Depression Paid Clinical Trials in Massachusetts

The goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample. The main questions it aims to answer are: what clinical profile / symptoms-based biomarkers scores can be used by clinics to administer PRISM therapy in conjunction with standard care of therapy? What are the initial guidelines for integrating PRISM neurofeedback training for MDD therapy with MDD Anhedonia? Participants will be randomly assigned to one of two arms, Active, or Sham. During the study, participants will perform the following: Complete clinical assessments using questionnaires, an MRI scan, and tasks that probe reward responsivity, learning, and motivation. Perform 15 (+/-3) neurofeedback training sessions (performed twice a week on nonconsecutive days for about 2 months). Complete the same clinical assessments, post-NF training MRI scan, and tasks same as in the screening/baseline stage. Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia. Read Less

This is a longitudinal study where individual with Major Depressive Disorder (MDD) will be monitored for 12 weeks. The study aims to develop an objective, sensor-based, algorithm able to detect the presence of depression as well as predict treatment response. Measurement-based treatment is considered optimal and the development of a valid passive, objective, behavioral and biological assessment of depressive symptoms that does not rely on clinician interviews will improve monitoring and ultimately improve treatment significantly. Read Less

The investigators will test the hypothesis that inhaled xenon will produce a rapid improvement in depressive symptoms in patients suffering from treatment-resistant depression. Specifically, the investigators will conduct a parallel randomized, double-blind crossover study that will compare the effects of xenon-oxygen (35:65 ratio by volume) added to treatment as usual (X-TAU group) to the effects of nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group). A total of 20 severely depressed patients, 10 with major depressive disorder (MDD) and 10 with Bipolar Depression (BP), will be exposed in random order to N-TAU and X-TAU in a double-blind protocol. Read Less

Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 14 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion. Read Less

This study is a clinical trial that evaluates what drives patient engagement and tests the impact of two strategies-automated motivational push messaging and coach support-to improve engagement with an evidence-based mobile app intervention for depression and/or anxiety. Read Less

The aim of this study is to test the effectiveness of a single-session, digital intervention teaching the principle of practicing the opposite, when administered to youths on the waitlist for psychotherapy, with usual waitlist procedures as a control condition. Read Less

The study will compare the impact FIRST (a transdiagnostic treatment built upon five empirically supported principles of change) versus usual care outpatient psychotherapy on youths' mental health outcomes and a candidate mechanism of change: regulation of negative emotions. Read Less

This study originally included 100 subjects with medication-refractory depression undergoing 10 Hz transcranial magnetic stimulation (10Hz-TMS) to the left dorsal lateral prefrontal cortex (DLPFC), with the goal of having 60 completers with good quality data. Subjects were recruited from the TMS clinics at Beth Israel Deaconess Medical Center, Brigham & Women's Hospital, and Butler Hospital. Subjects underwent an hour-long MRI scanning session, an optional DNA-sample collection, up to three 20 minute neuronavigation sessions for marking the site of TMS stimulation, questionnaires, and a behavioral testing battery before and after their TMS treatment course. The task battery included the Emotion Conflict Resolution (ECR) task, Multi-Source Interference Task (MSIT), War Game (Gambling) task, and Associative Learning with Reversal task. Subjects' scores on the Quick Inventory of Depressive Symptomatology (QIDS) and Beck Depression Inventory (BDI) were assessed before and after the TMS course. MRI data was utilized to identify brain regions whose connectivity to the stimulation site co-varies with the aforementioned measures of symptom improvement. This was the only study group until August 30, 2022, and the primary outcome was analyzed for the 10Hz-TMS group. Due to changes in clinical standard of care from 10Hz-TMS to a newer version of TMS termed intermittent theta burst (iTBS), in September 2022 a second group was added to include patients receiving this new form of TMS. This second group included another 100 patients with medication-refractory depression undergoing iTBS to the left dorsal lateral prefrontal cortex (DLPFC), with the intent to have 80 completers. Massachusetts General Hospital was added as a data collection site in lieu of Butler Hospital. Subjects will undergo an hour-long MRI scanning session, up to three 20 minute neuronavigation sessions for marking the site of TMS stimulation, questionnaires, and a behavioral testing battery before and after their TMS treatment course. The task battery will included the Emotion Conflict Resolution (ECR) task, Multi-Source Interference Task (MSIT), Penn Emotion Recognition Test, the Suicide/Death Implicit Association Test, and Associative Learning with Reversal task. Subjects' scores on the Beck Depression Inventory (BDI) were assessed before and after the TMS course. MRI data will be utilized to identify brain regions whose connectivity to the stimulation site co-varies with the aforementioned measures of symptom improvement. Read Less

Chronic Obstructive Pulmonary Disease (COPD) is prevalent and debilitating chronic disease in Veterans. COPD is highly co-morbid with depression and anxiety conferring greater morbidity and mortality risk. Physical activity is a modifiable behavior that can improve COPD outcomes. However, to date, interventions targeting physical activity have not addressed the high comorbidity between COPD and depression and/or anxiety symptoms ("emotional distress") despite emotional distress predicting poorer response to physical activity interventions. This CDA-2 proposal will develop and test the feasibility and pilot RCT of an integrative physical activity and mental health intervention for Veterans with COPD, emotional distress, and low physical activity. The intervention will be delivered via VA Video Connect enabling access to care among Veterans with substantial barriers to hospital-based outpatient care. Read Less

This study examines the feasibility and acceptability of a virtual tumor board for cancer and mental illness for patients with serious mental illness and a new cancer diagnosis. The study also examines the impact on patient care, psychiatric symptoms, and clinician self-efficacy in managing this population. Read Less

Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV. However, posttraumatic stress (associated with intimate partner violence and/or other traumas) and depression negatively impact PrEP adherence among women in SA. Addressing posttraumatic stress and depression will likely improve PrEP adherence and persistence (i.e., sustained PrEP adherence over time) during pregnancy and breastfeeding, which are periods of dramatically increased HIV risk. The overarching goal of this proposal is to develop and test the feasibility and acceptability of a cognitive behavioral intervention that targets common underlying factors of posttraumatic stress and depression to improve PrEP adherence and persistence during pregnancy and the postpartum transition. The specific aims of the project are to (1) explore the mechanisms by which posttraumatic stress and depression impact PrEP adherence and persistence during pregnancy via qualitative interviews; (2) develop a brief PrEP adherence and persistence intervention (~4 sessions) that reduces the negative impact of psychological mechanisms common to posttraumatic stress and depression on PrEP use, and builds behavioral skills to improve self-care; and (3) evaluate the feasibility, acceptability, and signals of preliminary efficacy of the intervention, which will be integrated into antenatal care, in a pilot randomized controlled trial. All data will be collected in the Midwife Obstetrics Unit (MOU) in Gugulethu, a peri-urban settlement and former township community outside of Cape Town, SA. Read Less

Randomized Controlled Trial comparing a coach-enhanced digital cognitive behavioral intervention (d-CBI) (RxWell) + treatment as usual (TAU) versus TAU alone for moderate depression as determined by Patient Health Questionnaire (PHQ-9) threshold as part of routine pediatric care. The study will be completed in pediatric practices with embedded behavioral therapists across 3 institutions (Children's Hospital of Pittsburgh, Boston Children's Hospital, Rady Children's Hospital, San Diego). Read Less