Anxiety & Depression Association of America

Multiple site studies with the recruitment of other sub-investigators and sites. It's sobering to consider how chronic illness makes us more vulnerable to suicidal thoughts and behavior. However, the existence of multiple risk factors also means that there are numerous ways to intervene. Addressing and improving even one risk area will reverberate and improve other areas and the quality of life. RIVER Foundation is completing a 500-participant pilot study researching the safety of oral and nasal ketamine at home with no therapy. The pilot study examined three psychological scales: P.H.Q. 9, G.A.D. 7, and PCL5 scores. The interim report will be available in Nov 2023 with a final report in June 2024. The lack of knowledge for the average medical practitioner makes ketamine a boutique medicine, often costly and unaffordable to those in need. Yet daily medical providers are eliminating ketamine as a choice in the treatment of chronic conditions. The pilot study demonstrated the who, and where. The who, was adults with a chronic condition. The pilot study demonstrated the majority of those who could use ketamine are not receiving it due to cost. According to the 500-participant study, ketamine is safe and effective for at-home use thus demonstrating the where (at home with no supervision).

Type: Observational

Start Date: Oct 2023

open study

Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by double-blind, randomized adjunctive treatment with clonazepam or pregabalin for persistent symptoms.

Type: Interventional

Start Date: Mar 2020

open study

The primary aim of our study is to determine the effectiveness of an transdiagnostic telenovela video intervention in reducing anxiety and depressive symptoms using a pre/post-test design with Spanish-speaking Latinxs.

Type: Interventional

Start Date: Jul 2024

open study

Using a randomized controlled trial design, the investigators will examine the effects of music engagement through choir training on the hearing, communication, and psychosocial well-being of older adults, particularly those at heightened risk of developing dementia.

Type: Interventional

Start Date: Oct 2024

open study

The purpose of this study is to study whether distressed medical residents, fellows, and faculty health professionals benefit from completing online an anonymous and interactive screening of stress, depression, substance use, and suicidal thoughts. The screening and ability to interact online with a clinician anonymously are hypothesized to increase willingness to come for counseling in person. Suicide risk factors are expected to be lower once the distressed medical trainee or faculty member receives treatment.

Type: Interventional

Start Date: Jan 2014

open study

The goal of this longitudinal study is to study the effects of a parenting skills group (Circle of Security Parenting, aka COSP) in mothers with postpartum depression. The main questions it aims to answer are: - Will changes in methylation of the OXTR rs53576 be apparent in mother and/or infant after having gone through the 8-week COSP program? - Will COSP participation be associated with improved symptoms of postpartum depression (over and above standard care), attachment style, and relational characteristics of the mother-infant dyad? - Will COSP participation be associated with changes in social behavior in the infant, and if so, do they persist throughout childhood? Participants will - Participate in an 8-week COSP program delivered remotely via Zoom. - Provide buccal swabs (mother and infant) to assess changes in methylation of OXTR rs53576 pre- versus post-intervention. - Complete a series of assessment questionnaires delivered remotely. - Videotape a play-based assessment in their home. - Receive infant developmental testing Researchers will compare characteristics of waitlist controls to those participating in the COSP program at the mid-way point of the program to see if the two groups differ.

Type: Interventional

Start Date: Aug 2023

open study

The proposed project seeks to demonstrate the engagement of post-exposure dopamine neurotransmission and downstream acute reorganization of dopaminergic resting-state neural networks as a means of increasing consolidation of extinction memories formed during analogue exposure therapy in adult women with PTSD. Participants will include 120 women aged 21-50 with a current diagnosis of PTSD related to physical or sexual assault, English speaking, and medically healthy. Participants will complete the stages of the study across 2-3 days, depending on participant need.

Type: Interventional

Start Date: Feb 2021

open study

Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to help alter the communication between groups of neurons in the brain. The purpose of this study is to test a personalized approach to brain stimulation as an intervention for depression. The study researchers will use a surgically implanted device to measure each individual's brain activity related to his/her depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms. This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies. The device used in this study is called the NeuroPace Responsive Neurostimulation (RNS) System. It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat depression.

Type: Interventional

Start Date: Jul 2019

open study

The goal of this study is to examine how whole-body hyperthermia affects the thermoinflammatory profile, which includes the combined immune and heat shock response, in patients with depression and whether these changes correlate with decreased depression in individuals with Major Depressive Disorder.

