Anxiety & Depression Association of America

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

Decision-making is an important process that is frequently shown to be impaired in patients with depression. While a number of preclinical and clinical studies have identified key regions involved in this process, it remains unclear exactly how these regions are influencing choice behavior especially when choices become more challenging. The goal of this project is to understand how these regions, such as the cingulate cortex, impact difficult choice behavior. Specifically, the researchers are interested in learning how disruptions in cognitive control might impact choice preferences during difficult decisions in depressed patients. To do this, this study will recruit participants with depression (as well as healthy controls) to perform game-like tasks in the laboratory while undergoing TMS or TI.

Type: Interventional

Start Date: Nov 2019

open study

The purpose of this research is to see if Crisis Response Planning (CRP), a brief strategy designed to help people cope effectively with emotional crises, combined with Cognitive Processing Therapy (CPT), a talk treatment for posttraumatic stress disorder (PTSD), will reduce suicidal thoughts and behaviors.

Type: Interventional

Start Date: Jan 2026

open study

This study aims to examine whether naturally occurring bacteria in the gastrointestinal tract are associated with mood changes following childbirth, including postpartum depression. Biological samples will be collected before and after delivery to determine whether specific patterns in gut bacterial composition are linked to emotional states. The purpose of the research is to improve understanding of whether such microbial changes can help identify individuals at higher risk for postpartum depression, enabling earlier recognition and intervention.

Type: Observational

Start Date: Nov 2025

open study

The purpose of the study is to evaluate a trauma informed digital multicomponent intervention design to improve health and safety outcomes for women with lifetime exposures to violence and co-occurring PTSD and/or depression symptoms

Type: Interventional

Start Date: Nov 2025

open study

The study will seek to prospectively validate the Enlighten Device for prediction of PPD by examining true/false positive and negative rates of the test using PPD outcomes collected through 3 months postpartum; compare the accuracy of biomarkers and algorithm in determining risk for PPD in blood compared to saliva; determine the utility of a week 6 sample collection in identifying women who are currently experiencing PPD thus bringing them to clinical attention. Our population will consist of pregnant women aged 18 and older up to 33 weeks of gestation. This research involves two groups of potentially vulnerable subjects: pregnant women and their infants. Because this is a study of postpartum depression (PPD), inclusion of these two vulnerable subjects is required. The study will enroll 1000 pregnant non-adolescent women of childbearing age who meet eligibility criteria. This project will address the following Aims: Specific Aim 1: Prospective collection of true/false positive and negative PPD outcomes through 3 months postpartum. Primary Hypothesis H1a: 80% or greater of pregnant women who develop postpartum depression (PPD) by 3 months after delivery will be determined to be Biomarker Positive by the Enlighten Test in T3. Primary Hypothesis H1b: 10% or fewer of pregnant women who are determined to be Biomarker Negative by the Enlighten Test in T3 will develop PPD by 3 months after delivery. Exploratory Aim 1: Investigation of clinical factors that may be associated with false positive and false negative rates, such as: medication use, stressful life events, & sociocultural context. Specific Aim 2: Comparison of prospective biomarker calls made in blood samples compared to saliva samples using the Enlighten Test. Primary Hypothesis H2: Biomarker calls made using blood versus saliva samples will demonstrate a high concordance rate of 75% or higher. Exploratory Aim 2: In individuals who develop PPD by 3 months postpartum, conduct an epigenome-wide study (EWAS) in saliva to identify saliva-specific epigenetic biomarkers to improve the algorithm's ability to predict PPD using saliva in the third trimester and Week 6 samples. Specific Aim 3: Determination of the utility of the Enlighten Test in identifying women currently experiencing PPD at W6 postpartum. Primary Hypothesis H3: 80% of women who meet criteria for PPD at W6 will be Biomarker Positive. Participants will be screened during the second or third trimester and enrolled during the third trimester, before week 30 weeks of gestation. Participants may self- identify through study advertisements in participating clinics, social media outlets, and community outreach efforts. Enrolled participants will undergo blood collection during their 3rd trimester completed by mobile phlebotomists in-person through ExamOne (~27-30 weeks, a standard pregnancy-related blood collection timepoint) for completion of the Enlighten Device test, the blood-based epigenetic biomarker test. Participants will then be interviewed at 2 weeks, 6 weeks, and 3 months postpartum for the development of depression symptoms. They'll also complete a multitude of other outcome measures at each of these visits.

