Anxiety & Depression Association of America

In post-traumatic stress disorder (PTSD), intrusive, traumatic, autobiographical memories lead to anxiety symptoms. Recent work suggests a new repetitive pulse transcranial magnetic stimulation (rTMS) brain target that might bring relief. Since this proposed target is not well understood, the goal of the study is to use functional magnetic resonance imaging (fMRI) to identify the brain regions and networks that change with rTMS stimulation at this target area in PTSD patients. Ultimately, this would lead to a personalized approach to rTMS treatment of PTSD based on brain imaging that can be used in a future clinical trial. Participants will be asked to complete psychological testing and questionnaires as well as an initial MRI and two separate TMS-fMRI sessions. Total participation time across all visits is estimated to be five to six hours. Research participation will take place at VA Palo Alto as well as at Stanford University.

Type: Interventional

Start Date: Aug 2023

open study

Novel invasive neurostimulation stimulation strategies through neurosurgical interventions are emerging as a promising therapeutical strategy for major depressive disorder. These have been applied mostly to the anterior cingulate cortex, but other limbic brain regions have shown promise as anatomical targets for new neurostimulation strategies. The researchers seek to study neural activity in limbic brain areas implicated in decision behavior and mood regulation to identify novel targets for treatment through electrical stimulation. To do this, the study team will record local field potentials (LFPs) from the orbitofrontal cortex, hippocampus and amygdala of epilepsy participants undergoing invasive monitoring (intracranial encephalography, iEEG) during choice behavior. Leveraging the high co-morbidity of depression and intractable epilepsy (33-50%), neural responses will be compared to reward across depression status to identify abnormal responses in depression. Finally, the researchers will use these as biomarkers to guide development of neurostimulation strategies for the treatment of depression.

Type: Interventional

Start Date: Oct 2021

open study

Older adults with serious illness and their caregivers have high rates of anxiety and limited access to effective, non-pharmacological treatments. A recent National Academy of Medicine report recommended increased emphasis on disseminating and implementing evidence-based psychotherapies in order to have maximal public health impact. Through this work, I will identify a sustainable and potentially scalable dyadic intervention and delivery model to manage symptoms of anxiety in older adults with serious illness and their caregivers in primary care.

Type: Interventional

Start Date: Apr 2022

open study

Traumatic brain injuries (TBIs) are common. Post-TBI depression is associated with anxiety, aggression, fatigue, distractibility, anger, irritability, and rumination. The current research group conducted a pilot clinical trial, which investigated the novel treatment combination of buspirone and melatonin (B+MEL) in outpatients with clinical depression. Compared to placebo, B+MEL was associated with a significant improvement in depressive symptoms. Depression following TBI may be different from clinical depression. The B+MEL combination has never been studied in patients with post-TBI depression. The B+MEL has shown promise in ameliorating cognitive difficulties in people with depression. Because cognitive problems are typical in people with post-TBI depression, we plan to measure the effect of the B+MEL combination on cognitive ability in post-TBI depression. Additionally, we are interested in measuring functional magnetic resonance imaging changes before and after treatment with B+MEL in order to gain insight into the brain mechanisms of our hypothesized clinical symptom changes. The goals of the proposed pilot research project are to assess changes in symptoms in patients with post-TBI depression following Buspirone + Melatonin combination (B+MEL), and the corresponding brain mechanisms underlying these hypothesized changes by measuring: 1) depressive symptoms; 2) cognitive symptoms; 3) functional magnetic resonance imaging.

Type: Interventional

Start Date: Aug 2020

open study

16.2 million American adults are affected by depression each year. The investigators are studying the relationship between sleep/wake cycle and depression. Mounting evidence suggests that abnormalities in circadian rhythms (biological changes that happen over the course of the day or night) are related to mood disorders. This may explain why people with depression frequently suffer with sleeping problems. The purpose of this study is to understand how circadian (sleep/wake) rhythms may be affected in depression and the best way to improve depression caused in this way. This will be performed by comparing circadian (sleep/wake) rhythms in people with and without depression. The study involves being kept awake for one night. For depressed individuals, this technique will likely result in a brief (<1 day) improvement in depression. Following this study, participants with depression will be offered antidepressant medication at no cost. During the study, the investigators use brain scans to learn more about brain chemistry in health and depression.