Type: Interventional

Start Date: Nov 2022

open study

- Assess the antidepressant/anxiolytic effect of creatine in male and female methamphetamine users - Assess creatine's effect on methamphetamine use - Assess the safety of creatine in male methamphetamine users with depression

Type: Interventional

Start Date: Nov 2015

open study

This study is intended to help develop new MRI imaging techniques for studying mood and anxiety disorders. Researchers believe that depression and anxiety disorders may cause structural and functional changes in the brain. This study will optimize the way MRI scans are collected to look at brain structure and examine how the brain behaves while subjects perform particular tasks. Healthy volunteers and individuals with major depressive disorder may be eligible for this study. Participants undergo magnetic resonance imaging (MRI) and neuropsychological testing. : Individuals will be asked to participate in an MRI study on one of several scanners. The scanner used will measure blood flow in the brain, concentrations of certain chemicals in the brain, or magnetic properties of the brain. The scan may involve They watching a screen presenting images or doing a task in which they respond to pictures or sounds. Participants may be asked to return for additional scans. The study also involves neuropsychological tests, which assess cognitive performance. Often, people with mood disorders have subtle changes in performance on these tests that allow researchers to pinpoint where brain abnormalities occur. Before the tests can be used in patients, they must be validated by using healthy subjects. These tests are presented either orally, in written form, or on a computer.

Type: Observational

Start Date: Dec 2006

open study

This study examines whether participating in poetry workshops can improve emotional well-being among patients with chronic digestive symptoms. Many individuals with long-standing digestive conditions experience distress, anxiety, isolation, and difficulty expressing their emotions in clinical settings. These emotional challenges can negatively affect daily life, relationships, and overall health. Poetry writing offers a creative and supportive way for participants to explore their feelings, express their experiences, and build emotional resilience. It also allows individuals to focus on aspects of their identity beyond their illness. The purpose of this research is to evaluate whether poetry workshops can reduce anxiety, lessen feelings of isolation, and strengthen participants' sense of community and well being. 1. Why is this study being done? The purpose of this research study is to offer a creative outlet for patients to explore their identity and story, build resilience, and seek hope. This study is being done because we understand that the psychological discomfort that can come upon hearing a diagnosis can lead to increased anxiety levels, negatively impacting a patient's well-being and relationships. Often healthcare practitioners may merely view a patient through the lens of their diagnosis, neglecting other aspects of their identity and humanity. Through reading various poems, crafting their own poems, and sharing their work with their peers, we hope the workshops offer a comforting opportunity for the participants to explore their identities and creativity.

Type: Interventional

Start Date: Jul 2026

open study

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of the SanaMente peer-led mental health and lifestyle program for rural Latino/a adults with chronic medical conditions and mental health concerns. The main questions it aims to answer are: - Is the SanaMente program feasible and acceptable for rural Latino/a adults with chronic medical conditions and mental health concerns? - Does participation in the SanaMente program improve mental health outcomes (depression, anxiety, and stress), healthy lifestyle behaviors (sleep, physical activity, and nutrition), and overall well-being? This is a single-arm pilot study without comparison group. Participants will: - Participate in the 6-8 week SanaMente peer-led group program. - Complete surveys at baseline, mid-program, and post-program assessing mental health, lifestyle behaviors, overall well-being, and program satisfaction. - Complete an exit survey and have the option to participate in a focus group to provide feedback on the program's usability, acceptability, perceived impact, and suggestions for improvement.

Type: Interventional

Start Date: Mar 2026

open study

The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder ([MDD], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.

Type: Interventional

Start Date: Apr 2026

open study

This is a feasibility trial of a digital mental health intervention aimed at adolescents (ages 14-18) with nonsuicidal self-injury and who are not currently engaged in mental health treatment. The study has two arms: a self-guided DMHI and an active control which will involve the delivery of non-interactive psychoeducational content via the same app interface. The primary goals of this project are to evaluate the feasibility of the intervention and trial procedures in preparation for a fully-powered randomized-controlled trial.

Type: Interventional

Start Date: Jun 2026

open study

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Type: Interventional

Start Date: Apr 2025

open study

Osteoarthritis (OA) is a major public health problem, and involvement of the knee is especially disabling. Symptomatic knee OA has an incidence rate between 40 to 1,020 per 100,000 person years1 and is among the most common causes of disability worldwide. Knee arthritis pain and disability are highly comorbid wiht depression (30-50%). Currently available treatments offer only limited relief. The Pilot project aims to establish feasibility of the rTMS neuromodulation of response to Tai Chi and improvement in pain and comorbid depression in patients with knee OA. There are several ways in which the pilot project will improve scientific knowledge, and clinical practice: 1) The sequential stimulation of two targets (M1 and l-DLPFC) has not been systematically examined for the treatment of comorbid MDD and knee OA. We hypothesize that using a multi-target rTMS strategy combining M1 and l-DLPFC- active targets will be well tolerated and more effective to treat comorbid symptoms than single site rTMS to M1+l-DLPFCsham. This hypothesis will be tested in Aim 1 of this proposal by comparing two experimental conditions: A) M1active and l-DLPFCactive; and B) M1active and l-DLPFCsham. 2) Identifying the relationship between improvement in pain and depression to improvement in pro-inflammatory cytokines would be novel. Adding an rTMS as a neuromodulation technique with novel stimulation sites to assist in the reduction of symptoms of pain and depression is another scalable to clinical use opportunity that will provide pilot data for future clinical trials. We will perform a pilot feasibility trial of rTMS for those presenting with knee osteoarthritis related pain and moderate to severe depression in 30 volunteers who are undergoing Tai Chi intervention. Tolerability and safety of rTMS added to Tai Chi will be assessed along with changes in symptoms of pain and depression, in preparation to future R-01 applications.

