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Depressive Symptoms clinical trials

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NCT ID: NCT05061225 Not yet recruiting - PTSD Clinical Trials

The Efficacy of a Physical Activity Counselling Intervention on Mental Health in Firefighters

Start date: October 11, 2021
Phase: N/A
Study type: Interventional

Objectives: The aim of this project will be to evaluate the efficacy of a lifestyle PA counselling program for physically inactive first responders with at least mild symptoms of either anxiety, depression or stress and their chosen support partners compared to a waiting list, and to determine the mediating effect of autonomous motivation. Additionally, the randomised controlled trial will be complemented with qualitative interviews to provide a deeper context and understanding to the quantitative findings. To the best of our knowledge, no randomized controlled trial to date has examined the outcomes of an online physical activity counselling intervention using peer-support in firefighters. Methods: Within mixed methods randomized controlled trials, we will follow a sequential explanatory design. In this design, qualitative results complement and help interpret quantitative findings. In order to address the main aims, a randomized controlled trial will be executed. CONSORT statement will be followed for reporting findings. Protocol will be submitted to clinicaltrials.gov. For addressing the secondary aim of the study, the study will follow a qualitative design based on interpretative phenomenology. Phenomenology is a model used for describing, understanding, and interpreting the lived experiences of the participants by means of discourse analysis. For the quantitative component, two arms with 24 firefighters will be required. Additionally, chosen support partners will enter the intervention arm. Participants in the intervention arm will be invited to a private facebook page where the researcher will upload weekly educational posts regarding different aspects of physical activity. For the qualitative component, participants will be invited to 2-3 focus groups where the experiences of the participants on the program will be discussed.

NCT ID: NCT04988529 Not yet recruiting - Depressive Symptoms Clinical Trials

Investigating the Effect of a Smartphone-based Serious Game on Depressive Symptoms.

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

The objective of the present project is to study the effect of a smartphone-based serious game intervention for depressive symptoms. The serious game is based on Cognitive Behavior Therapy CBT, being behavioural activation and the promotion of physical activity one of the most important components.

NCT ID: NCT04966650 Not yet recruiting - Depressive Symptoms Clinical Trials

Brief Nursing Advice for University Students With Depressive Symptoms

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

1. Project title Effectiveness of a Brief Nursing Advice in Promoting the Psychological Well-Being for University Students with Mild to Moderate Depressive Symptoms: A Randomized Controlled Trial 2. Investigators Principal Investigator Ms. Tiffany PY CHAN, Doctor of Nursing (Year 3 candidate), School of Nursing, The University of Hong Kong (HKU) Nursing Officer, University Health Service, The Chinese University of Hong Kong (CUHK) Co-investigator Dr. William HC LI, Associate Professor, School of Nursing, The University of Hong Kong (HKU) Dr. Scotty Luk, Director, University Health Service, The Chinese University of Hong Kong (CUHK) 3. Study site Recruitment of participants will be conducted on campus in CUHK 4. Aims of the project This study aims to assess the effectiveness of a brief nursing advice in reducing depressive symptoms among university students who presented mild to moderate depressive symptoms at the University Health Service. 5. Outcomes The primary outcome of this study is the university students' decreasing level of depressive symptoms.

NCT ID: NCT04902313 Not yet recruiting - Depressive Symptoms Clinical Trials

Cultivating Resilience in Oncology Practice

CROP
Start date: May 31, 2021
Phase: N/A
Study type: Interventional

The purpose of the CROP study is to investigate the potential to cultivate psychological resources and resilience in childhood cancer patients and their family members using a mobile phone-based intervention. The feasibility study aims to evaluate the implementation and participant experience of the digital intervention and register psychological outcome measures preliminary evidence for its acceptability, feasibility, and potential beneficial effects.