Type: Interventional

Start Date: Sep 2020

open study

Cognitive Behavioral Therapy (CBT) is the treatment of choice for youth anxiety. However, up to 80% of youth with anxiety disorders do not access the services they need. Child CBT clinics nationwide have extremely long waits, on the order of 10-12 months. This leads to a vicious cycle, as children waiting for care experience worsening symptoms and decreased motivation, so that by the time they access care, their needs are more intensive and the treatment lasts longer and it takes longer for new children to be able to be assigned. Recently, single-session interventions (SSIs) have been developed that enable children to access CBT skills. The proposed randomized trial will evaluate the effects of a brief, web-based, self-guided SSI designed to reduce parent accommodation of children's anxiety, a parenting behavior that has been shown to maintain and worsen child anxiety. The main aim of the study is to examine whether the SSI reduces parent accommodation. As a secondary aim, the investigators will explore whether the SSI reduces children's anxiety symptoms over the first 6 months of CBT. The investigators will recruit parents of children who are on the waitlist to receive outpatient CBT. Results may suggest a promising approach to intervene with parents and children waiting to receive therapy.

Type: Interventional

Start Date: Sep 2023

open study

Art therapy is used across the Military Health System for treatment of posttraumatic symptoms, but there is limited research on how art therapy is able to restore emotional expression and regulation in service members. This research hopes to learn about the effects of art therapy on emotional expression and regulation in service members as well as the neurological systems at work. If a participant chooses to be in this study, he or she will attend ten sessions over a period of twelve weeks. The first session will be an interview and self-assessment questionnaires to collect information on a variety of symptoms, experiences, and personality traits, and an MRI scan. During the MRI scan, participants will be asked to perform a task where they will be shown a series of neutral and negative images. The middle eight sessions will be one-hour art therapy sessions with a certified art therapist. The last session will consist of the same self-assessment questionnaires and another MRI scan.

Type: Interventional

Start Date: Feb 2022

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

This study aims to test whether aerobic exercise performed after fear extinction learning improves cognitive, physiological, and neural indices of extinction recall in a sample of trauma-exposed men and women with and without posttraumatic stress disorder (PTSD). Participants will complete a clinical intake visit (Day 0), followed by a three-day fear conditioning (day 1), fear extinction + activity (day 2), and fear extinction recall (day 3) protocol.

Type: Interventional

Start Date: Jan 2024

open study

The investigators propose a randomized 3-arm double-blinded parallel experimental trial (20 sessions over 4 weeks) in 75 patients with TRD. The three arms include (1) the combination of a fully Individualized form of intermittent Theta Burst Stimulation (iTBS) (using BOTH the frequency and electric field (E-field) targeting approaches) (Ind-iTBS)), (2) iTBS individualized using E-field targeting only (targeted-iTBS) and (3) Standard iTBS treatment (i.e., typical iTBS localized to the dorsolateral prefrontal cortex (DLPFC) using the Beam F3 method). Electroencephalography (EEG) data will be collected at rest and during a working memory task, at baseline, and at the end of treatment along with clinical assessments of depression severity. The target engagement dependent variable of interest in these three arms will be fronto-parietal theta connectivity measured through resting-state EEG. The investigators hypothesize that stimulation with Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity than that produced with targeted-TBS and standard iTBS. Aim: To evaluate the effects of two individualized forms of iTBS (i.e., using BOTH the frequency and E-field individualization; Ind-iTBS) compared to iTBS individualized for E-field targeting only (targeted-iTBS) and standard iTBS on fronto-parietal theta connectivity. Hypotheses: (1) Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity compared to both targeted-iTBS and standard iTBS. (2) Ind-iTBS will also lead to a greater reduction in depressive symptoms (as defined by the mean reduction in Montgomery Åsberg Depression Rating Scale Scores (MADRS)) compared to both targeted-iTBS and standard iTBS.

