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111 active trials for Anxiety Disorders

Treatments for Anxiety: Meditation and Escitalopram

We propose the first randomized, controlled study to assess the comparative effectiveness of Mindfulness-Based Stress Reduction (MBSR) with a medication for anxiety disorders. We will use escitalopram, gold-standard SSRI treatment for patients with anxiety disorders, and will examine the comparative effectiveness of the two treatments on anxiety symptoms and other outcomes important to patients.

Start: June 2018

School Withdrawal in Adolescents

The aim of the study is to evaluate the impact of the outpatient ambulatory child psychiatric care system on the functioning of anxio-depressive adolescents in school retreat by describing the modalities of individual psychic functioning.

Start: March 2019

Project COPE (Coping Options for Parent Empowerment)

The purpose of this research study is to collect information to better understand caregiver responses to COVID-19 stress and to help caregivers of children with Autism Spectrum Disorder (ASD) cope with these stressors.

Start: February 2021

Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder

This is an open trial that seeks to determine the safety and tolerability of using inositol for children and adolescents with bipolar disorder and comorbid anxiety disorders with an exploration of efficacy and dose-response.

Start: November 2021

Reducing Suicide Risk in Older Veterans Using Problem Solving Therapy

Suicide is a national crisis, especially among older Veterans for whom evidence-based suicide prevention efforts are lacking. This proposal responds to the national priority to develop and improve interventions for suicide prevention, with a focus on at-risk older Veterans. The randomized control trial will compare VA usual care, which is suicide safety planning, with brief Problem Solving Therapy and suicide safety planning. This study uses Problem Solving Therapy because it has support from our pilot data and from secondary data analysis from other studies for reducing late life suicide risk. This treatment also has support for alleviating two key risk factors for late life suicide risk, functional disability and executive dysfunction, and thus this study will examine how older Veterans with varying levels of functional disability and executive functioning respond to treatment to inform future targeted implementation. In accordance with national priorities, existing infrastructure in Problem Solving Training could be expanded to support more rapid VA-wide implementation.

Start: July 2021

Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

The proposed study will determine the feasibility, tolerability, and acceptability of a study that tests: 1) personalized treatment delivery (i.e., module sequencing and treatment discontinuation timing) aimed at increasing the efficiency of care, and 2) the research protocol designed to evaluate the effects of this personalized care. A sample of 60 participants with heterogeneous anxiety disorders (and comorbid conditions, including depression) will be enrolled in a pilot sequential multiple assignment randomized trial (SMART). Patients will be randomly assigned to one of three sequencing conditions: transdiagnostic treatment administered in its standard module order, module sequences that prioritize capitalizing on relative strengths, and module sequences that prioritize compensating for relative weaknesses. Next, after 6 sessions, participants will be randomly assigned to either continue or discontinue treatment to evaluate post-treatment change at varying levels of target engagement. This proposal will enable us to 1) test the feasibility, acceptability, and tolerability of the research protocol, treatment sequencing conditions, and early treatment discontinuation, 2) determine whether a preliminary signal that capitalization or compensation module sequencing improves treatment efficiency exists, and 3) explore preliminary associations between core process engagement at treatment discontinuation and later symptom improvement. The proposed study, and the subsequent research it will support, will inform evidence-based decision rules to make existing treatments more efficient, ultimately reducing patient costs and increasing the mental health service system's capacity to address the needs of more individuals.

Start: June 2021

Neurobiology of Generalized Fear-Conditioning & Avoidance in Anxiety Disorders

Anxiety disorders are among the most prevalent, costly, and disabling mental illnesses. One central, yet largely understudied, abnormality in anxiety disorders is the heightened tendency to display fear and avoidance in reaction to benign or safe events that resemble feared situations. The current project maps brain circuits associated with this abnormality in order to contribute to future brain-based diagnosis and treatments for clinical anxiety.

