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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • Shandong
      • Jinan, Shandong, China, 250100
        • Shandong University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. A score indicating mild or higher depressive symptoms on the Beck Depression Inventory (BDI);
  2. Age ranging from 18 to 29 years old;
  3. Educational background of undergraduate degree or above; -

Exclusion Criteria:

  1. Participants with no depressive symptoms
  2. Participants with writing difficulties, dysgraphia, or dyslexia
  3. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: expressive writing
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
From enrollment to the end of study at one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings