Clinical Studies

We invite you to participate in the TREE-Connect Study. 
   
This study aims to develop a hybrid intervention that combines a remote psychotherapy with a novel mobile health app (TREE-Connect). Together, this combined intervention can lead to improvement in depression and social connectedness in mid- and late-life. 
   
Participants will be randomized to one of two groups, each consisting of 9 weekly therapy sessions. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.
   
One group will be treated with 9 face-to-face video sessions of Engage & Connect, a psychotherapy aimed to increase engagement in rewarding social activities. The other group will receive 9 sessions of hybrid TREE-Connect app + video delivered psychotherapy (5 face-to-face video sessions and 4 app sessions).
   
The study also include 4 research assessments via video with questions about mood, thoughts and physical health. Participants will also track their activity levels using a wearable watch. We will invite interested participants to optional MRI scans. 

Total study participation is approximately 9 weeks.
   

The purpose of this study is to learn how whole-body hyperthermia (achieved in a sauna) may work to decrease feelings of depression and anxiety. We know that this intervention works in adults with depression, but we do not know how it works. We also want to find out if postpartum women will find this intervention acceptable, and whether the way it works may be different in postpartum women from other people. 

This research study is being done because we do not have very many treatments for depression or anxiety that work quickly. If we could learn more about how whole-body hyperthermia works, we might be able to develop other treatments to help people with depression or anxiety get better quickly. 

Participants will come to the Weill Cornell main campus on the Upper East Side once for about half a day (approximately 4 hours). They will answer surveys about their psychological health and then will participate in a sauna session, meant to heat their internal temperature to 38.5C (101.3F), which will last up to two hours. The sauna session involves lying down under a dome wearing only underwear or loose fitting clothing and with a small, flexible thermometer in the rectum or vagina to measure core temperature. Participants heads will be outside the sauna dome, which we will cool down with ice and provide water and other drinks throughout the procedure.

When the session is over, participants will be covered with towels for about 30 minutes while the body cools down. A member of our staff will be present at all times, and a doctor will be available close by.

After the sauna session is over, participants will answer additional psychological survey questions using an electronic link 3 times – 2 weeks, 4 weeks, and 6 weeks after the sauna session. They will also meet with a member of the study staff by Zoom for additional psychological questions 6 weeks after the sauna session.

Total study participation will last approximately 2 months.

The purpose of this study is to compare 2 forms of interventions for senior center clients over 60 experiencing symptoms of depression. 

Some participants enrolled in the study will receive 9 weeks of a type of psychotherapy called “Behavioral Activation” as delivered by a Master’s level mental health clinician. “Behavioral Activation” is a psychotherapy aimed at re-engaging participants in activities they once found rewarding and enjoyed but have abandoned after they developed depression.

Other participants will receive 9 weeks of a program called “Do More, Feel Better” as delivered by a trained non-professional volunteer. Do More, Feel Better” is a program also aimed at re-engaging participants in activities they once found rewarding and enjoyed but have abandoned after they developed depression. 

Participants will be assigned randomly (like the flip of a coin) to the intervention delivered by either a Master’s level mental health clinician or a trained volunteer.

Participants will participate in follow-up interview assessments via phone or video teleconferencing throughout the study. These interviews will take approximately 1 hour. Compensation is available for eligible participants who complete the follow-up assessments. 

Total study participation over the course of the study is approximately 14 hours over the course of 36 weeks.

This project hopes to learn how menopause is impacting the bodies and lives of female multiple sclerosis (MS) patients to enable better management of the disease. We want to see how menopause affects cognition in females with MS compared to healthy females.

This study will compare menopause-related changes in brain structure, function, metabolism, and vasculature in females with MS versus healthy females. Additionally, we want to look at the relationship between imaging biomarkers and cognition across the three stages of menopause. An imaging biomarker is a biologic feature detectable in an image.

Participants in this study will receive cognitive testing (taking about 1.5 hours), a blood draw (taking about 10 minutes), and a non-contrast MRI scan of their head (taking about 1 hour).

Total study participation will take roughly 3 hours. The cognitive testing, blood draw, and MRI may take place on either on the same day or on separate dates depending on schedules.

This study aims to learn and evaluate the relationship between vocal register, pitch, and loudness by investigating how vocal pitch changes with variations in loudness.

Participants will be required to sing in both chest register and head registers, with their vocal pitch being measured twice. They will also undergo a free laryngoscopy.

The total time commitment is approximately 1 hour and those who complete the study will receive $100 for their participation.

Almost 10 million children in the United States are affected by at least one allergic disease and the rates of allergy are rising. Prior public health research shows that children born to individuals who are anxious during pregnancy have higher rates of allergy, but the cause behind this occurrence is not known.

