Anxiety & Depression Association of America

This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania associated with bipolar I disorder.

Type: Interventional

Start Date: Jul 2025

open study

This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

Type: Interventional

Start Date: Jul 2025

open study

The goal of this clinical trial is to test the effectiveness of an online parenting program on Filipino parents living in California. The main aims are to: - Test the effectiveness of the online Incredible Years® model of parent training and its impact on primary outcomes. - Determine the impact of intervention engagement (i.e., higher attendance) on parenting practices and child behavior outcomes. - Describe Intervention delivery and its online implementation in real-world community settings. The study involves two phases: - Phase 1: Participants will receive the Online Incredible Years® School Age Basic & Advanced Parent Training Program (intervention) and complete parent-reported and child-reported measures at baseline, 3 months and 6 months. - Phase 2: Parenting Group Leaders will each participate in one semi-structured interview to inform the sustainability of the intervention in real world community settings. Researchers will compare 250 Filipino families, half of which will receive the intervention and the other half will receive the American Academy of Pediatrics' Bright Futures handouts (control) and be placed on a 3-month waitlist for the IY parenting program. Both groups will be followed for a minimum of 6 months with follow- up assessments that include parent-report and child report measures.

Type: Interventional

Start Date: Apr 2025

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

This study seeks to contribute to the growing body of literature on hypnosis by providing robust, data-driven insights into the physiological mechanisms underlying trance states. The integration of electroencephalogram (EEG) and other wearable-derived physiological data will offer a comprehensive assessment of the changes that occur during a standardized hypnosis protocol: the Harvard Group Scale of Hypnotic Susceptibility (HGSHS:A). The results of this study are intended to facilitate derivation and validation of an Artificial Intelligence/Machine Learning (AI/ML)-based monitor that quantifies a patient's instantaneous emotional/arousal state along the spectrum that spans anxiety through states of calmness and trance. Future investigations will explore the ability of using such an interactive virtual system as a component of a closed-loop adaptive device to create optimal states of non-pharmacological sedation using personalized audiovisual content to allay anxiety and discomfort during medical procedures, such as percutaneous biopsies.

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

This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.

Type: Interventional

Start Date: Jun 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

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Type: Interventional

Start Date: Jul 2024

open study

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

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

Veterans with bipolar disorders (BD) experience recurrent and seemingly unpredictable periods of severe impairments in psychosocial functioning, such as participation in social roles and activities. Many effective treatments for BD emphasize early detection of bipolar episodes, in order to make necessary treatment adjustments and prevent psychosocial impairments associated with acute mood episodes. Unfortunately, acute mood episodes in BD are also associated with a decrease in a patient's insight into their own symptoms, which can prevent one's ability to self-report first signs of symptoms and functional declines. Moreover, routine care visits for BD are typically too infrequent to capture and effectively monitor day-to-day changes in a patient's mood and functioning. Objective, low-effort, and continuous methods of tracking symptoms and social participation of Veterans with BD in real-time and in-situ are needed to provide early (i.e., days in advance) warning signs of acute bipolar episodes and functional declines, which in turn would enable well-timed interventions to prevent poor psychosocial outcomes. mHealth refers to the use of mobile and wireless devices as part of patient care and offers many potential opportunities for early detection of and intervention for acute mood states in this population. However, these mHealth approaches have not been investigated in Veterans with BD. In a Small Projects in Rehabilitation Research (SPiRE)-funded pilot study, the investigator team established high feasibility and acceptability of one such innovative passive mHealth approach using a smartphone program, or an app, in a small sample of Veterans with BD to track their smartphone's GPS/location. The pilot study used a priori location context ratings of visited places (e.g., a priori ratings on types of activities usually engaged in at a frequently visited location) to derive unobtrusive measures of social participation (e.g., time spent at work-related locations). The goal of this Merit Review proposal is to establish reliable and valid machine-learning algorithms using the same types of mHealth data to prospectively (days in advance) detect declines in social participation and prospective onset of mania and depression in Veterans with BD. This proposal has three aims: Aim 1. To establish a machine learning algorithm using GPS/location data for predicting prospective declines in social participation in Veterans with BD. Aim 2. To establish machine learning algorithms using GPS/location data for predicting prospective acute BD clinical states. The investigators will explore whether adding more burdensome daily self-report and voice diaries' speech analysis features improves the models' precision using statistical indices of prediction precision or accuracy. Aim 3. To explore clinical implementation of the mHealth-based algorithms in treatment of BD. Focus groups of VA providers and administrators will assess feasibility of algorithms' implementation in clinical care.

Type: Observational

Start Date: Sep 2024

open study

The goal of this research study is to adapt an ACT-self-help workbook to the prison setting and determine the feasibility acceptability, and effectiveness of this workbook. Participants can expect to be in the study for 13 weeks.

Type: Interventional

Start Date: Dec 2024

open study

The goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of PTSD. Participants will complete a baseline intake followed by two experimental sessions. During the first experimental session, participants will undergo an MRI session of imaginal exposure to traumatic memory cues followed by 30-minutes of moderate intensity exercise or low intensity exercise. Participants will complete a second session of imaginal exposure with MRI 24 hours later.

Type: Interventional

Start Date: May 2024

open study

The goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression. The main questions it aims to answer are: - Is deep brain stimulation effective in treating treatment resistant depression? - Does deep brain stimulation improve overall clinical well-being and functioning? Participants will be implanted with a deep brain stimulation device. They will then be monitored over a 5-year period by using multiple questionnaires to track their depression symptoms. The device will be turned off at certain time points, unbeknown to the participant, to show the efficacy of the device when it is turned on. The device will be ON for 8.5 months and OFF for 3.5 months during the first year. Researchers will compare questionnaire scores when the device is off versus on to see if the device is working in reducing depression.

Type: Interventional

Start Date: Oct 2023

open study

The goal of this neuroimaging pilot study is to understand developmental differences in the impact of therapeutic wavelength light (blue light) versus a non-therapeutic wavelength (red light) on emotional brain function in depression. The main questions this study aims to answer are: - Does acute exposure to blue light (vs red light) stabilize emotional brain function in depressed individuals? - Are stabilizing effects of blue light (vs red light) stronger for blue light in adolescents than young adults? Participants will complete: - A magnetic resonance imaging brain scan, in which we will examine the effect of blue versus red light on emotional brain function at rest and in response to rewards and losses. - A pupillometry test of sensitivity to blue vs red light - Clinical interviews and surveys - Screening measures for drug and alcohol use, MRI safety, and current pregnancy [if relevant] - Home sleep tracking with sleep diary and actigraphy for one week

Type: Interventional

Start Date: Jun 2023

open study