Negative EmotionsNCT07188519
A Study of Effects of Expressive Writing on College Students Experiencing Psychological Difficulties
A study testing expressive writing in people with Negative Emotions and Self Cognition, run by Shandong University at 1 site in China.
Trial summary
This study aims to improve college students' mental health through expressive writing. Over the next eight weeks, I would like you to write about some of the experiences that have had the greatest impact on your life. These may be positive or negative, and may relate to the present, past, or future. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Negative Emotions, Self Cognition
- What is being tested?
- expressive writing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2023to 31 Aug 2024
- 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 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A score indicating mild or higher depressive symptoms on the Beck Depression Inventory (BDI);
- Age ranging from 18 to 29 years old;
- Educational background of undergraduate degree or above; -
Who cannot join
- Participants with no depressive symptoms
- Participants with writing difficulties, dysgraphia, or dyslexia
- Participants with severe physical illnesses or without civil capacity -
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to improve college students' mental health through expressive writing. Over the next eight weeks, I would like you to write about some of the experiences that have had the greatest impact on your life. These may be positive or negative, and may relate to the present, past, or future. As you write, you may describe the event from both positive and negative perspectives. We encourage you to genuinely explore your deepest emotions and thoughts. Whatever you choose to write about, the crucial point is that you truly delve into your innermost feelings and reflections. You may relate your experiences to anyone in your life, including your parents, friends, and relatives. We hope you will endeavour to write about significant experiences you have never discussed in detail with others. During your writing, do not concern yourself with linguistic expression. We wish for you to convey your deepest emotions and thoughts as fully as possible. The content of your writing will not influence our perception of you; it is held in absolute confidence and security. The sole rule for this writing session is that once you begin writing, you must continue until the time concludes (each session is timed for 20-25 minutes). After the writing period ends, you may choose whether to submit your written text.
- Conditions
- Negative Emotions, Self Cognition
- Being tested
- expressive writing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expressive writingOther
Each of the four rounds consisted of three consecutive days of writing followed by a gap week.
| Study group | Role | What they receive |
|---|---|---|
| case study | Other | The intervention with EW on participants followed the design of Pennebaker and Beall (1986) with adjusted writing tasks based on Tolcher et al. (2024). Lasting for 40 days, it included four rounds of writing with a detached vantage point-one month, three months, and six months after the intervention Each of the four rounds consisted of three consecutive days of writing followed by a gap week. On each day, they were asked to write continuously for 20-25 minutes about her life experiences that had a significant impact on her, either positively or negatively. After writing on the third day of each round, they responded to the BDI-II and answered interview questions about their emotional state and self-cognition. Receives: Other: expressive writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
self cognition
Additionally, to assess changes at cognitive levels, we separately recorded and compared the items related to self-cognition (7 items) within the BDI-II. The specific determination rules were as follows:the direction of score change at the item level served as the basis for judgement. Within a given assessment interval, we compared the number of items that decreased (indicating improvement) with those that increased (indicating deterioration). If decreases outnumbered increases, we classified the interval as improvement-predominant; otherwise, deterioration predominated. If the two were comparable, the change was recorded as insignificant. Accordingly, we sequentially compared items across the self cognition dimensions in the nine assessments, thereby revealing the immediate and sustained manifestations of expressive writing at both cognitive levels. Besides, the cognitive words and self cognition related sentences in interview were also analysis as the evidences for self cognition.
Measured: From enrollment to the end of study at one year.
negative emotion and positive emotion
we separately recorded and compared the items related to emotional state (5 items) The specific determination rules were as follows: the direction of score change at the item level served as the basis for judgement. Within a given assessment interval, we compared the number of items that decreased (indicating improvement) with those that increased (indicating deterioration). If decreases outnumbered increases, we classified the interval as improvement-predominant; otherwise, deterioration predominated. If the two were comparable, the change was recorded as insignificant. Accordingly, we sequentially compared items across the negtaive emotion and positive emotion dimensions in the nine assessments, thereby revealing the immediate and sustained manifestations of expressive writing at both emotional levels. Besides, the emotional words used in the writing texts and emotional related senteneces in semi-strcutured interview also analysis as the evidences for positive and negtaive emotion.
Measured: From enrollment to the end of study at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start2 Nov 2023
- Primary completion30 Jun 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative EmotionsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention with EW on Anne followed the design of Pennebaker and Beall (1986) with adjusted writing tasks based on Tolcher et al. (2024) (See Figure 1). Lasting for 40 days, it included four rounds of writing with a detached vantage point-one month, three months, and six months after the intervention Each of the four rounds consisted of three consecutive days of writing followed by a gap week. On each day, Anne was asked to write continuously for 20-25 minutes about her life experiences that had a significant impact on her, either positively or negatively. After writing on the third day of each round, Ann responded to the BDI-II and answered interview questions about her emotional state and self-cognition. The gap week was intended to facilitate her psychological adjustment and prevent emotional overwhelm and habituation. It is an important component of the healing process, allowing for the deep, unconscious work of integration, meaning-making, and emotional regulation to occur.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siwei Zhu, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188519
- Sponsor's protocol ID
- ECSBMSSDU2023-1-85
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated and analyzed during the current study contain potentially identifiable information about research participants. As explicit consent for public data release was not obtained from participants, the raw data cannot be made publicly available to protect their privacy. Requests for access to de-identified data (where permissible) may be directed to the corresponding author and will be reviewed on a case-by-case basis in accordance with ethical guidelines
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Effects of Expressive Writing on College Students Experiencing Psychological Difficulties
- ClinicalTrials.gov ID
- NCT07188519
- Acronym / sponsor ID
- ECSBMSSDU2023-1-85
- Conditions
- Negative Emotions, Self Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 23 Sep 2025 (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.
