Anxiety & Depression Association of America

The primary objective of this protocol is to implement the UG3 phase (Phase 1) of a National Institute on Drug Abuse (NIDA) UG3/UH3 grant (RFA-DA-23-049). This phase is dedicated to the pilot testing of NEAT-O, a digital Cognitive Behavioral Therapy (CBT) program tailored for individuals with opioid use disorder (OUD) and concurrent anxiety or mood disorders - collectively referred to as internalizing disorders (INTDs). NEAT-O is based on an empirically supported CBT framework, specifically modified to address the complexities of comorbidity in substance use disorders (SUDs). This pilot study will evaluate the usability and acceptability of NEAT-O in 15 participants with OUD, with the goal of refining the program's content and delivery methods. The results of the pilot study will inform a comprehensive RCT in the UH3 Phase (Phase 2) (N=300). Progression to the UH3 phase, with its funding, depends on meeting milestones in Phase 1 including demonstrating protocol adherence and the program's acceptability and usability.

Type: Interventional

Start Date: Aug 2025

open study

This study will take a basic neuroscience approach to investigate pathological mechanisms underlying PTSD. Additionally, the study aims to identify how Transcranial Alternating Current Stimulation (tACS) brain stimulation can modulate and correct neural networks and related emotions of anxious arousal and hypervigilance, with the goal of assessing tACS brain stimulation technology as a novel intervention for symptoms of anxiety.

Type: Interventional

Start Date: Apr 2022

open study

Disasters have negative effects in the short term (physical trauma, adverse environmental exposures, and unstable housing) and the long term (relocation, changes in family functioning, and negative economic effects), which interact with social determinants to worsen health among the most vulnerable women, infants, and communities. Trauma and severe stress are directly linked to pregnancy complications, and raise blood pressure during pregnancy, alter stress hormones, and increase vulnerability to infection, all of which predispose to reduced fetal growth and preterm birth. Disasters also worsen mental health, and depression during pregnancy and postpartum, for instance, is associated with worse physical health during pregnancy, maternal impairment, poorer quality parenting, negative child behavior, and poorer infant cognitive development.The goal of this intervention is to improve mental health in pregnant women living in a disaster-affected region. The main questions this intervention aims to answer are: - Assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, and sustainability) of a pilot intervention in a disaster recovery environment. - Assess the effectiveness of the M-O-M-S pilot intervention in a disaster recovery environment. The study will recruit pregnant women in areas that have experienced a natural disaster. Women will be recruited in early pregnancy and attend a series of classes on the cognitive and relationship changes of pregnancy and motherhood, and mental preparation for labor, led by a "mentor," a mother who has experienced pregnancy, labor, and motherhood.

Type: Interventional

Start Date: Nov 2023

open study

The investigators are studying the feasibility, safety, and tolerability of administering accelerated repetitive Transcranial magnetic stimulation(a-rTMS) at frequencies other than standard 10 Hz for in-patient Subjects diagnosed with Major Depressive Disorder. Participants will be recruited from the Resnick Neuropsychiatric Hospital. This study will enroll 30 participants who will undergo up to three brain activity recordings, one MRI scan, one TMS procedure to determine the appropriate frequency and intensity for treatment, daily symptom assessments, and 25 TMS treatments. Participants will be asked to participate for up to 2 weeks.

Type: Interventional

Start Date: Apr 2025

open study

This investigation is a randomized pragmatic trial of a brief stepped care intervention delivered from an acute care medical trauma center that may both reduce the symptoms of posttraumatic stress disorder (PTSD) and diminish emergency department health service utilization.

Type: Interventional

Start Date: Jan 2023

open study

This randomized controlled trial compares a novel psychotherapy, Engage & Connect, with a Symptom Review and Psychoeducation intervention, tailored to reduce postpartum depression. The study includes 9-weeks interventions, delivered remotely. It will examine changes in social isolation, processing of social rewards and depression severity over 9 weeks of treatment.

Type: Interventional

Start Date: Nov 2022

open study

This study will determine the effects of pregnenolone on brain function, inflammation and depressive symptoms in people with HIV who have depression. Participants in this study will receive a pill of either pregnenolone or placebo, and can stay on their current antidepression medications. Brain imaging and behavioral assessments will be performed during the study.

Type: Interventional

Start Date: Mar 2023

open study

The purpose of this study is to use an experimental inflammatory challenge to examine whether older adults with symptoms of anxiety experience loss of pleasure or loss of motivation when they are exposed to inflammation. Loss of pleasure or loss of motivation will be evaluated using self-report questionnaires, computer tasks, and during a brain scan.

