eWrite: Writing Activities and Emotions

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT04539756
Collaborator
(none)
250
1
2
2.4
104.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: positive psychological intervention
  • Behavioral: Active control condition
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a two-arm parallel study, such that participants are assigned to either an active control group or intervention group.This is a two-arm parallel study, such that participants are assigned to either an active control group or intervention group.
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Does an Online Two-week Positive Psychological Intervention Improve Positive Affect in Young Adults?
Actual Study Start Date :
Sep 8, 2020
Actual Primary Completion Date :
Nov 20, 2020
Actual Study Completion Date :
Nov 20, 2020

Arms and Interventions

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.

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in positive affect at 1 week post-intervention [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.

    2. Change from baseline in positive affect at 1 week post-intervention [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.

    Secondary Outcome Measures

    1. Change from baseline in optimism at 1 week post-intervention [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.

    2. Change from baseline in life satisfaction at 1 week post-intervention [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.

    3. Change from baseline in psychological well-being at 1 week post-intervention [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.

    4. Change from baseline in perceived stress at 1 week post-intervention [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.

    5. Change from baseline in perceived social support at 1 week post-intervention [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.

    6. Change from baseline in loneliness at 1 week post-intervention [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.

    7. Change from baseline in depressive symptoms at 1 week post-intervention [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.

    8. Change from baseline in anxiety symptoms at 1 week post-intervention [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.

    9. Change from baseline in light physical activity (in general) at 1 week post-intervention [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.

    10. Change from baseline in moderate physical activity (in general) at 1 week post-intervention [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.

    11. Change from baseline in sleep quality (in general) at 1 week post-intervention [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.

    12. Change from baseline in sleep quantity (in general) at 1 week post-intervention [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.

    13. Change from baseline in negative affect at 1 week post-intervention [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.

    14. Change from baseline in negative affect at 1 week post-intervention [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.

    Other Outcome Measures

    1. Loneliness [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.

    2. Connectedness [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.

    3. Stress [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.

    4. School-specific stress [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.

    5. Light physical activity (today) [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.

    6. Moderate to vigorous physical activity (today) [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.

    7. Sleep quantity (today) [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.

    8. Sleep quality (today) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pittsburgh Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • University of Pittsburgh

    Investigators

    • Principal Investigator: Caitlin M DuPont, MS, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Caitlin M. DuPont, Principal Investigator, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT04539756
    Other Study ID Numbers:
    • STUDY20060287
    First Posted:
    Sep 7, 2020
    Last Update Posted:
    Jul 2, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Caitlin M. DuPont, Principal Investigator, University of Pittsburgh

    Study Results

    No Results Posted as of Jul 2, 2021