## Protocol Section
### Identification Module
**NCT ID:** NCT02472379

**Brief Title:** Writing About Experiences and Health in Older Adults

**Official Title:** Writing About Experiences and Health in Older Adults

#### Organization Study ID Info
**ID:** GEN
#### Organization
**Class:** OTHER
**Full Name:** University of California, Los Angeles
#### Secondary ID Infos
**ID:** F31AG048668
**Link:** https://reporter.nih.gov/quickSearch/F31AG048668
**Type:** NIH
**ID:** UL1TR000124
**Link:** https://reporter.nih.gov/quickSearch/UL1TR000124
**Type:** NIH
**ID:** R03AG049254
**Link:** https://reporter.nih.gov/quickSearch/R03AG049254
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2017-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-05-02

**Type:** ACTUAL

**Last Update Submit Date:** 2017-05-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-01

**Type:** ACTUAL

#### Start Date
**Date:** 2015-10

**Status Verified Date:** 2017-05

#### Study First Post Date
**Date:** 2015-06-15
**Type:** ESTIMATED
**Study First Submit Date:** 2015-06-10
**Study First Submit QC Date:** 2015-06-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute on Aging (NIA)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, Los Angeles

#### Responsible Party

**Investigator Affiliation:** University of California, Los Angeles

**Investigator Full Name:** Naomi Eisenberger

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Description Module

**Brief Summary:** UCLA researchers looking for healthy females (age 60+) to participate in a study investigating how writing about your experiences may be related to your health.

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 for blood draws and to fill out questionnaires 3 times: once prior to the 6-week writing period, once immediately after the 6-week period, and once 2-months after the writing period.

### Conditions Module

**Conditions:**

- Social Psychology

**Keywords:**

- Immune System

- Behavioral Sciences

- Women's Health

- Health Psychology

- Writing

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 78

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects will be asked to write about experiences with familiar individuals in their lives.

**Intervention Names:**

- Behavioral: Writing: Group 1

**Label:** Writing: Group 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects will be asked to write about experiences with familiar places in their lives.

**Intervention Names:**

- Other: Writing: Group 2

**Label:** Writing: Group 2

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Writing: Group 1

**Description:** Writing about experiences with familiar individuals in their lives, once a week for 6 weeks.

**Name:** Writing: Group 1

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Writing: Group 2

**Description:** Writing about experiences with familiar places, once a week for 6 weeks.

**Name:** Writing: Group 2

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Changes in proinflammatory cytokine and proinflammatory gene expression from blood draws

**Measure:** Inflammatory activity

**Time Frame:** baseline, post 6-week writing period, 2-months post-writing period

**Description:** Changes in self-report measures of health (e.g., pain, sleep) and well-being (e.g., social support, depression)

**Measure:** Health and well-being (self-report)

**Time Frame:** baseline, post 6-week writing period, 2-months post-writing period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy adults 60 years and older

Exclusion Criteria:

* Following a structured telephone interview, participants with the following conditions will not be able to participate:

  1. current smokers
  2. active, uncontrolled medical disorders
  3. chronic infection (e.g., Hepatitis C, HIV)
  4. use of certain medications (e.g., hypnotic and psychotropic medication, steroid use, opioid use)
  5. psychiatric disorders (e.g., current major depression, bipolar disorder)
  6. body mass index (BMI) greater than 35

Other exclusion criteria may apply.

**Healthy Volunteers:** True

**Maximum Age:** 100 Years

**Minimum Age:** 60 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** UCLA Clinical & Translational Research Center (CTRC)

**State:** California

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, Los Angeles

**Name:** Naomi I. Eisenberger, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of California, Los Angeles

**Name:** Mona Moieni, M.A.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
