Anxiety & Depression Association of America

The purpose of this study is to develop a technique called real time fMRI neurofeedback. This technique uses a regular MRI scanner, except that special software allows the researchers to measure activity in participants brain, using fMRI, and then give information, in the form of a feedback signal, which indicates brain activity in real time, while in the MRI scanner. The larger goal of this study is to develop ways to help people, including those with depression, better regulate brain activity. The researchers think that this may be helpful in managing psychiatric symptoms. This study design has three phases, however, only two phases (phase 2 and 3) are considered to be a clinical trial. Phase 2 (part 2) was registered and is NCT05934604. This is the phase 3 (part 3) for this project and is funded by the National Institutes of Health.

Type: Interventional

Start Date: Mar 2024

open study

Investigators plan to offer two evidence based interventions - Trauma Focused Cognitive Behavioral Therapy (CBT) (TF-CBT) and Trauma Systems therapy (TST) to traumatized children and their families. The investigators are looking to evaluate the effectiveness of these interventions in the context of additional stress related to racialized trauma and acculturation stress

Type: Interventional

Start Date: Jul 2023

open study

This study is evaluating the effects of riding on a cycle ergometer while experiencing virtual reality to determine its effect on mood.

Type: Interventional

Start Date: May 2022

open study

Addressing health disparities, especially in the face of coronavirus pandemic, requires an integrated multi-sector equity-focused, community-based approach. This study will examine the impact of Harlem Strong Community Mental Health Collaborative, a community-wide multi-sectoral coalition in which a health insurer works with a network of community-based organizations, medical providers, and behavioral health providers to engage in a network-wide implementation planning process to: (1) problem-solve financing, access, and quality of care barriers, (2) support capacity building for mental health (MH) task-sharing for community health workers, (3) facilitate coordination and collaboration across MH/behavioral health, primary care, and a range of social services, including case management, housing supports, financial education, employment support, and other community resources to improve linkages to services, and (4) identify a set of common MH, social risk, and health metrics and strategies to integrate these metrics into data systems across the network for continuous quality improvement of the system. The long-term goal of our study is to develop sustainable model for task-sharing MH care that will be embedded in a coordinated comprehensive network of services, including primary care, behavioral/MH, social services, and other community resources.

Type: Interventional

Start Date: Apr 2023

open study

The study will examine the role of digital wellness modules (brief mindfulness and light to moderate physical exercise) delivered through a smartphone wellness application and their short-term effects on health behavior motivation and change, and longer-term quality of life and non-pathological affective states.

Type: Interventional

Start Date: May 2024

open study

The Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program is an evidence-based intervention that prevents half of cases of postpartum depression and was one of two interventions recommended by the US Preventive Services Task Force in 2019. All effectiveness trials of ROSE and of the other recommended PPD prevention intervention included only low-income women a single risk factor that doubles incidence of PPD. Thus, the existing evidence base for PPD prevention consists primarily of women at increased risk for PPD. Based on data from the PIs' current implementation study of ROSE, many healthcare and community agencies in this implementation trial (78%) find it is more feasible for them to provide or offer ROSE to every woman as part of their standard workflow, than it is to create a screening and referral process for at risk women. In addition to being more feasible for agencies, universal prevention may also be advantageous because the cost of a screening false negative (resulting in a preventable case of PPD; $32,000) far exceeds the cost of ROSE delivery ($50-$300/woman). Effectiveness of ROSE among low-income women at risk for PPD is known (ROSE prevents ~50% of PPD cases). To inform a recommendation about using ROSE as universal vs. selective or indicated prevention, we need to determine the effectiveness of ROSE among general populations of women, including women screening negative for PPD risk. Thus, this project will assess ROSE effectiveness across PPD risk levels and across prevention approaches in a sample of 2,320 women from a large regional health system (based in Detroit, MI). Each proposed aim gathers a piece of information missing that is needed to guide decision-making about ROSE as universal prevention. We will assess ROSE as universal, selective, and indicated prevention in terms of: (1) ROSE effectiveness relative to a control for each prevention approach in preventing PPD and improving functioning; (2) cost outcome, (3) equity and (4) scalability of each prevention approach; and (5) mechanisms of ROSE effects across PPD risk levels. We will integrate results to advise about ROSE as universal prevention. This definitive PPD prevention trial will show how best to get an evidence-based program to those who need it in settings where they receive perinatal care by addressing a pragmatic and novel question (should ROSE be universal prevention?) and by examining equity and cost-outcome of universal vs. other prevention approaches.

Type: Interventional

Start Date: Jun 2023

open study

The purpose of this study is to examine the implementation and effectiveness of the psychosocial eHealth intervention, My Wellbeing Guide, on the proposed primary outcome, depressive symptoms, in patients diagnosed with cancer who receive care at Northwestern Medicine and the University of Miami Health System. Eligible patients will be directly contacted by the study team for recruitment. The intervention includes cognitive behavioral therapy management strategies for health-related stress in the form of animated videos, interactive activities, and written content. The intervention will be delivered via an online application over an 7-week period. Intervention participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up. Participants are randomized into either an intervention application (described above) or a control application (which will provide links to helpful resources for patients with cancer, such as the contact information for cancer support services at Northwestern University and the University of Miami, and the link to the National Cancer Institute website, and the American Cancer Society website.) Control participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.

Type: Interventional

Start Date: Dec 2022

open study

The goal of the current project is to establish the efficacy and mechanisms of exercise-enhanced fear extinction retrieval and generalization in posttraumatic stress disorder (PTSD). Exposure therapy is the gold standard treatment for PTSD, yet is only associated with remission rates of ~55% and in clear need of improvement. Exposure therapy is hypothesized to work through mechanisms of fear extinction learning, and as such, laboratory-based fear extinction paradigms are widely used as models of exposure therapy. Recent data demonstrates that moderate-intensity aerobic exercise, delivered specifically during or after fear extinction learning, can boost the consolidation of fear extinction learning. Consistent with emerging models of exercise's pro-extinction effect, our pilot data among women with PTSD found that moderate intensity aerobic exercise delivered after fear extinction learning leads to a reduction in subsequent fear responding 24hrs later, an effect that was mediated by exercise-induced increases in peripheral brain derived neurotrophic factor (BDNF). Our pilot data using multivariate pattern analyses (MVPA) also identified divided neurocircuitry organization of fear vs safety memories, and that this divided neural organization was altered in PTSD. Building on our pilot data, the current project would 1) compare the impact of different intensities of exercise delivered following fear extinction learning on multimodal measures of fear extinction retrieval and generalization, 2) identify the impact of exercise on MVPA representations of fear vs safety memories, and 3) demonstrate that spontaneous reactivations of extinction encodings in the acute consolidation window operate as candidate mechanisms by which exercise enhances extinction retrieval and generalization. Using a 3-day fear conditioning, fear extinction, and fear extinction retrieval and recognition task during functional magnetic resonance imaging (fMRI), 200 adults with PTSD would be randomly assigned to either resting control or 30min of either light, moderate, or high intensity exercise. Testing dose-response relationships between exercise intensity and fear extinction will inform translation of this research to clinical settings. A one week-follow-up extinction retrieval test would investigate the impact of exercise on longer-term retention. This project would provide a critical evaluation of the impact of aerobic exercise on consolidation and recall of extinction learning in PTSD samples, thereby providing a strong foundation to translate this research to clinical care and enhance clinical outcomes for PTSD. The project would also provide general knowledge regarding dose-response relationships and neural mechanisms that support enhanced extinction, thereby informing development of additional novel treatments.

Type: Interventional

Start Date: Sep 2025

open study

The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder. The main questions this study aims to answer are: - How safe is AL001 when compared to lithium carbonate? - How is AL001 broken down in the brain and body compared to lithium carbonate? Participants will be asked to: - Take both the study drug (AL001) and lithium carbonate each for a period of 14 days. - Stay overnight at MGH's research unit for two separate 2-week periods. - Participate in two separate 24 hour periods of multiple MRIs and blood draws.

Type: Interventional

Start Date: Apr 2026

open study

The goal of this clinical trial is to learn whether a music-based intervention can improve mental and physical health and strengthen coping skills among adults living in residential care settings in northern Arizona. The main questions it aims to answer are: Does participation in the music-based intervention reduce stress, anxiety, depression, and pain?, and Does participation increase the use of music as a coping strategy and improve overall well-being? Researchers will compare participants' pre-intervention and post-intervention responses to determine whether the music classes are associated with improvements in health and coping outcomes. Participants will: Attend a 6-week music class held once per week for one hour; participate in active music activities such as drumming and rhythm exercises; complete a brief survey before and after the intervention. Some participants are also invited to complete a short interview about their experiences.

Type: Interventional

Start Date: Mar 2026

open study

The proposed study aims to establish the feasibility and safety of subcutaneous tocilizumab, a monoclonal antibody (mAb) against interleukin (IL)-6 receptor, in adults with Major Depressive Disorder (MDD) and evidence of peripheral immune activation. IL-6 is a pro-inflammatory cytokine implicated in the pathophysiology of depression. The investigators hypothesize that neutralizing peripheral immune signaling via IL-6 receptor blockade with tocilizumab will improve neural and behavioral measures of reward processing. This is an open-label, proof-of concept, trial in which up to N=20 adults with MDD meeting a specific immune enrichment criterion will receive open-label tocilizumab over 8 weeks. A healthy control (HC) group (N=20) will undergo baseline neuroimaging and blood-based biomarker assessment without receiving the study drug to aid interpretation of findings. Blood-based immune markers and brain MRI scans (including task-based reward activation and resting-state functional connectivity) will be assessed at baseline for all participants and again post treatment for the MDD group.

Type: Interventional

Start Date: Mar 2026

open study

Sexual and gender minority adults often experience elevated levels of chronic stress due to stigma, discrimination, and social adversity, commonly referred to as minority stress. This persistent stress is associated with increased anxiety, mood disturbances, impaired sleep quality, and reduced quality of life. There is a need for safe, non-pharmacological interventions that can support mental well-being in this population. This randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Ashwagandha (Withania somnifera) root extract in reducing stress and improving anxiety and sleep quality in adults experiencing minority stress. A total of 80 adults aged 18 to 45 years who self-identify as sexual or gender minorities and report moderate to high perceived stress will be enrolled. Participants will be randomly assigned to receive either Ashwagandha root extract (300 mg capsules taken twice daily) or an identical placebo for 8 weeks. Efficacy will be assessed using validated psychological and quality-of-life questionnaires, including the Perceived Stress Scale, Depression Anxiety Stress Scale, Pittsburgh Sleep Quality Index, and other mood and minority stress measures. Salivary cortisol will be measured as a biological marker of stress. Safety will be evaluated through monitoring of adverse events throughout the study.

Type: Interventional

Start Date: Apr 2026

open study

Purpose of the Study Post-traumatic stress disorder (PTSD) is a common and serious condition, but many people cannot get the help they need because there are not enough mental health specialists (like psychologists or psychiatrists) available. This study is testing a new program called NurseNET. The goal of NurseNET is to train nurses to provide a proven, short-term trauma treatment called Narrative Exposure Therapy (NET). Why This Study is Important Most people see their nurse or doctor for health concerns. Because nurses are highly trusted and already work on the front lines of healthcare, they may be in the best position to offer PTSD treatment quickly and conveniently. This study aims to see if nurse-led care can bridge the gap between patients and the treatment they deserve. What the Study Involves Researchers will enroll 100 participants who have symptoms of PTSD. Participants will work with a trained nurse in a primary care setting to complete the NurseNET program. The Treatment: The program consists of 4 to 6 sessions. During these sessions, the nurse helps the patient talk through their life story and process difficult memories in a safe, supportive way. What We Are Measuring: The research team will look at several factors to see if the program is successful: Effectiveness: Do PTSD symptoms improve after working with the nurse? Feasibility and Acceptability: Do patients and nurses find this type of care easy to use and helpful? Health Impact: Since PTSD is linked to heart health, the study will also look at whether the treatment improves things like blood pressure or physical activity levels. Goal of the Research By the end of this study, researchers hope to show that nurses can safely and effectively provide trauma care. If successful, this model could be used across the United States to make PTSD treatment much easier to access for everyone.

