Anxiety & Depression Association of America

The purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (PTSD) and a number of other concerns following injury.

Type: Interventional

Start Date: Feb 2024

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

Cognitive behavioral therapy (CBT) is a brief, efficient, and effective treatment for individuals with depressive/anxiety disorders. However, CBT is largely underutilized within the Department of Veterans Affairs due to the cost and burden of trainings necessary to deliver all of the related disorder-specific treatments (DSTs). Transdiagnostic Behavior Therapy (TBT), in contrast, is specifically designed to address numerous distinct disorders within a single protocol in Veterans with depressive/anxiety disorders. The proposed research seeks to evaluate the efficacy of TBT by assessing psychiatric symptomatology and related impairment outcomes in Veterans with social anxiety disorder and comorbid posttraumatic stress via a randomized controlled trial of TBT and an existing DST. Assessments will be completed at pre-, mid-, and post-treatment, and at 6-month follow-up. Process variables also will be investigated.

Type: Interventional

Start Date: Apr 2024

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

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

Type: Interventional

Start Date: Jun 2022

open study

The purpose of this research is to investigate associations between mindfulness and meditation techniques and changes in maternal breastmilk in the mother pumping for her NICU infant.

Type: Interventional

Start Date: Sep 2025

open study

This research will help identify if a PTSD treatment group, called Cognitive Processing Therapy (CPT), that is used in community settings is helpful in reducing PTSD symptoms among people who are incarcerated. The goal of CPT is to create a space for people to modify unhelpful beliefs related to trauma. A total of 692 participants will be enrolled from 6 locations and can expects to be on study for up to 24 weeks.

Type: Interventional

Start Date: Dec 2025

open study

Depression is common among cancer survivors, but current screening methods are not always effective. To help improve depression screening for cancer survivors, this study will conduct a pilot randomized controlled trial (RCT) with 60 participants. The goal is to evaluate whether a text message-based approach to depression screening is feasible, acceptable, and potentially more effective than the current standard of care.

Type: Interventional

Start Date: Jan 2026

open study

Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs. ABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Type: Interventional

Start Date: Apr 2025

open study

The goal of this clinical trial is to learn if ABX-002 added to an existing antidepressant treatment will benefit depression symptoms in adults with moderate to severe major depressive disorder who have had an inadequate response to their antidepressant. This is a double-blind, placebo-controlled, 2-arm, parallel-group, Phase 2 study, randomized 1:1 (ABX-002: placebo). The study will include the following stages: 1. Screening, approximately 35 days 2. 42-day Treatment Period 3. 2-week post dose Safety Follow-up Period 4. 6-month postdose targeted safety follow-up period

Type: Interventional

Start Date: Sep 2024

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: Interventional

Start Date: Jul 2024

open study

Alcohol use disorders (AUDs) affect up to 60% of individuals with bipolar disorder during their lifetime and is associated with worse illness outcomes, yet few studies have been performed to clarify the causes of this comorbidity. Understanding biological risk factors that associate with and predict the development of AUDs in bipolar disorder could inform interventions and prevention efforts to reduce the rate of this comorbidity and improve outcomes of both disorders. Identifying predictors of risk requires longitudinal studies in bipolar disorder aimed at capturing the mechanisms leading to the emergence of AUDs. Previous work in AUDs suggest that subjective responses to alcohol and stress-related mechanisms may contribute to the development of AUDs. In bipolar disorder, altered developmental trajectory of critical ventral prefrontal networks that modulate mood and reward processing may alter responses to alcohol and stressors; consequently, the disruption in typical neurodevelopment may be an underlying factor for the high rates of comorbidity. No longitudinal data exist investigating if this developmental hypothesis is correct. To address this gap, the investigators will use a multimodal neuroimaging approach, modeling structural and functional neural trajectories of corticolimbic networks over young adulthood, incorporating alcohol administration procedures, clinical phenotyping, and investigating effects of acute stress exposure and early life stress. Research aims are to identify biological risk factors-i.e., changes in subjective response to alcohol and associated neural trajectories-that are associated with the development of alcohol misuse and symptoms of AUDs over a two-year longitudinal period in young adults with bipolar disorder and typical developing young adults. Longitudinal data will be collected on 160 young adults (50% with bipolar disorder, 50% female; aged 21-26). This study is a natural extension of the PI's K01 award. How acute exposure to stress and childhood maltreatment affects subjective response to alcohol and risk for prospective alcohol misuse and symptoms of AUDs will be investigated. The investigators will test our hypothesis that developmental differences in bipolar disorder versus typical developing individuals disrupt corticolimbic networks during young adulthood, increase sensitivity to stress, and lead to changes in subjective response to alcohol and placebo response increasing risk for developing AUDs.

