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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Active control condition
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:
  • placebo
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.
Behavioral: 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.
Other Names:
  • Positive psychology exercises

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
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.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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