HealthyeWriteNCT04539756
Writing Activities and Emotions
A study testing positive psychological intervention in people with Healthy, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- positive psychological intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to 20 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- If the participant does not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- positive psychological intervention, Active control condition
- Keywords
- Positive Psychological Intervention, Wellbeing, Optimism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive psychological interventionBehavioural
Also called Positive psychology exercises
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 conditionBehavioural
Also called placebo
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: positive psychological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
1-items asking participants to report how long they typically sleep each night.
Measured: 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
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.
Measured: 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
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.
Measured: Assessed twice, once before the intervention and a second time within one week of completing the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start8 Sep 2020
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm parallel study, such that participants are assigned to either an active control group or intervention group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caitlin M. DuPont, University of Pittsburgh
- Investigators
- Caitlin M DuPont, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539756
- Sponsor's protocol ID
- STUDY20060287
- Acronym
- eWrite
- Status last verified
- Jul 2021
- First submitted
- 31 Aug 2020
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not plan on sharing any of the individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does an Online Two-week Positive Psychological Intervention Improve Positive Affect in Young Adults?
- ClinicalTrials.gov ID
- NCT04539756
- Acronym / sponsor ID
- eWrite / STUDY20060287
- Conditions
- Healthy
- Keywords
- Positive Psychological Intervention, Wellbeing, Optimism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a two-arm parallel study, such that participants are assigned to either an active control group or intervention group.
| Arm | Type | Receives |
|---|---|---|
| Active control condition | Active comparator | Behavioral: Active control conditionParticipants 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. |
| Positive psychological intervention | Experimental | Behavioral: positive psychological interventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- If the participant does not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| positive psychological interventionAlso: Positive psychology exercisesParticipants 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. | Behavioural | Positive psychological intervention |
| Active control conditionAlso: placeboParticipants 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 | Behavioural | Active control condition |
Primary outcome
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.
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.
14 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: No. I do not plan on sharing any of the individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caitlin M DuPont, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive psychological intervention in people with Healthy, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.