Clinical Studies

Examining Approach Motivation in Depressed Middle-Aged and Older Adults

Description:

This behavioral study will examine how different self-report and clinical rating scales correlate with motivation processes in middle-aged and older adults with depression. The goal is to identify simple measures for characterizing abnormalities in motivation in depressed patients that can be used in the community. Administration of these measures at the outset and during treatment will allow community clinicians to optimize the selection and timing of behavioral interventions. 

Primary Investigator:
Faith Gunning, PhD
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Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders

Description:

The purpose of this study is to investigate feasibility for a new mobile app meant for treating anxiety in young adults. This study involves downloading and using an iPhone app and receiving text messages.

You’d be asked to use the app at least twice a week for 20-30 minutes each time. This study involves 8 in-person visits to the lab—at week 0-6 of using the app, and a follow-up visit six weeks later. Visits take between 30 minutes-2.5 hours, and you would receive $40 in compensation at each visit, for a total of $320.

The app is based on cognitive behavioral therapy, a gold-standard, evidence-based treatment for anxiety. Interacting with the app involves watching videos about anxiety, practicing exercises to target challenging thoughts and behaviors, and using relaxation and coping techniques. 

Primary Investigator:
Faith Gunning, PhD
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Data-Driven Multidimensional Modeling of Nonverbal Communication in Typical and Atypical Development

Description:

This study aims to develop and validate data-driven computational models of the temporal coordination and production of NVC behaviors during dyadic social interactions in TD, ASD, and DD children. We also aim to identify the fine-grained properties of coordination of motor movement and NVC captured by computational models that are most predictive of diagnostic group and one-year language outcomes. Finally, we will explore novel NVC coordination patterns via bottom-up clustering of motor 

Primary Investigator:
So Hyun Kim, PhD
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Brain and Behavioral Changes Over Time in Young Children with Autism

Description:

This study has the goal of furthering our understanding of the longitudinal course of autism spectrum disorder (ASD). Specifically, we propose a longitudinal study of young children with ASD (2-3 years) to identify the neurobiological underpinnings of early developmental changes in restricted repetitive behavior/interests (RRB), one of the most clinically impairing aspects of ASD - and their predictive contribution to later function. 

Primary Investigator:
So Hyun Kim, PhD
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Relief: A Behavioral Intervention for Depression and Chronic Pain in Primary Care

Description:

This 9-session behavioral intervention was developed to address the need of primary care interventions for people experiencing chronic pain and depression, which co-exist in late and mid-life, contributing to increased disability, high health care costs, psychiatric comorbidities, and suicide. Participants will have clinically significant depression and suffer from chronic pain and receive either 9 weeks of RELIEF therapy or Usual Care. Research assessments will be conducted at entry, and at 6, 9, and 12 weeks. 

Primary Investigator:
Dimitris N Kiosses, PhD
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Enhancing Your Wellness and Social Engagement

Description:

The purpose of the study is to help older adults engage in physical exercise and also to help social engagement (opportunities to meet new people). We want to determine whether the Fittle Silver application (app) is effective in engaging older adults in physical activity and increasing social support. The Fittle Silver app is placed on a computer tablet. You are being asked to take part in this study because you are an adult over the age of 60, and are not currently engaged in a physical exercise program or in regular physical exercise activities. 

Primary Investigator:
Sara Czaja, PhD
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Understanding Prediction Error and Affective Salience Abnormalities to Guide the Selection of Reward Exposure Activities

Description:

This pilot study examines the interaction of reward and salience abnormalities in depression with the goal to inform a simple-to-administer, structured assessment that will sharpen the targeting of behavioral interventions. 

This pilot studies the interplay of reward expectancy and salience functions in mid- and late-life depression. Focusing on three levels of analysis (neural circuitry, performance of PVS-related tasks, self-report/clinical observations) will offer a view of the relationship of neural activation with clinical symptoms. 

Primary Investigator:
Lindsay Victoria, PhD
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Neuroimaging Biomarker Development for Mood and Anxiety Disorders

Description:

Biomarkers have transformed how physicians care for patients with cancer, cardiovascular disease, and a host of other medical conditions by providing quantitative tools for diagnosing disease processes and targeting treatments to the patients most likely to benefit from them. In contrast, biomarkers for psychiatric disorders remain relatively elusive. This project will test a new strategy for developing neuroimaging (brain scan) biomarkers for diagnosing novel subtypes of depression and anxiety in individual patients and then investigate how dysfunction in specific circuits gives rise to specific clinical profiles of anxiety, reward processing, and anxious arousal within these subtypes.

