Emotional DisturbanceNCT07105137
AI-assisted GNW on Adolescent Emotional Distress
A study testing AI-GNW, NF-GNW and NWG in people with Emotional Disturbance and Emotional Regulation, run by Peking University at 1 site in China.
Trial summary
This cluster-randomized controlled trial aims to evaluate the efficacy of an AI-assisted Guided Narrative Writing (AI-GNW) in alleviating emotional distress among adolescents. Classes will be randomized in a 1:1:1 ratio to one of three arms-AI-GNW, a no-feedback GNW (NF-GNW), or a Neutral Writing Group (NWG)-and will… Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Disturbance, Emotional Regulation, Insomnia
- What is being tested?
- AI-GNW, NF-GNW and NWG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 486 participants
- Where
- 1 siteChina
- Study dates
- 19 May 2025to 25 Oct 2025
- 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 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Native speakers of Chinese who are proficient in reading and writing Chinese.
- Signed a informed consent form and voluntarily agreed to participate.
- Owns a smartphone, tablet, or similar electronic device and is able to complete the required questionnaires and writing tasks.
Who cannot join
- Prior clinical diagnosis of schizophrenia or any other major psychiatric disorder.
- Presence of severe cognitive impairment, language-expression difficulties, or any other condition that would impede writing ability.
- Participation in another similar psychological intervention or psychotherapy within the past three months.
- Inability to tolerate a group-based intervention setting due to personal health conditions (e.g., serious illness).
- Unwillingness or inability to provide necessary cooperation or to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence-Assisted Expressive Writing Intervention to Improve Adolescent Emotional Distress: A Cluster Randomized Controlled Trial
This cluster-randomized controlled trial aims to evaluate the efficacy of an AI-assisted Guided Narrative Writing (AI-GNW) in alleviating emotional distress among adolescents. Classes will be randomized in a 1:1:1 ratio to one of three arms-AI-GNW, a no-feedback GNW (NF-GNW), or a Neutral Writing Group (NWG)-and will complete a three-day writing intervention. On the first day, participants in both GNW conditions will recount a negative experience and reflect on their thoughts and feelings; on the second day, they will focus exclusively on the negative aspects of that experience; and on the third day, they will explore its positive dimensions. In contrast, NWG participants will objectively document their previous day's daily routine. After each session, those in the AI-GNW arm will receive individualized, AI-generated feedback, whereas NF-GNW participants will proceed without feedback.
Read the detailed description
Adolescent mental health, and in particular emotional distress, has emerged as a global public health challenge. A recent meta-analysis of 80,879 adolescents found that approximately 25.2 percent experienced clinically significant depression and 20.5 percent suffered from anxiety, with these emotional disturbances accounting for an estimated 45 percent of the total disease burden in this age group. In China, the situation is equally alarming: the 2022 Blue Book on National Depression reports that roughly half of all individuals diagnosed with an emotional disorder are school-aged, and as many as 41 percent have interrupted their studies as a result. Beyond inflicting serious harm on adolescents' physical and psychological well-being, persistent emotional distress undermines social engagement and academic performance, and may precipitate more severe psychopathology, such as major depression, anxiety disorders, or even suicidal behaviors, placing a heavy burden on families, communities, and the public health system. Thus, early and effective intervention is of paramount importance for improving youth mental health.
Schools represent a central arena in adolescents' daily lives and an ideal platform for delivering psychological interventions. In response to rising rates of youth emotional problems, the Chinese government has enacted a series of policies to bolster mental health education and intervention in schools. However, the vast size of China's adolescent population and the relative scarcity of professional resources mean that traditional one-to-one intervention models have limited reach when implemented at scale. Many schools lack sufficient numbers of qualified counselors, and non-specialist teachers often do not possess the training needed to deliver sustained, targeted support, resulting in modest and non-durable effects on students' emotional well-being.