The purpose of this study is to identify changes in the immune system of individuals who have anxiety in pregnancy and to determine whether those changes are related to the risk for allergy in their infants. This study will examine pregnant individuals both with and without anxiety to compare any changes in immune functioning.

Study participation will primarily consist of virtual visits where a member of the research staff will guide you through online surveys and assessments throughout pregnancy and postpartum. There are three in-person commitments for the duration of the study, which will include questionnaires and blood-draws. All visits will be individually scheduled with the research team.

Total study participation will last approximately 18 months and participants will be eligible for compensation up to $256.

The purpose of this study is to learn about changes in brain function, thoughts, feelings, and behavior that occur during treatment for depression and suicidal ideation.

Suicidality in mid- and late life is characterized with abnormalities in the Positive Valence System (PVS). The aim of the study is to examine if exposure to meaningful social rewards during psychotherapy engages PVS circuitry and improves mid- and late-life suicidality among depressed older adults.

Participants will be randomized to one of two groups, each consisting of 9 weekly therapy sessions. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

One group will be treated with Engage & Connect, which is a reward-based psychotherapy aimed to increase engagement in rewarding social activities. The other group will be treated with a form of psychotherapy called Symptom Review and Psychoeducation (SRP), which provides helpful education on depression and a review of the emotional difficulties one faces during depression.

Both groups will meet weekly with a study therapist on Zoom. Participants will also be asked to participate in 4 research assessments consisting of questions about mood, thoughts, and physical health, and 3 MRI scans.

Total study participation will last approximately 9 weeks.

This clinical trial is for adult participants 50 years of age or older who are not currently suspected of having cancer and do not have a personal history of invasive solid tumor or hematologic malignancy (blood cancer) within the past 3 years.
   
The purpose of this study is to understand the performance of a multi-cancer early detection (MCED) test and the impact of the MCED test on patients and providers. The MCED test is a new test that can be used for early detection of different types of cancers. This test is not yet approved by the U.S. Food and Drug Administration (FDA).
   
The main goals of this research study are to evaluate how providers will use the results of the MCED test in clinical practice, assess how providers will use the test to direct or recommend additional evaluation, assess participants’ perceptions of risks and benefits of screening with a multi-cancer early detection test, and to evaluate the potential impact of MCED test results on participant’s attitudes towards recommended screening.
   
The main procedure in this study is the MCED test. The test will be performed via blood drawn from a vein in participant’s arm. Participants will be asked to complete questionnaires throughout the course of the study, which will last approximately 3 years.
   
Most participants will have a “cancer signal not detected” test result indicating that no cancer signal has been detected. Some participants will have a “cancer signal detected” test result indicating that a cancer signal has been detected, and additional evaluations need to be performed to confirm whether or not the participant has cancer. The study healthcare provider will direct the participant to the appropriate tests or evaluation. If the additional evaluation indicates a cancer diagnosis, the healthcare provider will discuss treatment options with the participant.

The purpose of this study is to examine the effects of an abstinence period on semen parameters and sperm quality. There is no current data regarding the best time for men to produce a semen sample that will produce the highest quality sperm. This study aims to determine whether shorter abstinence periods may result in improved sperm quality.

Participants will be required to provide a total of 6 semen samples. The semen samples will be requested to be produced after 7 days, 5 days, 2 days, 1 day, and 3 hours of abstinence from sexual activity.

Samples will be analyzed using a variety of laboratory methods and personal identifiable information will be removed from this data. 

Participants will be required to come into the office for 6 study visits. Total study participation will last approximiately 15 days. 

This study aims to assess a mobile iPhone app called MAYA for use in middle-aged and older adults with anxiety or mood disorders.

Participants will be asked to use the app for at least two days a week, 20 minutes each day, for six weeks. Participants will have weekly check-ins as well as longer assessments at the beginning of the study, week 3, week 6 (end of treatment), and week 12 (follow up).

During assessments, participants will answer brief questionnaires designed to assess their symptoms and impressions of the app.

Total study participation will last about 12 weeks.

This study aims to learn how to best optimize a mobile iPhone Cognitive Behavioral Therapy (CBT) app, and whether a personalized mobile iPhone CBT program is more effective than a more comprehensive general mobile iPhone CBT program. Although the app is new, it is based on Cognitive Behavior Therapy, which is a traditional “gold-standard” behavior therapy approach to treat anxiety disorders.

Participants will be asked to use the app two times a week for about 20 minutes per session, and complete weekly virtual research assessments that range from 10 minutes to about 1.5 hours.

