Writing Activities and Emotions

Healthy Clinical Trial

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Official title:

Does an Online Two-week Positive Psychological Intervention Improve Positive Affect in Young Adults?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04539756
• Other study ID #: STUDY20060287
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: July 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Loneliness	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.
Other	Connectedness	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.
Other	Stress	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.
Other	School-specific stress	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.
Other	Light physical activity (today)	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.
Other	Moderate to vigorous physical activity (today)	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.
Other	Sleep quantity (today)	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.
Other	Sleep quality (today)	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.
Primary	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.
Primary	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	Change from baseline in optimism at 1 week post-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.
Secondary	Change from baseline in life satisfaction at 1 week post-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.
Secondary	Change from baseline in psychological well-being at 1 week post-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.
Secondary	Change from baseline in perceived stress at 1 week post-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.
Secondary	Change from baseline in perceived social support at 1 week post-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.
Secondary	Change from baseline in loneliness at 1 week post-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.
Secondary	Change from baseline in depressive symptoms at 1 week post-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.
Secondary	Change from baseline in anxiety symptoms at 1 week post-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.
Secondary	Change from baseline in light physical activity (in general) at 1 week post-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.
Secondary	Change from baseline in moderate physical activity (in general) at 1 week post-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.
Secondary	Change from baseline in sleep quality (in general) at 1 week post-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.
Secondary	Change from baseline in sleep quantity (in general) at 1 week post-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.
Secondary	Change from baseline in negative affect at 1 week post-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.
Secondary	Change from baseline in negative affect at 1 week post-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.