- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07479823
A Text-Based Expressive Writing Program for Adolescents at Risk of Suicide (WRITE-SAFE)
Effectiveness of a Text-Based Expressive Writing Intervention for Suicidal Adolescents and Young Adults: A Randomized Controlled Trial
The goal of this clinical trial is to learn if a structured expressive writing program can help reduce suicidal thoughts in adolescents and young adults who have experienced suicidal thoughts, suicide attempts, or self-harm. The study will include participants aged 13 to 24 years who are receiving mental health care or have recently been identified as being at risk for suicide.
The main questions the study aims to answer are:
- Does a structured expressive writing program lower suicidal thoughts compared with usual care alone?
- Does the program improve depression, impulsivity, and self-esteem?
Researchers will compare participants who receive the expressive writing program together with treatment as usual to participants who receive treatment as usual alone.
Participants will:
- Be randomly assigned to one of two groups: a writing program group or a usual care group
- Complete questionnaires about mood, suicidal thoughts, and well-being at the start of the study, after 4 weeks, and after 8 weeks
- If assigned to the writing program group, complete guided writing activities several times per week for 4 weeks. Each writing session will take about 15 to 20 minutes and will focus on understanding emotions, personal experiences, relationships, and meaning in difficult experiences.
Researchers will study whether this writing program is a helpful and practical way to support young people who are experiencing suicidal thoughts or emotional distress.
Study Overview
Status
Intervention / Treatment
Detailed Description
Suicide represents a major public health concern among adolescents and young adults. In South Korea, suicide has consistently ranked as the leading cause of death among individuals aged 10-29 years. Preventive interventions targeting suicidal ideation and early stages of suicide risk are therefore urgently needed.
Existing evidence-based interventions for suicidal behaviors, including dialectical behavior therapy (DBT) and cognitive behavioral therapy (CBT), have demonstrated clinical effectiveness but require intensive therapist involvement and specialized training. These characteristics limit their scalability and accessibility in many community and school-based settings.
Expressive writing is a brief psychological intervention originally developed by Pennebaker and colleagues, in which individuals write about emotionally significant experiences. The intervention is believed to promote emotional labeling, cognitive processing, and narrative integration of stressful experiences. Neuropsychological research suggests that labeling emotions may reduce amygdala activation and facilitate regulation through prefrontal cortical mechanisms. Meta-analytic studies have also reported improvements in psychological outcomes among adolescents who engage in expressive writing.
However, randomized controlled trials evaluating expressive writing interventions specifically for adolescents and young adults at risk of suicide remain limited. In addition, most existing interventions are unstructured, which may limit their suitability for high-risk populations.
The present study aims to develop and evaluate a structured text-based expressive writing program designed for adolescents and young adults with suicide risk. The intervention is designed to promote emotional awareness, self-understanding, relational awareness, and meaning reconstruction through guided writing prompts delivered over four weeks.
Participants aged 13-24 years with a history of suicidal ideation, suicide attempts, or non-suicidal self-injury will be recruited from clinical and community settings. After screening and baseline assessment, participants will be randomly assigned to one of two groups:
- Experimental group: 4-week structured expressive writing intervention plus treatment as usual (TAU)
- Control group: TAU alone
Participants in the intervention group will complete guided writing exercises multiple times per week. Each writing session will take approximately 15-20 minutes and will be supported by structured prompts designed to facilitate emotional expression and cognitive processing.
Primary and secondary outcomes will be assessed at baseline, 4 weeks (post-intervention), and 8 weeks (follow-up). The primary outcome is change in suicidal ideation measured using the Beck Scale for Suicide Ideation (BSSI). Secondary outcomes include depressive symptoms, impulsivity, self-esteem, and help-seeking behavior.
The study is designed as a randomized controlled trial with parallel assignment. A total of 160 participants will be enrolled. The findings of this study may contribute to the development of accessible and scalable suicide prevention interventions for adolescents and young adults.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hyun Ju Hong, MD, PhD
- Phone Number: 82+031-380-1500
- Email: honghj88@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents or young adults aged 13 to 24 years.
- Individuals with a history of suicidal ideation, suicide attempts, or non-suicidal self-injury.
- Individuals currently receiving mental health services or who have been evaluated as having suicide risk within the past 6 months.
- Ability to read and write in Korean.
- For participants under 19 years of age, both participant assent and parental consent are required.
Exclusion Criteria:
- Individuals requiring immediate psychiatric hospitalization.
- Severe intellectual disability or neurodevelopmental disorder that prevents participation in writing activities.
- Acute psychosis or manic episode that would interfere with participation in the study.