Type: Observational

Start Date: Nov 2025

open study

The goal of this open pilot trial is to learn if an adapted version of Cognitive Processing Therapy (CPT), delivered through telehealth, can treat posttraumatic stress disorder (PTSD) in adults who use syringe services programs. The main questions it aims to answer are: - Can the intervention be done in syringe services programs? - Are syringe services program clients and staff open to the intervention? - Can the intervention lower PTSD symptoms and help participants keep taking their medication for opioid use disorder (ex. Buprenorphine or methadone)? Participants will: - Attend 4-18 tele-delivered CPT sessions at the syringe services program - Complete between-session CPT practice with the support of SSP-based "coaches" - Meet with research staff monthly to complete surveys of their PTSD symptoms, drug use, and mental health

Type: Interventional

Start Date: Nov 2025

open study

This pilot randomized controlled trial will compare a novel mindfulness training to interoceptive exposure to establish feasibility and acceptability as an intervention for anxiety sensitivity.

Type: Interventional

Start Date: Sep 2025

open study

This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments.

Type: Interventional

Start Date: May 2024

open study

This research will use biobehavioral approaches to generate understanding about the linkages between sleep duration and timing, stressful life events, and depressive symptoms in adolescents, with a long-term aim of developing effective preventative interventions.

Type: Interventional

Start Date: Mar 2023

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 pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.

Type: Interventional

Start Date: Oct 2025

open study

The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.

Type: Interventional

Start Date: Jan 2025

open study

The goal of this trial is to test how augmented reality exposure therapy (ARET) may potentiate the effects of traditional exposure therapy administered to U.S. military personnel diagnosed with PTSD. 40 adult males and females over the age of 18 that have served, or are currently serving, in the U.S. military, with a current diagnosis of PTSD, will be recruited. Participants will be randomized into two groups: 20 participants will receive ARET + traditional ET, with the remaining 20 to receive traditional ET only. The main questions this trial aims to answer are: - what are the different clinical and psychosocial functioning outcomes between veterans/active-duty personnel with PTSD who receive ARET + traditional ET versus traditional ET only - what are the differences in acceptance and satisfaction of treatment, between ARET + traditional ET and the traditional ET-only group

Type: Interventional

Start Date: Sep 2025

open study

This study will look at: How practical it is to offer another round of proven therapy. How effective different therapy options are for people who didn't respond to the first treatment. The goal is to improve personalized care by: Identifying factors that might predict how someone will respond to a second treatment. Creating a simple tool to spot people who might not respond to treatment early, so they can start a different option sooner. The findings will help improve PTSD care by offering better follow-up treatments and matching patients with the approach that works best for them.

Type: Interventional

Start Date: Oct 2025

open study

Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.

Type: Interventional

Start Date: Dec 2024

open study

The goal of this randomized controlled trial is to evaluate the potential of a customized digital cognitive training intervention to target aspects of brain function in apathy of late-life depression and reduce symptoms of apathy and related cognitive and behavioral deficits. The investigators hypothesize that 4 weeks of a customized digital cognitive training program will lead to changes in brain connectivity, apathy severity, and cognitive control performance.

Type: Interventional

Start Date: Sep 2025

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

This study looks at the role of the Nociceptin/Orphanin FQ receptor system in the brain of individuals with current or past major depressive disorder (MDD). It also examines how individuals with a history of depression make certain decisions and which brain regions are involved in such decisions. Information collected through MRI, PET, biospecimens (i.e., blood, saliva) and behavioral tasks will be used to predict depressive symptoms in the future.

Type: Observational

Start Date: Dec 2021

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 purpose of this study is to examine if patients have a lower anxiety level during wide awake hand surgery while listening to their choice of music vs standardized relaxation music. Patients who are planning to undergo wide awake (local anesthetic only hand surgery) and agree to participate will be randomized to either a music intervention where they listen to their choice of music genre or standardized relaxation music during their time in the operating room. 170 participants will be enrolled and can expect to be on study for 2 weeks.

Type: Interventional

Start Date: Mar 2026

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

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