NCT ID: NCT04856033 Not yet recruiting - Ptsd Clinical Trials

Transcendental Meditation and PTSD

Start date: October 2021
Phase: Phase 3
Study type: Interventional

This paper describes the rationale and design of a Phase 3 RCT comparing Transcendental Meditation to Present Centered Therapy for posttraumatic stress disorder (PTSD), suicidal ideation, alcohol use, and depressive symptoms in Veterans. In this multisite trial, 450 Veterans meeting Diagnostic and Statistical Manual-5 (DSM-5) criteria for PTSD will be recruited from nine VA and academic medical center sites across the U.S. Study outcomes include changes in PTSD diagnosis and symptom severity (primary), suicidal ideation, alcohol use, and depressive symptoms. Participation includes baseline testing and post-treatment assessments at 12, 24, and 36-weeks. During each assessment visit, Veterans will complete diagnostic interviews, including the Clinician-Administered PTSD Scale for DSM-5 and the Alcohol Timeline Followback, as well as validated self-report measures. Cost-effectiveness of the treatments will be measured using intervention and healthcare costs, the proportion with PTSD diagnosis removed, and Quality-Adjusted Life Years. Finally, single-site substudies will examine pre-to-post-treatment changes in PTSD biomarkers and on magnetic resonance imaging (MRI).

NCT ID: NCT04708522 Not yet recruiting - Depressive Symptoms Clinical Trials

Breath Control and Mindfulness for Post Concussion Anxiety and Depression: a Feasibility Study

Start date: January 2021
Phase: N/A
Study type: Interventional

Persistent-post-concussion symptoms (PPCS) is a condition that effects on average one in seven persons following a concussion. Anxiety and depression symptoms are experienced by over one-third of those with PPCS. These symptoms can delay recovery from a concussion. Two techniques used to treat anxiety and depression symptoms are breath control and mindfulness exercises. This 8-week feasibility study will evaluate the implementation and compliance of a remote delivered breathing and mindfulness treatment program for individuals experiencing PPCS anxiety or depression symptoms.

NCT ID: NCT04444713 Not yet recruiting - Depressive Symptoms Clinical Trials

Do Network Centrality Predict Overall Depression Symptom Reduction With Lifting of Social Distancing Protocols?

Start date: June 22, 2020
Phase:
Study type: Observational

The aim of the study is to identify symptom-level intervention targets for depression related to the COVID-19 outbreak. First, we will assess centrality indices of the network of depression symptoms plus mechanism variables derived from the metacognitive model of psychopathology measured at a period of strict social distancing protocols (T1). Then, we will examine whether change in the most central symptom and metacognitive variables are more related to overall symptom reduction from the period of strict (T1) to a period of lifted social distancing protocols (T2) three months later. On the basis of the results, interventions can be suggested that protect the general public against increased psychological suffering and dysfunction during society's handling of pandemics.

NCT ID: NCT04378257 Not yet recruiting - Depressive Symptoms Clinical Trials

Efficacy of Therapist Guided e-Therapy Versus Self-Help Therapy on Psychological Distress Among Individuals in Oman During COVID-19 Pandemic

Start date: June 1, 2020
Phase: Phase 3
Study type: Interventional

Background: COVID-19 (Corona Virus Disease 2019) is a virulent infectious disease with an incubation period ranging between 2-14 days. This highly contagious disease is caused by Sars-Cov-2 (Severe Acute Respiratory Syndrome Coronavirus 2). The number of people infected by COVID-19 has increased exponentially since January as a result of traveling and contact with COVID-19 infected individual. Initially, the seriousness of COVID-19 was not gauged properly until World Health Organization classified it as Pandemic type infectious disease and rapidly made plans actions to fight against it on 20 January, 2020. The uncertainty and low predictability of COVID-19 not only threaten people's physical health, but also affect people's mental health, especially in terms of emotions and cognition. As consequence of public emergency, with its economic health and social impacts, psychological repercussions among people are inevitable at the short and long term. Importance and justify the study: This study will assess the effectiveness of e therapy in treating anxiety and depression during a pandemic. This would be a novel way of providing therapy during crises Hypothesis: We hypothesize that compared to self-help email delivered therapy, the therapist guided e-Therapy is more efficacious in reducing the level of psychosocial stress among distressed individuals in Oman during COVID19. Objective: The aim of this study is to assess the efficacy of six weeks therapist guided e-Therapy versus Self-help e-mail delivered therapy on Psychological distress among random sample of individuals live in Oman during COVID 19 pandemic. This study will recruit 60 participants from a list respondents to public survey who reported high levels of depression and anxiety, and randomize them to either therapist guided e-psychotherapy(intervention) or (control) self-help arms. Participants in the intervention arm will receive six sessions of therapist guided e therapy as described in the study schedule. Participants in the control arm will receive self-help psychotherapy contents similar to the intervention arm as detailed in the study schedule. Throughout the study, outcome and safety assessments will be conducted.

