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Depression clinical trials

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NCT ID: NCT05075629 Enrolling by invitation - Depression Clinical Trials

Mental Health in Undergraduate Health Science Students During the Covid-19 Pandemic.

Start date: October 12, 2021
Study type: Observational

A study will be conducted with a quantitative approach with correlational scope, observational analytical study, prospective cross-sectional. The objective is to compare the levels of anxious symptomatology, depressive symptomatology and substance use in university students who were exposed to SARS-CoV-2 with those who were not.

NCT ID: NCT05061719 Enrolling by invitation - Clinical trials for Major Depressive Disorder

An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Start date: September 2021
Phase: Phase 3
Study type: Interventional

This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.

NCT ID: NCT04971291 Enrolling by invitation - Clinical trials for Major Depressive Disorder

An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients

Start date: April 14, 2021
Phase: Phase 2
Study type: Interventional

The TARGET study is an active-controlled evaluation of AXS-05 compared to bupropion in patients with treatment-resistant major depressive disorder (MDD) who are adherent to study drug. Subjects are considered to have treatment-resistant MDD if they have had a historical inadequate response to 1 or 2 prior antidepressant treatments (ADTs) and a prospective inadequate response to treatment with bupropion SR, during the current major depressive episode. The TARGET study will first determine treatment adherence based on analysis of drug concentrations of dextromethorphan (in the AXS-05 group) and bupropion (in the bupropion group), and then evaluate the efficacy of AXS-05 in patients determined to be treatment-adherent. Efficacy data for evaluation of treatment effect will be obtained from assessments made during study AXS-05-301.

NCT ID: NCT04959227 Enrolling by invitation - Depression, Anxiety Clinical Trials

Investigation of Anxiety, Depression and Physical Activity Level in Whirling Dervishes

Start date: March 26, 2021
Study type: Observational

Sema, which means "to listen/hear" in lexical meaning, is a special physical activity performed in the form of rotating in different positions rhythmically with music.During the sema activity, although it is similar to dance therapy due to the cyclical movements it contains, it can also be evaluated as a physical activity. With Sema music therapy accompanied by musical melodies, it is similar to meditation, as the ties with the world are cut off and the attempt is made to reach divine love. Various studies have shown that physical activity, music therapy, dance therapy, and meditation have positive effects on depression and anxiety in the literature. However, there is no scientific study in the literature investigating the effects of Sema activity, which includes all these approaches, on depression, anxiety and physical activity. In order to support the literature in this sense, this study was planned to examine the effects of Sema activity on physical activity level, depression and anxiety. Individuals between the ages of 18-60 who are registered in Konya Mevlana Cultural Center who have been doing Sema for at least 1 year will be included in the study. Participants who agree to participate in the study will be asked to fill in the online Informed Volunteer Form, Demographic Information Form, Beck Anxiete Scale, Beck Depression Scale and International Physical Activity Scale - Short Form. The data will be analyzed statistically with SPSS version 23.0.

NCT ID: NCT04932018 Enrolling by invitation - Depression Clinical Trials

Exploring an Incubator to Decrease Stress in Farmers Occupational Stress and Depression in Beginning Kentucky Farmers

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this 6- month study is to determine the feasibility of a start-up incubator intervention designed to decrease occupational stress and depression for beginning Kentucky farmers. The objectives are to: #1) test the feasibility of a mentorship and start-up incubator intervention on depression in beginning Kentucky farmers using questionnaires administered prestudy, mid-study, and post-study; #2) explore associations between mentorship, occupational stress and depression in beginning Kentucky farmers using specific survey questionnaires to guide future research. This study's results will provide valuable data to agriculture and occupational health researchers. The data will illustrate the impact of mentorship and community support on improving depression and occupational stress of beginning Kentucky farmers.

NCT ID: NCT04927845 Enrolling by invitation - Anxiety Clinical Trials

StriveWeekly Trial Post-pandemic

Start date: May 19, 2021
Phase: N/A
Study type: Interventional

With the COVID-19 pandemic completely altering the landscape of higher education, students have been experiencing more stress than ever. With Harvard University's plan for students to return to campus for the 2021-2022 academic year, offering an online mental health program such as StriveWeekly could provide students with stress management support as they transition back after 1.5 years of remote learning. This study will use a randomized controlled trial design to test the effectiveness of a waitlist versus StriveWeekly. This study will allow us to test if a program that has previously demonstrated effectiveness with university students in reducing anxiety and depression symptoms will still be effective after the unprecedented amount of stressors during a global pandemic. Primary aim: We aim to evaluate the effectiveness of StriveWeekly in preventing or reducing symptoms of anxiety and depression. The use of a waitlist condition will allow us to experimentally assess if the online intervention is responsible for decreasing / preventing worsened anxiety, depression, and stress symptoms over time. Given the previously established effectiveness of StriveWeekly as an indicated prevention program, we expect students in the intervention condition to experience significantly better symptoms compared to the waitlist from baseline to posttest. Alternatively, if the transition back from remote learning and/or the broad pandemic context interferes with the acceptability or effectiveness of StriveWeekly, then we might expect to see little to no significant differences between the online intervention condition and waitlist condition from baseline to posttest. Secondary aims include: (a) testing moderators of intervention effectiveness and (b) evaluating the intervention in terms of acceptability (e.g., feedback on program name; demographically representativeness of student user sample; satisfactory adherence and satisfaction rates). Exploratory moderation analyses across groups will help determine whether or not the intervention condition produces unique or additive effects for students with certain characteristics over and above changes demonstrated by similar students in the waitlist condition. Acceptability analyses will allow for more nuanced evaluation of StriveWeekly's effectiveness as a program, beyond its ability to facilitate symptom reduction.

