Healthy Young AdultsNCT04207528
Campus Life Study: Harnessing Generativity Among Young Adults
A study testing Writing in people with Healthy Young Adults, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Recent research suggests that short, online interventions can enhance well-being, which is beneficial to both physical and mental health outcomes. Further, growing evidence suggests that prosocial behavior-a behavior that can be reliably manipulated through a short online intervention-may have beneficial effects on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 10 Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- enrolled in an upper-division psychology course
- 18 years of age or older
- fluent in English
- access to the internet and email
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: The Effects of Prosocial Writing on Psychological Well-being: A Randomized Controlled Trial Among Young Adults
Recent research suggests that short, online interventions can enhance well-being, which is beneficial to both physical and mental health outcomes. Further, growing evidence suggests that prosocial behavior-a behavior that can be reliably manipulated through a short online intervention-may have beneficial effects on well-being and physical health. Giving support to others appears to be just as beneficial as receiving support, and asking people to perform kind acts for others over the course of several weeks, for example, has been shown to both increase well-being and reduce the inflammatory potential of immune cells.
The purpose of the current study is to test a novel 3-week, online prosocial writing-based intervention in a sample of young adults. Previous intervention studies have manipulated prosocial behavior by asking participants to perform tangible acts of kindness for others, such as writing a note to a coworker or helping a neighbor. However, providing this type of direct support can be logistically challenging and may contribute to increased feelings of distress in certain contexts. Writing interventions designed to elicit feelings of generativity offer one alternative approach, though they have yet to be tested among young adults.
Participants (n = 200) will be randomized to one of two conditions--peer helping or a facts-only control--and instructed to write about their experiences in their first-year at UCLA (freshman or first-year after transfer). Those in the peer helping will be asked to write for the benefit of a student who is about to begin their first year, whereas those in the facts-only control will not. In total, participants will complete 4 writing assignments, each on a separate day over the course of one week. Valid self-report measures will be assessed at pre-intervention, each writing session, post-intervention, and at the 2-week follow-up. The investigators expect participants in the peer helping condition to experience a greater increase in well-being (primary outcome) across the intervention and the follow-up when compared to the control condition. Secondary outcomes will include depressive symptoms, anxiety, loneliness, physical symptoms, social support, and generativity. As an exploratory aim, will also assess several moderators (i.e., psychological distress, prosocial tendencies, generativity) and mediators (i.e., fulfillment of psychological needs, positive affect) of the intervention effects.
- Conditions
- Healthy Young Adults
- Being tested
- Writing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WritingBehavioural
After completing the baseline questionnaire, participants will be randomized to one of two conditions-a peer helping condition or a facts-only writing control. Participants will receive general instructions for completing the writing sessions and will be asked to write for at least 5 minutes per session. Topics covered in each session will vary and are related to common themes relating to life as a first-year university student (e.g., academics, adjusting to university, etc.). Participants will be instructed not to worry about grammar, spelling, or sentence structure and reminded that their responses will remain anonymous. Writing sessions (four in total) will be spaced 1 day apart and take place all within the same week.
| Study group | Role | What they receive |
|---|---|---|
| Peer Helping Condition | Experimental | Participants in the peer helping condition will be asked to write about their experiences in their first-year at UCLA (freshman or first-year after post-transfer), with an emphasis on using the experience to benefit someone who is about to be a first-year student. Receives: Behavioral: Writing |
| Facts-only Control | Active comparator | Participants in the facts-only writing condition will be asked to write facts about their experiences in their first-year at UCLA (freshman or first-year post-transfer). Unlike the previous conditions, they will not be instructed to write for the benefit of another individual. Receives: Behavioral: Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychological well-being
Well-being within the past week will be measured at baseline, post-intervention, and the 2-week follow-up via the 14-item Mental Health Continuum-Short Form (MHC-SF). The MHC-SF is comprised of three empirically derived subscales: the 3-item Emotional Well-Being Subscale, the 6-item Psychological Well-Being Subscale, and the 5-item Social Well-Being Subscale. Higher scores on each subscale, and the total score overall (range: 0-56), indicate greater well-being.