Primary Investigator:
Faith Gunning, PhD
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Validating a Measure of Social Communication Change in ASD

Description:

This study has the goal of furthering our understanding of measuring changes in the presentation of Autism Spectrum Disorder (ASD) symptoms over the lifetime. Specifically, we will measure subtle changes in core symptoms of ASD, including social skills and repetitive and restricted behaviors/interests through the Brief Observation of Social Communication Change (BOSCC). While other diagnostic tests (e.g. ADOS-2, ADI-R) measure these clinical symptoms, they are less sensitive to subtle changes across time that may be a result of intervention, therapy, or other developmental changes. The study will collect short video observations across age (6 months through adults, lifespan), setting (i.e. clinic, home), activity, and social partner (i.e. clinician, parent), in people with ASD, in addition to a typically developing sample at two time points (3-6 months apart, depending on the length of treatment).

Primary Investigator:
So Hyun Kim, PhD
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Using Canine Interaction to Enhance Treatment Motivation and Reduce Physiological Arousal in Service Members with PTSD.

Description:

The purpose of this study is to evaluate physical reactions associated with PTSD that develops due to the experience of military sexual trauma.

Primary Investigator:
Melissa Peskin, PhD
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Problem Adaptation Therapy for Mild Cognitive Impairment and Depression

Description:

This study aims to compare the effects of 15 sessions (12 weekly in first 12 weeks and 3 monthly booster sessions afterwards) of PATH-MCI (Problem Adaptation Therapy for Mild Cognitive Impairment) vs. ST-CI (Supportive Therapy for Cognitively Impaired Older Adults). Participants receive either 15 weeks of PATH-MCI or Supportive Therapy. Research assessments will be conducted at entry into the study, 6, 12, 24, 36, and 52 weeks.

Primary Investigator:
Dimitris N Kiosses, PhD
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Using Virtual Reality in Exposure-Based Treatment for Social Anxiety in Youth

Description:

Anxiety disorders are the most common mental health diagnosis in the US and are associated with avoidance that causes functional impairments and decreases quality of life. Social anxiety disorder is among the most prevalent anxiety disorders, with most common age of onset being in adolescence. The frontline treatment for social anxiety disorder is cognitive behavioral therapy with exposure. However, a significant number of adolescent patients do not get better after completing cognitive behavioral therapy or experience relapse. Providing realistic learning contexts for exposure could be the key to enhancing treatment effects in adolescents. This is often challenging for a variety of reasons, including difficulty realistically mimicking anxiety-provoking social situations due to limited resources, clinician training, time, or motivation. Virtual reality environments could provide contextual exposures for social anxiety. 

The aims of this study are threefold: to assess feasibility of using virtual reality in treatment of social anxiety in youth, to examine whether virtual reality invokes arousal similar to anxiety and test the physiological assessment protocol, and to evaluate whether exposure using virtual reality environments reduces symptoms of social anxiety and related functional impairment. 

Primary Investigator:
Shannon M. Bennett, PhD
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Imaging of Resting State Functional Connectivity Following Transcranial Magnetic Stimulation

Description:

In our previous work, we have developed bio-markers from brain images of transcranial magnetic stimulation (TMS) treatment for depression. 

The goal of the current study is to build on this past work by looking at the immediate neural effects of a single session of several forms of TMS, previously established to be effective and safe. 

The findings of this study will help figure out the best TMS targets and forms of treatment in future intervention studies. Data from the current pilot trial will also inform future efforts to effectively match a TMS treatment method to each individual, based on this individual's brain patterns. 

Primary Investigator:
Marc Dubin, MD, PhD
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D-Cycloserine Enhanced Imaginal Exposure Therapy for Post-Traumatic Stress Disorder (PTSD)

Description:

The purpose of this study is to treat symptoms of post-traumatic stress disorder (PTSD) resulting from various traumas using traditional treatment combined with the use of D-Cycloserine (DCS). 

