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Depression clinical trials

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NCT ID: NCT03794531 Enrolling by invitation - Obesity Clinical Trials

Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico

PROSPECT
Start date: December 17, 2018
Phase:
Study type: Observational

The overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,000 adults (30-75 years) in PR recruited with a multi-frame sampling of probabilistic plus community approaches, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.

NCT ID: NCT03768830 Enrolling by invitation - Pain Clinical Trials

Impact of Exercise on "Invisible" Symptoms and Quality of Life in Multiple Sclerosis Individuals

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Patients with multiple sclerosis (MS) struggle on a daily basis with accompanying, "Invisible" symptoms like primary fatigue, pain and emotional-cognitive disorders. With the disease progression, these symptoms only intensify, and in combination with basic physical symptoms, quality of life (QOL) rapidly decreases. An important goal of researchers and clinicians involves improving the QOL of individuals with MS, and the exercise therapy represents potentially modifiable behavior that positively impacts on pathogenesis of MS and these "Invisible" symptoms, thus improving the QOL. However, the main barrier for its application is low motivational level that MS patients experience due to fatigue with adjacent reduced exercise tolerability and mobility, and muscle weakness. Getting individuals with MS motivated to engage in continuous physical activity may be particularly difficult and challenging, especially those with severe disability or Expanded Disability Status Scale (EDSS 6-8). Till now, researchers have focused their attention mainly on the moderate or vigorous intensity of exercise and on cardiorespiratory training in MS patients to achieve improvements in daily life quality, less indicating the exercise content, and most importantly, breathing exercises. In addition, it is investigators intention to make exercise for MS patients more applicable and accessible, motivational and easier, but most important, productive. Investigators think that MS patients experience more stress with aerobic exercise or moderate to high intensity program exercise, and can hardly keep continuum including endurance exercise, or treadmill. Hypothesis: Investigators hypothesis is that 8-weeks of continuous low demanding or mild exercise program with the accent on breathing exercise can attenuate primary fatigue, pain, headaches, emotional-cognitive and sleep dysfunctions in MS patients and provide maintenance of exercise motivation. Investigators also propose that important assistant factor for final goal achievement is social and mental support of the exercise group (EDSS from 0-8) led by a physiotherapist. This will help to maintain exercise motivation and finally make better psychophysical functioning, and thus better QOL.

NCT ID: NCT03742128 Enrolling by invitation - Depression Clinical Trials

Health and Quality of Life Among Resettled Syrians in Norway

REFUGE-I
Start date: November 27, 2018
Phase:
Study type: Observational

Brief summary The civil war in Syria has taken a severe toll on the Syrian population, with over 350 000 dead and more than 10 million Syrians forced to leave their home since 2011. The majority of the estimated 5.6 million Syrians who have left the country as refugees currently reside in Syria's neighboring countries (Turkey, Jordan and Lebanon), while about 1 million have fled to Europe. In the peak year of 2015, a little over 10500 Syrians applied for asylum in Norway and an estimated 26 000 lived in the country at the start of 2018 according to statistics from the Norwegian Directorate of Immigration. Being a refugee or resettled refugee is psychologically stressful and increases the risk of ill mental health. Prior research has demonstrated high to very high levels of posttraumatic stress disorder (PTSD), depression and anxiety in refugees compared to normal populations. As highlighted in prior review articles on the subject, there is a lack of studies on refugees originating from the Middle Eastern countries, and there is a need for future studies on refugee mental health to move beyond the focus on PTSD, depression and anxiety in order to capture the wider psychological consequences associated with being a refugee or resettled refugee. With the current number of displaced people globally approaching an unprecedented 70 million, including more than 25 million refugees, the need to understand and address the health challenges in this population is more pressing than ever. The present study, REFUGE-I, constitutes the first phase of a planned longitudinal cohort study (REFUGE-study) on health and quality of life among resettled Syrian refugees in Norway. The overarching aims of REFUGE-I are to recruit a representative sample of Syrian adults who are willing to participate in the longitudinal cohort study and to obtain baseline information on health-related topics as well as demographics for this recruited sample. REFUGE-I will use a cross-sectional survey design. The study population will be a random and representative sample of 10 000 Syrians over 18 years who arrived in Norway between 2015 and 2017, and who currently live and have a registered residential address in Norway. The sampled group will be contacted and informed about the study through postal mail. Information about the study will also be distributed through other channels: regular media (e.g. television and newspapers), social media (e.g. Facebook), District Medical Doctors/Public Health Officers, and a study web-page with more detailed information on the study including instructive animation videos in Arabic. Those consenting to participate will be asked to fill out and return a postal survey questionnaire on demographics and health-related topics focusing on: Symptoms of posttraumatic stress, anxiety and depression Quality of life Self-reported physical health (focusing on subjective pain) Sleep difficulties and alcohol consumption patterns Social support Potentially traumatic experiences before or during the flight from Syria Stress experienced after arrival in Norway (post-migratory stress) Participants will also be asked whether the research group can contact them again for the second and third phase of the longitudinal study, and informed that consent to participation entails consent that survey data will be linked to Norwegian registry data on education, work participation and sick-leave, drug prescriptions and utilization of the health-care system. The registry data will be linked to survey data in the later phases of the larger longitudinal study. The main objective of the REFUGE-I study is to obtain and publish a thorough cohort profile that includes descriptive statistics for the final sample on the above-listed health-related topics, as well as information and statistics on potential selection bias issues that might affect the generalizability of findings. The study is a collaborative effort between five research institutions and universities in Norway and Sweden. One of the collaborating partners, The Swedish Red Cross University College, has already conducted a similar study on 1215 resettled adult Syrian refugees in Sweden, and results from REFUGE-I will be compared to the findings from the Swedish study. Moreover, an important long-term goal for the larger REFUGE-study is to help advance research on refugees by making resources from the study available online, and through the creation of a large database containing pooled data from the REFUGE-study and studies done through the Swedish Red Cross University College and potentially other national and international research groups.

