- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04539756
Writing Activities and Emotions (eWrite)
July 1, 2021 updated by: Caitlin M. DuPont, University of Pittsburgh
Does an Online Two-week Positive Psychological Intervention Improve Positive Affect in Young Adults?
The current study aims to test whether an online two-week positive psychological intervention can increase positive affect in college students.
Participants will be recruited from the University of Pittsburgh undergraduate subject pool.
Students will be ineligible if they are under the age of 18; currently prescribed medications for cardiac arrythmias; have a history of heart surgery, heart attack, or stroke; are currently pregnant; or currently have symptoms consistent with COVID-19.
This study includes an active control arm and an intervention arm.
Both arms will be required to complete writing activities every other day for two weeks.
Participants in the control arm will list their daily activities, while participants in the intervention arm will complete various positive psychology activities.
Questionnaires assessing mood, emotional well-being, social functioning and a few health behaviors will be administered pre- and post-intervention.
The investigators aim to recruit 250 undergraduate students with the hope that at least 50 participants per group will complete the entire study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be an undergraduate student at the University of Pittsburgh that is currently taking Introduction to Psychology.
- Must be at least 18 years old
- Not currently prescribed medications for cardiac arrythmias
- Report no history of heart surgery, heart attack, or stroke
- Not currently pregnant
- Must deny having current symptoms consistent with COVID-19.
Exclusion Criteria:
- If the participant does not meet the inclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active control condition
Participants in the active control condition will receive the same number of text message reminders and will complete the same number of writing activities as the intervention group.
The writing activity for the active control condition will ask them to list their activities for that day.
|
Participants will be asked to complete the same writing activity each day, which will ask them to list their daily activities.
Participants will be encouraged to process their daily activities superficially by the receiving the following instructions: (1) list each activity in brief, incomplete sentences, (2) document only facts about performing the activities, and (3) to not provide any information about emotional responses to performing the activities.
By following these instructions, participants are presumably deriving less meaning from their activities, which may minimize gains in positive affect in the active control condition
Other Names:
|
|
Experimental: Positive psychological intervention
Participants will be asked to complete writing activities every other day.
They will choose which activity they would like to complete each day, from a menu of six different activities.
Each activity is a different positive psychology exercise.
|
Participants will be asked to complete writing activities every other day.
They will choose which activity they would like to complete each day, from a menu of six different activities.
Each activity is a different positive psychology exercise.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in positive affect at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
Positive and Negative Affective Schedule (20-item).
The possible range for this questionnaire is from 5 - 50.
Baseline values will be subtracted from post-intervention values and a higher score on this measure represents a better outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
|
Change from baseline in positive affect at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
Positive Emotional Style Questionnaire.
The possible range for this questionnaire is from 0 - 36.
Baseline values will be subtracted from post-intervention values and a higher score on this measure represents a better outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in optimism at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
Life Orientation Test-Revised.
The possible range for this questionnaire is from 6 - 30.
Baseline values will be subtracted from post-intervention values and a higher score on this measure represents a better outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
|
Change from baseline in life satisfaction at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
PROMIS - General Life Satisfaction.
The possible range for this questionnaire is from 10 - 70.
Baseline values will be subtracted from post-intervention values and a higher score on this measure represents a better outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
|
Change from baseline in psychological well-being at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
Psychological Well-Being Scale.
The possible range for this questionnaire is from 42 - 294.
Baseline values will be subtracted from post-intervention values and a higher score on this measure represents a better outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
|
Change from baseline in perceived stress at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
Perceived Stress Scale.
The possible range for this questionnaire is from 0 - 40.
Baseline values will be subtracted from post-intervention values and a higher score on this measure represents a worse outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
|
Change from baseline in perceived social support at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
ISEL (12-item).
The possible range for this questionnaire is from 12 - 48.
Baseline values will be subtracted from post-intervention values and a higher score on this measure represents a better outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
|
Change from baseline in loneliness at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
UCLA Loneliness Scale (8-item).
The possible range for this questionnaire is from 0 - 24.
Baseline values will be subtracted from post-intervention values and a higher score on this measure represents a worse outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
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Change from baseline in depressive symptoms at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
PROMIS - Emotional Distress - Depression - Short Form.
The possible range for this questionnaire is from 8 - 40.
Baseline values will be subtracted from post-intervention values and a higher score on this measure represents a worse outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
|
Change from baseline in anxiety symptoms at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
PROMIS - Emotional Distress - Anxiety - Short Form.
The possible range for this questionnaire is from 7 - 35.
