NCT04539756

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

August 31, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 8, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
Last Updated

July 2, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

August 31, 2020

Last Update Submit

July 1, 2021

Conditions

Keywords

Positive Psychological InterventionWellbeingOptimism

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in positive affect at 1 week post-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

    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 Outcomes (14)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • +9 more secondary outcomes

Other Outcomes (8)

  • Loneliness

    Assessed every other day, after participants complete each activity for up to 2 weeks.

  • Connectedness

    Assessed every other day, after participants complete each activity for up to 2 weeks.

  • Stress

    Assessed every other day, after participants complete each activity for up to 2 weeks.

  • +5 more other outcomes

Study Arms (2)

Active control condition

ACTIVE COMPARATOR

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

Positive psychological intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: Positive psychology exercises
Positive psychological intervention

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

Also known as: placebo
Active control condition

Eligibility Criteria

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

  • Caitlin M DuPont, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: This is a two-arm parallel study, such that participants are assigned to either an active control group or intervention group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 7, 2020

Study Start

September 8, 2020

Primary Completion

November 20, 2020

Study Completion

November 20, 2020

Last Updated

July 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

I do not plan on sharing any of the individual participant data with other researchers.

Locations