Neural and Physiological Responses to Real-World Experiences

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT01723410
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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 [e-mail] for more information.

Condition or Disease	Intervention/Treatment	Phase
Gene Expression	Behavioral: Writing about people; Other: Writing about places, objects	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Neural and Physiological Responses to Real-World Experiences
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Writing condition Subjects will be asked to write about other individuals in their lives.	Behavioral: Writing about people; 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.	Other: Writing about places, objects

Outcome Measures

Primary Outcome Measures

1. inflammatory gene expression [baseline, six weeks post manipulation]

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

Secondary Outcome Measures

1. neural activity [baseline, six weeks post-intervention]

   Changes in neural activity from pre- to post-intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA CTRC & Brain Mapping Center	Los Angeles	California	United States	90095

Sponsors and Collaborators

• University of California, Los Angeles

Investigators

• Principal Investigator: Naomi I Eisenberger, PhD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Naomi Eisenberger, Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT01723410
• Other Study ID Numbers: GGSC-GRAT
• First Posted: Nov 7, 2012
• Last Update Posted: Dec 11, 2015
• Last Verified: Dec 1, 2015

Study Results

No Results Posted as of Dec 11, 2015