Moreover, school-based intervention programs confront several practical challenges. First, the number of licensed school-psychology professionals remains inadequate in many regions, leaving schools unable to provide consistent, high-quality support. Second, a persistent mismatch between intervention demand and available resources makes it difficult to tailor services to individual students' needs, undermining the overall effectiveness of existing programs.
Among the array of psychological interventions, writing-based approaches have gained prominence for their simplicity, low cost, and ease of dissemination in group settings such as classrooms. Writing interventions typically guide participants to articulate their emotions and thoughts in writing for 20-30 minutes per day over 3-5 consecutive days, thereby fostering emotional processing, adaptive expression, and the construction of personal meaning. Meta-analytic evidence confirms that such interventions yield significant improvements in emotional symptoms and related psychophysiological outcomes, including sleep quality. In Chinese adolescent populations, guided narrative writing has been shown to reduce examination anxiety and to ameliorate symptoms of depression and anxiety. Nevertheless, conventional writing interventions often lack mechanisms for timely, individualized feedback, which can dampen participant engagement and undermine the longevity of treatment gains.
Against this backdrop, the integration of artificial intelligence (AI) offers promising new avenues for enhancing psychological interventions. Prior research indicates that interventions incorporating ongoing, process-oriented feedback and interactive dialogue outperform those that provide no feedback. Yet, in large-scale implementations, human-delivered feedback is constrained by finite personnel resources. By leveraging natural-language processing techniques, AI systems can automatically detect emotional and cognitive markers in written text and deliver personalized feedback at scale, thereby addressing a critical gap in current practice. Introducing AI-driven feedback into adolescent writing interventions thus holds considerable promise for improving outcomes in emotional distress.
Building on these insights, the present study will recruit approximately 450 adolescent students and-using classes as clusters-randomly assign them in equal proportions to one of three arms: an AI-feedback Guided Narrative Writing group (AI-GNW), a no-feedback Guided Narrative Writing group (NF-GNW), or a Neutral Writing Group (NWG). We will evaluate the impact of AI-assisted narrative writing on emotional distress, comparing the trajectories of change across these three conditions.
- Conditions
- Emotional Disturbance, Emotional Regulation, Insomnia
- Being tested
- AI-GNW, NF-GNW, NWG
- Keywords
- AI-assisted, Expressive writing, Adolesents, Emotional distress, Insomnia
- Medical subject headings
- Affective Symptoms, Emotional Regulation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-GNWBehavioural
This is a three-day writing intervention. Each session lasts 20 minutes. On the first day, participants in both GNW conditions will recount a negative experience and reflect on their thoughts and feelings; on the second day, they will focus exclusively on the negative aspects of that experience; and on the third day, they will explore its positive dimensions. AI-GNW participants would receive AI-generated feedback.
NF-GNWBehavioural
guided narrative writing without feedbacks
NWGBehavioural
In contrast, NWG participants will objectively document their previous day's daily routine.
| Study group | Role | What they receive |
|---|---|---|
| AI-GNW | Experimental | Not described Receives: Behavioral: AI-GNW |
| NF-GNW | Active comparator | Not described Receives: Behavioral: NF-GNW |
| NWG | Sham comparator | Not described Receives: Behavioral: NWG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Child Anxiety and Depression Scale (RCADS)
RCADS is a 25-item scale that includes 15 items for general anxiety and 10 for depression, rated on a 4-point Likert scale (0 = never, 3 = always). Higher scores mean more severe emotional distress
Measured: Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34), and 3 (day 64) months after the intervention.
Secondary outcomes (3)
Non-Suicidal Self-Injury Assessment Tool (NSSI-AT)
Only the severity dimension was measured in this trial.
Measured: Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34), and 3 (day 64) months after the intervention.
Suicidal Behaviors Questionnaire-Revised (SBQ-R)
Measured: Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34), and 3 (day 64) months after the intervention.