Type: Interventional

Start Date: Jun 2026

open study

Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (<12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).

Type: Interventional

Start Date: May 2025

open study

The goal of this study is to learn how psychedelics may help symptoms of depression and anxiety. Participants with major depressive disorder experiencing symptoms of depression and anxiety will receive one dose of either a drug related to psilocybin or a placebo. Assessments include interviews, self-report questionnaires, EEG and fMRI to measure symptoms and brain function.

Type: Interventional

Start Date: Aug 2026

open study

NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.

Type: Interventional

Start Date: Jun 2025

open study

We will recruit 10 patients with OCD meeting established criteria for surgical evaluation. Following informed consent and baseline evaluations, each will be implanted with permanent DBS SenSight leads and the Medtronic Percept RC IPG, which has on-device neural recording capability and rechargeability. We will collect a broad array of neurobehavioral data across two environments with complementary advantages: the clinic and the home. The first 2 Aims test our mechanistic hypothesis by studying the pattern of VS neural activity in the controlled environment of the lab/clinic during two complementary paradigms: one based on a psychophysical behavioral task, the other based on ERP, a therapeutic behavioral intervention. The third aim tests this hypothesis in an ambulatory, naturalistic setting with chronic neural on-device recordings paired with time resolved behavioral measures. We will investigate a possible common neural basis underlying approach and avoidance across these 3 paradigms. Subjects will participate in research at 7 critical timepoints during routine clinic visits (Fig. 4): before implant, 1 day before DBS activation, immediately after DBS activation, 2 weeks, 3 months, 6 months, and 12 months after DBS initiation. At these timepoints, patients will complete clinical assessments, perform the Probabilistic Approach Avoidance Task (PAAT), and conduct exposure trials under the guidance of a psychologist. The clinic offers the most controlled environment and provides opportunities for collecting high temporal resolution behavior synchronized to local field potential (LFP) recordings. These data will allow us to identify the degree of overlap in the time-resolved neural activity driving individual decisions to approach potential rewards or avoid potential aversive stimuli (Aim 1), and resist performing compulsions in order to achieve relief after OCD symptoms are triggered (Aim 2). At home, our goal is to investigate patient trajectories along the approach-avoidance axis as OCD symptoms improve (Aim 3). We will leverage passive, on device recordings that occur in the background of everyday life activities and synchronize these neural recordings with data collected via wearables, ecological assessments, and video diaries. Capturing neural and behavioral data in the home environment is essential for understanding the neural and behavioral changes that occur over longer timescales than individual clinical visits. The neurobehavioral biomarkers generated by this dataset will provide trackable readouts of clinical status that could inform therapeutic decision-making and enable data driven intervention.

Type: Interventional

Start Date: Aug 2025

open study

In this research study, investigators examine how brain activity changes during tests of emotional processing, attention, and memory using multimodal neuroimaging methods including electroencephalography (EEG), functional magnetic resonance imaging (fMRI), and functional near-infrared spectroscopy (fNIRS). Transcranial magnetic stimulation (TMS) is used to probe and modulate brain networks related to cognitive flexibility and emotion regulation. The study includes multiple related sub-studies involving healthy participants and participants with depression. Some study components focus on mechanistic modeling using non-therapeutic neurostimulation in healthy participants, while other components include interventional approaches such as individualized EEG-synchronized repetitive TMS (rTMS), cognitive tasks, and brief cognitive behavioral therapy (CBT) in participants with depression. Certain study components also evaluate CBT alone without TMS to assess behavioral intervention effects.

Type: Interventional

Start Date: Feb 2024

open study

Posttraumatic Stress Disorder (PTSD) is a significant driver of suicide risk among Veterans, but there is a critical knowledge gap about how to treat PTSD among people at elevated risk for suicide. Although evidence-based treatments for PTSD reduce suicide risk, Veterans at high risk for suicidal behavior rarely receive these potentially life-saving treatments. Prior research suggests that a treatment that combines Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure protocol (DBT PE) for PTSD improves both PTSD and suicide-related outcomes. This study will evaluate whether DBT + DBT PE improves these outcomes more than Prolonged Exposure plus suicide risk management, the gold standard VA care for this population. The proposed study will also examine factors that make it easier and harder to implement these treatments in VA settings. The results will help to inform treatment guidelines for this high-priority Veteran population.

Type: Interventional

Start Date: Jul 2024

open study

This study has two primary objectives, each of which addresses critical clinical and research gaps for individuals who have co-occurring insomnia and depression. The first objective is to address whether sequential treatment of insomnia and depression is superior to a single treatment for either depression or for insomnia, and if so, which treatment sequence is optimal. The second objective is to determine if there are heterogeneity of treatment effects; that is, variation in which interventions are best for which individuals, and if so, to develop and individualized intervention rule to better match individuals with the treatment that is most likely to lead to the best outcomes. A large randomized trial will be conducted to meet these objectives.

Type: Interventional

Start Date: May 2023

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