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Anxiety clinical trials

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NCT ID: NCT06088069 Recruiting - Pain Clinical Trials

Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty

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

The aim of this study is to evaluate Virtual reality (VR) on perioperative anxiety, pain, hemodynamics, and stress hormones in patients undergoing Total hip arthroplasty (THA).

NCT ID: NCT06087471 Not yet recruiting - Depression Clinical Trials

Snack Foods and Their Impact on Mental Health and the Gut-brain Axis

NutriMood
Start date: October 16, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of snack foods on mental health and the gut-brain axis, in adults with mild to moderate symptoms of depression and anxiety.

NCT ID: NCT06087185 Recruiting - Obesity Clinical Trials

Obesity and Mindful Eating in Patients With Anxiety

OMETA
Start date: March 23, 2023
Phase: N/A
Study type: Interventional

Background: Obesity is chronic disease with high prevalence rates, functional disability and difficult long-term management. Anxiety is one of the most common psychological disorders in obesity, and when associated with other factors such as emotional eating and emotional dysregulation, it impairs treatment and interferes with lifestyle changes. Finding an intervention that improves the eating behavior of these patients and facilitates adherence to obesity treatment, associated with less emotional distress, is of great clinical interest. Objective: The aim of this study is to evaluate the effectiveness of the Mindful Eating (ME) intervention on neurocognitive and behavioral outcomes in patients with obesity and anxiety compared to the control group with exposure to videos promoting quality of life. Methods: A five-weeks randomized clinical trial will be performed with 52 patients in adulthood. The Mindful Eating intervention group will receive an online protocol with one meeting per week. This is a protocol that has been adapted for five weeks and consists of a group intervention with 10-15 participants. Mindfulness, Mindful Eating and Self-Compassion training will be based on the Eat for Life protocol. The control group will receive five videos of psychoeducation, one topic per week. After, all participants will receive lifestyle advices, a first-line "treatment-as-usual" to obesity. There will be a face-to-face assessment with anthropometric, behavioral and biological measurements pre and post-intervention. The outcomes may help in understanding the mechanisms underlying the change in eating behavior, in order to direct new therapeutic strategies for the treatment of anxiety and obesity comorbidities.

NCT ID: NCT06083987 Recruiting - Depression Clinical Trials

Sexual and Gender Minority Youth (SGMY) and Online Interventions to Increase Help-seeking for Anxiety and/or Depression

Start date: March 8, 2024
Phase: N/A
Study type: Interventional

the investigators will use 4 technology based tools (combinations of youtube videos, links to online resources, tiktok videos, and other media) in a study of 96 Sexual and Gender Minority Youth (SGMY) to determine the effectiveness of them in helping youth to seek out mental health help. Participants will be divided into 1 of 16 groups and will interact with other participants anonymously on Discord. Each group will have access to 1, 2, 3, or all 4 of the tools which are categorized by a specific subject (except for one group who will have no access to the tools in order to compare this outcome against those who use the tools). There will be a survey before starting the Discord portion which will last 4 weeks, and a survey afterwards.

NCT ID: NCT06081348 Not yet recruiting - Anxiety Clinical Trials

Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders

CALM
Start date: October 2023
Phase: Phase 2
Study type: Interventional

There are currently no approved medications for the treatment of anxiety in children and youth with neurodevelopmental disorders (NDDs), both common and rare. Sertraline, a selective serotonin reuptake inhibitor, has extensive evidence to support its use in children's and youth with anxiety but not within NDDs. More research is needed to confirm whether or not sertraline could help improve anxiety in children and youth with common and rare neurodevelopmental conditions. This is a pilot study, in which we plan to estimate the effect size of reduction in anxiety of sertraline vs. placebo. across rare and common neurodevelopmental disorders, and determine the best measure(s) to be used as a primary transdiagnostic outcome measure of anxiety, as well as diagnosis specific measures in future, larger-scale clinical trials of anxiety in NDDs.

NCT ID: NCT06080100 Recruiting - Anxiety Clinical Trials

RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION

Start date: November 1, 2023
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical trial is to propose for implementation and evaluate the effectiveness of xenon sedation for the relief of psychoemotional stress disorder before the operation of refractive laser vision correction patients with high anxiety and stress instability who underwent xenon analgosedation before refractive laser vision correction. The main question[s] it aims to answer are: 1. To develop a method of xenon sedation in patients with a high level of psychoemotional stress before surgery - refractive laser vision correction. 2. To evaluate the effect of inhaled xenon anesthesia in a sub-narcotic dose on the duration of surgery, satisfaction of surgeons and patients with anesthesia, the level of postoperative pain in patients in comparison with anxiolytics. The following will be studied: the level of preoperative anxiety, the dynamics of glycemia and blood cortisol levels, heart rate variability, electrical microamplitudes of the ECG signal, the anti-stress and analgesic effect of xenon. If there is a comparison group: the researchers will compare [the group with xenon sedation and the control group] to see if there is [an anti-stress effect of xenon in patients before laser vision correction].

