Gene ExpressionNCT01723410
Neural and Physiological Responses to Real-World Experiences
A study testing Writing about people and Writing about places, objects in people with Gene Expression, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gene Expression
- What is being tested?
- Writing about people and Writing about places, objects
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults between the ages of 35-50
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA CTRC & Brain Mapping Center
Los Angeles, California, 90095
About this study
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
- Being tested
- Writing about people, Writing about places, objects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Writing about peopleBehavioural
Subjects will be asked to write about other people in their lives once a week for 6-weeks.
Writing about places, objectsOther
| Study group | Role | What they receive |
|---|---|---|
| Writing condition | Experimental | Subjects will be asked to write about other individuals in their lives. Receives: Behavioral: Writing about people |
| Writing | Placebo comparator | Subjects will be asked to write about places or objects in their lives. Receives: Other: Writing about places, objects |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory gene expression
Changes in inflammatory gene expression from pre- to post-intervention.
Measured: baseline, six weeks post manipulation
Secondary outcomes (1)
neural activity
Changes in neural activity from pre- to post-intervention.
Measured: baseline, six weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gene ExpressionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi Eisenberger, University of California, Los Angeles
- Investigators
- Naomi I Eisenberger, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723410
- Sponsor's protocol ID
- GGSC-GRAT
- Status last verified
- Dec 2015
- First submitted
- 1 Nov 2012
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Physiological Responses to Real-World Experiences
- ClinicalTrials.gov ID
- NCT01723410
- Acronym / sponsor ID
- GGSC-GRAT
- Conditions
- Gene Expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Writing condition | Experimental | Behavioral: Writing about peopleSubjects will be asked to write about other individuals in their lives. |
| Writing | Placebo comparator | Other: Writing about places, objectsSubjects will be asked to write about places or objects in their lives. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults between the ages of 35-50
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Writing about peopleSubjects will be asked to write about other people in their lives once a week for 6-weeks. | Behavioural | Writing condition |
| Writing about places, objects | Other | Writing |
Primary outcome
inflammatory gene expression
Time frame: baseline, six weeks post manipulation
Changes in inflammatory gene expression from pre- to post-intervention.
1 secondary outcome
neural activity
Time frame: baseline, six weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi I Eisenberger, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Writing about people and Writing about places, objects in people with Gene Expression, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory gene expression (time frame: baseline, six weeks post manipulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.