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Filter by:Hypothesis: Myofascial temporomandibular joint disorder and related symptoms are associated with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter muscle hyperactivity and spasm This study will examine the use of onabotulinumtoxinA (Botox) to treat myofascial pain disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint disorder (TMD) in a double blind cross-over randomized clinical trial by injecting 50 units Botox in temporalis and masseter muscles in 32 patients with 6 months follow up. The objective of the proposed study will be to establish the safety and efficacy of botox in treating TMD associated with bruxism. By the time patients reach the specialists office, most have failed maximal conservative therapies, including non-chew diet, night guard, oral analgesics, muscle relaxants, physical therapy, and a portion have even undergone more invasive procedures, such as manipulation under anesthesia, arthroscopy, and arthroplasty surgeries with limited improvement or recurrence. Primary outcome of the study will be 50% reduction in pain. Secondary outcomes will be 50% reduction in surgical therapy, 25% increase in maximal inter-incisal opening (MIO). The investigators look forward to working with you on the proposed study
This research is a continuation of the Youth Readiness Intervention (YRI) randomized clinical trial by adding additional pre and post intervention data collection upon treatment of the control group (N=222) with the intervention which was proven effective in the larger trial. The overall research has investigated whether participation in the YRI intervention will improve emotional regulation, prosocial attitudes/behavior, social support and daily and functioning among war-affected 15-24 year olds in Sierra Leone. In this sub-study which will involve treatment of the control group with the effective YRI intervention, the investigators will add an additional measure of self-regulation as observed via DNA methylation in buccal cells collected via cheek swabs. As before, after the YRI intervention, youth will be offered a free educational opportunity at the EducAid program in Freetown or in one of its upline/provincial sites. This stage of the research, as in the treatment with the main group, will test whether youth enrolled in the YRI psychosocial intervention go on to demonstrate improved attendance and behavior in a subsidized education program. In the previous phase of the trial, the investigators did observe significant effects for the YRI intervention and evidence that the program is indeed effective. For instance, post-intervention, YRI youth reported greater improvements in emotion regulation (β=0.109, 95%CI 0.026 to 0.191, δ=0.31), prosocial attitudes/behaviors (β=0.149, 95%CI 0.057 to 0.240, δ=0.38), and social support (β=0.119, 95%CI 0.009 to 0.229, δ=0.26) than controls, and greater reductions in functional impairments (β= -0.175, 95%CI -0.299 to -0.050, δ= -0.35). Differences in symptoms were non-significant at six-month follow-up for the full sample; moderator analyses showed that, for individuals in the top quartile of baseline symptoms, YRI youth had greater improvements in emotion regulation and social support than controls. At eight-month follow-up, teachers reported that YRI participants were 8.9 times more likely to be in school (28.8% v. 4.7%) and showed better attendance (β=3.553, 95%CI 0.989 to 6.118, OR=34.93) and academic performance (β= -0.954, 95%CI -1.807 to -0.102, δ= -1.31). In this final phase of the trial as the investigators treat the wait list control group, the investigators will test whether intervention effects observed in self-report data on improved emotion-regulation are also upheld in biomarker data. Thus, the investigators will now provide YRI treatment to the wait list control group and employ the use of biomarkers as a measure of the intervention's effectiveness. The objective of the study will be to assess whether DNA methylation (collected via cheek swabs of buccal cells) is associated with changes in emotion regulation pre- and post- intervention. The aim is to test the hypothesis that the YRI is associated with improvements emotion-regulation evidence both in self-report data on emotion-regulation and in buccal cell DNA methylation. This study will add to the evidence base for effective, culturally sensitive mental health services for youth and young adults affected by war and other forms of adversity.
Hypothesis of this study is that mindfulness meditation would decrease the severity of obsessive-compulsive symptoms.
The purpose of this study is to evaluate adherence to treatment with, and safety and tolerability of, the medical information device #1 (MIND1) system in subjects with Schizophrenia or Bipolar I Disorder who are currently treated with oral aripiprazole.
The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with autism spectrum disorders
This study will examine the effect of offering information sessions to a randomized group of patients with OCD spectrum disorders. Psychoeducation is a component of first line treatment; though intended to be informative in nature, these psychoeducation services can have a positive effect on quality of life, sense of self-efficacy, functioning and a person's readiness to engage in long term treatment. However, no studies have dismantled and tested the independent effect of psychoeducation from standard treatment such as Cognitive Behavioural Therapy. This study aims to directly test the potential effect of one aspect of CBT that if found to be helpful, can become a distinct early intervention component of care so that as people await services, they can profit from the early benefits associated with attending these information sessions. This study therefore sets out to examine the potential early benefits of providing education about the illness on symptom functioning, quality of life and readiness to engage in more formal treatment. We will offer 4 structured information sessions to individuals allocated to a wait list for services related to the treatment of OCD and OCD Spectrum Disorders in order to directly test the benefit of adding a didactic structured psychoeducation program to our services. The study will be a randomized trial where subjects (N=50) will be randomly assigned to receive either 1) 4 educational sessions covering information on diagnosis, treatment, available resources and self care for OCD and OCD Spectrum Disorders or 2) wait list as per usual with no additional information sessions. The experimental design is a 2 (treatment condition) by 2 (assessment phase) repeated measures factorial design. It is hypothesized that subjects participating in the psychoeducation group compared to the wait list control group will see greater reductions in self-reported measures of symptom severity and improvement in other measures of quality of life, level of functioning, self-efficacy and readiness to engage in treatment. If this study can demonstrate that the addition of a short structured informative intervention of 4 sessions can confer early benefits for those suffering with OCD and OCD spectrum disorders, then it provides another route by which patients can improve this condition specifically while waiting for consultation and the opportunity to receive a more structured, evidence-based treatment.
The purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. The first augmentation strategy is Problem Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. The second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication.
This study is an 8-week open-label trial testing Lurasidone (Latuda®) as a treatment for mania in children and adolescents with Bipolar I, Bipolar II, and Bipolar Spectrum disorders. We hypothesize that Lurasidone will be safe, tolerable, and effective in improving the core symptoms of bipolar disorders in children and adolescents ages 6-17.
The specific aim of this cluster-randomized (site) comparative effectiveness research study is to determine whether children who are (1) 5-12 years of age, (2) cared for in ePROS practices or clinics using an electronic health record (EHR), (3) have attention-deficit hyperactivity disorder (ADHD), and (4) are to receive treatment with stimulant medication for the first time in these practices, have superior clinical outcomes if their clinicians have access to an EHR-guided clinical decision support system (intervention group) than if their clinicians have no such access (control group).
The purpose of the study is to explore the efficacy of 6 weeks treatment of an investigational medication, RO4995819, versus placebo as adjunctive therapy in patients with major depression.