Type: Interventional

Start Date: Aug 2023

open study

US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of two arms. This study is direct to participant and will not utilize clinical sites.

Type: Interventional

Start Date: Oct 2023

open study

This project a single-site 3-arm parallel group randomized clinical trial conducted at a tertiary level 1 trauma center among patients undergoing operative fixation of a lower extremity fracture.

Type: Interventional

Start Date: Nov 2022

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 purpose of this pilot study is to investigate the efficacy of medical play in the dental setting to improve the behaviors and cooperation of neurotypical patients during dental visits. The specific aims of the study are as follows: 1. To evaluate differences in behaviors and cooperation levels of subjects utilizing medical play before a routine dental exam visit in comparison to those undergoing a routine dental exam visit without use of medical play. 2. To evaluate whether subjects who have a dental exam visit, with or without use of medical play, show improved behaviors and improved completion of components of the dental exam compared to their previous routine dental visit. 3. To evaluate provider perceptions of the behavior and cooperation of children using medical play before dental exam visits compared to dental exam visits without medical play. 4. To evaluate caregiver perceptions of the behavior and cooperation of children using medical play before dental exam visits compared to dental exam visits without medical play. 5. To evaluate patient perceptions of the dental exam, visit when medical play is used in comparison to dental exam visits without medical play. The hypotheses are as follows: 1. Subjects will have increased positive behaviors and improved cooperation during dental exam visits when medical play is utilized beforehand. 2. Providers will report improved behavior and cooperation from patients when medical play is utilized beforehand. 3. Parents will report improved behavior and cooperation from their children and report greater satisfaction with the dental visit when medical play is utilized beforehand. 4. Patients will report experiencing less anxiety, via the Modified Child Dental Anxiety Scale - Faces Version (MCDAS-f) after appointments in which medical play is utilized.

Type: Interventional

Start Date: Oct 2022

open study

This study will test clinical and cost effectiveness of an integrated tele- and bachelor's-level counselor/coach delivered behavioral activation (BA) and fall prevention (FP) for low-income homebound older adults. The long-term objective of the proposed study is to improve access to depression treatment and fall prevention for growing numbers of low-income homebound seniors. We plan to recruit 320 low-income, racially diverse homebound seniors who are served by a home-delivered meal (HDM) program and other aging-service agencies in Central Texas. In a 4-arm, pragmatic clinical trial with randomization prior to consent, the participants in the integrated Tele-BA and FP (TBF hereafter) arm will receive 5 Tele-BA sessions and 4 in-home FP sessions. Those in the Tele-BA or FP alone arms will receive the respective intervention and 4 bimonthly telephone check-in (booster) calls, and those in the Attention Control (AC) arm will receive 5 weekly telephone check-in calls followed by 4 bimonthly follow-up calls. Follow-up assessments will be at 12, 24, and 36 weeks after baseline.

Type: Interventional

Start Date: Nov 2021

open study

We propose to study approach/avoidance behavior as measured by the Approach Avoidance task in 20 epilepsy patients undergoing implementation of depth electrodes for seizure monitoring in the Epilepsy Monitoring Unit at MGH. We will also study the effects of VC/VS electrical stimulation on approach-avoidance conflict in 20 adult patients who have undergone DBS implantation for severe MDD and/or OCD. There are 100-200 patients in the world with DBS electrodes in the VC/VS, and our research team cares for more than any other institution. Both participant groups will be assessed with respect to reward-aversion decision conflict using the task. The task will be performed with concurrent EEG recordings in DBS patients, and with continuous recording through our invasive neurophysiology rig in EMU subjects.

