View clinical trials related to Psychological Distress.
Filter by:Despite being originated in Wuhan, in the China mainland region of the Hubei, Italy has been the hardest-hit country in the world by the COVID-19 pandemic during the month of March. Due to the uncontrollable spread of the contagion, the Italian Government has been forced to impose a series of restrictions and social distancing measures, culminating in the extension of lockdown to the entire Italian territory on March 8th. During this period, the general population has been overwhelmed by feelings of worry, anxiety, and discomfort. The discomfort is reinforced by the lengthening of the lockdown, to the point that it may be considered as a mass model of chronic or subchronic mild stress. The predictable effects of this stress on mental health have already been claimed, Post-traumatic symptoms were found in 7% among 285 Wuhan and surrounding cities' residents during the COVID-19 outbreak. A recent survey in the Italian general population reported similar outcomes. In this context, the psychic conditions of the most fragile ones, i.e. those already affected by a severe mental disorder, represent a major concern. Having a history of psychiatric illness is regarded as one of the most relevant predictors of a negative psychological impact of quarantine. Patients with severe mental disorders may be among the hardest hit subjects, as they may be more vulnerable by the COVID-19 outbreak for a series of clinical and psychological factors. In the Italian context, the vulnerability of these patients may be increased by the lockdown of mental health services as a consequence of mass quarantine and optimization of health resources toward action to contrast COVID-19-related sanitary emergencies. Despite several reports investigated the psychological effects of COVID-19 pandemic on health-care workers, COVID-19 affected people, or the general population, at the moment, no study has investigated the effects of the distress caused by fear of contagion and mass quarantine on severe mental disorder patients. The present study aimed at providing a first evaluation of anxiety, depressive, stress-related symptoms in these patients.
Breast cancer is the most common women's cancer and the third leading cause of death. Advances in prevention, detection and primary treatment have improved overall survival leading to its growing acceptance as a long-term disease. Following the announcement of breast cancer, but also after primary treatment, some symptoms appear directly compromising psychic and physical spheres. Hippotherapy is an emerging specialized rehabilitation approach performed through specially trained horses by accredited health professionals. The proposed hippotherapy program offers key elements for physical, psychic and social reinforcement, complementing conventional care. The aim is to provide patients with tools to consolidate their self-awareness and thus strengthen their ability to cope with the disease.
This study will be a randomized wait list controlled trial studying the efficacy of an Integrative Yoga Therapy for patients with chronic pain and psychological distress. Individualised yoga program will consist of a 8-week guided self-help program. This study will primarily investigate whether an individually tailored yoga can be beneficial for patients suffering from chronic pain reducing pain, anxiety depression, while improving overall quality of life.
This study will examine the effects of a smartphone-based lifestyle medicine (LM) for improving psychological well-being in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of common mental disorders (e.g., depression and anxiety), modifying different lifestyle factors simultaneously may be effective to improve our psychological well-being. Chinese dietary recommendations will be integrated into the app to increase the acceptability towards mental health intervention. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for improving psychological well-being.
Title: Acceptance and Commitment Therapy for older adults experiencing psychological distress: A hermeneutic single case efficacy design (HSCED) series. Anxiety and depression in older age is associated with increased level of disability and lower quality of life (OAs). Unfortunately, pharmacological treatments are disproportionality relied upon to manage the mental health of OAs. Despite cognitive behaviour therapy (CBT) being the recommended psychotherapy, there is evidence that CBT is less effective for OAs than younger populations. An alternative treatment, Acceptance and Commitment Therapy (ACT), has been shown to be effective in reducing distress for OAs experiencing physical health difficulties. Several case studies have also indicated that ACT can be effective for OAs with psychological difficulties. ACT aims to change how a person interacts with their thoughts/feelings; to reduce avoidance; and to promote value-focused living. The study aims to use an adjudicated HSCED to answer the following questions: i) Is ACT an effective intervention for older adult clients experiencing psychological distress. ii) Do meaningful changes occur for client-participants over the course of ACT intervention? iii) What specific factors (ACT-specific, non-specific, extra-therapeutic) contribute to observed changes? iv) Are observed changes broadly attributable to the ACT intervention? v) What adaptations may facilitate change when using ACT with older adult clients. For the study, up to four participants will be recruited from an OA community mental health team, each receiving up to 12 individual sessions of ACT. Participants will be required to complete a number of questionnaires throughout the study, including before/after sessions. Post-treatment, there will be a semi-structured 1:1 interview to explore any changes participants experienced, before a six-week follow-up is employed to check stability of change.
