Neural and Physiological Responses to Real-World Experiences

Gene Expression Clinical Trial

Official title:

Neural and Physiological Responses to Real-World Experiences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723410
• Other study ID #: GGSC-GRAT
• Status: Completed
• Phase: N/A
• First received: November 1, 2012
• Last updated: December 10, 2015
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 50 Years

Eligibility

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:

1. claustrophobia, left-handedness, or presence of metal in their body (for the neuroimaging procedures),

2. possible presence of a depressive disorder, which may interfere with the gratitude intervention (assessed by the Patient Health Questionnaire; Spitzer et al., 1999),

3. regular use of medications that may impact inflammatory processes (anti-inflammatory drugs, steroids, opioids),

4. current smokers or excessive caffeine users (> 600 mg/day) because of known effects on inflammation, and

5. pregnancy (which would affect oxytocin gene expression).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gene Expression

Intervention

Behavioral:
• Writing about people
Subjects will be asked to write about other people in their lives once a week for 6-weeks.

Other:
• Writing about places, objects

Locations

Country	Name	City	State
United States	UCLA CTRC & Brain Mapping Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory gene expression	Changes in inflammatory gene expression from pre- to post-intervention.	baseline, six weeks post manipulation	No
Secondary	neural activity	Changes in neural activity from pre- to post-intervention.	baseline, six weeks post-intervention	No