Active clinical trials for "Anxiety Disorders"

Native Americans (NA) are at greater risk for anxiety and depression early in life with 10-39% of NA youth reporting clinical levels of anxiety or depression. This is concerning given potential negative effects of these conditions across the lifespan (substance use, suicide). Available culturally adapted prevention and early interventions (PEIs) for anxiety and depression in NA youth are limited. Two are indicated for at-risk youth (e.g., trauma), one universal PEI was not efficacious, community stakeholders served as consultants with no youth or parents involved, and evaluation used minimal mixed methods. Thus, there is a critical need for the development and evaluation of a culturally consonant, brief prevention and early intervention (PEI) for anxiety and depression in NA youth using a CBPR approach that include youth and parents and mixed method evaluation. The investigators' short-term goal is to provide the community with a potentially successful PEI to mitigate NA youth's anxiety and depression that integrates culture and traditions for delivery in schools. The Specific Aims of the proposed research are to 1) culturally adapt COMPASS for Courage for NA youth living on a Northern Plains tribal reservation (chosen by the Cultural Advisory Board; CAB), 2) evaluate the feasibility and acceptability of the culturally-adapted COMPASS with NA youth living on the reservation, and 3) estimate effect size changes in anxiety and depressive symptoms of the culturally adapted COMPASS with the NA youth. The investigators propose to build upon the investigators' strong community relationships and CBPR methods to achieve these aims. The investigators will partner with the CAB to culturally adapt COMPASS for NA youth in year 1 within a CBPR framework, including NA youth and parents. In year 2, the investigators will train three NA providers from the tribal community and pilot test the adapted PEI among 30 NA 8-12-year-olds in two schools serving youth from the reservation in Years 2 and 3. The investigators will evaluate feasibility and acceptability using mixed methods including focus groups of key stakeholders (youth, parents, and teachers) and estimate effect sizes of changes in anxiety and depressive symptoms using a pre-post, single group design. The investigators hypothesize NA youth will find the adapted COMPASS intervention to be acceptable, enjoyable, and culturally appropriate and there will be pre- to post-intervention reductions in anxiety and depressive symptoms. The long-term goal is to continue refining and tailoring the adapted COMPASS intervention and evaluate its efficacy and sustainability. The investigators plan to submit an R01 (Clinical Trial) in response to the FOA, Intervention Research to Improve Native American Health (PAR-20-238), in Year 3 for a full-scale clinical trial that will be informed by the study's findings.

This project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in American Indian and Alaska Native communities. Access to culturally competent and effective behavioral health services is limited in many of these communities. The investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, Family Spirit Strengths (FSS) that can be embedded within home visiting services. The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), and materials informed and developed based on an Indigenous advisory group. The FSS program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. The investigators will use a randomized controlled trial, whereby half of the participants will receive FSS and the other half will receive an evidence-based nutrition education program. The investigators' study is grounded in participatory processes and led by a team of Indigenous and allied researchers.

It is emphasized in the studies that the child and parent anxiety that occurs in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative process is distraction interventions the child and family with preoperative family-centered activities. Teaching children anxiety coping skills with the involvement of their parents can reduce preoperative anxiety. This study was planned to Comparison of the effectiveness of two different distraction interventions (distraction with play dough- distraction with kaleidoscope) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery

The goal of this randomised controlled trial is to compare the effects of Immersive Virtual Reality(IVRE)(NIVRE) and Non Immersive Virtual Reality in children having dental anxiety.The main question[s] it aims to answer are: Does preoperative IVRE and NIVRE has any effect on dental anxiety in children measured with self-reported dental anxiety scale; Malay translated Modified Child Dental Anxiety Scale faces version (MMCDASf)? Does preoperative IVRE and NIVRE has any effect on dental anxiety in children measured with physiological measure, Pulse Rate(PR)? Is there any difference in dental anxiety measured using MMCDASf and PR between IVRE,NIVRE and control group at pre-test and post-test? What is the correlation between self-reported MMCDASf and physiological measure PR?

The present IIT (Investigator-Initiated Trial) study is a prospective, randomised, placebo-controlled, double blind trial. Women hospitalised with signs of preterm birth can be recruited for the study. Participants will take study medication for 2 weeks (or until birth) and fill out a questionnaire at 3 time points (at baseline, after 1 week and after 2 weeks) to assess state of anxiety and sleep quality. Furthermore, information regarding adverse events and the further course of the pregnancy are recorded.