Measured: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Secondary outcomes (9)
Change in depressive symptoms
Depressive symptoms over the past week will be measured at baseline, post-intervention, and the 2-week follow-up via the 20-item Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a measure of symptom severity, with higher scores (range: 0-60) indicating greater depressive symptoms.
Measured: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in anxiety and worry
Symptoms of anxiety over the past week will be measured at baseline, post-intervention, and the 2-week follow-up via the 7-item Generalized Anxiety Disorder- 7 (GAD-7). Higher scores on the GAD-7 (range: 0-21) indicate greater severity of symptoms. Three additional items were added by the investigators to assess worry about vocational future: "I worry that I won't finish my degree," "I worry about what I will do after I finish my degree," and "I worry that I am not prepared for what comes after college (e.g., getting a job, graduate school)." These items are scored on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree), with higher scores indicating greater worry (range: 3-15).
Measured: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in loneliness
Feelings of loneliness over the past week will be measured at baseline, post-intervention, and the 2-week follow-up via the 8-item UCLA Loneliness Scale- Short Form 8. A higher overall score (range: 8-32) indicates greater feelings of loneliness.
Measured: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in physical symptoms and health-care center visits
Frequency of experiencing common physical symptoms (e.g., runny nose) over the past week will be measured at baseline, post-intervention, and the 2-week follow-up via a 13-item adapted version of the Pennebaker Inventory of Limbic Languidness (PILL). This measure includes 10-items assessing physical symptoms (range: 0-70), such as headache, shortness of breath, and coughing/sore throat, and 3-items assessing overall feelings of sickness ("how many days have you been sick?") and healthcare utilization ("how many visits have you made to the student health center?"). Greater scores indicate more physical symptoms/feelings of illness.
Measured: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in sleep disturbance
Sleep disturbance over the past week will be measured using the 4-item PROMIS Sleep Disturbance Scale at baseline, post-intervention, and the 2-week follow-up. Scores range from 4 to 20, with higher scores indicating more disturbance.
Measured: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in social support
Social support will be measured at baseline, post-intervention, and the 2-week follow-up using the 21-item 2-way Social Support Scale. This scale measures 4 dimensions of social support: instrumental support received, instrumental support given, emotional support received, and emotional support given. A higher total score (range: 0-105) indicates more feelings of perceived support.
Measured: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in generativity
Feelings of generativity will be measured at baseline, post-intervention, and the 2-week follow-up using the 13-item Generativity Scale. This measure consists of two subscales: generative desire and generative achievement, with higher scores (range: 13-78) indicating greater desire/achievement.
Measured: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in positive and negative affect
Daily reports of positive and negative affect will be assessed at baseline, post-intervention, the 2-week follow-up, and at each writing session using the 10-item positive affect subscale and 10-item negative affect subscales of the Positive and Negative Affect Schedule (PANAS-X). Two additional adjectives were also included, happy and calm. Greater scores indicate higher feelings of positive (range: 10-50) and negative affect (range: 10-50).
Measured: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in fulfillment of psychological needs
Fulfillment of psychological needs will be measured at baseline, post-intervention, the 2-week follow-up, and at each writing session using the 9-item Balanced Measure of Psychological Needs. This item has three subscales: autonomy, connectedness, and relatedness, with higher scores (range: 9-45) indicating greater needs satisfaction.
Measured: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start6 Jan 2020
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young AdultsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcie D. Haydon, MA, CPhil, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207528
- Sponsor's protocol ID
- IRB#19-002092
- Status last verified
- Feb 2020
- First submitted
- 13 Dec 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Prosocial Writing on Psychological Well-being: A Randomized Controlled Trial Among Young Adults
- ClinicalTrials.gov ID
- NCT04207528
- Acronym / sponsor ID
- IRB#19-002092
- Conditions
- Healthy Young Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 23 Dec 2019 (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.