Type: Interventional

Start Date: Jan 2021

open study

The purpose of the study is to test the effects of brief, low-intensity transcranial focused ultrasound (TUS) on electrophysiological, behavioral, and cognitive markers related to anxiety disorders.

Type: Interventional

Start Date: Apr 2023

open study

The main goal of this research is to use behavioral, brain, and clinical data to determine which type of antidepressant might be optimal before people with depression start treatment.

Type: Interventional

Start Date: Sep 2022

open study

Chronic intracalvarial cortical stimulation is a minimally invasive method involving the neurosurgical placement of an electrode above the inner table of the skull. Over time, intracalvarial cortical stimulation is intermittently activated to modulate locally and distally connected brain regions. Because of the important role played by the dorsolateral prefrontal cortex in mood regulation, the goal of this study is to apply intracalvarial prefrontal cortical stimulation (IpCS) over the dorsolateral prefrontal cortex in severely treatment-resistant depressed (TRD) patients. Per the DSM-V and Centre for Medicare and Medicaid Services (CMS) nomenclatures, TRD patients are commonly defined as those whose treatment failed to produce response or remission after 2 or more attempts of sufficient duration and treatment dose. In the investigator's study, eligible TRD subjects will have a diagnosis of major depressive disorder with a suboptimal response to an adequate dose and duration of at least two different antidepressant treatment categories. These subjects will also have had exposure and transiently (non-durably) responded to non-invasive neurostimulation. The investigator anticipates that severely Treatment Resistant Depressed (TRD) Subjects with IpCS of the dorsolateral prefrontal cortex will show a significant decrease in depression symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at four months post-implant when compared to baseline. The investigator will enroll up to 20 subjects with severe refractory depression in an open trial, followed for up to one year. Depressive and cognitive symptoms will be rated periodically to assess the safety and efficacy of this procedure.

Type: Interventional

Start Date: Jul 2022

open study

The investigators will test the hypothesis that inhaled xenon will produce a rapid improvement in depressive symptoms in patients suffering from treatment-resistant depression. Specifically, the investigators will conduct a parallel randomized, double-blind crossover study that will compare the effects of xenon-oxygen (35:65 ratio by volume) added to treatment as usual (X-TAU group) to the effects of nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group). A total of 20 severely depressed patients, 10 with major depressive disorder (MDD) and 10 with Bipolar Depression (BP), will be exposed in random order to N-TAU and X-TAU in a double-blind protocol.

Type: Interventional

Start Date: Dec 2019

open study

Currently, there are limited options in the management of anxiety and panic attack symptoms in the Emergency Department (ED). The most common treatment method is the use of anti-anxiety and anti-depressant medications; however, these drugs have serious health risks which make them ineffective as a long-term treatment option. The CalmiGo handheld device, formerly known as "myReLeaf", provides an alternative early intervention option in treating patients presenting with anxiety and panic attack symptoms by using guided breathing, aromatherapy, and grounding techniques. The hypothesis of this study is that CalmiGo will provide a drug-free, early intervention, and long-term treatment option in the ED that will improve patients' anxiety and panic attack symptoms. Patients who present to the ED with anxiety or panic attack symptoms will be considered eligible for this study. These patients will be approached, and they will give informed consent to participate in the study. Patients will be enrolled in the study which consists of completing validated surveys asking about their anxiety and panic symptoms, using CalmiGo, and allowing investigators to access their medical records. These surveys will be completed before and after using CalmiGo in the ED to measure the presence and severity of anxiety and panic symptoms. The goal of this study is to analyze the effectiveness of using CalmiGo to improve anxiety and panic attack symptoms based on validated survey responses. Overall, this study seeks to identify CalmiGo as an effective and alternative early intervention treatment option for patients presenting to the ED with anxiety or panic attack symptoms.

Type: Interventional

Start Date: Aug 2019

open study

This study aims to identify the influence of social determinants of health domains on vascular function in a low income, racial, and ethnic minority population at risk for disparities. We hypothesize that individuals of a lower social economic position and those struggling with depression are at greater risk of cardiovascular disease.