Treatment is offered on an individual basis for 12-14 weekly sessions lasting approximately 75-90 minutes each. This cognitive-behavioral treatment aims to introduce skills and techniques that will reduce symptoms and improve quality of life. One essential component of the treatment includes describing one's traumatic experience. Participants will be randomly assigned to take either a low dose of D-Cycloserine (DCS; a broad-spectrum antibiotic) or a placebo pill prior to their weekly session to examine the effects of DCS on treatment. Thus treatment incorporates traditional techniques that have been shown to be effective in treating PTSD, with cutting edge pharmacology to enhance the treatment. Treating clinicians are all highly experienced in working with PTSD, civilians and disaster workers. 

Primary Investigator:
JoAnn Difede, MD
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A Comprehensive Psychological Intervention to Improve Community and Vocational Reintegration Following Burn Injury and Other Trauma

Description:

The purpose of this study is to treat symptoms of posttraumatic stress disorder (PTSD) resulting from burn trauma using traditional treatment. 

The burn intervention study offers 14 sessions of free individual treatment for burn survivors with posttraumatic stress disorder. The treatment protocol focuses on reduction of the symptoms of PTSD, while simultaneously introducing skills to address the numerous sequelae of burn injury including feelings of depression, coping with scarring and/or disfigurement, reintegrating back into work, community, and social circles, and improving general functioning and quality of life. 

Primary Investigator:
JoAnn Difede, MD
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Virtual Reality for Pain Management in Burn Patients

Description:

We are conducting a randomized proof-of-concept study to assess the efficacy of virtual reality (VR) vs standard of care in 50 adult patients in the NewYork-Presbyterian Burn Unit. The participants who are randomized to receive the virtual reality intervention will also receive opioids, which is the standard of care and is known to be effective.

Participants will be randomly assigned to two groups. The first group will receive VR during their procedure in addition to the standard-of-care. The other group will receive standard of care during the wound dressing change procedure (and no VR). The reported levels of pain and the total amount of narcotic and analgesics from admission through discharge from the hospital will be recorded and analyzed as a secondary outcome: whether the VR condition impacts total received dose in the two days post-procedure and through hospital stay. 

Primary Investigator:
JoAnn Difede, MD
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A Non-Inferiority Randomized Controlled Clinical Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Consequent to Military Sexual Trauma (MST) in Male and Female Military Personnel and Veterans

Description:

The purpose of this study is to compare two kinds of therapy for post-traumatic stress disorder (PTSD): exposure therapy (ET) and interpersonal psychotherapy (IPT). The results of this study will allow us to see if IPT and ET are equally effective in treating PTSD due to military sexual trauma, with the long-term goal of making PTSD treatment effective for as many people as possible. 

Primary Investigator:
JoAnn Difede, MD
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A POC Clinical Trial for a First-in-Class Vasopressin 1a Receptor Antagonist

Description:

We are seeking participants for a clinical trial which will test an experimental drug for the treatment of post-traumatic stress disorder (PTSD). 

Following the initial screening phase, you will receive the medication treatment for 8 weeks and the placebo for 8 weeks. The study will last a total of 18 weeks, and you will be assessed at baseline and then every 2 weeks until the end of the study. You will be compensated for all completed assessments (up to a total of $400). 

Primary Investigator:
JoAnn Difede, MD
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Efficacy of Biomarker-Guided rTMS for Treatment Resistant Depression

Description:

Depression is the second leading cause of disability worldwide, due partly to the fact that existing antidepressants are not effective for all patients and it is often challenging to match individual patients to the treatments that are most likely to help them. This study will test a new strategy for using fMRI brain scans to predict antidepressant response and assist clinicians in choosing antidepressant treatments. Transcranial magnetic stimulation targeting one of two depression-related brain areas is most likely to benefit an individual patient. 

Primary Investigator:
Conor Liston, MD, PhD
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Positive Valence System Function and Reward Exposure Therapy for Late-Life Depression

Description:

The goal of this study is to learn about changes in the brain that occur during Engage, a psychotherapy for depression in older adults, and how they may differ from changes that occur during supportive therapy. Older adults with depression will receive 9 weeks of either Engage or supportive therapy and will complete research assessments before the therapy begins and at weeks 3, 6, and 9 of treatment. Research assessments will include questionnaires, computer tasks, and recordings of electrical brain activity (also called electroencephalography or EEG). 

