Anxiety & Depression Association of America

A double-blinded placebo-controlled randomized trial to evaluate the effect of preventative treatment of depression in survivors of aneurysmal subarachnoid hemorrhage (aSAH), a type of stroke.

Type: Interventional

Start Date: Mar 2019

open study

The proposed study will test whether a working memory training (WMT) program improves fear extinction learning and its underlying neural circuitry in Veterans with posttraumatic stress disorder (PTSD). WMT is designed to improves the ability to maintain task-relevant information in mind. The project will further validate the relationship between working memory and fear extinction using novel computational and multivariate analyses that link to specific PTSD symptoms. If WMT can enhance fear extinction learning, then WMT may be a powerful adjunctive treatment that can enhance exposure therapy outcomes or be leveraged as a stand-alone treatment. This project supports the Department of Veteran Affairs mission of developing viable targets of treatment for Veterans with PTSD.

Type: Interventional

Start Date: Oct 2024

open study

Investigators will examine the efficacy of a faith-based depression intervention, in reducing symptoms of depression among African American adults in Wisconsin. Twelve church groups, each with 10 people (N=120) will be invited to participate. This intervention will be the first evidence-based, faith-based intervention designed for African Americans if validated.

Type: Interventional

Start Date: Oct 2024

open study

Although most people recover from acute pain (such as pain caused by injury, surgery, repetitive motion, or unknown causes), many people do not fully recover and will experience chronic pain. Untreated posttraumatic stress disorder (PTSD) appears to be a key risk factor for the transition from acute pain to chronic pain. However, few published studies have addressed the issue of preventing the transition from acute to chronic pain via PTSD reduction. This project will aim to test whether trauma-related PTSD symptoms can be reduced using either Stellate Ganglion Block (SGB) treatment or Cognitive Processing Therapy (CPT), and whether reducing PTSD symptoms can prevent the transition from non-injury based acute pain to chronic pain.

Type: Interventional

Start Date: Sep 2023

open study

The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on women veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed to examine effects on physical and mental health outcomes.

Type: Interventional

Start Date: Sep 2022

open study

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.

Type: Interventional

Start Date: Sep 2022

open study

Studies show that hormones affect the brain's fear extinction network, which is relevant for therapy involving exposure and response prevention (EX/RP), a first-line treatment for obsessive compulsive disorder (OCD). This study will examine the effect of delivering EX/RP to women during different phases in their menstrual cycle to determine the effects of hormones on the fear extinction network and on their OCD symptoms.

Type: Interventional

Start Date: Jun 2022

open study

This is a hybrid1, effectiveness-implementation study of yoga-based exercises (YE) as an adjunctive tool for rehabilitation among persons with Severe Mental Illness (SMI). The two-arm randomized controlled trial will compare the efficacy of YE compared to the Wellness Lifestyle Program (WLP). Primary outcomes of the study will be self-report and performance-based measures of community functioning, defined in the investigators study as social, leisure, employment, and life skills functioning in the community. Secondary outcomes will include cognition and physical fitness measures.

Type: Interventional

Start Date: Oct 2022

open study

The purpose of this study is to test whether a program called "Mindful Moms" can be helpful for specific measures of mood and health in pregnant women with depressive symptoms, compared to group-based education workshops.

Type: Interventional

Start Date: Oct 2021

open study

The purpose of this study is to use eye-tracking technology to study attentional biases, reward sensitivity, and cognitive control in adult patients with bipolar disorder with or without anxiety and/or substance use disorder comorbidity.

