Anxiety & Depression Association of America

This study looks to identify genes that may affect a person's chances of developing bipolar disorder (BP) and related conditions.

Type: Observational

Start Date: Aug 1994

open study

The purpose of this study is to look at how signals in the brain, body, and behavior relate to anxiety and memory function. This project seeks to develop the CAMERA (Context-Aware Multimodal Ecological Research and Assessment) platform, a state-of-the-art open multimodal hardware/software system for measuring human brain-behavior relationships. The R61 portion of the project is designed to develop the CAMERA platform, which will use multimodal, passive sensor data to predict anxiety-memory state in patients undergoing inpatient monitoring with intracranial electrodes for clinical epilepsy, as well as to build CAMERA's passive data framework and active data framework.

Type: Observational

Start Date: Jul 2024

open study

Few treatments target core features of suicidal thoughts and behaviors in Veterans. Real-time functional magnetic resonance imaging neurofeedback can provide information regarding brain activation associated with suicide-specific rumination, defined as a "repetitive mental fixation on one's suicidal thoughts and intentions." The goal of this feasibility study is for Veterans to learn strategies for modulating activity within brain regions that have been demonstrated to contribute to the maintenance of rumination, as they receive neurofeedback feedback signals from the brain.

Type: Interventional

Start Date: Aug 2024

open study

The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation (tDCS) in hospitalized adult patients with Treatment Resistant Depression (TRD), assess for any preliminary effect on depressive and cognitive symptoms, and explore the utility of biomarkers to assess response to tDCS.

Type: Interventional

Start Date: Oct 2024

open study

This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.

Type: Interventional

Start Date: Mar 2024

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

Patient frequently report experiencing discomfort associated with cystoscopy or urodynamic studies (UDS), and a small percentage of patients refuse these important procedures due to discomfort or fear of discomfort. Heating pads are an inexpensive and low-risk way to reduce patient discomfort during these procedures, which to our knowledge has not been investigated in the United States.

Type: Interventional

Start Date: Jan 2025

open study

This study aims to assess the feasibility and acceptability of the Maya Perinatal Cognitive Behavioral Skills App, a novel app for pregnant and postpartum individuals experiencing difficulties with mood, anxiety, or stress. Participants will complete the 12-module app to learn evidence-based strategies previously shown to help manage mood and anxiety. Assessments will include app feedback questionnaires, feedback interviews, a daily symptom tracker, and symptom measures. The study investigators hypothesizes that participants will find content to be helpful in developing skills to manage anxiety and mood difficulties during the perinatal period, and that the app interface, session structure, and pacing will be acceptable and feasible for this population. It is further hypothesized that increased Maya Perinatal Cognitive Behavioral Skills App use, engagement, and satisfaction will be associated with lower self-reported anxiety and mood symptoms.

Type: Interventional

Start Date: Sep 2023

open study

Lengthy wait times to access treatment for youth anxiety disorders is a critical issue. To help address this issue, investigators will pursue the following aims in N = 65 families on waitlists for outpatient youth anxiety psychosocial treatment. Aim 1 Pilot Phase: Develop and pilot a single session intervention (SSI) tailored for families on waitlists for outpatient psychosocial treatment for youth anxiety disorders. Investigators will pilot the single session intervention (SSI) with N = 5 families and use cognitive response interviewing to obtain data from parents and children, ensuring the content is understandable and accessible. The SSI will include psychoeducation on the cognitive behavioral conceptualization of anxiety, introduction to self-regulation strategies to manage physiological manifestations of anxiety, and cognitive restructuring of anxiogenic thoughts. The SSI will also involve parents and present strategies on how parents can support their children in managing anxious feelings and thoughts. Investigators will refine the SSI based on these data. Following the Pilot Phase, investigators will enroll an additional N = 60 families and randomize them to either the SSI (n = 30) or waitlist control (n = 30). Aim 2 Test Phase Acceptability, and Satisfaction: Examine acceptability of the refined SSI, as well as satisfaction with the SSI. Investigators hypothesize that users will find the module to be acceptable and will report high satisfaction. Aim 3 Test Phase Anxiety Outcomes: Demonstrate reductions in youth anxiety symptom severity. Investigators hypothesize that anxiety symptom severity and impairment will be significantly lower among youth who receive the refined SSI relative to youth on waitlist control. The main risk or discomfort from this research is that participants might feel uncomfortable answering questions about their behavior and feelings. Another possible risk is breach of confidentiality that could identify a participant as having elevated levels of anxiety. The benefits of this SSI would include increasing accessibility and scalability of treatment for youth anxiety disorders. Overall, this study will provide critically needed data to advance resource efficient treatment options for youth anxiety disorders.

Type: Interventional

Start Date: Feb 2023

open study

This study aims to compare the effectiveness of a standard mobile iPhone cognitive behavioral therapy program to a personalized mobile iPhone cognitive behavioral therapy program that introduces new skills over a shorter period of time. Participants will use the Maya app for two days per week, at least 20 minutes per day, for six weeks. Assessments will include a weekly check in with a member of the research team, questionnaires, and optional magnetic resonance imaging (MRI) and electroencephalographic (EEG) recordings at the beginning and end of the 6-week intervention. The investigators think that that the less burdensome personalized program will be just as effective at improving symptoms of anxiety and depression as the general program.

Type: Interventional

Start Date: Aug 2024

open study

The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC).

