- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07188519
- Original Trial
A Study of Effects of Expressive Writing on College Students Experiencing Psychological Difficulties
September 22, 2025 updated by: Siwei Zhu, Shandong University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
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Jinan, Shandong, China, 250100
- Shandong University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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; -
Exclusion Criteria:
- Participants with no depressive symptoms
- Participants with writing difficulties, dysgraphia, or dyslexia
- Participants with severe physical illnesses or without civil capacity -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: case study
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.
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Each of the four rounds consisted of three consecutive days of writing followed by a gap week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the end of study at one year.
|
|
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.
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From enrollment to the end of study at one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2023
Primary Completion (Actual)
June 30, 2024
Study Completion (Actual)
August 31, 2024
Study Registration Dates
First Submitted
September 16, 2025
First Submitted That Met QC Criteria
September 22, 2025
First Posted (Estimated)
September 23, 2025
Study Record Updates
Last Update Posted (Estimated)
September 23, 2025
Last Update Submitted That Met QC Criteria
September 22, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- ECSBMSSDU2023-1-85
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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