Chinese PTSD Symptom Scale (CPSS)
Measured: Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34), and 3 (day 64) months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start19 May 2025
- Primary completion25 Oct 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisturbanceStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinyin Zang, PhD, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105137
- Sponsor's protocol ID
- AI-assisted GNW
- Status last verified
- Jun 2026
- First submitted
- 16 May 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participants' privacy, authors wishing to access the data should contact the corresponding author and provide a statistical analysis plan addressing a new research question. The study trial management group will discuss all requests.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Assisted Expressive Writing Intervention to Improve Adolescent Emotional Distress: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07105137
- Acronym / sponsor ID
- AI-assisted GNW
- Conditions
- Emotional Disturbance, Emotional Regulation, Insomnia
- Keywords
- AI-assisted, Expressive writing, Adolesents, Emotional distress, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 25 Oct 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 5 Aug 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 cluster-randomized controlled trial aims to evaluate the efficacy of an AI-assisted Guided Narrative Writing (AI-GNW) in alleviating emotional distress among adolescents. Classes will be randomized in a 1:1:1 ratio to one of three arms-AI-GNW, a no-feedback GNW (NF-GNW), or a Neutral Writing Group (NWG)-and will complete a three-day writing intervention. On the first day, participants in both GNW conditions will recount a negative experience and reflect on their thoughts and feelings; on the second day, they will focus exclusively on the negative aspects of that experience; and on the third day, they will explore its positive dimensions. In contrast, NWG participants will objectively document their previous day's daily routine. After each session, those in the AI-GNW arm will receive individualized, AI-generated feedback, whereas NF-GNW participants will proceed without feedback.
Detailed description
Adolescent mental health, and in particular emotional distress, has emerged as a global public health challenge. A recent meta-analysis of 80,879 adolescents found that approximately 25.2 percent experienced clinically significant depression and 20.5 percent suffered from anxiety, with these emotional disturbances accounting for an estimated 45 percent of the total disease burden in this age group. In China, the situation is equally alarming: the 2022 Blue Book on National Depression reports that roughly half of all individuals diagnosed with an emotional disorder are school-aged, and as many as 41 percent have interrupted their studies as a result. Beyond inflicting serious harm on adolescents' physical and psychological well-being, persistent emotional distress undermines social engagement and academic performance, and may precipitate more severe psychopathology, such as major depression, anxiety disorders, or even suicidal behaviors, placing a heavy burden on families, communities, and the public health system. Thus, early and effective intervention is of paramount importance for improving youth mental health.
Schools represent a central arena in adolescents' daily lives and an ideal platform for delivering psychological interventions. In response to rising rates of youth emotional problems, the Chinese government has enacted a series of policies to bolster mental health education and intervention in schools. However, the vast size of China's adolescent population and the relative scarcity of professional resources mean that traditional one-to-one intervention models have limited reach when implemented at scale. Many schools lack sufficient numbers of qualified counselors, and non-specialist teachers often do not possess the training needed to deliver sustained, targeted support, resulting in modest and non-durable effects on students' emotional well-being.
Moreover, school-based intervention programs confront several practical challenges. First, the number of licensed school-psychology professionals remains inadequate in many regions, leaving schools unable to provide consistent, high-quality support. Second, a persistent mismatch between intervention demand and available resources makes it difficult to tailor services to individual students' needs, undermining the overall effectiveness of existing programs.
Among the array of psychological interventions, writing-based approaches have gained prominence for their simplicity, low cost, and ease of dissemination in group settings such as classrooms. Writing interventions typically guide participants to articulate their emotions and thoughts in writing for 20-30 minutes per day over 3-5 consecutive days, thereby fostering emotional processing, adaptive expression, and the construction of personal meaning. Meta-analytic evidence confirms that such interventions yield significant improvements in emotional symptoms and related psychophysiological outcomes, including sleep quality. In Chinese adolescent populations, guided narrative writing has been shown to reduce examination anxiety and to ameliorate symptoms of depression and anxiety. Nevertheless, conventional writing interventions often lack mechanisms for timely, individualized feedback, which can dampen participant engagement and undermine the longevity of treatment gains.