- Participation in another suicide prevention clinical trial during the study period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Expressive Writing Intervention plus Treatment as Usual
Participants in this group receive a structured expressive writing intervention in addition to treatment as usual.
|
A structured expressive writing program in which participants complete guided writing sessions several times per week for four weeks.
Each session lasts approximately 15 to 20 minutes and focuses on emotional awareness and personal reflection.
|
|
Active Comparator: Treatment as Usual
Participants receive treatment as usual, which may include standard mental health care or counseling services.
|
Participants receive the standard mental health care or support services that are normally available during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Suicidal Ideation
Time Frame: Baseline, 4 weeks, and 8 weeks
|
Suicidal ideation will be measured using the Beck Scale for Suicide Ideation (BSSI).
The outcome measure is the change in BSSI score between baseline and follow-up assessments.
|
Baseline, 4 weeks, and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Depressive Symptoms
Time Frame: Baseline, 4 weeks, and 8 weeks
|
Depressive symptoms will be measured using the Beck Depression Inventory (BDI).
The outcome measure is the change in BDI score between baseline and follow-up assessments.
|
Baseline, 4 weeks, and 8 weeks
|
|
Change in Impulsivity
Time Frame: Baseline, 4 weeks, and 8 weeks
|
Impulsivity will be measured using the Barratt Impulsiveness Scale (BIS-11).
The outcome measure is the change in BIS-11 score between baseline and follow-up assessments.
|
Baseline, 4 weeks, and 8 weeks
|
|
Change in Self-Esteem
Time Frame: Baseline, 4 weeks, and 8 weeks
|
Self-esteem will be measured using the Rosenberg Self-Esteem Scale.
The outcome measure is the change in self-esteem score between baseline and follow-up assessments.
|
Baseline, 4 weeks, and 8 weeks
|
|
Change in Alexithymia
Time Frame: Baseline, 4 weeks, and 8 weeks
|
Alexithymia will be assessed using the Toronto Alexithymia Scale (TAS-20).
The outcome measure is the change in TAS-20 score between baseline and follow-up assessments.
|
Baseline, 4 weeks, and 8 weeks
|
|
Program Acceptability
Time Frame: 4 weeks
|
Acceptability of the intervention will be assessed using the Acceptability of Intervention Measure (AIM).
The measure evaluates participants' perceived acceptability and satisfaction with the intervention.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSHH-2026-EW-RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Suicidal Ideation
-
Northwestern UniversityNot yet recruitingSuicidal Ideation and Behavior
-
University GhentRecruitingSuicide | Suicidal Ideation and Behavior | Crisis InterventionBelgium
-
Shira BarzilaySchneider Children's Medical Center, IsraelRecruiting
-
University of WashingtonUnited States Department of Defense; Military Suicide Research ConsortiumCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation ActiveUnited States
-
The Catholic University of AmericaUniversity of Washington; VA Office of Research and DevelopmentCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation Active
-
Emory UniversityGeorgia Institute of TechnologyCompletedSuicide, Suicidal IdeationUnited States
-
Columbia UniversityNational Institute of Mental Health (NIMH)RecruitingSuicidal Ideation and BehaviorUnited States
-
Bradley HospitalNational Institute of Mental Health (NIMH); Instituto Nacional de Psiquiatría...Not yet recruitingSuicidal Ideation/BehaviorMexico
-
Oriana Arellano FaúndezActive, not recruitingSuicidal Ideation | Suicidal Ideation and BehaviorsChile
-
VA Office of Research and DevelopmentJames J. Peters Veterans Affairs Medical Center; VISN 2 Mental Illness Research... and other collaboratorsRecruitingHealth | Reintegration Difficulties | Suicidal Ideation and Behaviors | ConnectednessUnited States
Clinical Trials on Structured Expressive Writing Intervention
-
Kinnaird College for WomenNot yet recruitingPsychological DistressPakistan
-
University of WaterlooCompletedThe Effects of Expressive Writing and Compassionate Letter Writing on Emotional Distress IntoleranceDistress IntoleranceCanada
-
Centre for Addiction and Mental HealthCompletedMajor Depression | Generalized Anxiety Disorder (GAD)Canada
-
Arizona State UniversityCancer Support Community ArizonaCompletedQuality of Life | Distress, EmotionalUnited States
-
University of Roma La SapienzaCompleted
-
Massachusetts Institute of TechnologyNorthwestern University; Columbia University; University of FloridaCompleted
-
Royal Cornwall Hospitals TrustUniversity of PlymouthRecruiting
-
Trustees of Princeton UniversityCompleted
-
New York UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Recruiting
-
University of Texas at AustinUnknownPost Traumatic Stress DisorderUnited States