Type: Interventional

Start Date: Jul 2023

open study

Integrative-Mind-Body Skills Group (I-MBS-G) is an 8-week group that teaches skills to build inner resources for effective mood management. This group incorporates a holistic approach to wellness through meditation and mindfulness practices, guided imagery, breath and body awareness, and relaxation techniques. Mind-body approaches have demonstrated effectiveness in reducing stress mood symptoms and improving quality of life. The study hypothesis is that the Mind-Body Skills taught in the group will reduce mood symptoms in graduate and medical students.

Type: Interventional

Start Date: Apr 2023

open study

Recent Veterans of the Afghanistan and Iraq conflicts are presenting in VA care with high rates of posttraumatic stress disorder (PTSD), depression, anxiety, and substance use disorders. Difficulties with social relationships and community reintegration are common functional impairments with these disorders. VA is transforming to a Whole Health, patient-centered system of care that will address these issues as part of health care. In a previous study, Omnis Salutis (OS) was developed with Veteran and clinician input. OS is a three-session intervention in which Veterans learn about Whole Health and practice communicating their health mission to providers and social supports. OS was shown feasible to deliver, acceptable to Veterans, and preliminarily effective at improving physical, mental, and social functioning. This study will use a large, multisite randomized controlled trial to test the impact of OS on Veterans' social and physical functioning and Veteran engagement in mental health care. Results will support broad delivery of OS throughout the VA.

Type: Interventional

Start Date: Feb 2023

open study

This research study is designed to test if electrical stimulation of the surface of the brain in the frontal region will help treat depressive symptoms. Participants receive intermittent electrical stimulation to the brain, which involves surgically placing electric leads in between the tough fibrous membrane covering the surface of the brain and the surface of the brain itself. This type of stimulation is referred to as bilateral subdural prefrontal cortical stimulation (PCS) because it will specifically target the outer layer of the brain at the midline, right behind the forehead. It uses a pacemaker-like device, the Proclaim Elite SCS System (non-rechargeable) or the Eterna SCS System (rechargeable), both by Abbott Laboratories for stimulation. Although the U.S. Food and Drug Administration (FDA) has approved the Proclaim Elite SCS system for brain stimulation for patients with chronic pain and muscular diseases, such as Parkinson's, its use is still investigational, and the surgery is still experimental for patients who have depression.

Type: Interventional

Start Date: Sep 2021

open study

The goal of this clinical trial is to evaluate if the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices is able to improve depressive symptoms and urinary incontinence in women who delivered a healthy, singleton infant 2-60 months before enrollment in the study and are aged 22 years and older, but under the age of 60 years. The main question it aims to answer is: Does the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices improve depressive symptoms and urinary incontinence? Participants will be asked to: Undergo twelve treatments Complete the Patient Health Questionnaire-9 Complete the 6-item Hamilton Depression Rating Scale Complete the Edinburgh Postnatal Depression Scale Complete the Therapy Comfort Questionnaire Complete the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Complete the Female Sexual Function Index Complete the Warwick-Edinburgh Mental Wellbeing Scale Complete the Columbia Suicide Severity Rating Scale-Screen Version Complete the Subject Satisfaction Questionnaire Complete the Therapy Comfort Questionnaire

