- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01723410
Neural and Physiological Responses to Real-World Experiences
December 10, 2015 updated by: Naomi Eisenberger, University of California, Los Angeles
UCLA researchers looking for healthy individuals (aged 35-50) who have a home computer with internet access, are not pregnant, planning to become pregnant, or currently breastfeeding (if female), to participate in a study investigating whether real-world experiences alter the brain and body.
This study takes place over an eight week period and involves providing the names of 8 close friends or family members, completing a neuroimaging session, providing blood and saliva (for genetic analysis), and a 6-week period in which participants login twice a week to complete online questionnaires.
Compensation is up to $210 for those who complete all aspects of the study.
Please email realworld.ucla@gmail.com
for more information.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA CTRC & Brain Mapping Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults between the ages of 35-50
Exclusion Criteria:
Following a structured telephone interview, prospective participants with the following conditions will not be able to participate:
- claustrophobia, left-handedness, or presence of metal in their body (for the neuroimaging procedures),
- possible presence of a depressive disorder, which may interfere with the gratitude intervention (assessed by the Patient Health Questionnaire; Spitzer et al., 1999),
- regular use of medications that may impact inflammatory processes (anti-inflammatory drugs, steroids, opioids),
- current smokers or excessive caffeine users (> 600 mg/day) because of known effects on inflammation, and
- pregnancy (which would affect oxytocin gene expression).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Writing condition
Subjects will be asked to write about other individuals in their lives.
|
Subjects will be asked to write about other people in their lives once a week for 6-weeks.
|
|
Placebo Comparator: Writing
Subjects will be asked to write about places or objects in their lives.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
inflammatory gene expression
Time Frame: baseline, six weeks post manipulation
|
Changes in inflammatory gene expression from pre- to post-intervention.
|
baseline, six weeks post manipulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neural activity
Time Frame: baseline, six weeks post-intervention
|
Changes in neural activity from pre- to post-intervention.
|
baseline, six weeks post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
November 1, 2012
First Submitted That Met QC Criteria
November 5, 2012
First Posted (Estimate)
November 7, 2012
Study Record Updates
Last Update Posted (Estimate)
December 11, 2015
Last Update Submitted That Met QC Criteria
December 10, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- GGSC-GRAT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.