Neural and Physiological Responses to Real-World Experiences

NCT01723410 | Completed DMC

• 1 other identifier: GGSC-GRAT
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gene Expression

Outcome Measures

Primary Outcomes (1)

• inflammatory gene expression

  Changes in inflammatory gene expression from pre- to post-intervention.

  baseline, six weeks post manipulation

Secondary Outcomes (1)

• neural activity

  baseline, six weeks post-intervention

Study Arms (2)

Writing condition

EXPERIMENTAL

Subjects will be asked to write about other individuals in their lives.

Behavioral: Writing about people

Writing

PLACEBO COMPARATOR

Subjects will be asked to write about places or objects in their lives.

Other: Writing about places, objects

Interventions

Writing about people BEHAVIORAL

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

Writing condition

Writing about places, objects OTHER

Writing

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults between the ages of 35-50

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA CTRC & Brain Mapping Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Artifacts

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Naomi I Eisenberger, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 7, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

US (1)