McLean Hospital
Belmont, Massachusetts, 02478, United States
NCT Number: NCT01850472
The purpose of this research study is to investigate how the brain processes emotions, and the way these processes affect behavior. Specifically, we hypothesize that individual differences in reward responsiveness will correlate with differential activation in mesolimbic regions of the brain and predict future wellbeing in follow-up interviews.
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Notify Me18 year–45 year
All sexes
Observational
Belmont, Massachusetts, 02478, United States
The purpose of this research study is to investigate how the brain processes emotions, and the way these processes affect behavior. Specifically, we hypothesize that individual differences in reward responsiveness will correlate with differential activation in mesolimbic regions of the brain and predict future wellbeing in follow-up interviews. Participating in this study involves up to two sessions and up to 7.5 hours. In the present observational study, each participant will be exposed to the same experimental procedure.
Visit 1 will take about 4.5 hours, from 12pm to 4:30pm. The visit will take place at the Center for Depression, Anxiety and Stress at McLean. During this visit, a clinical interviewer will conduct a diagnostic SCID interview to ensure that participants qualify to take part in this research study. Participants will then complete several tasks. These tasks include several different "game-like" situations and arithmetic riddles, all of which are simple but require participants to work hard and remain alert for an extended period of time. The goal during these games is to earn as much money as you can or to avoid losing money. Participants will do so by responding (pressing a keyboard button) quickly and accurately. These tasks are intended as assessment tools, and are not a form of therapy or intervention. In addition, we will test participants' ability to keep their hand in cold water. Participants will also be asked to provide blood (via a saline IV) and saliva samples at different times during this session, and we will also conduct urine drug and pregnancy tests. The IV will be in place for a total of around 3 hours, and is used to reduce discomfort from multiple blood draws.
Visit 2 will take place at the McLean Imaging Center at McLean Hospital. During the first part of the session, the fMRI scanner will take structural pictures of brain anatomy. Next, additional images will be obtained while participants complete several different "game-like" tasks, similar to the tasks performed in visit 1. Again, these tasks are intended as assessment tools, and are not a form of therapy or intervention. The whole fMRI session will last up to about 2.5 hours; participants will spend about 1.5 hours in the fMRI machine, and about a half-an-hour completing questionnaires and providing saliva samples. Prior to the fMRI scan, another urine sample will be obtained to check for drugs which may interfere with the experiment.
After the second study session is complete, participants will be re-contacted through the internet every four weeks for a total of six months, to complete some questionnaires. At the end of six months, participants will be asked to return to McLean to complete an in-person interview. This follow-up period is purely observational and not intended to assess health outcomes, as there is no intervention in this study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 hour long scan during session 2
Functional magnetic resonance imaging (fMRI) data are acquired while participants perform the instrumental learning task. fMRI data allows us to measure aspects of brain activity.
Time frame: Administered during session 1 twice for a total of 10 minutes
The instrumental learning task is designed to measure participant learning from reward and punishment. It will be administered twice during session 1 to calculate changes in reward and punishment sensitivity.
Time frame: 15 minute task during session 2
The instrumental learning task is designed to measure reward sensitivity.
Time frame: Administered continuously during the two study sessions (total 7 hours); follow-up questionnaires sent out every 2 weeks for a total of 4 months
At all sessions participants will fill out self-report questionnaires regarding aspects of mood and affect, demographics, caffeine and alcohol consumption, etc. Questionnaires will be completed on paper forms or through the electronic data entry system "RedCap Survey", a HIPPAA compliant secure and encrypted online database. We will use these data to assess changes in participant behavior.
Time frame: Given three times during session 1 for a total of 35 minutes
The probabilistic reward task is designed to measure sensitivity to reward and reward learning. It will be administered three times during session 1 to calculate changes in reward and punishment sensitivity.
Time frame: 6 months after completion of session 2
The LEDS interview is designed to assess life experiences and emotional responses.
Time frame: During sessions 1 and 2 (a total of 7 hours) saliva samples will be repeatedly gathered
A total of ten saliva samples will be taken before, during and after the tasks in sessions 1 and 2 to monitor changes in hormone levels.
Time frame: 5 minute saliva sample gathered at the beginning of session 1
One Saliva sample will be gathered from each participant to analyze genetic markers.
Time frame: 3 blood samples, each taking 10 minutes, gathered over the course of session 1 for a total of 30 minutes
Blood will be drawn from participants before, during and after the various tasks in session 1. Changes in inflammatory cytokine levels in blood plasma will be measured to gauge physiological responses to tasks.
Time frame: Administered in session 2 during two hour long scan
The instrumental learning task is designed to measure participant learning from reward and punishment.
Time frame: Given 3 times during session 1 for a total of 9 minutes
The Reaction Time task is designed to control for individual differences in reaction time and fatigue during the session.
Mclean Hospital
Other
Acronym: MIDAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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