Effectiveness of ICBT for Severe Health Anxiety in Clinical Psychiatry.
Health AnxietyHypochondriasis5 moreThe aim of this study is to evaluate the clinical effectiveness of internet-based cognitive therapy for severe health anxiety within regular psychiatric care. A longitudinal cohort study will be conducted investigating 400 patients who have received ICBT for severe health anxiety between 2018-2020 in an outpatient psychiatric clinic providing Internet-based treatment. The primary outcome measure will be the Short Health Anxiety Inventory, SHAI, and a within-group design with repeated measures will be used for primary analysis. It is hypothesized that ICBT will be associated with a significant reduction in health anxiety as measured with SHAI, both after treatment and at six-month follow-up.
Effect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder
Social Anxiety DisorderThe purpose of this study is to learn more about how the hormone, oxytocin, impacts social behavior in terms of cooperation with others, attention processing, and reward processing, among patients with social anxiety disorder. Based on available research, the investigators predict that in patients with social anxiety disorder, oxytocin will improve social cooperation during an online ball-tossing game called Cyberball, reduce attention toward socially threatening cues during a dot-probe task, and lead to greater willingness to work for monetary rewards for others rather than themselves during an effort expenditure task.
WEUKBRE5559: IMI PROTECT: Benzodiazepines & Fracture
Anxiety DisordersThe studies described in this protocol are all performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Workpackage 2 and Workgroup 1. Primary aim of these studies is to develop, test and disseminate methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE) studies applicable to different safety issues and using different data sources. To achieve this, results from PE studies on five key adverse events (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the methodological aspects of the studies in this protocol and not on the clinical consequences of the association under investigation. Benzodiazepines (BZDs) are one of the therapeutic groups most widely used, mainly indicated as hypnotics and anxiolytics. Guidelines recommend treatment courses not exceeding 4-6 weeks. However, long-term treatment is highly prevalent, particularly in older people with a prevalence ranging from 15 to 30%. However, treatment is often taken as needed. Hip/femur fractures are a major cause of morbidity and mortality, impair quality of life and impose a considerable economic burden. Among people aged 50 years and older, a case-fatality rate of 20% is associated within the first year. The relationship between benzodiazepines and hip fractures remains controversial. Psychotropic medication has been traditionally associated with hip fractures. Among psychotropic medication, long elimination half-life benzodiazepines were found to increase the risk of hip fractures in a case-control study published in the late eighties. Since then, several investigations have been performed, mostly in older patients focusing on the relationship between benzodiazepines and hip fractures, and between benzodiazepines and falls as a mechanism underlying this effect. A review performed in 2003, which included 11 epidemiological studies, reported that results were not always consistent. Seven out of eight cohort and population based case-control studies, found an association, but different results were reported according to benzodiazepines' half-life. In four hospital-based case-control studies no association between benzodiazepines use and hip fracture has been described. Data on dosing was only included in three of the studies, and once more results were not conclusive. Results ranged from no effect to an increased risk with high dose regimens. Results from subsequent succeeding studies have also shown contradictions, with no association reported in one of the studies, and an association described for the short-term use of short half-life, high-potency benzodiazepines. Even though there is epidemiological evidence suggesting that the use of benzodiazepines increases the risk of hip fractures, problems rise with the definition of benzodiazepine exposure, or biases such as confounding by indication and the control for confounders. These remain unresolved topics that should be addressed in future studies. In the present protocol, it is proposed to further asses the risk of hip/femur fractures associated with benzodiazepines using different study designs in different primary databases, and to compare the results in order to evaluate the impact of design and population differences on the outcome of the study association. The objective of this study is to assess the association between benzodiazepines use and hip/femur fracture with different study designs (descriptive, cohort, nested case-control, case crossover and self control case series) across different primary care databases (Bavarian, Mondriaan, National Databases (Denmark), General Practice Research Database (GPRD), Base de Datos para la Investigación Farmacoepidemiologica en Atencion Primaria (BIFAP) and The Health Improvement Network (THIN)) and to compare the results between databases, across designs to evaluate the impact of design/database/population differences on the outcome of the studied association.
The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors
Gastric BypassDepression1 moreThe morbidly obese frequently present with mood and anxiety disorders, which are often treated with serotonin reuptake inhibitors (SRI) antidepressant drugs. The investigators hypothesized that gastric bypass surgery would decrease the absorption of SRI. The investigators also wished to determine whether a reduction in SRI levels would increase the likelihood of worsening depressive symptoms.
Effects of a CRF1 Receptor Antagonist on Human Startle in Normal Female Volunteers
Anxiety DisordersBackground: - Research has shown that the hormone corticotropin-releasing hormone (CRH) is involved in stress and anxiety, and that drugs that block the effect of CRH in the body can reduce anxiety. GSK561679 is an experimental drug that attempts to reduce anxiety by blocking the effect of CRH. Researchers are interested in comparing GSK561679 with other treatments for anxiety. Objectives: - To determine the effectiveness of GSK561679 compared with placebo and alprazolam (Xanax), as a possible treatment for fear and anxiety. Eligibility: - Healthy female volunteers between 21 and 50 years of age. Design: This study will involve one screening visit, four testing visits, and one follow-up visit over a period of 8-9 weeks. The testing sessions will be between 6-11 days apart. Participants must follow these dietary restrictions to participate in the study. No nicotine, alcohol, or caffeine (including chocolate and soft drinks) for 24 hours before the start of the study. No nicotine in the past 6 months, and no nicotine until the final blood sample is collected at the follow-up visit. No alcohol or caffeine for 24 hours before a testing visit or for 72 hours after each visit. No grapefruit or grapefruit products from 14 days before the first dose of study medication until collection of the final blood sample. Participants will receive a dose of GSK561679, alprazolam, or placebo 3 hours before the testing, and will take an additional pill 1 hour before the testing. During the tests, participants will receive brief electric shocks and hear sudden loud noises. The noises and shocks will be given over a period of approximately 40 minutes per session. Skin conduction, heart rate, and blinking will be monitored throughout the tests, and participants will be asked about anxiety levels and will be tested on mood, memory, and concentration. Blood and saliva samples will also be taken during these sessions. Participants will stay in the clinical center for 1 to 2 hours after the study testing to ensure that the sedation has worn off. Participants will not be allowed to drive home or take public transportation alone after study visits, so alternative transportation must be arranged.
Information and Anaesthesia in Paediatrics
AnxietyThis study aims to investigate whether detailed and illustrated information (comics) about anaesthesia reduce preoperative anxiety in children being subjects to craniotomy. Children scheduled for craniotomy are randomized to groups receiving a comic leaflet explaining the course of anaesthesia before preanaesthesia visit or no intervention. Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.
Quality of Life in Younger Leukemia and Lymphoma Survivors
Anxiety DisorderCancer Survivor8 moreRATIONALE: Collecting information about the effect of hematologic cancer and its treatment on quality of life may help doctors learn more about the disease and plan the best treatment. PURPOSE: This phase I trial is studying quality of life in younger leukemia and lymphoma survivors.
Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)
Social PhobiaThe study is designed to evaluate the safety and efficacy of paroxetine on the long-term use in Japanese Social Anxiety Disorder (SAD) subjects.
Pet Partners for Promotion of Academic Life Skills
Stress PreventionCortisol11 moreThe current study utilized a randomized controlled trial, conducted in a real-life setting, to determine whether, how, under which conditions, and for whom, infusing various levels of human-animal interaction (HAI) in a 4-week, university-based stress prevention program provides an effective approach to prevent negative ramifications of university students stress, promote student executive functioning and learning, while safeguarding animal welfare. This study will examine effects of sole exposure to evidence-based stress prevention content, hands-on HAI with registered PET Partner teams, or combinations thereof on students' moment-to-moment well-being and longer-term functioning in socioemotional, cognitive and physiological domains.This study will also develop a comprehensive coding system and measure the dynamic nature of behavior of participants, handlers and animals during university- based animal assisted activities, as well as the HAI environment. The data and analyses will then be utilized to inform the development of a quantitative measure to capture of the quality of human animal interaction in various settings to experimentally determine causal pathways underlying program effects on humans and animals.
Music's Effects on Anxiety During Epidural Placement
AnxietySatisfactionThe objective of the study is to determine if playing the song "Weightless" by Marconi Union during labor epidural placement, decreases laboring parturient anxiety and improves satisfaction with the experience.