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NCT01492348
The overall objective of this study is to test the effectiveness of a systems-level approach to primary care recognition and management of PTSD and depression in the military health system. More specifically, the investigators will test the effectiveness of a telephone care management with preference-based stepped PTSD/depression care--STepped Enhancement of PTSD Services Using Primary Care (STEPS UP)--as compared to Optimized Usual Care (OUC). Primary Hypothesis 1: Active duty primary care patients with PTSD, depression, or both who are randomly assigned to STEPS UP will report significantly greater reductions in PTSD and depression symptom severity compared to participants assigned to OUC over 12-months of follow-up. Hypothesis 2: Active duty primary care patients with either PTSD, depression, or both who are randomly assigned to STEPS UP will report significantly greater improvements in somatic symptom severity, alcohol use, mental health functioning, and work functioning compared to participants assigned to OUC over 12-months of follow-up. Hypothesis 3: The STEPS UP program will be both more costly and more effective compared to OUC over the 12-months of follow-up, and will have a favorable cost-effectiveness ratio in terms of dollars per quality adjusted life years saved. Hypothesis 4: Active duty primary care patients participating in STEPS UP, their clinicians, care managers, and family members will report that STEPS UP is acceptable, effective, satisfying, and appropriate PTSD and depression care.
NCT03055468
Introduction: The prevalence of Diabetes Mellitus (DM) is on the rise the world over. About 30% of DM patients suffer from Depression. Depression in DM patients is associated with adverse outcomes including poor medication adherence, poor glycaemic control, and early death. In resource constrained sub-Saharan Africa (SSA) clinics where patient volumes are high and staff shortages rife, peer support has been suggested as a means of delivering psychosocial care for persons with chronic illnesses in order to improve patient's outcomes. However, little has been done to examine the efficacy of peer support on clinical outcomes. Project aims: The main study objective will be developing a peer support model of depression care for patients with DM and testing its efficacy on clinical outcomes. Methods: This study will employ both qualitative and quantitative measures. First, the investigators will present the peer support model to health workers within the DM clinic, and ask them about the feasibility of using such a model for DM patients with depression. The investigators will then identify 10 DM patients with major depression and initiate them on antidepressants. Once the patients are in clinical remission, the investigators will interview them to assess their perceptions about the feasibility of using peer support for DM patients newly diagnosed with depression. The investigators will also interview health care workers and hospital administrators to assess their perception about using peer support within the clinics, and potential barriers that need to be addressed before implementation of the model. Based on the data from the qualitative interviews, the investigators will refine and adapt the peer support model, and then train 10 DM patients who have received antidepressants and are in clinical remission to deliver peer support to newly diagnosed patients with depression. Newly diagnosed depressed patients will be randomly assigned to receive either antidepressants plus peer support (n=65) or antidepressants alone (n=65). Study participants will be followed for 48 weeks and assessed for, glycaemic control, depression severity, mental illness stigma, depression treatment uptake and adherence. Result: the investigators anticipate that the findings about the efficacy of peer support on DM and depression outcomes will be useful in generating data about effect sizes necessary for calculating a sample size for a cluster randomized trial (CRT).
NCT01884246
Individuals in Appalachian Kentucky are vulnerable to cardiovascular disease (CVD) by virtue of having high rates of multiple CVD risk factors. There is a critical need to develop and test CVD risk reducing interventions that are appropriate and effective in Appalachia. In the absence of such interventions, the dramatic CVD disparities seen in this area will continue to rise. Lifestyle interventions reduce CVD risk by 44%. The investigators and others have demonstrated that lifestyle change is most effective when patients are given the tools to engage in effective self-care, and that interventions individualized to patients' specific needs and barriers are more effective than interventions that are not. The central hypothesis is that to be successful in Appalachia, CVD risk reducing interventions must focus on patient-centered lifestyle change that increase individuals' abilities to engage in self-care, must be culturally appropriate, and must have components that overcome barriers faced by individuals living in Appalachia. The investigators propose a randomized, controlled comparative effectiveness trial with 300 individuals from Appalachian Kentucky who do not have a primary care provider and who are at risk for CVD by virtue of having two or more modifiable CVD risk factors. The investigators will compare (1) a patient-centered, culturally appropriate, self-care CVD risk reduction intervention (HeartHealth) designed to improve multiple CVD risk factors while overcoming barriers to success with (2) referral of patients to a primary care provider for management of their CVD risk factors. The investigators propose the following specific aims to be tested at 4 months and 1 year after baseline. To compare the short and long-term impact of the interventions on: 1\) the risk factor selected by patients (i.e., tobacco use, blood pressure, lipid profile, hemoglobin-A1c (HgA1c) for diabetics, body mass index, waist circumference, depressive symptoms, or physical activity level); 2) all of the CVD risk factors of each patient; 3) quality of life; 4) patient and healthcare provider satisfaction; 5) desirability and adoptability by assessing adherence to recommended CVD risk reduction measures, and retention of recruited individuals. The investigators hypothesize that in comparison to the referral strategy, the multifaceted patient-centered, self-care intervention will engender more favorable outcomes across all measures.
