NCT07188519

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

September 16, 2025

Last Update Submit

September 22, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From enrollment to the end of study at one year

Study Arms (1)

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.

Other: expressive writing

Interventions

Each of the four rounds consisted of three consecutive days of writing followed by a gap week.

case study

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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; -

You may not qualify if:

  • Participants with no depressive symptoms
  • Participants with writing difficulties, dysgraphia, or dyslexia
  • Participants with severe physical illnesses or without civil capacity -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong University

Jinan, Shandong, 250100, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 23, 2025

Study Start

November 2, 2023

Primary Completion

June 30, 2024

Study Completion

August 31, 2024

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations