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Stress, Psychological clinical trials

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NCT ID: NCT05888272 Recruiting - Stress Clinical Trials

Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up

Start date: April 4, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to examine the impact of the "Doing What Matters in Times of Stress" guided self-help handbook, along with phone-based lay helpers sessions, on the psychological well-being, business performance, and incidence of intimate partner violence among women entrepreneurs in Ethiopia.

NCT ID: NCT05830435 Recruiting - Clinical trials for Stress, Psychological

Trier Social Stress Test in Virtual Reality

Start date: November 25, 2022
Phase: N/A
Study type: Interventional

Background The Trier Social Stress Test (TSST) is a valid and gold standard way for inducing psychosocial stress and is widely used in research and diagnostics. One of the downsides of the TSST is the difficulty to maintain the same experimental conditions repeatedly. A TSST in virtual reality (TSST-VR) is constant and requires far less time and personnel. Our TSST-VR version consist of three stress levels (no stress, moderate stress, high stress), a novelty in this field. Aim The aim is to investigate whether there is a statistically significantly greater increase directly after the TSST-VR in psychological and physiological stress parameters in the moderate and high stress levels compared to the no stress condition (control). Method A randomized controlled trial is conducted in healthy adults, with the three stress levels as conditions. Cortisol and questionnaires on anxiety and physical arousal are measured at baseline, during and after the TSST. Heart rate is measured continuously and adverse events are monitored.

NCT ID: NCT05829031 Recruiting - Clinical trials for Stress, Psychological

Tailored Ecological Momentary Music Intervention for Stress Reduction

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

Ethnic discrimination is associated with mental and physical health impairments. In view of the negative impact of discrimination on health, it is of great importance to investigate interventions to counteract these negative effects. Based on findings of a pilot study (clinicaltrials.gov identifier: NCT04957966), this study investigates the effectiveness of a tailored ecological momentary music intervention to reduce biological (salivary cortisol, salivary alpha-amylase) and psychological (perceived stress, perceived ethnic discrimination) stress reactions after discriminatory and/or stressful events in the daily life of Turkish immigrant women (N = 50, age range 18-65 years). An intra-individually randomized design will be used, i.e., participants will be assigned on a random basis either to intervention events (they can choose to listen to music for the duration of 10 or 20 minutes) or to control events (participants are instructed to not listen to music). The whole study period consists of 35 days with a baseline period (week 1), intervention period (week 2-4), and post period (week 5).

NCT ID: NCT05734638 Recruiting - Hypertension Clinical Trials

Stress and Blood Pressure Management for Caregivers

Stress/HTN
Start date: September 11, 2023
Phase: N/A
Study type: Interventional

Due to health and wealth disparities, no demographic group is more at risk than African American women for the double jeopardy of stress from caregiving for persons living with dementia (PLWD) and stress associated with hypertension (HTN). This double jeopardy puts those they care for in jeopardy as well: Reduced quality of life and longevity, disability, cognitive decline, and stroke associated with HTN1 impede caregiving activities and resultant health and well-being for persons living with Alzheimer's disease and related dementias (ADRD). Although successful multi-component interventions have addressed ADRD caregiver stress (REACH II) and the Savvy Caregiver program, to our knowledge there are no interventions that target the complexity of chronic caregiving stress and HTN self-care for African American women caregivers of persons living with ADRD. This project will test two interventions for their effectiveness in improving outcomes for the target group: Mindfulness in Motion (MIM) and the Dietary Approaches to Stop Hypertension (DASH). MIM includes mindful awareness and movement from a seated position, breathing exercises, healthy sleep, and guided mindfulness meditation. The DASH component will be tailored for Black Americans. It uses a critical thinking approach that involves problem solving, participant-centered goal setting, health coaching, reflection, and development of self-efficacy (confidence) to promote physical activity and healthy eating. Solid empirical evidence demonstrates its effectiveness in reducing blood pressure among mixed-race samples.

NCT ID: NCT05724420 Recruiting - Stress, Emotional Clinical Trials

STRIVE - Resilience Curriculum for Novice Physicians-In-Training

Start date: April 4, 2023
Phase: N/A
Study type: Interventional

The goal of this trial is to compare self-reported resilience scores in junior physicians-in-training after completion of formal resilience training. The main questions this trial aims to answer are: - Does formal resilience training improve self-reported resilience scores? - Does the timing of resilience training (i.e., first vs second year of residency training) impact the effect of training? All participants will be provided with resources on resilience and learner support as per usual institutional practice. The intervention group will also participate in a formal resilience training program. Researchers will compare self-reported resilience scores 3 months after training to determine the effect of the training program.

NCT ID: NCT05721482 Recruiting - Hypertension Clinical Trials

Stress and Hypertension in Dementia Caregivers

MIM-DASH
Start date: January 17, 2023
Phase: N/A
Study type: Interventional

No demographic group is more at risk for the double jeopardy of caregiving stress and hypertension (HTN) than African American women caring for a family member with Alzheimer's disease and related dementias (ADRD). Both situations lead to reduced quality of life and cardiovascular disease-a complication of uncontrolled hypertension. Maintaining the health of these caregivers is critical to support the well-being of the care recipients. Although some multi-component interventions have addressed ADRD caregiver's stress and quality of life, gaps remain in targeting interventions to address the complexity of chronic caregiving stress and hypertension self-care in African American women. This pilot study builds on the investigator's earlier work which showed that stress, blood pressure knowledge, and complex diet information deficits all interfered with older African American women's hypertension self-care. Lifestyle changes (stress management, reducing sodium, eating fruits/vegetables, and physical activity) are effective in managing hypertension. The investigator's Stage I pilot study is based on the scientific rationale that these lifestyle changes can be promoted by addressing stress reactivity/stress resilience, the psychological and physiological response of the body to stress, as the underlying mechanism to facilitate behavioral change. In this way the study can improve health outcomes (caregiver stress, quality of life, cardiovascular disease risk).

NCT ID: NCT05629637 Recruiting - Clinical trials for Stress, Psychological

Feasibility and Acceptability of Mindfulness-based Resilience Training for Rural Law Enforcement Officers

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

Rural law enforcement officers (LEOs) are exposed to unique and significant stressors, yet have access to fewer resources, compared to urban counterparts, to mitigate harmful effects of stress. This elevates risk for maladaptive coping strategies such as problematic alcohol use, mental health consequences, and aggression and excessive use of force. The proposed supplement will assess feasibility and accessibility of Mindfulness-Based Resilience Training (MBRT), with added intervention components addressing alcohol use, in under-resourced rural LEOs to ensure success in a future multisite efficacy trial assessing effects of MBRT on mental health and behavioral outcomes.

NCT ID: NCT05552053 Recruiting - Depression Clinical Trials

Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women

RISE
Start date: June 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

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

NCT ID: NCT05525299 Recruiting - Clinical trials for Psychological Distress

Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors

Start date: October 30, 2022
Phase: N/A
Study type: Interventional

Target Issue: Cognitive impairment in older cancer survivors is highly prevalent and the co-existing neuro-psychiatric symptoms, particularly depression, would further complicate the psychosocial consequence of existential suffering. However, no reminiscence-based interventions are specifically developed for older people with cancer have been developed and evaluated. Target Population: Cancer survivors aged 65 years old and above with a mild cognitive impairment identified by the HK-MoCA 5-Min Protocol cognitive assessment. Intervention: This research project aims to implement a brief reminiscence-based intervention that includes six reminiscence chatting sessions among older cancer survivors. The proposed reminiscence-based intervention has great potential to provide psychological and spiritual care as well as comfort to those who are weak, aged and are in need of assistance. Study Objectives: 1. To evaluate the effect of a reminiscence-based life review intervention on copying with existential suffering including meaning of life (primary outcome), cognitive function, psychological distress and social support (secondary outcomes) in older cancer survivors 2. To explore older cancer survivors' experience of the intervention regarding the impact of the intervention on their existential suffering Study Method: The investigator will recruit 116 voluntary elder patients from the outpatient oncology clinics of the Queen Mary Hospital to participate in the study. They will be individually randomized at a 1:1 ratio to receive usual care or the brief reminiscence-based intervention at home. Outcomes will be assessed at baseline (T0), post-intervention (T1), and 6-week follow-up (T2). A qualitative interview regarding the feedback on the intervention will be undertaken only in the intervention group.

NCT ID: NCT05521360 Recruiting - Clinical trials for Stress, Psychological

Autonomic Modulation Training for Police Exposed to Post-Traumatic Stress Injuries

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

Police officers are exposed to hazardous, disturbing events that impose stress and long-term trauma. Upwards of 15-26% of public safety personnel (PSP) report one or more mental health symptoms. Accumulated stress and posttraumatic stress injuries (PTSI) result in chronic physical and mental health disorders including anxiety, depression, substance abuse, and cardiovascular disease. PTSI are related to reduced occupational performance, absenteeism, and risky behaviour, with implications for both police and public safety. Recent empirical evidence and government reports highlight a mental health and suicide crisis among various PSP sectors in Canada. Prior research forms an urgent call for evidence-based programs that build resilience and wellness capacity to prevent PTSI symptoms before they manifest as severe, chronic, diagnosable disorders. The current study addresses the limited effectiveness issues associated with existing interventions for PTSI among PSP and also considers sex and gender as central determinants of health. Advances in physiology and neuroscience demonstrate that resilience is maintained by the healthy functioning of psychophysiological systems within the body. Objective biological measures have shown that chronic stress and trauma disrupt both psychological and physiological functioning, eroding resilience and reducing wellness capacity. Traditional interventions to build resilience among PSP have not adequately addressed the physiological underpinnings that lead to mental and physical health conditions, as well as burnout and fatigue following trauma. Together with previous empirical research lead by the NPA, the current proposal addresses this gap in PSP intervention research by employing Autonomic Modulation Training (AMT), a biological approach to building resilience and wellness capacity among PSP exposed to PTSI. Prior research shows that core AMT techniques effectively reduce psychophysiological stress and mental health symptoms in clinical and non-clinical populations. Further, research has shown that AMT techniques improve police health and occupational performance when completed during scenario-based, in-person training. The aim of the proposed study is to test if a web-based delivery of AMT for police officers can build resilience and wellness capacity, and reduce symptoms of PTSI with similar effectiveness as in-person training. An additional novel scientific contribution of the current proposal includes an examination of sex and gender in baseline biological presentation of PTSI among police, and in response to a resilience building intervention.