in this high-risk group. Older adults with co-occurring anxiety and SCC will be recruited to participate in a 6-week single-blind randomized controlled trial. IATP group (Intervention group) will undergo attention and functional training. Control group will receive health education. Investigators will compare the IATP with health education to see if cognitive function, anxiety symptoms, and level of pro-inflammatory biomarkers in comparison to health education will improved after intervention and over 24 weeks.