NCT01579942
The investigators are doing this study to find out if they can use electroencephalographic (EEG) recordings, which measure brain waves, to predict response to antidepressant treatments, as well as to distinguish patients who have depression from those who do not. In particular the investigators want to test the usefulness of a new type of analysis of EEG recordings called brain network activation or BNA. BNA allows to identify patterns of activation in brain networks and to track their changes over time.
NCT02289248
Subjects with depressive episodes will be recruited to undergo a brief 2 week course of IV infusions of ketamine in combination with cognitive behavioral therapy for 8 weeks.
NCT01049789
This is a two-phase study that is designed to test a novel behavioral intervention to treat depression in Human Immunodeficiency Virus (HIV) adolescents and young adults. Four Adolescent Trials Network (ATN) sites will be assigned to either the Combination Cognitive Behavioral Therapy and Medication Management (COMB) treatment group or the Treatment as Usual (TAU) group. Phase I involves pilot testing of a 24-week intervention consisting of Cognitive Behavioral Therapy (CBT) and Medication Management (MM) manuals at sites assigned to the COMB treatment group. Participants enrolled at TAU sites will receive treatment for depression that is typical at that site, which may include medication management, psychosocial therapy, or a combination of the two. Psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Study coordinators and site clinicians, regardless of group assignment, will document depression symptoms and treatment regimens for all participants for 24 weeks. In addition, site staff and participants at COMB sites will participate in an exit interview. The findings from these interviews will be used to revise both CBT and MM intervention manuals at the end of Phase I. Phase II is a feasibility study of the revised CBT and MM manuals. Phase II involves similar procedures as Phase I; sites assigned to COMB will implement the revised CBT and MM manuals. Participants at TAU sites will receive treatment for depression that is typical at that site. As in Phase I, psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Depression symptoms and treatment regimens for all participants will be documented for 24 weeks. Additionally, all Phase II participants will have 2 follow-up visits at weeks 36 and 48. Again, site staff and participants at COMB sites will participate in an exit interview. The findings from these interviews will be used to revise both CBT and MM manuals at the end of Phase II.
NCT02279966
To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning, attention) in working patients with major depressive disorder (MDD).
NCT01567943
The investigators will evaluate the efficacy of a comprehensive 12-week contingency management intervention for treating alcohol dependence for persons with severe mental illness who are seen within the context of a community mental health center setting. The primary contingency will be submission of alcohol-free urines. Additional reinforcers will be provided for intensive outpatient addiction treatment attendance. Reinforcers will be vouchers or actual items useful for day-to-day living. Participants will be 120 adults diagnosed with alcohol dependance and severe mental illness.
NCT01698255
This randomized pilot study will test the feasibility of a behavioral intervention for late life depression. Enrolled participants will receive 9 weeks of a specialized form of psychotherapy we call "ENGAGE" or standard of care psychotherapy. ENGAGE is a stepped care psychotherapy based on what is currently known about older adults' response to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until individuals recover from their depression. The treatment components of ENGAGE were selected to match the most common problems seen in older adults with depression. They include instructing the participant in basic problem solving techniques and encouraging re-engagement in rewarding activities. Participants will be depressed, older adult clients of Westchester Jewish Community Services or outpatient research subjects recruited by the Cornell Institute of Geriatric Psychiatry. In addition to receiving therapy, study participants will also undergo research assessments at the beginning of the study and then at weeks 6 and 9.
NCT00944762
This study will determine the effectiveness of a specialized psychotherapy for treating elderly stroke survivors who are depressed.
NCT01402570
In this study, people who have symptoms of post polio will take oral glutathione supplements for three months. Their levels of fatigue, physical activity and sleep efficiency will be assessed.