Start: July 2017

Recovering Damaged Cells for Sequelae Caused by COVID-19, SARS-CoV-2

Post-acute sequelae of SARS-CoV-2 infection can cause multiple system function disorders, and complicated symptoms last for an extended period. The virus can cause this continued infection, or the virus causes immune system function disorder and post-infectious autoimmune disease. The clinical symptoms can be smell loss, taste loss to liver function disorder, kidney function failure, different. No matter how complicated the systems showed in the clinic, all of the symptoms are due to the specific cells being damaged. Our clinical study is focused on recovering the damaged structure and function of the cells that could restore the organ function back to normal or close to normal

Start: March 2021

Promote Access to Stop Suicide: Comparison of Follow up Services for Youth at Risk for Suicide

This research study is designed to answer specific questions about new ways to provide services for youth at-risk of suicide.

Start: May 2017

Cultural Adaptation of a SSI for Youth Anxiety

The overarching objective of this protocol is to (1) adapt and (2) disseminate an evidence-based, brief (approximately 30 minute) single session intervention (SSI) to better reflect the cultural and linguistic diversity of Latin, Haitian, and Haitian-American individuals via a fully online platform.

Start: March 2021

Engaging Pacific Islanders in Mental Health Treatment

This study will create and pilot test a culturally grounded intervention (Talking Story) to increase mental health treatment seeking among Pacific Islanders with mental disorders (e.g., major depressive disorder, generalized anxiety disorder).

Start: January 2022

Improving Access to Child Anxiety Treatment

There is strong evidence that cognitive behavioral therapy (CBT) with exposure is the preferred treatment for youth with anxiety disorders, but outpatient services that provide this type of treatment are limited. Even for those who do have access to anxiety-specific treatment, a traditional outpatient model of treatment delivery may not be suitable. Among the numerous logistical barriers to treatment access and response is the inability to generalize treatment tools to settings outside of the office. Patient-centered (home-based or telehealth; patient-centered telehealth closed as of 5/1/21) treatment models that target symptoms in the context in which they occur could be more effective, efficient, and accessible for families. The present study aims to compare the efficacy, efficiency, and feasibility of patient centered home-based CBT and patient centered telehealth CBT with a traditional office-based model of care. The question proposed, including proposed outcomes, have been generated and developed by a group of hospital, payer, patient and family stakeholders who will also contribute to the iterative process of protocol revision. The investigators anticipate 379 anxious youth to be randomized to receive outpatient treatment using telehealth (patient-centered telehealth closed as of 5/1/21), home-based services, or treatment as usual using a traditional outpatient model. Results of this study are expected to provide evidence for the efficacy and efficiency of patient-centered treatment, as well as increase treatment access and family engagement in the treatment process.

Start: July 2018

Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop

In this proposal, the investigators extend their previous SPiRE feasibility and preliminary effectiveness study to examine STEP-Home efficacy in a RCT design. This novel therapy will target the specific needs of a broad range of underserved post-9/11 Veterans. It is designed to foster reintegration by facilitating meaningful improvement in the functional skills most central to community participation: emotional regulation (ER), problem solving (PS), and attention functioning (AT). The skills trained in the STEP-Home workshop are novel in their collective use and have not been systematically applied to a Veteran population prior to the investigators' SPiRE study. STEP-Home will equip Veterans with skills to improve daily function, reduce anger and irritability, and assist reintegration to civilian life through return to work, family, and community, while simultaneously providing psychoeducation to promote future engagement in VA care. The innovative nature of the STEP-Home intervention is founded in the fact that it is: (a) an adaptation of an established and efficacious intervention, now applied to post-9/11 Veterans; (b) nonstigmatizing (not "therapy" but a "skills workshop" to boost acceptance, adherence and retention); (c) transdiagnostic (open to all post-9/11 Veterans with self-reported reintegration difficulties; Veterans often have multiple mental health diagnoses, but it is not required for enrollment); (d) integrative (focus on the whole person rather than specific and often stigmatizing mental and physical health conditions); (e) comprised of Veteran-specific content to teach participants cognitive behavioral skills needed for successful reintegration (which led to greater acceptability in feasibility study); (f) targets anger and irritability, particularly during interactions with civilians; (g) emphasizes psychoeducation (including other available treatment options for common mental health conditions); and (h) challenges beliefs/barriers to mental health care to increase openness to future treatment and greater mental health treatment utilization. Many Veterans who participated in the development phases of this workshop have gone on to trauma or other focused therapies, or taken on vocational (work/school/volunteer) roles after STEP-Home. The investigators have demonstrated that the STEP-Home workshop is feasible and results in pre-post change in core skill acquisition that the investigators demonstrated to be directly associated with post-workshop improvement in reintegration status in their SPiRE study. Given the many comorbidities of this cohort, the innovative treatment addresses multiple aspects of mental health, cognitive, and emotional function simultaneously and bolsters reintegration in a short-term group to maximize cost-effectiveness while maintaining quality of care.