This study aims to improve college students' mental health through expressive writing. Over the next eight weeks, I would like you to write about some of the experiences that have had the greatest impact on your life. These may be positive or negative, and may relate to the present, past, or future. As you write, you may describe the event from both positive and negative perspectives. We encourage you to genuinely explore your deepest emotions and thoughts. Whatever you choose to write about, the crucial point is that you truly delve into your innermost feelings and reflections. You may relate your experiences to anyone in your life, including your parents, friends, and relatives. We hope you will endeavour to write about significant experiences you have never discussed in detail with others. During your writing, do not concern yourself with linguistic expression. We wish for you to convey your deepest emotions and thoughts as fully as possible. The content of your writing will not influence our perception of you; it is held in absolute confidence and security. The sole rule for this writing session is that once you begin writing, you must continue until the time concludes (each session is timed for 20-25 minutes). After the writing period ends, you may choose whether to submit your written text.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention with EW on Anne followed the design of Pennebaker and Beall (1986) with adjusted writing tasks based on Tolcher et al. (2024) (See Figure 1). Lasting for 40 days, it included four rounds of writing with a detached vantage point-one month, three months, and six months after the intervention Each of the four rounds consisted of three consecutive days of writing followed by a gap week. On each day, Anne was asked to write continuously for 20-25 minutes about her life experiences that had a significant impact on her, either positively or negatively. After writing on the third day of each round, Ann responded to the BDI-II and answered interview questions about her emotional state and self-cognition. The gap week was intended to facilitate her psychological adjustment and prevent emotional overwhelm and habituation. It is an important component of the healing process, allowing for the deep, unconscious work of integration, meaning-making, and emotional regulation to occur.
| Arm | Type | Receives |
|---|---|---|
| case study | Other | Other: expressive writingThe intervention with EW on participants followed the design of Pennebaker and Beall (1986) with adjusted writing tasks based on Tolcher et al. (2024). Lasting for 40 days, it included four rounds of writing with a detached vantage point-one month, three months, and six months after the intervention Each of the four rounds consisted of three consecutive days of writing followed by a gap week. On each day, they were asked to write continuously for 20-25 minutes about her life experiences that had a significant impact on her, either positively or negatively. After writing on the third day of each round, they responded to the BDI-II and answered interview questions about their emotional state and self-cognition. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A score indicating mild or higher depressive symptoms on the Beck Depression Inventory (BDI);
- Age ranging from 18 to 29 years old;
- Educational background of undergraduate degree or above; -
Key exclusion criteria (3 listed)
- Participants with no depressive symptoms
- Participants with writing difficulties, dysgraphia, or dyslexia
- Participants with severe physical illnesses or without civil capacity -
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 |
|---|---|---|
| expressive writingEach of the four rounds consisted of three consecutive days of writing followed by a gap week. | Other | case study |
Primary outcome
self cognition
Time frame: From enrollment to the end of study at one year.
Additionally, to assess changes at cognitive levels, we separately recorded and compared the items related to self-cognition (7 items) within the BDI-II. The specific determination rules were as follows:the direction of score change at the item level served as the basis for judgement. Within a given assessment interval, we compared the number of items that decreased (indicating improvement) with those that increased (indicating deterioration). If decreases outnumbered increases, we classified the interval as improvement-predominant; otherwise, deterioration predominated. If the two were comparable, the change was recorded as insignificant. Accordingly, we sequentially compared items across the self cognition dimensions in the nine assessments, thereby revealing the immediate and sustained manifestations of expressive writing at both cognitive levels. Besides, the cognitive words and self cognition related sentences in interview were also analysis as the evidences for self cognition.
negative emotion and positive emotion
Time frame: From enrollment to the end of study at one year
we separately recorded and compared the items related to emotional state (5 items) The specific determination rules were as follows: the direction of score change at the item level served as the basis for judgement. Within a given assessment interval, we compared the number of items that decreased (indicating improvement) with those that increased (indicating deterioration). If decreases outnumbered increases, we classified the interval as improvement-predominant; otherwise, deterioration predominated. If the two were comparable, the change was recorded as insignificant. Accordingly, we sequentially compared items across the negtaive emotion and positive emotion dimensions in the nine assessments, thereby revealing the immediate and sustained manifestations of expressive writing at both emotional levels. Besides, the emotional words used in the writing texts and emotional related senteneces in semi-strcutured interview also analysis as the evidences for positive and negtaive emotion.
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 23 Sep 2025.
- Individual participant dataSharing planned: Undecided. The datasets generated and analyzed during the current study contain potentially identifiable information about research participants. As explicit consent for public data release was not obtained from participants, the raw data cannot be made publicly available to protect their privacy. Requests for access to de-identified data (where permissible) may be directed to the corresponding author and will be reviewed on a case-by-case basis in accordance with ethical guidelines
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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 expressive writing in people with Negative Emotions and Self Cognition, run by Shandong University at 1 site in China.
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 3 inclusion and 3 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 23 Sep 2025. 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 China. 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?
self cognition (time frame: From enrollment to the end of study at one year.). 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 23 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.