NCT01630681
The aim is to evaluate the effects of Internet based Stepped Care on anxiety, depression and health related quality of life in cancer patients with anxiety and depression symptoms, compared to Standard Care, and to evaluate the health-economic effects of the intervention. The investigators also want to examine the development of anxiety and depression symptoms and health related quality of life in cancer patients without initial symptoms. The primary hypothesis is that Internet based Stepped Care (I-SC) is more effective in relieving anxiety and depression symptoms in cancer patients, compared to Standard Care (SC). Secondary hypotheses are that less anxiety and depression symptoms also means improved health related quality of life and that I SC is cost-effective or at least cost neutral compared to standard care. The IT-platform Carebase.se is developed within U-CARE. The platform will be used for delivering of interventions and for collection of all patient reported outcomes. Patients with anxiety or depression symptoms according to the Hospital Anxiety and Depression Scale will be randomized to I SC or SC. Patients with no initial anxiety or depression symptoms will be included in descriptive studies. All patients, in the randomized controlled trial and the descriptive study will followed up during 24 months I-SC comprises interactive support (Step 1) and Cognitive Behavioral Therapy (CBT; Step 2). Step 1 starts directly after randomization and extends over a 24 months period. Step one comprises web-based patient education including psycho-education and easy interventions strategies employed in CBT. Step 1 also includes a FAQ, a discussion board for patients and a personal diary. Project staff (nurses) is responsible for the FAQ and to moderate the discussion board. The nurses will be supervised by a CBT psychologist. They can also turn to other experts in the project group for advices about how to answer patients' questions. Patients with remaining anxiety or depression symptoms at 1, 4 or 7 months after randomization will be offered Step 2. Step 2 comprise conventional Internet based CBT for common psychological concerns. The participants' chooses to work with modules that correspond to prioritized concerns, e.g. anxiety or depression. The CBT is structured and manualized and include conventional treatment methods with homework and weekly contacts with the psychologist. Step 2 extends over a 10-week period.
NCT02323763
The investigators propose to explore the link between bipolar disorder, anxiety, and suicide by investigating intertemporal discounting in depressed, suicidal patients with bipolar I and II disorder who have various levels of anxiety. The investigators will determine the effect of anxiety on their intertemporal discounting (small rewards now compared to larger rewards later) in a decision-making paradigm and investigate the associated functional neuroanatomy using functional magnetic resonance imaging (fMRI).
NCT01263236
The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of LY2940094 in healthy male subjects.
NCT01832805
50 Right-handed antidepressant-free unipolar depressed patients (age 18-65 years) will be treated with in total 20 Theta burst sessions; these will be spread over 4 days. On each stimulation day, a given patient shall receive 5 sessions with a between session delay of 10 to 15 minutes. Patients will be selected using the structured Mini-International Neuropsychiatric Interview (MINI). All will be at least stage I treatment resistant. Because concomitant antidepressant treatment can confound outcome results, all patients will go through a medication washout before entering the study and they will be free from any antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the treatment protocol. Only habitual benzodiazepine agents will be allowed. All patients will be closely matched for gender and age with 50 never-depressed medication-free healthy volunteers. Only baseline measurements will be collected: no volunteer will undergo the treatment. We expect that real Theta burst treatment and not sham will result in a significant and clinical meaningful response.
NCT03039387
Deficient cognitive control (CC) and the use of dysfunctional emotion regulation strategies (ERS) are both central characteristics of major depression. Both are associated with reduced activity of the dorsolateral prefrontal cortex (dlPFC). Transcranial direct current stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the cortical excitability. The goal of this randomized, sham-controlled, double blind clinical trial is to examine the effect of transcranial direct current stimulation (tDCS) on the CC and ERS in depressed patients compared to healthy subjects. Overall, the study will include 44 participants (22 depressed Patients and 22 healthy subjects). Each participant will complete a CC task while receiving sham tDCS in one session and anodal tDCS in the other session (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting phase by means of a questionnaire and psychophysiological measures (heart rate variability). The investigators hypothesize (a) an amelioration of CC by anodal tDCS and (b) a reduced use of the dysfunctional emotion regulation strategy 'rumination' after anodal tDCS. Overall this experiment will provide new and reliable data for the development of new treatment methods.
NCT01887782
This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the standard conventional high frequency left sided stimulation protocol. The Left dorsolateral prefrontal cortex will be the site of stimulation in both treatment conditions. The site of stimulation will be targeted using MRI co-registration. The study seeks to determine if the two treatment protocols have similar effectiveness in treating major depression.
NCT01514422
The purpose of this study is to evaluate minocycline as a potential treatment for bipolar depression when added to a mood-stabilizing medication. Minocycline is an antibiotic that is approved for the treatment of infections and acne. Participation in this research study is expected to last 8 weeks, and includes five outpatient visits.
NCT01957410
To evaluate if somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) obtained with electroencephalography (EEG) and electromyography (EMG) can be used to detect changes in cortical plasticity in responders to a single IV infusion of ketamine as compared to non-responders.
NCT02657980
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment