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Filter by:This study will evaluate the efficacy and safety of ALKS 5461.
This study will evaluate the efficacy and safety of ALKS 5461.
The aim of this study is to examine if repetitive computerized cognitive training improves working memory in patients who are on sick leave due to complex symptom disorders (chronic pain, chronic fatigue, anxiety, depression and or sleep disorders), and whether effects of cognitive control training transfer to other tasks.
Background: - People with attention-deficit hyperactivity disorder (ADHD) often have problems with motivation and rewards. . Omega-3 fats have helped symptoms of ADHD improve in children. Researchers want to learn more about the brain activity of people with ADHD and see how taking omega-3 fats might help. Objective: - To learn more about how omega-3 fats affect brain activity and ADHD symptoms. Eligibility: - Adults age 18 55 with ADHD symptoms. Design: - Participants will be screened with medical history and review of medical records. - For study visit 1, participants will have a medical examination and be interviewed to confirm they have ADHD. They will have an IQ test and give blood and urine samples. Height, weight, and blood pressure will be measured. They will also need to sign consent to agree to take part in the study. They will be asked to complete a food diary for 4 days - For visit 2, participants will give a blood sample. They will complete questionnaires about their mood and ADHD symptoms.. They may give a blood or saliva sample for genetic testing. - Participants will have a magnetic resonance imaging (MRI) scan. They will lie on a table that slides in and out of a metal cylinder. It makes loud noises; participants will get earplugs. This scan examines the structure of the brain. - Participants will have a functional MRI scan. This scan measures the function of the brain while the volunteer is performing tasks in the scanner. They will stop ADHD medications 48 hours before this scan. - Participants will receive key-lime flavored omega-3 smoothie mix or placebo to takeevery day - For visit 3, participants will give blood samples and complete questionnaires. - For visit 4, participants will be weighed and have a blood test and MRI scans as per before. They will repeat the questionnaires and will guess whether they received the omega-3 or placebo.
The objectives of this 10-week study are to evaluate the efficacy, safety, and tolerability of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive disorder (MDD) who have shown an inadequate response to standard antidepressant treatment. A secondary objective of this study is to assess the pharmacokinetics (PK) of AVP-786 and potential correlations with pharmacodynamic effects.
Children with autism spectrum disorders often engage in problem behaviors such as self-injury, destruction, aggression, and stereotypy. Prior research has clearly shown that these problem behaviors may interfere with learning, daily functioning, and social participation. As such, engaging in problem behaviors has a negative impact on the health and quality of life of children with autism spectrum disorders and their families. One promising solution to reduce problem behaviors in this population is the Prevent-Teach-Reinforce (PTR) model, which relies on the evidence-based practices of positive behavior support. Although the use of PTR has been gaining considerably support in schools, the model has never been evaluated as part of a rigorous large-scale study using parents as interventionists. Thus, the purpose of the project is to conduct an assessment of the effectiveness of a home-based version of the PTR model in reducing problem behaviors in children with autism spectrum disorders and in improving families' quality of life. Our hypotheses are that implementing the PTR will (a) produce larger reductions in problem behaviors than participating in an individual parent training session, (b) increase engagement in prosocial behaviors, (c) decrease parental stress, and (c) improve the quality of life of the family. The results of the study will allow an examination of whether PTR is an effective and acceptable model to reduce problem behaviors at home in this population. Given that problem behaviors incur high societal costs when they persist into adolescence and adulthood, the study may potentially lead to large cost reductions in the treatment of difficulties associated with autism spectrum disorders. By reducing engagement in problem behaviors, the implementation of the model may also promote and facilitate the social participation as well as improve the quality of life and health of children with autism spectrum disorders and their families.
The overarching goal of this study is to build the most cost-effective adaptive implementation intervention involving a site-level implementation intervention strategy: Replicating Effective Programs (REP), and the augmentation of REP using either External Facilitation or a combination of an External and Internal Facilitation to improve patient outcomes and the uptake of an evidence-based program for mood disorders (Life Goals-LG) in community settings.
The study is to explore the effectiveness of omega-3 fatty acids and mindfulness-based stress management program to maintain healthy mental state in hospital nurses. The participants will be junior nurses who work in inpatient wards and are not clinically depressed. The participants will be randomly allocated to four intervention arms: 1) Mindfulness-based stress management program plus omega-3 fatty acids pills ; 2) Mindfulness-based stress management program plus placebo pills; 3) Psychoeducation leaflet plus omega-3 fatty acids pills; and 4) Psychoeducation leaflet plus placebo pills. Thirty participants will be allocated to each arm. These interventions will terminate until three months from registration for each participant. Information about depression and anxiety symptoms (primary outcome), insomnia, burnout, presenteeism, quality of life, sick leave, consultation about mental state of herself, and oxidative stress will be collected at 3 months, 6 months (primary time point) and 12 months from registration for each participant.
This study will investigate the effectiveness of mindfulness-based cognitive therapy (MBCT) for mood stabilization in perinatal women (preconception, pregnant, and postpartum) with a history of mood disorders. MBCT is a short-term group psychotherapy that has shown effectiveness in preventing depressive relapse. MBCT teaches mindfulness practices and cognitive-behavioral techniques.
Background: There is need for more effectiveness studies concerning treatment of emotional symptom problems indicating anxiety and depression in adolescents. SMART is the only treatment manual for combined emotional disorders developed in Norwegian. Purpose: To find the best individualized treatment for adolescents with emotional difficulties by: Finding criteria for the selection of appropriate patients for treatment with cognitive-behavior therapy program SMART in an outpatient population (14-18 years). Finding predictors of completion of treatment program SMART. Examining the effects of treatment with the SMART program at 6 months follow-up. Design: A randomized controlled study in six outpatient clinics in the north of Norway. N= 160 referred adolescents (14-18 years) with score above 6 on the Emotional Problems scale of the Strength and Difficulties Questionnaire (SDQ). Two thirds are treated according to the SMART-manual immediately, while the waiting list control group is treated with SMART after six weeks. Hypothesis: The SMART treatment is an effective treatment for emotional symptom problems. Publication: The results sought published internationally and nationally and will be communicated to clinicians.