NCT ID: NCT04852302 Enrolling by invitation - Depression Clinical Trials

Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor

Start date: August 11, 2021
Phase: N/A
Study type: Interventional

Background: Psychological distress affects many people diagnosed with a primary malignant brain tumor (PBT). Distress can include negative feelings such as anger, fear, or sadness. Researchers want to see if a type of therapy called CALM can help. It promotes well-being in people who have cancer that cannot be cured. Objective: To find out if the CALM therapy can help people with a PBT suffering from distress. Eligibility: English-speaking adults ages 18 and older who have a PBT and are taking part in NIH protocol #16C0151. Design: This study will not take place in person. It will be done by smartphone, computer, or tablet. Participants will fill out 7 surveys. The surveys will take 40 to 60 minutes to complete. They are all electronic. They will ask about physical and emotional symptoms, depression, feelings about death and dying, feelings about close relationships, and general well-being. Participants will be assigned to a CALM therapist. They will have 3 to 6 individual therapy sessions in 6 months. Each session will last 45 to 60 minutes. Sessions may be audio recorded. If needed, participants may have extra sessions. CALM includes symptom management and discussions of meaning, purpose, and mortality. Participants may have a family member take part in at least one CALM session with them. After the third CALM session, participants will be asked questions about CALM. After 3 and 6 months, participants will complete the 7 surveys again. Participation will last about 6 months.

NCT ID: NCT04846790 Enrolling by invitation - Depression Clinical Trials

The Effect of a Combined Nature-based and Virtual Mindfulness Intervention on Perceived Stress in Healthcare Workers

Start date: July 16, 2021
Phase: N/A
Study type: Interventional

Rationale: Healthcare workers that care for patients with COVID-19 are at increased risk for stress-related symptoms. When these symptoms are chronic, they can result in burnout and other mental health conditions that can exacerbate the current national health crisis. Social distancing can limit the accessibility of mental health services. Feasible and effective interventions are needed to reduce stress-related symptoms and promote resilience in this population, while adhering to federal and local guidelines to mitigate the transmission of SARS-CoV-2. Objectives: To investigate the feasibility and efficacy of a combined nature-based and virtual mindfulness intervention on stress-related symptoms and psychological resilience in healthcare workers that care for patients with COVID-19. Both components are reported to reduce levels of perceived stress and increase psychological resilience; however, the potential additive effect of their combined delivery is unknown. Methods: Ninety healthcare workers will be randomized into one of three groups: Nature+Mindfulness (n=30), Nature only (n=30), and Control (n=30). All participants will undergo assessments at baseline (week 0), post nature intervention (~week 1), and post mindfulness intervention (~week 3). The two intervention groups will have one final assessment at 2-month follow-up (~week 11). Perceived stress is the primary endpoint and will be assessed with the Perceived Stress Scale. Secondary endpoints include sleep quality, burnout, posttraumatic stress, anxiety, depression, mindfulness, self-efficacy, and psycho-social-spiritual healing. Anticipated Results: We anticipate that participants in the Nature+Mindfulness group will have greater reductions in stress-related symptoms and greater increases in psychological resilience compared with the Nature only and Control groups.

NCT ID: NCT04838210 Enrolling by invitation - Pregnancy Related Clinical Trials

Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care

Start date: May 21, 2021
Phase: N/A
Study type: Interventional

This study will provide high-quality, representative data on the capacity of Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care (EleVATE GC) to reduce perinatal depression, preterm birth, and low birthweight in African-American women. If findings from this study indicate that EleVATE GC is feasible and effective, this model could be implemented nationwide to help achieve mental and obstetric health parity for low-income women of color in the United States.

NCT ID: NCT04830527 Enrolling by invitation - Depressive Symptoms Clinical Trials

EMA Baseline Screening System for Therapists Who Treat Youths With Depressive Symptoms

Start date: November 24, 2020
Phase: N/A
Study type: Interventional

Youth depression is a matter of concern worldwide. It affects an important part of the young population around the world and its consequences both physically and mentally make this issue an important research field for psychologists and other health related professionals (Zuckerbrot, Cheung, Jensen, Stein & Laraque, 2018). Two of the biggest challenges that clinicians and researchers face when dealing with youth depression are adherence and the establishment of a therapeutic alliance (TA; Nock & Ferriter, 2005). While several treatments are available to relief depressive symptomatology in youths, a significant number do not access them for a variety of reasons (DiMatteo, Lepper & Corgan, 2000). In the last decades, substantial research has been conducted on how youths and the general population perceive therapy, and different methods have been developed to assess clients and therapists in order to improve outcomes and other aspects of the psychotherapy process, such as feedback tools and real-time measurements like Ecological Momentary Assessment (EMA) (Shiffman, et al., 2008). With the aid of Information Communication Technologies (ICTs) and eMental Health strategies, feedback and assessment tools can be presented in a friendly manner, providing a novel way to possibly improving adherence rates and TA scores. This study aims to develop and test the effectiveness of an Ecological Momentary Assessment mobile application to improve initial adherence and TA in psychotherapy for youths with depression. The hypotheses for this trial are: 1. Applying an EMA baseline screening application one week before the beginning of treatment for youth depression will significantly improve the TA. 2. Applying an EMA baseline screening application one week before the beginning of treatment for youth depression will significantly improve initial adherence.