Type: Observational

Start Date: Mar 2019

open study

Of the estimated 30 million Americans who suffer from Major Depressive Disorder, approximately 10% are considered treatment resistant. Deep brain stimulation (DBS) to a region of the brain called the subcallosal cingulate (SCC) is an emerging strategy for treatment resistant depression (TRD), which involves placement of electrodes in a specific region of the brain and stimulating that area with electricity. This is believed to reset the brain network responsible for symptoms and results in a significant antidepressant response. A series of open-label studies have demonstrated sustained, long-term antidepressant effects in 40-60% of patients who received this treatment. A challenge to the effective dissemination of this fledgling treatment is the absence of biomarkers (objective, measureable indications of the state of the body and brain) to guide device placement and select stimulation parameters during follow-up care. By using a DBS device called the Percept PC (Medtronic, Inc) which has the ability to both deliver stimulation to and record electrical signals directly from the brain, this study aims to identify changes in local field potentials (LFPs), specific electrical signals that are thought to represent how the brain communicates information from one region to another, to see how this relates to DBS parameter settings and patient depressive symptomatology. The goal of this study is to study LFPs before and during active DBS stimulation to identify changes that correlate with the antidepressant effects of SCC DBS. The study team will recruit 10 patients with TRD and implant them with the Percept PC system. Participants will be asked to complete short questionnaires and collect LFP data twice daily for the first year of the study, as well as have weekly in person research procedures and assessments with the study team for up to one year. These include meetings with the study psychiatrist, psychologist, symptom ratings, and movement, voice, and video recordings. A brief discontinuation experiment will be conducted after 6 months of stimulation, in which the stimulation will be turned off and patterns of LFP changes will be recorded. The entire study is expected to last about 5 years, parcellated into several study phases. All participants are required to live in the New York metropolitan area for the first several months of the study.

Type: Interventional

Start Date: Mar 2023

open study

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.

Type: Interventional

Start Date: Aug 2022

open study

The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks). Participants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.

Type: Interventional

Start Date: Jul 2024

open study

The purpose of this study is to use smartphone technology to capture individual location emotional and cognitive data, to examine how real-world behaviors thoughts, emotions, and brain activity are related to one another.

Type: Interventional

Start Date: Nov 2023

open study

A double-blind randomized placebo-controlled trial to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with posttraumatic stress disorder (PTSD) symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV).

Type: Interventional

Start Date: Dec 2023

open study

Although there are an increasing number of mental health treatment adaptations for older adults, there are still a number of factors to consider when making these adaptations. Cognitive decline is one such factor that places significant burden on older adults and can interfere with traditional mental health therapies. Engage is a behavioral treatment approach that has shown to be effective in treating late life depression. The investigators are testing the feasibility of Engage as a treatment method for late life depression in older adults with cognitive decline. The objective is to corroborate Engage as an alternative late life depression treatment method for a sub-population of older adults with cognitive decline. Cognitive decline poses a unique mental health treatment barrier that is often over looked in younger populations. With a relatively higher prevalence of cognitive decline in older adulthood, it is imperative that a feasible mental health treatment program that can be effective in the presence of cognitive decline.

Type: Interventional

Start Date: Sep 2023

open study

The proposed study seeks to evaluate effectiveness, implementation processes, and cost of MOTIVATE among older Veterans with chronic musculoskeletal (MSK) pain and comorbid depressive symptoms.

Type: Interventional

Start Date: Sep 2023

open study

Herbal Medicine is known as the medicinal use of herbal substances as a means of treating different conditions in the human body to ensure that the body remains in optimal health and wellness. These substances are known to contain very active ingredients in it and as such is also a very potent means of managing diseases and ailments in the body. Herbal medicine has always been a standby source of getting relief from various conditions over centuries, however, it can be categorically said that the mode of usage of these herbal substances has changed over time. Traditional healers help individuals to make meaning out of the natural herbs seen around that can be useful to one's health. Herbal medicine is the use of plants to treat disease and enhance general health and wellbeing. Herbs can interact with other pharmaceutical medications and should be taken with care. Always seek a regular medical doctor (GP) about any health concerns and tell them about any herbal medicines you are taking or thinking of taking. Never stop taking prescribed medications in favor of herbs without first discussing it with your GP.

Type: Observational [Patient Registry]

Start Date: Oct 2024

open study

The SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program is a telephone-based clinical service designed to help identify and manage behavioral health issues among PACE/PACENET enrollees. The purpose of the current project is to a) explore moderators of treatment response among beneficiaries in the SUSTAIN Clinical Program and b) to evaluate the sustained clinical effects of the program.

Type: Observational

Start Date: Mar 2014

open study

This protocol proposes an initial randomized clinical trial that includes all patients with suicidal ideation (SI) at baseline, and with SI as the primary outcome measure to examine whether Right Unilateral Low-Amplitude Pulse - Seizure Therapy (RUL LAP-ST) treatment has more magnitude and rate of remission of SI as conventional pulse amplitude Right Unilateral Electroconvulsive Therapy (RUL ECT) (based on our prior secondary analysis). Our central hypothesis is that RUL LAP-ST has significantly less cognitive/memory side effects (no memory side effects were noted in our prior studies for 500mA and 600mA) and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT, while maintaining better anti-suicidal effect.