This study aims to determine and compare acupuncture therapy and chiropractor group therapy to reduce anxiety and depression among HIV/AIDS patients at Being Alive, Los Angeles. In this controlled clinical trial, a total of 30 patients will be divided into two groups, 15 in the acupuncture therapy group, 15 in the chiropractor group therapy. The Hospital Anxiety and Depression Scale (HADS), The Patient Health Questionnaire 9-item (PHQ-9) and Generalized Anxiety Disorder 7- item scales (GAD-7) will be used as screening tools for depressive and anxiety symptoms respectively.

Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy

It is emphasized in studies that child and parent anxiety that arises in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative period is therapeutic play interventions. This study was planned to compare the effectiveness of two different therapeutic play interventions (bubble breathing play therapy and tell-show-do play therapy) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery.

The current study examines the effectiveness of the StayFine app for relapse prevention of anxiety or depressive disorders in youth using a randomized controlled trial. In addition, ecological momentary assessment (EMA) is used to explore fluctuations in emotions, psychological factors as predictor of the intervention effect and potential differential mechanisms of change. A total of 254 healthy youths remitted from an anxiety and/or depressive disorder, aged 13-21 years old, will be recruited for the study. Participants will be randomized to either 1) use the StayFine app exclusively for monitoring, or 2) use the StayFine app for monitoring and interventions supported by an expert patient. Stratification blocks are of random size and depend on previous episodes (1/2/3 or more) and previous treatment (yes/no). The intervention is based on the well-established Preventive Cognitive Therapy (PCT) for relapse prevention for adults and Cognitive Behavioral therapy adapted for the relapse prevention phase, both supplemented for anxiety and adolescents. In both conditions adolescents monitor their symptoms five times in three years and feedback and treatment advice is given in case of relapse. The primary outcome will be time to relapse. Secondary outcomes are (core) symptoms of depression and anxiety, number and duration of relapses, global functioning and quality of life. Mediators and moderators will be explored. Exploratory endpoints are monitoring and wearable outcomes.

Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs. This rate doubles for those with adverse perinatal outcomes (APO) and triples in Black women. Recent research points to racism as one significant source of these health disparities. Cultural adaptations to improve communication with providers decrease rates of depression in minority patients as well as improve adherence to treatment, insight and alliance. Discrimination stress and worries about experiencing medical consequences are thought to increase systemic inflammation, a mechanism known to drive mental and physical symptoms. Inflammation has been implicated in both PMADs and APO, suggesting a shared underlying etiology. Evidence from our work suggests that inflammation contributes to the pathophysiology of PMADs. The proposed pilot randomized control trial will allow the investigators to build on promising preliminary results and identify whether our culturally relevant mobile Health (mHealth) intervention is effective in improving outcomes among Black pregnant women randomized to the intervention compared to a control group. The culturally relevant modules include building communication and self-advocacy skills and provide a support network. The primary objective of this research is to provide guidance for clinical care of Black women during the perinatal period, with the goal to improve mental health and physical health outcomes. A secondary goal is to examine novel inflammatory signatures that change as a function of the intervention to reduce PMADs in this population. As inflammation may be diagnostic of PMADs, identification of its role may shed light of potential intervention targets and provide critical knowledge to improve women's long-term health. PMAD symptoms will be assessed prospectively in 150 Black pregnant women, half of whom will be randomized to receive the culturally relevant mHealth intervention. The investigators hypothesize that women in the intervention group will have reduced rates of PMADs and APOs, an increase in adherence to mental health treatment and will report increased self-advocacy skills, increased communication with providers, and reduced levels of discrimination related stress. Participants will also have improved biological risk indicators including lower circulating C-reactive protein and a transcription profile of differentially expressed inflammatory genes, marked by a decreased activity of inflammatory transcription factors from blood spots. Given the high burden of both PMADs and APOs among Black mothers and the numerous consequences on maternal and child outcomes, it is imperative that investigators develop and implement effective interventions, and test the biological mechanisms that might drive these effects. This work is interdisciplinary, building on a network of community advocates to implement a novel mHealth intervention informed by real world experiences designed to enhance self-advocacy, reduce stress and prevent adverse outcomes