Type: Interventional

Start Date: Mar 2023

open study

This is a research study to find out if childhood trauma and stress are associated with depression or suicidal risk. The study will assess the effects of both short-term and long-term stress on biomarker (e.g. miRNA [MiRNA]) levels. miRNAs are a type of RNA (genetic material that is translated into protein) that are found in throughout the body and blood. They are called microRNA because their size is much smaller than typical RNA molecules. miRNAs are highly responsive to environment. This responsiveness is reflected in their expression in individuals who are affected by environment such as stress. The investigators are gathering genetic material, including DNA and RNA, from each participant. The RNA will be taken from the small vesicles and cells in the participant's blood and analyzed. The vesicles are small objects that occur normally in the blood and that contain RNA. This information may help us to understand the cause of mental illness and to improve medical and psychiatric care in the future. There will be 450 participants enrolled in this study.

Type: Observational

Start Date: Feb 2021

open study

The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. "Healthy" individuals without brain inflammation are also eligible to participate. The digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.

Type: Observational [Patient Registry]

Start Date: Jul 2023

open study

This study will examine the effects of brain stimulation on pain symptoms associated with Major depressive disorder. This study will enroll 54 Subjects. Study subjects will be asked to complete surveys about their mood and well-being, 2 blood draws, 2 MRIs, 3 electroencephalograms, and receive 30 treatments of blinded transcranial magnetic stimulation. There is no control group as all subjects will receive some form of active treatment. Subjects are required to participate in 30-33 study visits and volunteer 40 hours of their time. Compensation for this study is $150 for completing all study activities.

Type: Interventional

Start Date: Mar 2023

open study

Depression is more common after a spinal cord injury (SCI) than in the general population. Unfortunately, it is unknown how depression is typically treated in individuals with SCI or if commonly used treatment methods are effective. This study will investigate the safety and impact of a novel method for treating depression called repetitive transcranial magnetic stimulation (rTMS). rTMS is a type of non-invasive brain stimulation. Fourteen individuals with a cervical or thoracic level SCI and depression will complete an approved treatment plan using rTMS. Participants will be treated using rTMS five days a week for four weeks. After four weeks of treatment, the study team will review the safety of rTMS and assess changes in depressive symptoms. If the results are positive, larger studies can be designed to develop better treatment options for individuals with SCI and depression.

Type: Interventional

Start Date: Feb 2026

open study

Background: Nicotine dependence leads to about 480,000 deaths every year in the United States. People with major depressive disorder (MDD) are twice as likely to use nicotine compared to the general population. They have greater withdrawal symptoms and are more likely to relapse after quitting compared with smokers without MDD. More research is needed on how nicotine affects brain function in those with MDD. Objective: To understand how nicotine affects symptoms of depression and related brain function. Eligibility: People aged 18 to 60 years, at the time of consent, with and without MDD who do not smoke cigarettes or use other nicotine products. Design: Participants will have 2 or 3 study visits over 1 year. Participants will have 2 MRI scans no less than 4 days apart. Each scan visit will last 5 to 7 hours. At each scan, they will have urine and breath tests to screen for recent use of alcohol, nicotine, and illegal drugs. Before each scan, they will take 1 of 2 medications: nicotine or placebo. Participants will receive each medication once. They will not know which medication they are receiving at each scan. For each MRI scan, they will lie on a table that slides into a cylinder. Sometimes they will be asked to lie still. Sometimes they will complete tasks on a computer. Tasks may include identifying colors or playing games to win money. Each scan will take about 2 hours. Participants will answer questions about their thoughts, feelings, and behaviors before and after each scan. They will have a blood test after each scan.

Type: Interventional

Start Date: Feb 2023

open study

An open-label, multi-center, prospective study to evaluate feasibility and efficacy of accelerated TMS for patients with Major Depressive Disorder (MDD).

Type: Interventional

Start Date: Aug 2025

open study

The goal of this single-site, single-arm pilot study is to examine the impact of breathwork training for posttraumatic stress symptoms in an adult veteran population. Participants will complete a single, in-person breathwork session (2 hours) led by a certified breathwork facilitator and engage in an integration session (30 minute) with a licensed psychologist. Participants will be invited to engage in two, optional, virtual follow up breathwork sessions (40 minute practice each) during weeks 2 and 3 following the in-person breathwork session.

Type: Interventional

Start Date: May 2025

open study

The goal of this randomized controlled trial is to pilot the virtual delivery of cognitive behavioral therapy for insomnia (CBT-I) and nightmares (CBT-I&N) via telehealth as an early intervention for treating posttraumatic sleep disturbance in acute trauma patients exposed to interpersonal violence. The main aims are to: 1. Test the acceptability, feasibility, and satisfaction of sleep-focused CBT delivered early after trauma 2. Evaluate the impact of sleep-focused CBT delivered early after trauma on sleep disturbance 3. Evaluate the impact of sleep-focused CBT delivered early after trauma on PTSD symptoms The investigators will compare CBT-I and CBT-I&N to sleep education control. Participants will meet with a provider for 6 weekly sessions via telehealth and complete surveys on the participants' symptoms.

