- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05524597
Writing About Experiences and Health in Older Adults II
UCLA researchers looking for healthy older adults (aged 65+) to participate in a study investigating how writing about experiences can affect your brain and body.
Once a week for 6 weeks, participants will write about their experiences and fill out online questionnaires. Participants will also come to the UCLA campus to complete a neuroimaging session (fMRI), provide a blood spot sample, and fill out questionnaires 2 times: once prior to the 6-week writing period and once immediately after the 6-week writing period.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Naomi Eisenberger, Ph.D.
- Phone Number: 3108494330
- Email: neisenbe@ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- Center for Cognitive Neuroscience
-
Contact:
- Naomi Eisenberger
- Phone Number: 3108494330
- Email: neisenbe@ucla.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adults age 65 years and older
Exclusion Criteria:
- current smokers
- active, uncontrolled medical disorders
- chronic infection (e.g., Hepatitis C, HIV)
- use of certain medications (steroid use, opioid use)
- psychiatric disorders (e.g., current major depression, bipolar disorder)
- body mass index (BMI) greater than 35
- left-handed
- claustrophobic
- metal in body
Other exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Writing about Experiences
Participants will be asked to write about experiences with familiar individuals in their lives.
|
Participants will be asked to write about different kinds of experiences.
|
|
Placebo Comparator: Writing about Places
Participants will be asked to write about experiences with familiar places in their lives.
|
Participants will be asked to write about different kinds of experiences.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Psychological Distress
Time Frame: Baseline, 6 weeks, 10 weeks
|
Composite measure of depression, anxiety, stress (Beck Depression Inventory, Spielberger Trait Anxiety, and Perceived Stress Scale)
|
Baseline, 6 weeks, 10 weeks
|
|
Change in Social Support
Time Frame: Baseline, 6 weeks, 10 weeks
|
measure of perceived social support (Social Provisions Scale)
|
Baseline, 6 weeks, 10 weeks
|
|
Change in Social Participation
Time Frame: Baseline, 6 weeks, 10 weeks
|
measure of participation in social activities (Lifestyle Activities Questionnaire)
|
Baseline, 6 weeks, 10 weeks
|
|
Change in Inflammatory Gene Expression
Time Frame: Baseline, 6 weeks, 10 weeks
|
changes in proinflammatory gene expression
|
Baseline, 6 weeks, 10 weeks
|
|
Change in Dorsal Anterior Cingulate Cortex (dACC) Activity in response to stress
Time Frame: Baseline, 6 weeks
|
Parameter estimates from dACC region-of-interest
|
Baseline, 6 weeks
|
|
Change in Anterior Insula Activity in response to stress
Time Frame: Baseline, 6 weeks
|
Parameter estimates from bilateral anterior insula region-of-interest
|
Baseline, 6 weeks
|
|
Change in Amygdala Activity in response to threat
Time Frame: Baseline, 6 weeks
|
Parameter estimates from bilateral amygdala region-of-interest
|
Baseline, 6 weeks
|
|
Change in Ventral Striatum Activity in response to prosocial behavior
Time Frame: Baseline, 6 weeks
|
Parameter estimates from bilateral ventral striatum region-of-interest
|
Baseline, 6 weeks
|
|
Change in Septal Area Activity in response to prosocial behavior
Time Frame: Baseline, 6 weeks
|
Parameter estimates from septal area region-of-interest
|
Baseline, 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Memory
Time Frame: Baseline, 6 weeks, 10 weeks
|
changes in recall ability (Montreal Cognitive Assessment Test)
|
Baseline, 6 weeks, 10 weeks
|
|
Change in Beliefs about Aging
Time Frame: Baseline, 6 weeks, 10 weeks
|
changes in cognitive, affective, and social beliefs about aging (Expectations Regarding Aging survey)
|
Baseline, 6 weeks, 10 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01AG071498 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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