Patients undergoing hematopoietic stem cell transplantation (HCT) often continue to experience anxiety, depression, isolation, and other psychosocial distress due to the severe nature of the transplant experience. Storytelling interventions that provide an opportunity for emotional disclosure have shown preliminary efficacy to alleviate psychosocial distress and improve emotion regulation during health challenges. Not only are these changes observed in response to such interventions, but they can also be directly strengthened with HRV biofeedback (HRVB) training, a device-driven breath pacing practice that uses colored light signals to provide feedback to increase vagal tone and improve emotional responses and sleep quality by regulating negative affect and stress. This randomized controlled trial will explore the effects of HRV biofeedback (HRVB) training combined with a digital storytelling intervention and changes in psychosocial distress with a modified waitlist control in a population of Hematopoietic cell transplantation (HCT) patients.
Psychological and existential distress are a common cause of suffering among patients nearing the end of life, and a major reason for requesting medical aid in dying. Existing treatments for psychological and existential suffering have low efficacy and are challenging to use in a palliative context. There is a need to develop scalable, brief, and rapidly effective therapeutic approaches that can reduce psychological and existential distress in patients nearing the end of life. Repetitive Transcranial Magnetic Stimulation is an effective treatment for refractory depression, and new protocols and increasing availability of rTMS may make this therapy feasible and acceptable for patients who suffer from psychological or existential distress near the end of life. Among patients with advanced illness followed by a PC provider, the study objectives are to: 1. Identify the lowest and range of therapeutic rTMS dose to relieve psychological distress, including an analysis of clinical predictors of response. 2. Test the feasibility and preliminary efficacy of rTMS for the treatment of psychological distress including: 1) ease of recruitment; 2) completion of follow-up; 3) effect size and variance estimates of treatment for primary and secondary outcomes; and 4) patient satisfaction with treatment. This study is a phase 2a dose-finding open-label clinical trial, followed by a phase 2b prospective, sham-control or sham-crossover study, depending on the therapeutic dose identified in phase 2a. The investigators will enroll eligible patients from an inpatient palliative care unit and administer rTMS according to established best practice international guidelines. Two screening tests will be conducted (one completed by patient and another by the treating physician) to ensure the patient has no contraindications to rTMS. In the open-label dose-finding study, investigators will determine the appropriate dose of treatment that leads to positive patient outcomes, assess characteristics associated with positive and rapid response to rTMS, and examine if this treatment is feasible and acceptable to patients by measuring rates of enrollment and completion of the treatment sessions. Based on results from this first phase, a phase 2b feasibility and preliminary efficacy randomized clinical trial will be conducted to measure the effect of rTMS by comparing patient symptoms before and after the rTMS intervention.
We conducted a randomized, controlled trial of dignity therapy for terminally ill patients with the aim of reducing dignity-related distress and demoralization and improving spiritual well-being.
Background: Emotional problems such as symptoms of depression, anxiety and psychosocial distress are the leading contributors to health burden among adolescents worldwide. There is an urgent need for evidence-based psychological interventions for young people, especially those living in adversity. WHO has developed Early Adolescent Skills for Emotions (EASE), a brief group psychological intervention delivered by non-specialist providers for young adolescents impaired by distress and exposed to adversity. We aim to evaluate the feasibility of delivering EASE for young adolescents living in public schools of rural Rawalpindi, Pakistan. Objectives: To evaluate the feasibility of delivering Early Adolescent Skills for Emotions (EASE) program to young adolescents and their caregivers in Rawalpindi, Pakistan to inform the design, including sample size estimation, for a full-scale adequately powered definitive cluster randomised controlled trial. Methods: A two arm, single blind, pilot cluster randomized controlled trial will be conducted with adolescents of both gender (aged 13-15 years) with high psychological distress, studying in grade 8 and 9th of middle and high public school in rural Rawalpindi. Schools will be the units of randomization. 8 public schools, stratified by gender, will be randomized into EASE plus Treatment as Usual (TAU) (n=4) and TAU alone (n=6). 60 young adolescents at-risk of psychosocial distress as assessed by Self-Reported-Pediatric Symptom Checklist (PSC), cut-off ≥28 will be included in the study. No power calculations have been calculated for the present pilot trial; however, the sample will be adequate to inform the parameters of planned definitive cRCT. In the intervention arm, adolescents will receive 7-weekly group sessions and their caregivers will receive 3-weekly group sessions in public schools. Data on the number of outcomes will be collected at baseline, immediately and 3-months' post-intervention follow-up. The findings will inform the sample size required for a definitive trial. A detailed mixed-methods process evaluation will be conducted to identify areas of improvements prior to proceeding to a definitive cRCT. Discussion: The results of pilot trial will be used to inform the design of definitive cluster randomized controlled trial in government led scaled-up implementation of healthy school initiative in Rawalpindi district of Pakistan.
The overall objectives of the Optima project is to: (1) Compare the effect of standardized group based cognitive therapy and cardiac rehabilitation versus usual cardiac rehabilitation in patients with sign of psychological distress measured by a questionnaire (HADS score), (2) To investigate spontaneous variation in psychological distress with HADS over time in order to optimize time of measuring HADS. (3) To investigate if the intervention can be implemented to other cardiac rehabilitation sites with the same effect as on BFH (that it is not person dependent).