Recent research suggests that short, online interventions can enhance well-being, which is beneficial to both physical and mental health outcomes. Further, growing evidence suggests that prosocial behavior-a behavior that can be reliably manipulated through a short online intervention-may have beneficial effects on well-being and physical health. Giving support to others appears to be just as beneficial as receiving support, and asking people to perform kind acts for others over the course of several weeks, for example, has been shown to both increase well-being and reduce the inflammatory potential of immune cells.
The purpose of the current study is to test a novel 3-week, online prosocial writing-based intervention in a sample of young adults. Previous intervention studies have manipulated prosocial behavior by asking participants to perform tangible acts of kindness for others, such as writing a note to a coworker or helping a neighbor. However, providing this type of direct support can be logistically challenging and may contribute to increased feelings of distress in certain contexts. Writing interventions designed to elicit feelings of generativity offer one alternative approach, though they have yet to be tested among young adults.
Participants (n = 200) will be randomized to one of two conditions--peer helping or a facts-only control--and instructed to write about their experiences in their first-year at UCLA (freshman or first-year after transfer). Those in the peer helping will be asked to write for the benefit of a student who is about to begin their first year, whereas those in the facts-only control will not. In total, participants will complete 4 writing assignments, each on a separate day over the course of one week. Valid self-report measures will be assessed at pre-intervention, each writing session, post-intervention, and at the 2-week follow-up. The investigators expect participants in the peer helping condition to experience a greater increase in well-being (primary outcome) across the intervention and the follow-up when compared to the control condition. Secondary outcomes will include depressive symptoms, anxiety, loneliness, physical symptoms, social support, and generativity. As an exploratory aim, will also assess several moderators (i.e., psychological distress, prosocial tendencies, generativity) and mediators (i.e., fulfillment of psychological needs, positive affect) of the intervention effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Helping Condition | Experimental | Behavioral: WritingParticipants in the peer helping condition will be asked to write about their experiences in their first-year at UCLA (freshman or first-year after post-transfer), with an emphasis on using the experience to benefit someone who is about to be a first-year student. |
| Facts-only Control | Active comparator | Behavioral: WritingParticipants in the facts-only writing condition will be asked to write facts about their experiences in their first-year at UCLA (freshman or first-year post-transfer). Unlike the previous conditions, they will not be instructed to write for the benefit of another individual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- enrolled in an upper-division psychology course
- 18 years of age or older
- fluent in English
- access to the internet and email
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| WritingAfter completing the baseline questionnaire, participants will be randomized to one of two conditions-a peer helping condition or a facts-only writing control. Participants will receive general instructions for completing the writing sessions and will be asked to write for at least 5 minutes per session. Topics covered in each session will vary and are related to common themes relating to life as a first-year university student (e.g., academics, adjusting to university, etc.). Participants will be instructed not to worry about grammar, spelling, or sentence structure and reminded that their responses will remain anonymous. Writing sessions (four in total) will be spaced 1 day apart and take place all within the same week. | Behavioural | Facts-only Control, Peer Helping Condition |
Primary outcome
Change in psychological well-being
Time frame: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Well-being within the past week will be measured at baseline, post-intervention, and the 2-week follow-up via the 14-item Mental Health Continuum-Short Form (MHC-SF). The MHC-SF is comprised of three empirically derived subscales: the 3-item Emotional Well-Being Subscale, the 6-item Psychological Well-Being Subscale, and the 5-item Social Well-Being Subscale. Higher scores on each subscale, and the total score overall (range: 0-56), indicate greater well-being.
9 secondary outcomes
Change in depressive symptoms
Time frame: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in anxiety and worry
Time frame: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in loneliness
Time frame: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in physical symptoms and health-care center visits
Time frame: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in sleep disturbance
Time frame: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in social support
Time frame: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in generativity
Time frame: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in positive and negative affect
Time frame: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
Change in fulfillment of psychological needs
Time frame: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up
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 12 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Writing in people with Healthy Young Adults, run by University of California, Los Angeles 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 4 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 12 Feb 2020. 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 in psychological well-being (time frame: At the baseline survey (1 day before the intervention begins), at the post-intervention survey (2 days after the final writing assignment), and and at the 2-week follow-up). 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 12 Feb 2020.