NCT ID: NCT03736538 Enrolling by invitation - Depression Clinical Trials

Nitrous Oxide- Suicidal Ideation

Start date: October 30, 2018
Phase: Phase 1
Study type: Interventional

Most clinical major depression responds to standard treatments (medication and psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond to these treatments and are referred to as treatment-resistant major depression (TRMD). New treatments for TRMD are needed, and one promising line of research are drugs known as N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, the investigators of this study demonstrated that the NMDA antagonist nitrous oxide is effective in TRMD, reducing depressive symptoms, guilt, and suicidal thinking. To more closely investigate suicidal thinking, this study is designed as a double-blind, randomized, prospective, inpatient trial comparing inhaled nitrous oxide (N2O) plus treatment as usual versus inhaled placebo plus treatment as usual. All unipolar depressed, acutely suicidal inpatients will receive standard treatment for their depression/ suicidal thinking (TAU). Additionally, participants will undergo a maximum of four one hour inhalation sessions as inpatients and 2 booster sessions as outpatients during which they will receive either inhaled nitrous oxide (50% nitrous oxide/50% oxygen = active treatment) or placebo gas (50% nitrogen/50% oxygen). A target total of 50 patients with suicidal ideation and unipolar depression will be enrolled, 25 of whom will be assigned to the TAU control group and 25 of whom will be assigned to the N2O + TAU experimental group.

NCT ID: NCT03726138 Enrolling by invitation - Anxiety Clinical Trials

The Association of Sleep and Psychological Symptoms With Prognosis of MSK Pain in Danish General Practice

Start date: November 1, 2018
Phase:
Study type: Observational

Musculoskeletal (MSK) pain is a major public health concern. Approximately one in four consult their general practitioner (GP) with a musculoskeletal problem during the course of a year, making it the largest diagnostic group. Modifiable factors including affective disorders (e.g. anxiety and depressive symptoms) and sleep problems may be important prognostic factors for MSK pain. However, there is a lack of prospective research examining the interaction between these conditions in patients with MSK pain in a GP-setting.

NCT ID: NCT03716869 Enrolling by invitation - Clinical trials for Major Depressive Disorder

Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The primary goal of the proposed study is to compare the effectiveness of universal school based screening for adolescent major depressive disorder to the current school process of targeted screening based on concerning behavior.

NCT ID: NCT03686605 Enrolling by invitation - Clinical trials for Screening Tool for Depresion in Cancer Pain Patients

The Edmonton Symptom Assessment System (ESAS) as a Screening Tool for Depression in Cancer Pain Patients

Start date: September 24, 2018
Phase:
Study type: Observational [Patient Registry]

Compare Thai versions of the Edmonton Symptom Assessment System (ESAS) and the Hospiral Anxiety and Depression Scale (HADS) with Diagnostic and Statistical Manual (DSM-5), as a screening tool for depression in cancer pain patients

NCT ID: NCT03668600 Enrolling by invitation - Clinical trials for Depressive Disorder, Major

Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

Start date: August 23, 2018
Phase: Phase 3
Study type: Interventional

Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.