Baseline values will be subtracted from post-intervention values and a higher score on this measure represents a worse outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
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Change from baseline in light physical activity (in general) at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
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1-items asking participants to report minutes of light physical activity that they perform 'in general.' Baseline values will be subtracted from post-intervention values and a higher number on this measure represents a better outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
|
Change from baseline in moderate physical activity (in general) at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
1-item asking participants to report minutes of moderate to vigorous physical activity that they perform 'in general.' Baseline values will be subtracted from post-intervention values and a higher number on this measure represents a better outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
|
Change from baseline in sleep quality (in general) at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
1-item asking participants to report their overall sleep quality in general.
Sleep quality was assessed on a Likert scale from Very bad (0) to Very good (5).
Higher scores reflect a better outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
|
Change from baseline in sleep quantity (in general) at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
1-items asking participants to report how long they typically sleep each night.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
|
Change from baseline in negative affect at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
Positive and Negative Affective Schedule.
The possible range for this questionnaire is from 5 - 50.
Baseline values will be subtracted from post-intervention values and a higher score on this measure represents a better outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
|
Change from baseline in negative affect at 1 week post-intervention
Time Frame: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
Negative Emotional Style Questionnaires.
The possible range for this questionnaire is from 0 - 36.
Baseline values will be subtracted from post-intervention values and a higher score on this measure represents a worse outcome.
|
Assessed twice, once before the intervention and a second time within one week of completing the intervention.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loneliness
Time Frame: Assessed every other day, after participants complete each activity for up to 2 weeks.
|
Participants will be asked to rate how much they agree with the following statement on a visual analogue scale from "Not at all accurate (0)" to "Extremely Accurate (100)".
The statements states: Today I feel lonely or isolated.
Higher scores reflect worse outcomes.
|
Assessed every other day, after participants complete each activity for up to 2 weeks.
|
|
Connectedness
Time Frame: Assessed every other day, after participants complete each activity for up to 2 weeks.
|
Participants will be asked to rate how much they agree with the following statement on a visual analogue scale from "Not at all accurate (0)" to "Extremely Accurate (100)".
The statements states: Today I feel connected to others.
Higher scores reflect better outcomes.
|
Assessed every other day, after participants complete each activity for up to 2 weeks.
|
|
Stress
Time Frame: Assessed every other day, after participants complete each activity for up to 2 weeks.
|
Participants will be asked to rate how much they agree with the following statements on a visual analogue scale from "Not at all accurate (0)" to "Extremely Accurate (100)".
Stress will be assessed by the one-item statement: 'Today I feel stressed.'
Higher scores reflect worse outcomes.
|
Assessed every other day, after participants complete each activity for up to 2 weeks.
|
|
School-specific stress
Time Frame: Assessed every other day, after participants complete each activity for up to 2 weeks.
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Participants will be asked to rate how much they agree with the following statements on a visual analogue scale from "Not at all accurate (0)" to "Extremely Accurate (100)".
School stress will be assessed by the one-item statement: 'Today I feel nervous or overwhelmed about school.'
Higher scores reflect worse outcomes.
|
Assessed every other day, after participants complete each activity for up to 2 weeks.
|
|
Light physical activity (today)
Time Frame: Assessed every other day, after participants complete each activity for up to 2 weeks.
|
Participants will self-report minutes of light physical activity that they completed that day.
Larger numbers reflect better outcomes.
|
Assessed every other day, after participants complete each activity for up to 2 weeks.
|
|
Moderate to vigorous physical activity (today)
Time Frame: Assessed every other day, after participants complete each activity for up to 2 weeks.
|
Participants will self-report minutes of moderate to vigorous physical activity that they completed that day.
Larger numbers reflect better outcomes.
|
Assessed every other day, after participants complete each activity for up to 2 weeks.
|
|
Sleep quantity (today)
Time Frame: Assessed every other day, after participants complete each activity for up to 2 weeks.
|
1-items asking participants to report how long they slept the night before.
|
Assessed every other day, after participants complete each activity for up to 2 weeks.
|
|
Sleep quality (today)
Time Frame: Assessed every other day, after participants complete each activity for up to 2 weeks.
|
Sleep quality was assessed on a 1-item Likert scale asking participants to rate their subjective sleep quality from Very bad (0) to Very good (5).
Larger numbers represent better outcomes.
|
Assessed every other day, after participants complete each activity for up to 2 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Caitlin M DuPont, MS, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2020
Primary Completion (Actual)
November 20, 2020
Study Completion (Actual)
November 20, 2020
Study Registration Dates
First Submitted
August 31, 2020
First Submitted That Met QC Criteria
August 31, 2020
First Posted (Actual)
September 7, 2020
Study Record Updates
Last Update Posted (Actual)
July 2, 2021
Last Update Submitted That Met QC Criteria
July 1, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- STUDY20060287
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
I do not plan on sharing any of the individual participant data with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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