Primary Investigator:
Jennifer Bress, PhD
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Brain Function, Emotions, and Behavior in Healthy Older Adults

Description:

The purpose of this study is to compare thinking, emotions, and brain function in older adults without a history of psychiatric illness to older adults who are receiving treatment for depression in our other studies. This research is being done to help develop, understand, and improve treatments for depression in older adults. 

Research assessments will be conducted at three time points – baseline, week 6, and week 9 – and will include measuring brain activity, computer tasks, and questionnaires about mood and thoughts. Participants are compensated for each visit. 

Primary Investigator:
Jennifer Bress, PhD
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Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

Description:

The purpose of this clinical trial is to determine whether screening for breast cancer with tomosynthesis mammography is superior to digital mammography. To determine that, we are studying whether women who are screened for breast cancer with tomosynthesis mammography have fewer advanced breast cancers compared with the number of such cancers found when women are screened for breast cancer with digital mammography. This study will also compare whether there is a difference in the number of additional tests recommended after tomosynthesis mammography and digital mammography. 

Primary Investigator:
Michele B Drotman, MD
Contact Name:
Eileen Chang
Contact Email:
eic2002@med.cornell.edu
Contact Phone:
212-746-6248

Genetic Markers of Longitudinal Course of PTSD Symptoms Following Traumatic Events

Description:

Weill Cornell Medical College researchers seek participants who experienced a traumatic event for a one year post traumatic stress disorder (PTSD) study. Participants will be assessed for PTSD and related symptomatology and followed up for 1 year. Participants will also contribute saliva sample for genetic biomarkers analysis.

This study aims to test genetic predictors of PTSD following trauma and to understand the longitudinal course of PTSD in trauma survivors, including psychiatric symptoms, impairment, and reaction to reintegration to daily life. All assessments are free of cost and confidential.

Primary Investigator:
JoAnn Difede, MD
Contact Name:
Annell Ovailes
Contact Email:
ano2015@med.cornell.edu
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Pancreatic Cancer Early Detection Using a Urine Test for Mutated K-ras DNA

Description:

This clinical trial is for men and women diagnosed with metastatic pancreatic cancer as well as healthy individuals. The purpose of this research study is to develop a safe method for finding pancreatic cancer using a new technology of finding and detecting pancreatic cancer DNA markers in adult urine. In order to continue to improve the way pancreatic cancer is found in patients, the researchers must be able to obtain urine samples from patients who may or may not have pancreatic cancer and test their urine for DNA fragments that contains pancreatic DNA markers. Eligible patients will have urine and blood collected for correlative reference. 

Primary Investigator:
Allyson J Ocean, MD
Contact Name:
Alice F. Mercado
Contact Email:
alm2051@med.cornell.edu
Contact Phone:
646.962.3080

A Computerized Intervention Targeting Cognitive Control Network Deficits in Depression

Description:

The Weill Cornell Institite of Geriatric Pyschiatry is conducting a research study of depression in adults ages 45-75 years old using a cognitive training delivered on iPads. This study is voluntary and will not influence your regular medical care.

Eligible individuals who agree to participate will:

  • Receive 4 weeks of computerized training sessions designed to enhance brain activity and improve cognitive abilities (sessions are free of charge)
  • Take part in clinical interview
  • Receive two MRI scans

All information is confidential. To learn more, please call 212-746-3749.

Primary Investigator:
Faith Gunning, PhD
Contact Name:
Maria Coluccio
Contact Email:
mac2118@med.cornell.edu
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Evaluation of an anxiety intervention for older adults with cancer and informal caregivers of older adults with cancer

Description:

This study is for men and women who are 65 years or older with cancer and informal caregivers of people 65 years or older with cancer. Informal caregivers are family and/or friends of cancer patients who provide physical, emotional, and/or practical support to the patient and are not paid for providing this care.

To participate in this study, patients and/or caregivers must also be experiencing elevated anxiety levels. This study is being conducted because approximately 60% of new cancer diagnoses are in patents 65 years or older, anxiety is common in these patients and their caregivers, and psychological interventions specifically for older adults with cancer and their informal caregivers have not been developed and evaluated. The purpose of this study is to determine whether the intervention has a clinically significant effect on patients' and caregivers' anxiety.

Primary Investigator:
Holly G Prigerson
Contact Name:
Lauren Meador
Contact Email:
lam2030@med.cornell.edu
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Can Cognitive Training Decrease Reactive Aggression? The Role of Improved Emotion Regulation, Emotion Awareness, and Impulse Control

Description:

The purpose of this study is to find out if participating in activities that train cognitive skills can improve your ability to manage your emotions. 