Type: Interventional

Start Date: Nov 2025

open study

By doing this research project, the investigators hope to learn which strategies work best to help veterans who are not benefiting from their first PTSD treatment or not completing between-session homework assignments regularly that might improve treatment response. The investigators also want to learn how best to match the right type and amount of treatment to each individual veteran. By conducting this research project, they hope to: - See if trying a different treatment strategy for veterans not responding to their first PTSD treatment would be more helpful - See if sending text message prompts between sessions encourages more completion of between-session homework

Type: Interventional

Start Date: Dec 2025

open study

Cardiac rehabilitation is the standard-of-care treatment option for patients with cardiovascular disease and has been shown to improve many aspects critical to patient recovery. Investigators believe that individuals who have had a stroke need to be treated similarly. Investigators will study the effects of a comprehensive modified cardiac rehabilitation program to determine if it can improve some of the physical and psychosocial problems common in survivors of stroke with and without depression.

Type: Interventional

Start Date: Aug 2025

open study

The goal of this research is to investigate whether a peer-delivered illness self-management program called Taking Action can help college students with serious mental illnesses. Participants will be randomly assigned to either the experimental condition (Taking Action) or the control condition (information only). Participants in the experimental condition will attend five 2.5-hour Taking Action sessions. Participants will complete three interviews (baseline, post-intervention, and follow-up) to assess how well the program works, is liked, and benefits students clinically and academically. The investigators seek to test the following hypotheses: Compared to controls, students who do the Taking Action program will report greater improvements in mental health self-management attitudes, skills, and behaviors and will report greater improvements in mental health symptoms and recovery, and better academic outcomes.

Type: Interventional

Start Date: Sep 2024

open study

The goal of this study is to learn the extent to which client-therapist brain activity may synchronize during a psychosocial intervention for depression symptoms. The study will compare behavioral activation, a client-centered type of cognitive-behavioral therapy, to psychoeducation which delivers information on strategies to recover from depression symptoms. Participants will answer questions about their mental and physical health, attend one psychosocial intervention session receiving either Behavioral Activation or Psychoeducation with simultaneous brain activity measurement and complete follow up surveys two weeks and one month following the intervention.

Type: Interventional

Start Date: Apr 2025

open study

The purpose of this research study is to investigate the impact of virtual reality experiences on individuals undergoing radiotherapy, aiming to assess whether this immersive technology can reduce anxiety and enhance patient overall treatment satisfaction. By comparing different virtual reality techniques and a standard informational video, the study seeks to identify optimal strategies for leveraging virtual reality to improve the patient experience during radiotherapy.

Type: Interventional

Start Date: Dec 2024

open study

The goal of this study is to find the best way to help participants and families manage the stress of facing a serious illness and be better able to "bounce back" or be resilient after a difficult situation. Participants will take part in the "Promoting Resilience in Stress Management" PRISM program, which is designed to provide skills to change or improve the impact of stress in everyday life. The name of the intervention used in this research study is: -PRISM (a mobile app program comprised of 6 sessions of skills-based, manualized resilience education)

Type: Interventional

Start Date: Oct 2023

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

The study will investigate whether a nociceptin receptor antagonist will normalize neural and behavioral processes of approach/avoidance decision-making in unmedicated individuals with major depressive disorder (MDD) and anxiety disorders. More specifically, the study aims to investigate dysregulation within (1) corticostriatal-midbrain circuitry and (2) nociceptin/orphanin FQ peptide and the nociceptin receptor (NOPR).

Type: Interventional

Start Date: Feb 2025

open study

Severe childhood adversity accounts for a large portion of psychiatric illness, and an increased risk for major depressive disorder (MDD). For some individuals, childhood adversity has negative psychological and medical consequences; others preserve mental and physical health despite such experiences (they are resilient). In spite of this, little is known about the neurobiological mechanisms related to childhood adversity, especially oxidative stress abnormalities in the brain. To fill this gap, this study combines functional, structural, and molecular imaging approaches to examine the role of oxidative stress abnormalities related to childhood adversity.

Type: Observational

Start Date: Feb 2021

open study