NCT ID: NCT06079814 Recruiting - Pain Clinical Trials

Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy

Start date: October 10, 2023
Phase: N/A
Study type: Interventional

The aim of this research is to conduct a two-group randomized controlled intervention study to determine the effect of virtual reality applications on pain and anxiety during cystoscopy. The study population will consist of patients who have applied to the urology outpatient clinic of a University Hospital for cystoscopy. The study sample will be composed of patients who volunteer to participate in the study and meet the criteria during the planned dates of the research. Data will be collected using a 'Personal Information Form' created by the researcher through a literature review, the 'Visual Analog Scale' (VAS) for assessing pain, and the 'State Anxiety Inventory' (SAI) for assessing anxiety.

NCT ID: NCT06078124 Not yet recruiting - Depression Clinical Trials

Sibling-Support for Adolescent Girls (SSAGE)

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

Forcibly displaced adolescents face increased risks for mental illness and distress, with adolescent girls disproportionately affected in part due to the heightened gender inequity that often accompanies forced displacement. Although the family unit has the potential to prevent mental illness and promote healthy development in adolescents, few family interventions have employed a gender transformative approach or included male siblings in an effort to maximize benefits for adolescent girls. Therefore, the investigators propose to assess an innovative whole-family and gender transformative intervention-Sibling Support for Adolescent Girls in Emergencies (SSAGE)-to prevent mental health disorders among adolescent girls in Colombia who were recently and forcibly displaced from Venezuela. The proposed R34 study will adapt the SSAGE curriculum through human-centered design with a range of stakeholders, including Venezuelan refugees, Colombian returnees and relevant civil society organizations. The proposed study will then employ a hybrid type 1 effectiveness-implementation pilot randomized control trial (RCT) to test the program's effectiveness and mechanistic pathways as well as to explore determinants of implementation in order to establish the feasibility, acceptability, and fidelity of SSAGE. To address these aims, the investigators will enroll 180 recently arrived, forcibly displaced adolescent girls in an RCT and examine the program's effectiveness on the prevention of mental illness (through reduction in anxiety, depression, interpersonal sensitivity, and somatization symptoms) one-month post-intervention. The investigators will use contextually adapted and piloted measures to collect additional data on the hypothesized mechanistic pathways, including family attachment, gender equitable family functioning, self-esteem, and coping strategies. The implementation evaluation will employ mixed methods to assess the program's feasibility, acceptability, fidelity and barriers and facilitators to successful implementation. Potential findings can support humanitarian program implementation, as well as inform policy to support adolescent girls' mental health and to prevent the myriad disorders that can arise as a result of exposure to displacement, conflict, and inequitable gender norms in their households and communities.

NCT ID: NCT06078007 Not yet recruiting - Anxiety Clinical Trials

Effectiveness of a Guided Mobile App Intervention for Depression and Anxiety in University Students (PROMES-U Study)

PROMES-U
Start date: October 2023
Phase: N/A
Study type: Interventional

Background: Symptoms of depression and anxiety are prevalent among Spanish university students. Minimally guided online interventions have shown promise in reducing symptomatology and preventing increased mental distress. There is a need to evaluate the effectiveness of guided preventive mental health interventions for depression and anxiety in university students. Methods: two-arm multicenter randomized controlled trial (RCT), addressed to undergraduate students from 6 public universities with symptoms of depression and/or anxiety. Students will be evaluated through an online survey assessing mental health problems, use of mental health services, sociodemographic variables, self-perceived health, childhood and adolescent adversities, recent stressful events, social networks, personality and university experiences. A total of 600 students will be randomly assigned to: intervention group (guided E-health prevention intervention) or control group (treatment as usual with self-monitoring). The intervention, in app format, is based on principles of cognitive behavioral therapy, includes weekly feedback based on content and participation from a psychologist and self-monitoring. Assessments will take place post-intervention (up to 6 weeks), at 6 months and 12 months after randomization. The primary outcome will be the reduction of depressive or anxiety symptoms post-intervention, assessed with the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 (GAD-7) and the Patient Health Questionnaire-Anxiety and Depression Scale (PHQ-ADS). Secondary outcomes of the RCT will be mental wellbeing, academic stress, comorbid symptoms, and adherence. Analyses will be conducted on an intention-to-treat and per protocol basis. Discussion: The results of the PROMES-U RCT will provide valuable information on a guided preventive online intervention that could be delivered in the campus context. In addition, results will provide information on the positive impact of the intervention on other relevant factors involved in mental health among university students.

NCT ID: NCT06077175 Recruiting - Anxiety Clinical Trials

HAND MASSAGE AFTER ACUTE CORONARY SYNDROME

Start date: October 30, 2023
Phase: N/A
Study type: Interventional

Patients suffering from Acute coronary syndrome may be hospitalized again in a shorter time than expected, and after being discharged, they may live within the limitations imposed by the disease until the end of their lives. This situation causes anxiety in individuals. Today, various methods are used to reduce high levels of anxiety. Massage is the planned and purposeful application of touch and is the most common, most important and oldest complementary treatment used in traditional practices. It is also thought that the comfort levels of individuals experiencing ACS will increase by reducing their anxiety. This study was planned to determine the effect of hand massage applied to patients with ACS on comfort, anxiety level and vital signs.