Type: Interventional

Start Date: Mar 2025

open study

In this study, researchers are examining the best sequence of interventions for posttraumatic stress disorder (PTSD) and tinnitus. Participants will either receive psychotherapy for PTSD first (Cognitive Processing Therapy; CPT), followed by treatment for tinnitus (Cognitive Behavioral Therapy for Tinnitus; CBT-t); or vice-versa. We also aim to identify changes in brain functioning after receiving therapy.

Type: Interventional

Start Date: Aug 2025

open study

The investigators will be randomizing 300 college student participants with high levels of social media use into either a 1) control condition (no intervention), a 2) mindfulness meditation cognitive intervention, or 3) a social media reduction + exercise replacement intervention. Participants complete intervention activities daily for two weeks. The investigators will collect self-report and behavioral measures of social media use and related psychological constructs at three time points: baseline, immediately after the intervention period, and one-week after the intervention period (three weeks from baseline).

Type: Interventional

Start Date: Aug 2025

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

This is a mixed-methods study that includes three steps. The first is a focus group to collect opinions and feedback about implementation of aTMS among clinicians, technicians, nurses, and other clinical staff at the St. Louis Park (SLP) clinic who are experienced with delivering TMS. The second is the delivery of a set of questionnaires delivered to TMS patients at the SLP clinic who are awaiting the start of their TMS series. The third is the delivery of aTMS utilizing the MagVenture TMS device to patients on the SLP rTMS waitlist. The purpose of this feasibility study is to examine the acceptability and efficacy of Accelerated Transcranial Magnetic Stimulation (aTMS) delivered using an accelerated schedule. Repetitive Transcranial Magnetic Stimulation (rTMS) is traditionally delivered once a day, five days a week, for nearly 7 weeks for a total of 36 treatments. While aTMS is quick to deliver, a standard session lasting 10-20 minutes, this schedule is time intensive for patients. It often requires time off from work to accommodate daily driving time to and from the clinic as well as treatment time. This can be disruptive to a patients life and ability to attend all treatment sessions while continuing with their own life responsibilities.

Type: Interventional

Start Date: Jun 2025

open study

The purpose of this research study is to evaluate different depression treatment approaches among cancer survivors. A cancer survivor is defined as anyone who is living and has been diagnosed with cancer. Participants will be randomly assigned to either receive a mobile app for depression treatment, called "Moodivate", or to receive telehealth depression treatment sessions. Approximately 2/3 of participants enrolled will receive the mobile app and the remaining 1/3 will receive depression treatment via telehealth. Participants that receive Moodivate may later be assigned to also receive depression treatment via telehealth based their response to the Moodivate app. Participants will be asked to either use the Moodivate app and/or receive depression treatment via telehealth for a period of 10 weeks. All participants will be asked to electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as general experiences using Moodivate and participating in this trial. Participation in this study will take about 24 weeks. Participation in this study may help improve options for emotional wellness for cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and/or loss of confidentiality.

Type: Interventional

Start Date: Aug 2025

open study

This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Psychological support is defined as providing safety, reassurance, active listening, and empathetic presence during the drug administration session in a nondirective manner. We hypothesize that Psi-PS may provide a safe treatment for participants. The primary objective of study is to characterize the safety of psilocybin combined with psychological support (Psi-PS) for individuals with co-occurring alcohol use disorder (AUD) and PTSD.

Type: Interventional

Start Date: Jun 2025

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

Conditions treated in intensive care units (ICUs) such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are common. These can lead to high rates of depression, anxiety, and PTSD that worsen quality of life. Yet there are few effective strategies able to overcome barriers of limited access to mental health care. Even less is known about the experiences of patients from racially and ethnically minoritized populations because of they haven't been included well in past research. To address this problem, the investigators developed Blueprint, a mobile app that coaches people to use adaptive coping skills to self-manage their symptoms. The investigators found that it reduced depression symptoms and improved quality of life compared to placebo. To confirm these promising findings, the investigators are doing a formal test of Blueprint. The investigators will enroll 400 people who received ICU care from 4 hospitals (Duke, UCLA, Colorado, and Oregon). These patients will be randomized to receive either the Blueprint mobile app or a special Education Program mobile app the investigators developed. -both delivered through similar mobile app platforms. Our specific aims are to see which program improves symptoms better across 6 months of follow up. This project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity.

Type: Interventional

Start Date: Oct 2024

open study

This research study is being done to test the feasibility of an existing supportive program (PRISM) to address psychological symptoms (i.e., depressive and anxiety symptoms) that young adult participants diagnosed with cancer or desmoid tumor may experience. The name of the intervention used in this research study is: -Promoting Resilience in Stress Management (PRISM) Program

Type: Interventional

Start Date: Sep 2024

open study