NCT06483568

Brief Summary

The goal of this clinical trial is to learn if engaging in a multi-activity positive psychology intervention increases emotional well-being The main aims of this project are to:

  1. 1.Test the efficacy of a multi-activity positive psychology intervention for increasing emotional well-being in a racial-ethnically and socioeconomically diverse sample.
  2. 2.Identify physical and social behavioral mechanisms driving positive psychology intervention effects on emotional well-being change and the durability of these effects over time.
  3. 3.Examine physical health outcomes stemming from emotional well-being gains.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

April 26, 2024

Last Update Submit

June 28, 2024

Conditions

Keywords

Emotional Well-BeingHappinessGratitudeKindnessSelf-CompassionCapitalization

Outcome Measures

Primary Outcomes (12)

  • Life Satisfaction

    Satisfaction with Life Scale, 1-7 scale, higher scores better

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Positive Affect

    Scale of Positive and Negative Affect, 1-5 scale, higher scores better

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Negative Affect

    Scale of Positive and Negative Affect, 1-5 scale, lower scores better

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Meaning in Life

    Meaning in Life Questionnaire, 1-7 scale, higher scores better

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Optimism

    Life Orientation Test-Revised, 1-5 scale, higher scores better

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Perceived General Health

    Medical Outcomes Study (MOS) Short Form Health Survey (SF-36), General Health Perceptions Subscale, 1-5, higher scores better

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Blood Pressure

    Systolic and Diastolic Blood Pressure In-lab measurement with OMRON 10 Series Wireless Upper Arm Blood Pressure Monitor

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Heart Rate

    In-lab measurement with OMRON 10 Series Wireless Upper Arm Blood Pressure Monitor

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Peak Expiratory Flow Rate

    In-lab measurement with EasyOne Air Spirometer

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Grip Strength

    In-lab measurement with Jamar Plus+ Digital Hand Dynamometer

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Momentary Mood

    Rate your current mood. 1 (very bad) to 7 (very good), higher scores better

    3x daily; weeks 1-8, 19, 20

  • Momentary Meaning in Life

    Daily Meaning Scale, 1-7, higher scores better

    3x daily; weeks 1-8, 19, 20

Secondary Outcomes (42)

  • Amusement

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Awe

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Compassion

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Contentment

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • Joy

    baseline, immediate post-treatment, 14-week post-treatment follow-up

  • +37 more secondary outcomes

Study Arms (2)

Positive Psychology Intervention Activities

EXPERIMENTAL

Four week intervention with four weekly activities including gratitude journal, random acts of kindness, self-compassionate letter, and capitalizing on positive events activities.

Behavioral: Pathways to Happiness Intervention

Personal Organization Activities

SHAM COMPARATOR

Control participants will complete procedure-matched activities related to personal organization, including writing in a completed tasks journal, completing a weekly task burst, productivity letter, and talking to others about tasks activities.

Behavioral: Personal Organization Activities

Interventions

Four weeks of activities including a gratitude journal, random acts of kindness, self-compassionate letter, and capitalizing on positive events activities.

Positive Psychology Intervention Activities

Four weeks of activities including a completed tasks journal, weekly "task burst," productivity letter, and talking to others about task activities.

Personal Organization Activities

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fluent or native English speaker capable of completing survey questionnaires in English

You may not qualify if:

  • Major depressive disorder (PHQ-9 \> or = 15)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants will not be aware of whether their activities are considered the active or control activities as both will be described as self-improvement activities. The PI and all research staff interacting with participants will not be aware of their condition assignment.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to complete positive psychology intervention activities or procedure-matched activities related to personal organization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 26, 2024

First Posted

July 3, 2024

Study Start

July 15, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Individual participant data collected during the trial, after deidentification, and the study protocol materials will be shared on the Open Science Framework.

Shared Documents
STUDY PROTOCOL
Time Frame
Data and materials will be shared concurrent with publication and will be available indefinitely on the Open Science Framework.
Access Criteria
Anyone who wishes to access the data will be able to do so