Type: Interventional

Start Date: Mar 2026

open study

The goal of this study is to test a sleep health program designed specifically for U.S. Marine Corps personnel. Researchers want to determine if this program helps Marines improve the participants sleep quality and overall mental health. The study will evaluate whether the program improves sleep quality and duration and reduces symptoms of depression, anxiety, PTSD, and suicide ideation. There are three distinct sleep health programs that will be evaluated; participants will be randomly assigned to one of five groups to receive different combinations of the sleep health programs. To measure results, researchers will use participant surveys for all enrolled participants and wearable sleep-tracking devices for a sub-set of participants. The study team expects that Marines who receive the most comprehensive version of the program will show the greatest improvements in sleep and psychological well-being.

Type: Interventional

Start Date: Mar 2026

open study

This phase II trial tests the safety, side effects and how well group retreat psilocybin therapy works for the treatment of anxiety and depression in patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or with hematologic cancers for which no treatment is currently available (incurable). For patients with metastatic, incurable cancer, unrelieved anxiety and existential distress can cause profound suffering. Psilocybin therapy can relieve anxiety and existential distress by disrupting patterns of thinking that contribute to anxiety and depression. Psilocybin is a substance being studied in the treatment of anxiety or depression in patients with cancer. In this study, a pharmaceutical grade of psilocybin will be used that has been approved by the FDA for research, provided by Filament Health. Psilocybin acts on the brain by resetting the brain's activity and increasing connections between brain regions, particularly those involved in mood regulation and self-perception. In this study psilocybin is combined with structured discussions and reflections that enable patients to have new insights about their situation. In a prior study, group retreat psilocybin therapy was proven to be safe and this study tests a refined dosing regimen for symptoms of anxiety and depression in patients with metastatic solid tumors or incurable hematologic malignancies.

Type: Interventional

Start Date: May 2026

open study

The goal of this neuroimaging study is to investigate how emotional states fluctuate in people with bipolar disorder (BD) compared to healthy controls, and to understand the neural mechanisms driving mood instability. The main questions it aims to answer are: - Can emotional states be decoded from fMRI brain activity using machine learning? - Do individuals with BD show more unstable emotional state trajectories (e.g., high metastability, low fractal scaling) than healthy controls? - Does amplifying positive emotions stabilize brain and emotional dynamics in BD? Researchers will compare individuals with bipolar disorder (BD-I or BD-II, currently depressed or mixed state) to healthy controls without psychiatric history to see whether the BD group shows greater fluctuations in emotional brain activity and whether positive emotion regulation strategies normalize this instability. Participants will: - Complete self-report questionnaires on mood, emotion regulation, anxiety, and daily functioning. - Recall and provide short descriptions of personal positive and negative memories to be used in the MRI task. - Undergo fMRI scanning, including: - Resting-state scans - A Think and Regulate Affective States Task (TReAT) where they recall autobiographical memories, rate emotions, and practice amplifying positive mood. - Structural and diffusion MRI for brain mapping. - Receive physiological monitoring (heart rate, respiration) during scanning. - Complete post-scan surveys on emotional state and task experience. This research will help clarify how the brain supports or disrupts emotional regulation in bipolar disorder and may inform the development of personalized, neurobiologically informed treatments for mood instability.

Type: Interventional

Start Date: Oct 2025

open study

The study's objective is to conduct a Phase II randomized controlled trial examining the preliminary efficacy of the VoiceLove app compared to usual care on maternal postpartum depression in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). Primary aim: Assess the effects of VoiceLove on maternal postpartum depression, measured by the Edinburgh Postnatal Depression Scale (EPDS). The estimates from this study will be used for a future definitive Phase III trial. Secondary aim: Assess feasibility, acceptability, and patterns of communication and engagement among mothers, partners, and NICU clinicians during the NICU hospitalization, measured through app usage metrics, satisfaction surveys, and qualitative interviews. Additionally, we will evaluate effects of infant length of stay.

