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People experiencing severe mental illnesses (SMI), including schizophrenia, psychosis, bipolar disorder and major depressive disorder, are prone to poorer physical health and increased incidences of premature mortality when compared to the general population (De Hert et al., 2009; Hert et al., 2011; Hennekens et al., 2005; Tiihonen et al., 2009 . High-intensity-interval-training (HIIT) is a type of exercise involving alternating short bursts of high intensity exercise with recovery periods of rest/ light exercise (Weston, Wisløff & Coombes, 2014). HIIT improves physical health, quality of life and cognition in the general population and in those with physical health disorders (Gomes-Neto et al., 2017; Hwang, Wu & Chou, 2011; Wen et al., 2019). It has been proposed that HIIT may improve symptoms, physical health and time to discharge among inpatients with SMI. The research will involve three stages: 1) Focus groups, 2) A pilot study, 3) Follow-up qualitative interviews and focus groups. Firstly, a series of focus groups with inpatients with SMI, carers of individuals with SMI and clinical staff will be conducted. The focus groups will scope perceptions of attitudes, and practicalities of a pilot RCT. The information gained will be used to inform a pilot HIIT trial which will evaluate whether HIIT is acceptable and feasible amongst this population group. Each focus group will run for ≈2 hours and will involve an open discussion about the benefits and barriers of conducting HIIT exercise sessions in a population with SMI. Secondly, the HIIT pilot study will be trialed. The final protocol will be developed with feedback from the focus group but will involve an RCT where 12 weeks of HIIT will be compared to 12 weeks of treatment-as-usual (TAU). HIIT will be conducted, twice a week, in a supervised environment using a stationary bike. Inpatients with a diagnosis of SMI will be eligible to participate. Thirdly, follow-up qualitative interviews, with pilot study participants, those that withdrew and those that did not want to take part, and focus groups with clinical staff will address the acceptability and feasibility of HIIT.
Major depression (MD) is common during adolescence and associated with significant morbidity and mortality. One important factor for the development and maintenance of adolescent MD are disturbances in emotion regulation, including deficits in cognitive reappraisal (CR). CR is a particularly effective emotion regulation strategy that aims at reinterpreting emotional events to modify affective responses. Adolescents with MD apply this strategy less often than their healthy peers and show disturbances in brain activation patterns underlying CR. In this study, MD adolescents will be randomly assigned to a group that receives a task-based training in CR or to a control training group. It will be examined whether the task-based CR training is superior to the control training with regard to improvements in negative affect, perceived stress in daily life and depressive symptoms. Moreover, during the four training sessions, the event-related potential "Late Positive Potential" (LPP) will be recorded to assess neurophysiological indices of CR processes and gaze fixations on emotional areas within negative pictures and affective responses to pictures will be collected to identify mechanisms underlying training effects.This study will provide first evidence for the efficacy of a short-time training that has previously shown to be effective in healthy individuals. Moreover, the study will identify neurobiological mechanisms that predict training effects. The results of this pilot investigation will lay the ground for a clinical trial to investigate whether a CR training added to an established intervention improves treatment effects for adolescent MD.
The aim of this mixed methods research is to conduct feasibility pilot testing of an existing mindfulness intervention called HEADS: UP. The intervention is designed to help people affected by stroke self-manage symptoms of anxiety and depression.
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant bipolar depression. In this open-label study, all participants will receive accelerated theta-burst stimulation.
Treatment resistant depression remains a major problem for individuals and society. Surgical procedures may provide relief for some of these patients. The most frequently considered surgical approach is deep brain stimulation (DBS) of a part of the brain called the subcallosal cingulate region. However, the effectiveness and safety is not well established. The investigators will use a novel approach using advanced imaging technique (magnetic resonance tractography) to evaluate the feasibility and safety of this surgical approach. An innovative method for the definition of DBS target will be applied that redefines the concept of targeting as one of targeting a symptomatic network rather than a structural brain region using subject-based brain anatomy to define the target location. The correlation between imaging findings at baseline with the mood score changes at different time points of the study will be investigated.
The purpose of this study is to understand the effectiveness of pharmacogenomic testing in using antidepressants and to understand how EHR - driven clinical decision support system can be used to deliver PGx test results by healhcare providers.
Objective: To analyze the effectiveness and cost-utility as a coadjuvant treatment of subclinical, mild or moderate depression of the recommendations of Mediterranean lifestyles intervention in primary care patients.The effectiveness of a monitoring by Information and communications technology (ICTs), and the effectiveness of the intervention in chronic comorbid pathology will also be analyzed. Methodology: Design: Randomized multicentre pragmatic clinical trial in 3 parallel groups. Subjects: Primary care patients with subclinical, mild or moderate depression. Sample Size: We will recruit 250 patients to achieve a reduction of at least 4.8 points on the Beck depression scale. Interventions: 1. Usual antidepressant treatment with psychological advice and / or psychotropic drugs by the primary care physician (Treatment As Usual - TAU). 2. TAU + Mediterranean lifestyle (ML). Program that will work weekly in 6 sessions of 2 hours in a group to improve the following aspects: daily physical activity + adherence to the Mediterranean diet pattern + sleep hygiene + careful exposure to the ambient light. 3. TAU + ML + ICTs: recommendations of Mediterranean lifestyle (previous point) + monitoring using ICTs. Measurements: The main variable will be the depressive symptomatology evaluated by the BDI II and the secondary variables will be the quality of life, the use of health and social resources, and personal variables related to adherence to the program.
Repetitive Transcranial Magnetic Stimulation (rTMS) is a neuromodulatory technique that is effective in major depression. There is preliminary evidence suggesting that rTMS is effective in peripartum depression as well, however this comes from a number of very small studies. The objective is to study the effectiveness of rTMS in peripartum depression. The investigators will do so using an open label design in which participants will receive rTMS for four weeks. The focus is on clinical improvement in depressive symptoms; however the investigators will also look at other aspects such as perinatal anxiety and maternal-infant bonding as measured by self-report questionnaires.
Major depressive disorder (MDD) is a leading cause of disability worldwide. Up to 50% of patients experience treatment resistant depression (TRD), which accounts for a vast majority of disease burden. Current medications for TRD have limited efficacy and can be associated with intolerable side effects. Therefore, there is a need for finding new treatment targets. Accumulating evidence suggests some patients with MDD including those with TRD, display brain inflammation. Thus, patients with TRD may benefit from medications that can reduce this inflammation. Minocycline is an antibiotic which can cross the blood-brain barrier and has effects on several systems implicated in depression. The principal investigator led the first pilot study of minocycline as an add-on treatment in TRD demonstrating that it led to a significant reduction in depressive symptoms compared to placebo and these findings require replication in a larger sample to confirm the efficacy and tolerability of this treatment approach. This study is a 12 week, double-blind, placebo-controlled trial of minocycline as add-on treatment for patients suffering from a major depressive episode who have failed to respond to at least two adequate trials of antidepressant treatment. After screening and randomization to the two parallel arms of the trial, 50 patients will receive minocycline added to treatment as usual (TAU) and 50 patients will receive placebo added to TAU. Clinical assessment will include the Hamilton Depression Rating Scale (HAMD-17), Clinical Global Impression scale (CGI), Patient Health Questionnaire (PHQ-9), and the Generalized Anxiety Disorder scale (GAD-7) at each study visit (screening, baseline, week 2, 6, and 12). Side effects checklists will be undertaken at each visit. Minocycline will be started at 100 mg once daily and will be increased to 100 mg twice daily at two weeks. Secondary outcomes include inflammatory biomarkers measured at baseline, weeks 6 and 12. This trial will provide further evidence of minocycline's efficacy and acceptability as a treatment option for patients with TRD and provide insights into its mechanism of action.
This study aims to examine the relation between iron status and maternal-child interactions as well as maternal depressive symptoms in mothers from central Pennsylvania.