Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention
1 other identifier
interventional
250
0 countries
N/A
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.Test the efficacy of a multi-activity positive psychology intervention for increasing emotional well-being in a racial-ethnically and socioeconomically diverse sample.
- 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.Examine physical health outcomes stemming from emotional well-being gains.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2024
CompletedStudy Start
First participant enrolled
July 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedJuly 3, 2024
June 1, 2024
12 months
April 26, 2024
June 28, 2024
Conditions
Keywords
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
EXPERIMENTALFour week intervention with four weekly activities including gratitude journal, random acts of kindness, self-compassionate letter, and capitalizing on positive events activities.
Personal Organization Activities
SHAM COMPARATORControl 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.
Interventions
Four weeks of activities including a gratitude journal, random acts of kindness, self-compassionate letter, and capitalizing on positive events activities.
Four weeks of activities including a completed tasks journal, weekly "task burst," productivity letter, and talking to others about task activities.
Eligibility Criteria
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
Condition Hierarchy (Ancestors)
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
- 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
- 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
Individual participant data collected during the trial, after deidentification, and the study protocol materials will be shared on the Open Science Framework.