Type: Interventional

Start Date: Mar 2024

open study

The overall aim of this program of research is to improve the mental health of people who identify as LGBTQ+ by increasing their social support through a brief intervention. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, brief acceptance-based behavioral therapy (ABBT). To achieve the specific aims, the investigators will conduct a fully-powered, randomized clinical trial (n=240) with two treatment arms: treatment-as-usual (TAU) vs. ABBT.

Type: Interventional

Start Date: Jan 2023

open study

Mania is a core symptom of bipolar disorder involving periods of euphoria. Decreased inhibitory control, increased risk-taking behaviors, and aberrant reward processing are some of the more recognized symptoms of bipolar disorder and are included in the diagnostic criteria for mania. Current drug therapies for mania are frequently intolerable, ineffective, and carry significant risk for side effects. Presently there are no neurobiologically informed therapies that treat or prevent mania. However, using a newly validated technique termed lesion network mapping, researchers demonstrated that focal brain lesions having a causal role in the development of mania in people without a psychiatric history can occur in different brain locations, such as the right orbitofrontal cortex (OFC), right dorsolateral prefrontal cortex (DLPFC), and right inferior temporal gyrus (ITG). This lesion network evidence converges with existing cross-sectional and longitudinal observations in bipolar mania that have identified specific disruptions in network communication between the amygdala and ventro-lateral prefrontal cortex. The OFC is associated with inhibitory control, risk-taking behavior, and reward learning which are major components of bipolar mania. Thus, the association between OFC with mania symptoms, inhibitory control, risk-taking behavior, and reward processing suggests that this region could be targeted using non-invasive brain stimulation.

Type: Interventional

Start Date: Dec 2022

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 purpose of this study is to determine the extent to which an online pathway to depression treatment (iPath*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression.

Type: Interventional

Start Date: Jul 2024

open study

Double-blind placebo controlled study of Cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure(TM) Formulation (Nantheia ATL5(TM)). Subjects complete 3 weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched healthy population subjects are enrolled and complete baseline data collection only. All subjects may complete optional procedures of driving assessments and functional MRI (fMRI).

Type: Interventional

Start Date: Dec 2022

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

This study includes a randomized experimental component where therapists will systematically deliver an experimental behavioral probe or a supportive control condition. The aim is to evaluate effects on meaningful health-relevant measures including morning activation levels, depression symptoms, rumination, and aspects brain connectivity previously linked with depression.

Type: Interventional

Start Date: Jul 2022

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

Clinically significant anxiety affects 20% of preschoolers and can become chronic, leading to depression, substance abuse, school-drop out and even suicide. To reduce anxiety and prevent its sequelae, clinically affected children must be effectively treated early. Available interventions for clinically anxious preschoolers are effective for some, but not all children, with as many as 50% of 4-7 year olds continuing to meet criteria for an anxiety disorder after treatment. This trial aims to help learn how Camp Kidpower, trainings using either structured games or a playgroup, may lower anxiety in preschool age children. Playing these games and learning that kids can do it, can teach kids how to keep going when they are feeling anxious. To find out if Kidpower works by helping kids stay in charge of their behaviors and emotions, the study will look at parts of the brain as well as behaviors related to effortful control and fear, before and after training. The study hypothesizes that Kidpower will produce greater increases in Error-related negativity (ERN), Interchannel Phase Synchrony (ICPS) and effortful control (EC) behaviors than in the Playgroup control.

Type: Interventional

Start Date: Jul 2021

open study

Posttraumatic Stress Disorder (PTSD) is a common and serious condition affecting many Veterans. There are effective treatments for PTSD, but additional treatments are needed in order to better serve Veterans suffering from PTSD. Transcranial magnetic stimulation is one such promising treatment. It involves use of powerful magnet to stimulate the specific brain regions in Veterans with PTSD. Transcranial magnetic stimulation has been shown effective in treating depression, but currently it is unclear if it is an effective treatment for PTSD. This is a randomized clinical trial enrolling 91 Veterans with PTSD comparing the effectiveness of transcranial magnetic stimulation treatment and sham transcranial magnetic stimulation in treating PTSD. The hypothesis is that those who receive transcranial magnetic stimulation will experience improved functioning.

Type: Interventional

Start Date: Dec 2020

open study

This study originally included 140 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.

Type: Interventional

Start Date: Apr 2018

open study

This study is designed to examine SV2A density in MDD and PTSD as a correlate of synaptic density, and to determine whether ketamine administration will reverse the synaptic loss in vivo in human subjects. To our knowledge, this is the first human study to examine SV2A in vivo in MDD and PTSD and to use the first known drug (ketamine) that rapidly reverses synaptic loss to determine whether ketamine administration could restore some of the structural changes associated with depression and PTSD. After a screening process to determine eligibility, all subjects will participate in an MRI, and 2-3 PET scans with the administration of ketamine for one of the scans. Cognitive testing and a stress test may also be done on scan days.

Type: Interventional

Start Date: Apr 2016

open study

This research study is designed to look at the involvement of the glutamate system in depression. Each subject will undergo a screening appointment to determine study eligibility. Thereafter, the study will take 2 or 3 visits depending on schedule availability and will consist of one MRI scan, and PET scan. Subjects will also participate in cognitive testing. Depending on camera time, staff availability and subject schedule, total study participation may last 1-2 months.

Type: Interventional

Start Date: Aug 2011

open study