Type: Interventional

Start Date: Jul 2024

open study

Despite medical advancements, PTSD remains a major issue in Veterans1. Current treatment strategies have relatively poor adherence. In patients with PTSD and cirrhosis, there is greater cognitive impairment as well as changes in gut microbiome structure and function2,3. In addition, when there is concomitant cirrhosis, medication-related treatment options become even narrower from a safety and tolerability perspective and cognitive issues pertaining to cirrhosis could impact participation3. Changes in gut microbiome in Veterans with cirrhosis and PTSD compared to those with cirrhosis without PTSD is characterized by a greater relative expression of pathobionts and reduction in stool microbiome diversity with reduction in bacteria that produce beneficial short chain fatty acids (SCFA)2. Modulation of the gut microbiome in patients with cirrhosis and PTSD may be an important therapeutic target. In prior studies with cirrhosis alone, microbial modulation using diet, antibiotics such as rifaximin, probiotics, and fecal microbiota transplant have improved gut microbial diversity and clinical outcomes in some cases4,5. In patients with cirrhosis without PTSD and in patients with PTSD without cirrhosis there is emerging evidence regarding prebiotics and other forms of gut microbial modulation. Prebiotics are such an example6. Prebiotics are natural fibers derived from carbohydrates and can be beneficial to gut microbiota (good bacteria in the gut)6. Resistant starches (RS) are dietary fiber prebiotics found naturally in many foods including potatoes, plantains, and legumes6,7. In addition to being highly accessible, RS have been shown to be well tolerated with few adverse reactions. While no studies of RS exist in PTSD + cirrhosis patients, a meta-analysis of RS in IBD has shown RS to be an effective treatment in both animal and clinical studies where improvements in clinical remission and reduced mucosal damage were found7. However, there is insufficient data regarding patients with PTSD and cirrhosis regarding gut microbial structure and function modulation with dietary supplements such as resistant starches. These starches can improve SCFA production in elderly subjects, which could in turn affect the gut-brain axis favorably8.

Type: Interventional

Start Date: Jul 2024

open study

This study will be conducted to determine the effect of daily Tetrasol consumption in supporting gut health using assessments of gastrointestinal symptoms (GSRS) and bowel habits (BSS) as primary outcome measures. The investigators also intend to explore fecal and blood biomarkers of intestinal permeability/function, determination of anxiety and stress levels through both validated assessments and saliva and blood biomarkers, establishment of intervention safety and tolerability through comprehensive metabolic panels and overall compliance, explore the effects of the intervention on inflammation and acute stress (Cold Presser Test), blood lipid profiles, and gut microbiota composition as secondary outcomes.

Type: Interventional

Start Date: Feb 2024

open study

The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are: - Does psilocybin with assisted therapy help improve symptoms for people with depression? - How long do the effects of this treatment last? Participants will: - Take part in a couple of screening and preparation visits. - Be given psilocybin in one or two treatment sessions. - Attend a series of follow-up sessions over the following year. - Complete forms and surveys to test how their symptoms have changed and what they thought of their experience. Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants.

Type: Interventional

Start Date: Apr 2024

open study

Deficits in motivation and pleasure are common in depression, and thought to be caused by alterations in the ways in which the brain anticipates, evaluates, and adaptively uses reward-related information. However, reward processing is a complex, multi-circuit phenomenon, and the precise neural mechanisms that contribute to the absence or reduction of pleasure and motivation are not well understood. Variation in the clinical presentation of depression has long been a rule rather than an exception, including individual variation in symptoms, severity, and treatment response. This heterogeneity complicates understanding of depression and thwarts progress toward disease classification and treatment planning. Discovery of depression-specific biomarkers that account for neurobiological variation that presumably underlies distinct clinical manifestations is critical to this larger effort.

Type: Observational

Start Date: Jun 2021

open study

In this research study, the investigators are examining how brain activity (electrical and blood flow) changes during tests of emotional processing, attention and memory in the magnetic resonance imaging (MRI) scanner and outside the MRI using functional near-infrared spectroscopy (fNIRS). Investigators are also using non-invasive brain stimulation to probe different parts of the brain and measuring brain activity (electrical and blood flow). Study 1 This study includes healthy participants and researchers hope this will help us develop improved brain-based treatments for emotional difficulties like depression. Study 2 This study includes participants with depression and researchers hope this will help us develop improved brain-based treatments for emotional difficulties like depression.

Type: Observational

Start Date: Feb 2024

open study