Type: Interventional

Start Date: Jun 2023

open study

The transition from high school to college is a developmentally sensitive period that is high risk for escalations in alcohol use. Although risky drinking is a common problem among freshmen, engagement in treatment services is very low. The proposed study will test a behavioral activation intervention that addresses factors limiting participation in standard treatment services by targeting alcohol use indirectly, by directly addressing concerns most relevant to incoming college freshmen, and by integrating an intervention into the college curriculum.

Type: Interventional

Start Date: Sep 2019

open study

Digital mental health interventions are a cost-effective and efficient approach to expanding the accessibility and impact of psychological treatments; however, little guidance exists for selecting the most effective program for a given individual. In the proposed study, decision rules will develop for selecting the digital program that is most likely to be the optimal intervention for each user. These treatment recommendations can be implemented in the context of large healthcare delivery systems to improve the delivery of digital mental health interventions at scale. The overarching aim of the current study is to better understand for whom and how leading digital interventions work in a large healthcare setting. The study builds on the existing literature and follows expert recommendations by using machine learning (ML) methods to develop precision treatment rules (PTRs) for three leading digital interventions for emotional disorders (e.g., anxiety, depression, and related mental health disorders). Specifically, ML methods will be used to develop PTRs to optimize clinical outcomes and associated intervention engagement. This study will leverage a unique partnership between Boston University (BU), SilverCloud Health (SC)--a leading provider of digital mental health care--and Kaiser Permanente (KP)--one of America's leading health care providers. A clinical trial (RCT) will be conducted to evaluate the relative effectiveness of three distinct empirically supported digital mental health interventions (from SC's existing library of programs) in a sample recruited from KP primary care and other clinical settings. Data from this trial will be used to develop theoretically and empirically informed, reliable selection algorithms for managing treatment delivery decisions. Algorithms will be validated in a separate "holdout" dataset by examining whether allocation to predicted optimal treatment is associated with superior outcomes compared to allocation to a non-optimal treatment. The role of user engagement will be determined, and other mechanisms in treatment outcome.

Type: Interventional

Start Date: Apr 2023

open study

Little is known about whether and how brief mindfulness therapies yield clinically beneficial effects. This gap exists despite the rapid growth of smartphone mindfulness applications and presence of mental health treatment gap. Specifically, no prior brief, smartphone mindfulness ecological momentary intervention (MEMI) has targeted generalized anxiety disorder (GAD). Moreover, although theories propose that mindfulness intervention can boost attentional control (AC), executive functioning (EF), perspective-taking, and social cognition skills they have largely gone untested. Thus, this randomized controlled trial (RCT) aims to address these gaps by assessing the efficacy of a 14-day smartphone mindfulness EMI (vs. placebo). Participants with GAD will be randomly assigned to either MEMI or self-monitoring placebo (SMP). Those in treatment will exercise multiple core mindfulness strategies (open monitoring, acceptance, attending to small moments, slowed rhythmic diaphragmatic breathing). Also, those in MEMI will be reminded before bedtime that mindfulness is a lifelong practice. Comparatively, participants assigned to SMP will only be prompted to practice self-monitoring. They will notice their thoughts, rate any distress associated with them, and will not be taught any mindfulness strategies. All prompts will occur 5 times a day, for 14 consecutive days. They will complete self-reports and neuropsychological assessments at pre-, post-, and 1-month follow-up. Multilevel modeling analyses will determine if treatment (vs. self-monitoring placebo (SMP)) produces substantially larger reductions in trait worry and negative perseverative cognitions as well as steeper increases in AC and EF (inhibition, set-shifting, working memory updating). In addition, the investigators hypothesized that MEMI (vs. SMP) would lead to greater increases in performance-based and self-reported trait mindfulness, empathy, and perspective taking. Findings will advance understanding of the efficacy of unguided, technology-assisted, brief mindfulness in a clinical sample.

Type: Interventional

Start Date: Nov 2018

open study