Against this backdrop, the integration of artificial intelligence (AI) offers promising new avenues for enhancing psychological interventions. Prior research indicates that interventions incorporating ongoing, process-oriented feedback and interactive dialogue outperform those that provide no feedback. Yet, in large-scale implementations, human-delivered feedback is constrained by finite personnel resources. By leveraging natural-language processing techniques, AI systems can automatically detect emotional and cognitive markers in written text and deliver personalized feedback at scale, thereby addressing a critical gap in current practice. Introducing AI-driven feedback into adolescent writing interventions thus holds considerable promise for improving outcomes in emotional distress.
Building on these insights, the present study will recruit approximately 450 adolescent students and-using classes as clusters-randomly assign them in equal proportions to one of three arms: an AI-feedback Guided Narrative Writing group (AI-GNW), a no-feedback Guided Narrative Writing group (NF-GNW), or a Neutral Writing Group (NWG). We will evaluate the impact of AI-assisted narrative writing on emotional distress, comparing the trajectories of change across these three conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AI-GNW | Experimental | Behavioral: AI-GNW |
| NF-GNW | Active comparator | Behavioral: NF-GNW |
| NWG | Sham comparator | Behavioral: NWG |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Native speakers of Chinese who are proficient in reading and writing Chinese.
- Signed a informed consent form and voluntarily agreed to participate.
- Owns a smartphone, tablet, or similar electronic device and is able to complete the required questionnaires and writing tasks.
Key exclusion criteria (5 listed)
- Prior clinical diagnosis of schizophrenia or any other major psychiatric disorder.
- Presence of severe cognitive impairment, language-expression difficulties, or any other condition that would impede writing ability.
- Participation in another similar psychological intervention or psychotherapy within the past three months.
- Inability to tolerate a group-based intervention setting due to personal health conditions (e.g., serious illness).
- Unwillingness or inability to provide necessary cooperation or to sign the informed consent form.
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 |
|---|---|---|
| AI-GNWThis is a three-day writing intervention. Each session lasts 20 minutes. On the first day, participants in both GNW conditions will recount a negative experience and reflect on their thoughts and feelings; on the second day, they will focus exclusively on the negative aspects of that experience; and on the third day, they will explore its positive dimensions. AI-GNW participants would receive AI-generated feedback. | Behavioural | AI-GNW |
| NF-GNWguided narrative writing without feedbacks | Behavioural | NF-GNW |
| NWGIn contrast, NWG participants will objectively document their previous day's daily routine. | Behavioural | NWG |
Primary outcome
Revised Child Anxiety and Depression Scale (RCADS)
Time frame: Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34), and 3 (day 64) months after the intervention.
RCADS is a 25-item scale that includes 15 items for general anxiety and 10 for depression, rated on a 4-point Likert scale (0 = never, 3 = always). Higher scores mean more severe emotional distress
3 secondary outcomes
Non-Suicidal Self-Injury Assessment Tool (NSSI-AT)
Time frame: Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34), and 3 (day 64) months after the intervention.
Suicidal Behaviors Questionnaire-Revised (SBQ-R)
Time frame: Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34), and 3 (day 64) months after the intervention.
Chinese PTSD Symptom Scale (CPSS)
Time frame: Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34), and 3 (day 64) months after the intervention.
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 10 Jun 2026.
- Individual participant dataSharing planned: No. To protect participants' privacy, authors wishing to access the data should contact the corresponding author and provide a statistical analysis plan addressing a new research question. The study trial management group will discuss all requests.
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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 AI-GNW, NF-GNW and NWG in people with Emotional Disturbance and Emotional Regulation, run by Peking 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 5 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 10 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
Revised Child Anxiety and Depression Scale (RCADS) (time frame: Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34), and 3 (day 64) months after the intervention.). 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 10 Jun 2026.