Start: June 2019

Low Intensity Focused Ultrasound for Emotion Regulation

Amygdala is highly involved in emotional response, emotional reactivity and anxiety. Amygdala functions are therefore involved in a wide range of psychiatric disorders including generalized and social anxiety, specific phobia, obsessive compulsive disorder and posttraumatic stress disorder. Therefore, potential clinical implications of amygdala stimulation are great. However, to date, such efforts have been limited by the inability of non-invasive neuromodulation techniques (e.g. transcranial magnetic stimulation - TMS) to reach the amygdala and the highly invasive (i.e. neurosurgical) nature of methods (e.g. deep brain stimulation - DBS) which can, but to our knowledge has rarely been used, target these areas. In order to overcome these current limitations, study invesitgators propose the use of low intensity focused ultrasound pulsation (LIFUP) to affect amygdala activity to improve emotion regulation.

Start: June 2019

Feasibility of a Group Blended Transdiagnostic CBT Protocol for Emotional Disorders

The aim of this study is to analyze the feasibility of a blended transdiagnostic group protocol for the treatment of depression and anxiety disorders (emotional disorders) in a one-group clinical trial.

Start: March 2021

PTSD Treatment and Emotion Regulation Skills Training for Women With Military Sexual Trauma (PE+ER)

Prior research has found that Veterans with military sexual trauma (MST) who have more difficulties with emotion regulation were more likely to drop out of PTSD treatment prematurely. The purpose of this pilot study is to determine whether integrating evidence-based emotion regulation skills training with a scientifically validated treatment for PTSD called Prolonged Exposure (PE), will enhance PTSD treatment retention and 'dose received' and subsequently improve treatment outcomes for MST-related PTSD and difficulties with emotion regulation. Results from this project that examine the feasibility of integrating these two treatments will provide methodological evidence and justification for a randomized control trial, if warranted.

Start: August 2021

Stepped-Care Cognitive-Behavioral Treatment for Youth With ASD and Anxiety

This study implements a parent-led, flexible, individually-tailored cognitive-behavioral intervention for children with ASD and anxiety.

Start: February 2019

Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD

This study implements an anxiety-focused, parent-led, therapist-assisted cognitive behavioral teletherapy for parents of youth with ASD and anxiety.

Start: July 2019

A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

This is a study in minors (7 to 17 years old) diagnosed with generalized anxiety disorder (GAD) and evaluated using standard questionnaires as having at least moderate severity of GAD. Participating minors will be assigned to receive either the study drug escitalopram or a pill without any drug in it called a placebo. The purpose of this research is to study the safety and effectiveness of escitalopram in minors with GAD.

Start: May 2019

A Self-guided App-Based Virtual Reality Cognitive Behavior Therapy for Anxiety Disorder in Children

To examine the efficacy of a fully self-guided app-based virtual reality cognitive behavior therapy (VR CBT) using low-cost (cardboard) virtual reality goggles compared with a wait-list control group and to determine its user friendliness. We hypothesize that children with GAD enrolled in the self-guided app will present lower scores of anxiety.

Start: August 2021