Type: Interventional

Start Date: Feb 2026

open study

This study teaches participants who are having colorectal surgery how to use mindfulness to feel calmer and manage pain better. Participants will be randomized (like a flip of a coin) into one of two groups: Mindfulness Intervention or Standard Treatment. Those in the Mindfulness group will have a 30-minute Zoom session before surgery to learn simple mindfulness exercises like deep breathing, using senses, and staying focused on the present. On the day after surgery, participants will watch a short video review of the mindfulness exercises. Regardless of the group assigned, participants may be asked to complete questionnaires, and some participants will be asked to complete a semi-structured interview via Zoom, about 2 weeks to 1 month after surgery. Additionally, access to the mindfulness curriculum will be provided to those not randomized to that group. Investigators will collect information such as age, surgery details, pain levels, and pain medication usage. Participants will also fill out surveys before and after surgery to assess physical and mental well-being. All personal information will be kept safe, and interviews or Zoom sessions will be deleted after notes are taken without names attached. Participants will be in this study for about 4 weeks.

Type: Interventional

Start Date: Feb 2026

open study

The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation (tACS) approach in antenatal depression.

Type: Interventional

Start Date: Aug 2025

open study

The purpose of this research study is to refine customized in-app notifications in order to optimize users' experience with a mobile app called Wysa for Chronic Pain. This app is designed to support people who have chronic pain and who also experience symptoms of depression and/or anxiety. This version of the app is not currently available to the public. Eligible participants will be asked to download and use the Wysa for Chronic Pain study app for several weeks, and to use it as they normally would if they were not part of a research study. At the beginning and end of the study period, participants will be asked to complete brief surveys about their mood, pain, physical function, and sleep. Additionally, a few participants will be asked to share their experience with the study app at the end of the research study in a casual interview using a secure audio/video recorded call. Participating in the interview portion is optional.

Type: Interventional

Start Date: Jun 2025

open study

The goal of this clinical trial is to learn if music use affects anxiety or pain levels in parturients admitted to labor and delivery. It will also learn about the effect of music use on patient satisfaction. The main questions it aims to answer are: Does music use affect anxiety levels in parturients admitted to labor and delivery? Does music use affect pain levels in parturients admitted to labor and delivery? Does music use affect patient satisfaction in parturients admitted to labor and delivery? Researchers will compare music to a control (no music) to see if music affects anxiety levels in parturients admitted to labor and delivery. Participants will: Listen to music or listen to no music for a 10 minute duration in the labor and delivery unit. Answer questions about anxiety and pain levels at a few different timepoints. Have information collected from medical charts (vital signs and cervical dilation). Rate their satisfaction with care.

Type: Interventional

Start Date: May 2025

open study

The goal of this clinical trial is to test a brief, new psychotherapy (called Positive Processes and Transition to Health - Single Session, or PATH-SS) that aims to provide relief for people who are suffering after experiencing a sexual assault. This research will explore whether this new psychotherapy reduces sexual assault related distress, including posttraumatic stress and depression symptoms. The main questions it aims to answer are: Does PATH-SS leads to improvements in PTSD and depression symptoms (pre- to post- and 1-month follow-up)? Do participants perceive PATH-SS to be acceptable, helpful, and do they complete/adhere to treatment? Participants will complete a pre-treatment/baseline assessment to confirm eligibility, and those who are eligible will receive the single-session intervention and will complete a post-treatment and a 1-month follow-up assessment of stressor-related symptoms.

Type: Interventional

Start Date: Jul 2025

open study

The overall objective of the project is to determine the effectiveness of tele-delivered behavioral activation (BA) by trained lay counselors (Tele-BA-S) to prevent Post-stroke depression (PSD) in low-income, older stroke survivors with subthreshold depression (SD).

Type: Interventional

Start Date: Apr 2026

open study

This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.

Type: Interventional

Start Date: May 2025

open study

This is a double-blind active placebo controlled clinical trial for individuals with moderate to severe depression. The purpose of this study is to assess if nebulized ketamine can reduce depressive symptoms.

Type: Interventional

Start Date: Oct 2024

open study