Depression Paid Clinical Trials in Massachusetts

This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period. Read Less

The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to participants with elevated levels of distress due to their illness and/or treatment. The intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient and referring problem. Cognitive Behavioral Therapy (CBT) Acceptance Commitment Therapy (ACT) Mindfulness-Based Cognitive Therapy (MBCT) Mindfulness-Based Stress Reduction (MBSR) Meaning-Centered Psychotherapy (MCP) Cognitive Behavioral Therapy for Insomnia (CBT-I) CBT for other cancer-related physical symptoms like pain, fatigue, and nausea. Participation in this research study is expected to last about 26 weeks. It is expected that about 100 people and 15 therapists will take part in this research study. Read Less

Compared to civilian students in higher education, student Veterans have high rates of mental health disorders (PTSD: 40% vs. 9% and Depression: 24% vs 12.1%). As a result, Veterans with mental health disorders can be more likely to experience academic issues, such as lower enrollment rates and slower degree attainment on average. In addition, student Veterans with mental health disorders can experience substantial challenges with the already-difficult transition to the student role, with difficulties related to education planning, academic skills, and mental health management. Though many student Veterans could benefit from programming embedded in supported education interventions, current in-person VA supported education treatments are often difficult to access - or not available locally - for these Veterans. In addition, there is no widely available, VA-specific online or mobile-app based resource for students, which is a substantial gap in resources for student Veterans. The goal of this project is to develop and evaluate a comprehensive mobile app for student Veterans with mental health disorders. This intervention will use the principles of Veteran supported education research and manualized treatments to develop a personalized academic success app, VetEd, to address a variety of academic and psychiatric symptom-related educational barriers for student Veterans. Specifically, VetEd will provide a resource to (1) orient student Veterans with mental health disorders to successfully transition to the role of student as defined by their self-created educational roadmap, which will include helping students acquire (2) academic skills, (3) mental health management skills, and (4) up-to-date information on psychiatric, academic, and financial resources to help them successfully meet higher-education expectations. This overall study will involve three aims: 1) Developing a Veteran-centered educational support app to help student Veterans with mental health disorders to identify their perceived academic needs, app preferences, and evaluate Veteran-centered content; 2) Testing and iteratively revising the VetEd app (n =15) by assessing app software, content, human-computer interface, usability, satisfaction data, and preliminary exploration of changes in educational functioning (course activity completion, academic self-efficacy, and retention; and 3) Completing final revisions of the VetEd app for a future grant application of a larger RCT. This pilot project is significant and innovative in three key respects: (1) it extends services based in previous, effective supported education research to address both psychiatric and academic concerns for Veterans with mental health disorders; (2) is potentially cost-effective and easy to disseminate nationally; and (3) focuses on improving Veterans' academic functioning and quality of life is substantially different than current VA mobile app offerings. Results from this pilot project will inform the development of a Merit Review application for a larger, randomized clinical trial of VetEd with student Veterans. Read Less

The purpose of the study is to do a preliminary assessment of whether fluoxetine is effective, safe, and tolerable for the treatment of depression in adults with Down syndrome. Read Less

This study aims to address treatment and service disparities and prevent disability among racial/ethnic and linguistic minority elders. It tests the effectiveness and implementation readiness of the Positive Minds-Strong Bodies Enhanced intervention (PMSB-E), a combined mental and physical health intervention designed to be implemented in low-resource community settings. This renewal grant project includes a streamlined intervention with new components designed to improve and maintain participant outcomes. Read Less

This is a parallel group study design. The investigators propose to compare an online, synchronous group-based yoga intervention developed for individuals with depression to an online, synchronous individualized, evidence-based behavioral therapy for depression, or Brief Behavioral Activation Treatment for Depression (BA). This study is a multi-site randomized trial of adults with clinically significant depressive symptoms. Participants (N=518) will be randomized in an equal allocation ratio (i.e., 1:1) across two intervention groups: yoga and BA. Interventions will be provided over a 12-week period and assessments will occur at baseline (week 0), week 6, week 12, week 18, and week 24. Read Less

VOICES Veterans Socials (VS) support Veterans in the community through weekly social groups. Veterans socials have the potential to improve social functioning, mental health symptoms, and create lasting social support. This project aims to evaluate and improve Veterans Socials to help older Veterans with depression by adapting materials, interviewing VS attendees, and collecting questionnaires. The goal is to improve the program based on the results for future use and research. Read Less

The purpose of this study is to assess the efficacy of an oral medication, IGC-AD1 that is a natural THC-based (Tetrahydrocannabinol) formulation, administered in micro doses, twice a day, on symptomatological Agitation, in patients with mild to severe dementia from Alzheimer's. Read Less

The investigators will complete a pragmatic randomized trial (N=260 randomized participants) of the 26-week blended collaborative care (CC) intervention compared to enhanced usual care (eUC) in patients admitted for acute coronary syndrome (ACS) or heart failure (HF) found to have current depression, generalized anxiety disorder (GAD), or panic disorder (PD). The CC intervention will use a novel three-pronged approach to these high-risk patients. Care managers will provide centralized care coordination and specific interventions targeting: (1) the psychiatric disorders, (2) cardiac health behaviors, and (3) the cardiac illness. The primary study outcome will be physical function at 26 weeks, measured by the Duke Activity Status Index (DASI), given links between function and new cardiac events. The investigators will also examine effects on numerous other outcomes important to patients and healthcare systems. Specific Aim 1 [patient-centered outcomes-primary aim]: To compare between-group differences in the CC and eUC conditions on improvements in physical function, health-related quality of life, mental health, patient satisfaction, and other key patient-reported outcomes at 26 and 52 weeks. Specific Aim 2 [adherence and medical outcomes]: To compare between-group differences on health behaviors (physical activity, diet, smoking, medication adherence) and major adverse cardiac events. Specific Aim 3 [cost]: To compare healthcare costs between groups and assess the cost-effectiveness of CC. Hypotheses: The investigators expect this bolstered CC program to be associated with superior improvements in physical function, health-related quality of life, patient satisfaction, and adherence at 26 weeks, with promising effects on major adverse cardiac events. The investigators likewise expect the intervention to be cost-effective (<$10,000/quality-adjusted life year) over the study period. Read Less

The goal of this clinical trial is to estimate the importance of neuroimaging in accelerated intermittent theta burst stimulation (aiTBS) for depression. Participants will receive aiTBS treatment, but they will not know if their treatment spot was found with neuroimaging or head measurements. Read Less

This study is a waitlisted randomized controlled trial. We aim to assess the level of compliance for those learning the intervention and to evaluate the impact of the practice on neuropsychological and somatic outcomes using validated scales. Enrollment into the study will be ongoing until we are able to get a sufficient sample size as described in the "Statistical Consideration" section. Upon enrollment and randomization, surveys will be administered to both the intervention and control groups at four time-points: baseline, T2, T3, and T4, each of which are 6 weeks apart. Compliance data will be collected weekly for 12 weeks for both groups. Read Less

The purpose of this study is to test the effectiveness of a universal, digital, single-session intervention for youth mental health, functioning, and well-being. The investigators will be providing access to a brief online program (Project SOLVE) for students as part of the school curriculum. Ukrainian students living in Poland will be randomly assigned to receive Project SOLVE either immediately or after 3 months. The program is designed to help students manage stress and reach their academic and personal goals by teaching them how to solve problems systematically. The investigators would like to evaluate the effectiveness of this intervention in improving students' mental health and well-being. Read Less