To help us learn about brain changes related to using the app, participants may also agree to optional MRI and/or EEG scans that occur before the start of the study, and 4 or 6 weeks later when finished using the app. 

Total study participation will last about 12 weeks. 

This study will test the effect of the oral medication, escitalopram, on male fertility in comparison to a placebo (pills with no study drug). Escitalopram is approved by the U.S. Food and Drug Administration (FDA) and is a commonly prescribed anti-depressant among men of reproductive age. Escitalopram is thought to have negative effects on male fertility but has never been assessed in comparison to a placebo or for healthy individuals.

Participants will be randomized into one of the study groups to receive either a placebo or escitalopram for 6 weeks. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Prior to taking the first pill, all participants will receive semen and blood testing, as well as take two questionnaires. Upon completion of taking the pills, participants will come back to the office twice more for the same tests and questionnaires. 

All participants must engage in sexual activity (either with a partner or via self-stimulation) at least once per week during the study. Total study participation is expected to last 10 weeks.

This study will test the effectiveness of Engage & Connect, a 9-week remotely delivered psychotherapy for postpartum depression that focuses on reducing social isolation and helping mothers engage in more pleasurable activities.

Participants will be randomized to one of two groups, each consisting of 9 weekly therapy sessions. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

One group will be treated with Engage & Connect, which is a psychotherapy aimed to increase engagement in rewarding social activities. The other group will be treated with a form of psychotherapy called Symptom Review and Psychoeducation (SRP), which provides helpful education on postpartum depression and a review of the emotional difficulties one faces during postpartum depression.

In both groups, participants will meet with a therapist weekly on Zoom.

Participants will also be asked to participate in 4 research assessments consisting of questions about mood, thoughts, and physical health.

Information shared with the study team is completely confidential and will not be shared with others outside of the team. We do not provide information to insurance companies or other entities.

All participants will receive 9 weekly therapy sessions and there is no cost to participate. Compensation is available up to $120.

For more information and to have a member of the study team contact you, please fill out this form. 

The purpose of this study is to test a novel assessment of social feedback in adults with depression. It aims to study the association between activity levels, mood, and social aspects of life over the course time.

Participation includes four research assessments consisting of questions about your mood, thoughts, and physical health, as well as a computerized task designed to measure cognitive functioning.

This study will have two groups of participants, one for adults with depression, and one for healthy volunteers.

Compensation is available up to $160.

Repetitive transcranial magnetic stimulation (rTMS) is an FDA-cleared treatment for depression and obsessive compulsive disorder (OCD) that uses focused magnetic field pulses to stimulate target brain areas. Multiple brain targets in the prefrontal cortex have shown consistent evidence of treatment efficacy in both depression and OCD, but there are currently no established methods for selecting the optimal target site in individual patients.

Additionally, rTMS may underperform or even fail if the rTMS regimen is under-dosed. Delivering an adequate dose of stimulation can be especially challenging during the COVID-19 pandemic, because standard protocols require patients to visit a clinical TMS suite daily for brief sessions for up to 42 days, which poses numerous logistical challenges during the pandemic.

In this open-label study, we will test a new 5-day accelerated rTMS protocol with established efficacy in two recent publications. Subjects will complete a 5-day course of rTMS delivered hourly for 10 hours per day. Subjects who show a partial response to treatment but not a full response will then receive a second 5-day course. The goals of the study are to determine the overall efficacy and trajectory of response to accelerated rTMS for depression or OCD in an open-label context and to identify predictors of differential response to each treatment.

The Weill Cornell Institute of Geriatric Psychiatry is conducting a research study on how brain processes affect emotion regulation, social functioning, and well-being in adults ages 45-70 years old. This study is voluntary and will not influence your regular medical care.
   
   Eligible individuals who agree to participate will take part in:
   • An initial screening interview
   • Clinical interviews
   • Cognitive assessments
   • Self-report questionnaires
   • One MRI scan
   
Participants will not be charged for any services. Participants will be compensated up to $300 by the end of the study. All information is confidential. To learn more, please call the study contact.

The purpose of this study is to investigate differences in iron in the brains of subjects with and without beta-amyloid deposition. Iron is an essential mineral in your body, and beta-amyloid is a protein associated with Alzheimer’s disease. Studies suggest that excess iron in the brain may be involved in processes that lead to Alzheimer's disease. This study will use MRI scans, blood samples, and fluid samples to analyze the relationship between brain iron and proteins related to Alzheimer's disease. Eligible participants will be compensated up to $550 for completing 3 baseline procedures and up to $1100 for participating in the entire study. Additional details will be discussed with the study team.