This research study is being done because severe mental illnesses can contribute to problems managing emotions during stressful situations. These difficulties with managing emotions result from difficulties with cognition. Cognition refers to your thinking skills—your ability to remember, focus, think quickly, reason, solve problems, and recognize other people’s emotions. We are interested in finding out if by training your thinking skills; we can improve your ability to manage emotions and aggression. 

We have developed a program that includes several activities that help people think better faster, and more efficiently. The purpose of the study is to see if the treatment program that includes computer training activities can help improve your thinking skills and your ability to manage your emotions.

Primary Investigator:
Anthony O. Ahmed
Contact Name:
Anthony O. Ahmed
Contact Email:
aoa9001@med.cornell.edu
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rTMS Augmentation of Escitalopram in Depression Executive Dysfunction Syndrome

Description:

This study is being done because there is evidence that some people with depression can improve following stimulation to the brain using a treatment called Repetitive Transcranial Magnetic Stimulation or rTMS. The purpose of this study is to see whether rTMS may improve the ability of an antidepressant medication, escitalopram, to treat late-life depression in individuals with certain types of cognitive problems. Currently, it is unknown whether rTMS adds to the benefit of escitalopram for individuals with this type of depression.

Primary Investigator:
George S Alexopoulos, MD
Contact Name:
Irena Ilieva
Contact Email:
iri9005@med.cornell.edu
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Collection of Airway, Blood, and/or Urine Specimens from Subjects for Research Studies

Description:

Currently recruiting: People with lung disease and Healthy Volunteers

This clinical trial is designed to collect samples from healthy individuals and individuals with lung disorders to compare specific factors in each. Blood, urine, and airway cells are collected to learn more about the specific causes of lung disease, how lung disease manifests, progresses, and how it can be treated.  Normal healthy volunteers will be used to establish what is considered a normal range for various parameters. This trial is also used to store specimens for future genetic studies.

The purpose of this study is to collect samples from healthy individuals and individuals with lung disease to help in the understanding of the origins and mechanisms of various lung disorders. The main idea is to see if there are changes within the genetic expression of airway cells in patients with lung disorders before there are actual physical changes within the lungs. 

This is a collection study, and no study medication will be given to treat airway disorders. This study is comprised of three main parts. The first is a telephone pre-screening interview. The interview will take about 15 minutes, where questions will be asked about the subject’s background. This will determine if a subject is eligible for the second portion of the study, called the initial screening visit. This will take 4-5 hours and may include blood and urine tests, a physical exam, a chest x-ray, an EKG, and a breathing test. Compensation for completion of the initial screening visit will be $50. If a subject is considered eligible, they will undergo the third part of the study, called the bronchoscopy.  A bronchoscopy is a routine procedure doctors use to look at the inside airways of the lungs. A very thin and flexible tube is inserted down the throat into the lungs for sample collection. The bronchoscopy will take about 2 hours. 

Potential subject compensation as follows:
Full screening: $50
Partial screening: $25
Bronchoscopy: $200
Patient referral (if referred patient completed entire study): $25/patient

Key eligibility:

  • This study is open to men and women ages 18 and older and who are able to provide consent
  • Volunteer subjects with lung disease, the lung disease must be proven with any of the following: symptoms, chest X-rays, pulmonary function tests, lung biopsy, family history, and or/diseases or organs with known association with lung disease
  • Healthy volunteer subjects, must be deemed in overall good health without a history of chronic lung disease or specific drug use
  • Individuals with certain allergies will not be accepted for their safety
  • Women who are pregnant or nursing will not be accepted for their safety
  • Detailed eligibility reviewed when you contact the study team
Primary Investigator:
Clotell Hanks, MD
Contact Name:
Grace W. Mammen
Contact Email:
gwm2004@med.cornell.edu
Contact Phone:
(646) 962-4537

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Weill Cornell Medicine psychiatrists are recognized research leaders who maintain the highest level of integrity and human subject protection. Clinical studies are currently underway to develop and test new medications and forms of psychotherapy as well as introduce new methods of imaging techniques to research science. Novel therapies, including the use of virtual reality technology, are also being examined for use as treatment. All clinical studies depend upon individuals participating in a variety of meaningful investigations.

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