NCT ID: NCT04307875 Not yet recruiting - Hypertension Clinical Trials

Hypertension and Diabetes Assessment in the Rohingya Refugee Population and in the Host Communities in Bangladesh

Start date: October 1, 2021
Phase:
Study type: Observational

Due to a massive outbreak of violence against the Rohingya minority residing in the Rakhine State of Myanmar in late 2017, several hundred thousand Rohingya fled the country and sought a shelter in Bangladesh. Currently, in the refugee settlement areas east of the city of Cox's Bazar, close to 1 million Rohingya refugees live in refugee camps close to the municipalities of Ukhia and Shamlapur. According to previous examinations, there is a serious burden of non-communicable diseases in Bangladesh. But little is known about the health status and the epidemiology of non-communicable diseases in the Rohingya refugee population in Bangladesh. Most importantly, scientific evidence on non-communicable disease in humanitarian emergencies is rather limited. The aim of this study is to close this gap and to systematically assess the burden of hypertension and diabetes within the Rohingya refugee population in refugee camps in Bangladesh and in the host community in the Chittagong province. This assessment will help to design and to introduce community-based intervention strategies aiming to improve the population health status and reduce the disease burden.

NCT ID: NCT03972020 Not yet recruiting - Breast Cancer Clinical Trials

Mindful-life: Mindfulness Based Intervention vs Cognitive Behavioral Therapy in Patients With Breast Cancer

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Breast cancer is the most common cancer pathology among women worldwide and represents a complex psychological challenge for those affected. Diagnosis and subsequent treatments can have a significant impact not only on the physical well-being of people, but also on their psychological well-being. Tumor-related distress is described as an "unpleasant emotional multifactorial experience of a psychological, social and / or spiritual nature that can interfere with the ability to effectively cope with cancer, physical symptoms and treatment" from the National Comprehensive Cancer Network.Studies have shown that from one third to half of breast cancer patients can experience psychological distress. The psychological distress, understood as symptoms of anxiety, depression and stress, is related to a lower quality of life, a lower compliance related to a lower efficacy of the treatments, a higher mortality and a higher risk of suicide, so much so that this discomfort it is recognized as the sixth vital sign in cancer treatment. Both the diagnosis of cancer and the treatments related to the disease, can lead to the alternation of depressive phases and in some cases even to the presence of major depression: it is estimated that the levels of depression reach thresholds that oscillate between 5 and 25% between women suffering from breast cancer. In reference to what are the interventions aimed at reducing depressive symptomatology in patients with breast cancer, in this study we refer in particular to 2 treatments, of which several studies attest to their effectiveness: interventions based on Mindfulness (MBI) and interventions based on cognitive behavioral therapy (CBT). Cognitive-behavioral therapy (CBT) is an empirically supported treatment for depression. Numerous studies have shown that CBT is both effective in treating acute depression and preventing subsequent relapses and relapses after the end of active treatment. MBI-based interventions have been widely disseminated both at the clinical and research level as short, cost-effective interventions. Several systematic reviews have shown the effectiveness of MBIs in improving anxiety and depressive symptoms, sleep, fatigue, disease adaptation and stress reduction, with coping and well-being improved in patients with chronic illnesses including also the oncological pathologies. In particular, a meta-analysis of studies conducted on women with breast cancer confirmed the effectiveness of MBI in reducing symptoms of anxiety, depression and stress, suggesting the importance of these treatments in improving the mental health of these women. In addition, studies have shown that the improvements achieved are stable even at long-term follow-up.