We have developed and validated a non-invasive method to estimate the clearance of cerebrospinal fluid (CSF) from the brain. This study tests the hypothesis that reduced CSF clearance is predictive of a) future amyloid lesions, b) brain atrophy, and c) cognitive decline in healthy elderly adults or those with Mild Cognitive Impairment (MCI). 

 Measuring brain CSF clearance with novel, experimental imaging techniques may advance the understanding of Alzheimer’s disease (AD) progression at its earliest stages. 

All subjects will be enrolled at Weill Cornell Medicine. Study participation consists of 3-5 visits, lasts approximately two years and involves: 1) medical assessment with neurologist, 2) surveys assessing subjective health and well-being, 3) cognitive testing, 4) brain MRI, 5) amyloid PET-CT (FDA approved), 6) tau PET-CT, routine blood & urine analyses, donation of blood for research purposes. The visits occur using telehealth technology, and 3-5 in-person at the Weill Cornell Medicine Clinical and Translational Science Center (CTSC) and the Citigroup Biomedical Imaging Center (CBIC). 

Abnormalities in the Positive Valence System (PVS) are associated with depressive symptoms and reduced behavioral activation in mid- and late-life. This study will investigate the engagement of the PVS during exposure to social rewards, part of a novel streamlined psychotherapy for mid- and late-life depression. Use of computational modeling will enable identification of neuroimaging and behavioral profiles associated with greater treatment response, and may guide future personalization of psychotherapy.

The purpose of this study is to better identify and predict individuals at risk for Alzheimer's disease (AD) who are most likely to benefit from personalized, evidence-based interventions. Studies have shown that endocrine aging (menopause, perimenopause) increases Alzheimer’s disease risk specifically in women. Our goal is to unravel the biological mechanisms behind the increased risk by analyzing how various measures of brain function, biochemistry, laboratory values, and other risk factors may influence Alzheimer’s risk as women age. The ultimate goal of this research is to help characterize the optimal window of opportunity for therapeutic intervention in women at risk for Alzheimer’s.

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

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.

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. 

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. 

Military sexual trauma (MST) is defined as uninvited/unwanted sexual attention (such as touching, cornering, pressure for sexual favors, or verbal remarks), threat of or attempted 
sexual contact, sexual assault, or any sort of sexual activity between at least two people in which one of the people is involved against their will. This research is being done because MST has been identified as a pervasive problem with profound psychological and physical consequences.

The purpose of this study is to compare two kinds of therapy for post-traumatic stress disorder (PTSD) due to MST: prolonged exposure therapy (PE) and interpersonal psychotherapy (IPT). The results of this study will allow us to see if IPT and PE 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. 

Participants will be randomized into one of two study groups and will receive either PE or IPT. Randomization means that you are put into a group by chance, similar to flipping a coin.

IPT focuses on addressing the effects PTSD has had on relationships with other people through talking about emotions in response to recent interactions with others.

PE focuses on teaching individuals to gradually approach their trauma-related memories, feelings, and situations to gain confidence in their ability to manage them.  The therapist will monitor distress levels during the sessions.

Participation consists of 10 weekly sessions for the PE group and 14 weekly sessions for the IPT group. All participants will also complete a post-treatment assessment and a six-month follow-up assessment after finishing the weekly therapy sessions therapy. Total participation in the study will be approximately 10 months.

The information discussed during both IPT, and PE sessions is completely confidential and will not be shared with anyone outside of this research study. All services provided are separate from the United States Department of Veteran Affairs (VA), the Department of Defense (DOD), the Veterans Health Administration (VHA), Military Behavioral Health, or any other military institution.

If you are interested in hearing more about the study, please call 212-821-0783 or visit the Program for Anxiety and Traumatic Stress Studies (PATSS) website. 

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. 

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. In order to help benefit people with depression in the future, we also need to evaluate older adults with no history of depression.

Participation in this study includes research assessments that will be conducted at three time points – baseline, week 6, and week 9.  Each assessment will consist of questionnaires about your mood and thoughts, computerized tasks designed to measure cognitive and emotional functioning, and measurements of your electrical brain activity (EEG).

Total study participation will last approximately 9 weeks and participants will be compensated for each visit. Those who participate in the entire study will be eligible to earn up to $230.

The goal of this study is to learn about changes in the brain of older adults that occur during treatment for depression with two types of psychotherapy called Engage therapy and supportive therapy, and how they differ from one another.

Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice.

Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.

Participants will be randomized into one of the two study groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Study participation will last for approximately 9 weeks, with weekly therapy appointments. Participants will also 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). 

All participants will be compensated for their participation in this study. Those who participate in the entire study will be eligible to earn up to $260.