NCT ID: NCT03647826 Enrolling by invitation - Clinical trials for Mental Health Wellness 1

Mind Power - A CBT Based Program for Adolescents

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to strengthen school achievement and positive mental health, and to prevent and reduce school dropout and mental distress among high school students. The researchers will scale up techniques that have already been proven highly effective in preventing common mental disorders (depression, anxiety) in high risk groups (indicated and selective prevention). The researchers will disseminate these techniques to entire first year classes of high school students irrespective of risk factors (universal prevention). The study will report whether universal delivery in school of "Mind Power" - a Cognitive Behaviour Therapy (CBT) based programme - will strengthen school grades, self-efficacy, self-esteem, self-regulation, mental perceptions and well-being, and prevent and reduce school dropout, and symptoms of anxiety and depression. In addition the researchers will analyse whether such universal delivery prevents more mental distress, and is more cost-effective than when it is delivered only to those at high risk for school failure, dropout, or mental distress.

NCT ID: NCT03615222 Enrolling by invitation - Depression Clinical Trials

The Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life: Promoting Recovery by Targeting Mindfulness and Psychological Flexibility

SERVE: IMPACT
Start date: October 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Research by the investigators' team and others demonstrates that posttraumatic stress disorder (PTSD), depression, alcohol use disorders (AUD), traumatic brain injury (TBI), and chronic pain frequently co-occur among post-9/11 war Veterans and are associated with functional impairment and suicide risk; however, no treatment currently exists that has been specifically designed to promote functional recovery among Veterans experiencing any combination of these most common mental and physical wounds of war. The investigative team has: (A) identified multiple modifiable psychosocial factors (emotion regulation, psychological flexibility, self-compassion) that prospectively predict impairment and suicidal ideation in Veterans; (B) characterized long-term trajectories of resilience and functional disability in Veterans; (C) determined that high utilization of VA mental health services appears to have little, if any, impact on the functional recovery of Veterans on the moderate and severely impaired trajectories; (D) identified psychological flexibility (i.e., the ability to remain present in the moment despite emotional distress and to persist in changing behavior in the pursuit of one's values and goals) as a unique, prospective predictor of membership in the severely impaired functional trajectory and of suicidal ideation, even after accounting for the effects of co-morbidity; and (E) demonstrated that Acceptance and Commitment Therapy (ACT)-a trans-diagnostic, mindfulness-based behavior therapy that seeks to improve functioning by targeting psychological flexibility -can lead to recovery, including sustained improvements in functional disability, quality of life (QoL), suicidal ideation, PTSD, and AUD symptoms among severely impaired Veterans with co-occurring PTSD-AUD. This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior RR&D MERIT awards, SERVE has followed a cohort of post-9/11 Veterans since 2010 and has identified numerous risk and protective factors. SERVE's overall objective is to understand and improve the long-term functional outcomes of post-9/11 Veterans. Consistent with the investigators' conceptual model, the central hypothesis is that psychological flexibility and other trans-diagnostic treatment targets mediate the effects of the most common mental and physical wounds of war on long-term functioning and self-directed violence (i.e., suicide risk). Thus, integrated interventions specifically designed to improve functioning associated with these conditions are most likely to promote long-term recovery among the most impaired Veterans. The investigators will test the central hypothesis and accomplish the overall objective by pursuing the following specific aims: Aim 1: Identify treatment targets that prospectively predict functional disability and self-directed violence (SDV) in post-9/11 Veterans with PTSD, depression, chronic pain, TBI, and/or AUD. To achieve this aim, the investigators will follow 500 Veterans for 2 years in order to prospectively evaluate the impact of several novel, treatment-relevant factors on functional disability and SDV over time. H1: Novel factors (mindfulness, perceived burdensomeness, thwarted belongingness, and moral injury) along with established treatment targets (psychological flexibility, self-compassion, and emotion regulation) will prospectively predict functional disability and SDV after accounting for covariates. Aim 2: Develop, refine, and evaluate the feasibility and acceptability of a transdiagnostic, personalized ACT-based behavioral therapy (ACT-FX) specifically designed to improve functioning in Veterans. The investigators will use the Successive Cohort Design method to refine ACT-FX. The investigators will then evaluate the feasibility and acceptability of ACT-FX in 60 Veterans randomly assigned to ACT-FX or treatment as usual (TAU) and who will remain in the longitudinal assessment study (Aim 1) for long-term follow-ups. H2: ACT-FX will be feasible and acceptable to Veterans with complex mental and physical wounds of war. Aim 3: (Exploratory) Evaluate if participation in ACT-FX leads to the emergence of a new trajectory class among Veterans in Project SERVE that is characterized by long-term functional recovery. H3: ACT-FX treatment will predict membership in a new trajectory class characterized by functional recovery compared to Veterans receiving TAU who will continue to exhibit flat or worsening trajectories. Impact: The proposed research will help identify novel modifiable factors for functional recovery and provide proof-of-concept, within the context of the longitudinal study, that ACT-FX promotes recovery. This innovative project has potential to advance VA healthcare by promoting long-term functional recovery in Veterans.