Artificial Intelligence (AI)NCT07589088
AI-GF-GNW on Prolonged Grief Reactions
A study testing AI-Assisted Grief-Focused Guided Narrative Writing, No-Feedback Guided Narrative Writing and Free Writing in people with Artificial Intelligence (AI) and Prolonged Grief Symptoms, run by Peking University at 1 site in China.
Trial summary
Prolonged Grief Disorder (PGD) is a severe, disabling condition characterized by intense yearning and difficulty accepting the reality of loss, which significantly impairs the academic and psychosocial functioning of bereaved adolescents. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Artificial Intelligence (AI), Prolonged Grief Symptoms, Depression - Major Depressive Disorder
- What is being tested?
- AI-Assisted Grief-Focused Guided Narrative Writing, No-Feedback Guided Narrative Writing and Free Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Junior and senior high school students currently studying in Chinese Mainland, aged 10-19;
- Between 6 and 60 months prior to the experimental period, experienced the death of a significant family member or close friend or close friend;
- The total symptom score of PG-13-R is between 20-29 points;
- Ability to write and understand written guidelines, to use the mobile phone to interact with AI;
- Consent to participate in the study.
Who cannot join
- Diagnosed or previously diagnosed with mental illness
- The bereavement time does not meet the time window
- PG-13-R score is not within the range
- At present, there is suicidal ideation or recent severe self harm behavior (Reynolds' Suicidal Ideation Questionnaire, SIQ-JR-4>0), and a crisis intervention hotline is provided when necessary.
- Has received other grief counseling or is currently taking psychiatric medication within the past month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: AI-Assisted Grief-Focused Guided Narrative Writing for Subclinical Prolonged Grief Disorder in Bereaved Chinese Adolescents: A Three-Arm Parallel Randomized Controlled Trial.
Prolonged Grief Disorder (PGD) is a severe, disabling condition characterized by intense yearning and difficulty accepting the reality of loss, which significantly impairs the academic and psychosocial functioning of bereaved adolescents. While Grief-Focused Cognitive Behavioral Therapy (GF-CBT) is effective, its high cost and resource-intensive nature limit its accessibility for adolescents in mainland China. Grief-Focused Guided Narrative Writing (GF-GNW) offers a scalable, low-cost alternative that facilitates memory integration.
Furthermore, integrating Artificial Intelligence (AI) to provide personalized, structured feedback has the potential to simulate therapist functions and enhance intervention efficacy. However, the specific efficacy of AI-assisted feedback in this context remains empirically unvalidated.
This parallel randomized controlled trial aims to examine the effectiveness of AI-assisted GF-GNW (AI-GF-GNW) in treating Chinese adolescents (aged 10-19) with subclinical PGD, compared to a no-feedback NF-GF-GNW group and a free writing group. Primary outcomes include PGD symptom severity, while secondary outcomes assess depression, anxiety, and daily functioning. We hypothesize that both active intervention arms will significantly alleviate PGD and related symptoms compared to the free writing group, and that the AI-GF-GNW group will demonstrate a significantly greater reduction in symptoms and functional impairment than the NF-GF-GNW group.
- Conditions
- Artificial Intelligence (AI), Prolonged Grief Symptoms, Depression - Major Depressive Disorder, Anxiety, Disabilities
- Being tested
- AI-Assisted Grief-Focused Guided Narrative Writing, No-Feedback Guided Narrative Writing, Free Writing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assisted Grief-Focused Guided Narrative WritingBehavioural
Participants will independently complete the intervention writing tasks via the H5 platform. Participants were required to complete a 6-day, 3-session narrative writing task. Each session requires more than 20 minutes of uninterrupted writing. Session 1 requires describing the specific details and feelings of the bereavement event; Session 2 requires describing the negative impact of the event and one's own negative feelings; Session 3 requires a description of the positive impact of the event and one's own positive feelings, with a one-day interval between each session, synchronized with the NF-GF-GNW group. When participants complete and submit their writing, they will immediately receive a response generated by the AI large language model. Participants are not allowed to engage in any additional interaction with the AI large language model other than submitting writing content and receiving feedback.
No-Feedback Guided Narrative WritingBehavioural
All processes are the same as the AI-GF-GNW group, except that when participants complete their writing and submit, the platform will only display a "submission successful" prompt and will not provide any feedback on the writing content.
Free WritingBehavioural
Participants in the FWG will not receive structured guidance, and are only required to write freely about their loss experiences. The writing sessions will follow the same schedule and duration as the other groups.
| Study group | Role | What they receive |
|---|---|---|
| AI-GF-GNW | Experimental | Not described Receives: Behavioral: AI-Assisted Grief-Focused Guided Narrative Writing |
| NF-GF-GNW | Experimental | Not described Receives: Behavioral: No-Feedback Guided Narrative Writing |
| FWG | Active comparator | Not described Receives: Behavioral: Free Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Grief Disorder-13-Revision (PG-13-R)
PG-13-R is a standardized diagnostic tool designed to assess the severity of prolonged grief disorder symptoms over the past month. The instrument consists of 10 questions scored on a 5-point Likert scale, alongside 2 true/false questions and 1 open-ended question assessing functional impairment and duration.Who gets 30 points or higher will be considered as clinical prolonged grief reactions.
Measured: Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)
Patient Health Questionnaire (PHQ-9)
PHQ-9 is a brief, validated screening tool used to measure the severity of depression symptoms in adolescents over the past two weeks. 9 questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Measured: Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)
Secondary outcomes (2)
Generalized Anxiety Disorder (GAD-7)
GAD-7 is an easy-to-perform initial screening tool for generalized anxiety disorder. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Measured: Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)
WHO Disability Assessment Schedule-short version(WHODAS 2.0)
WHODAS 2.0 is a comprehensive instrument developed by the World Health Organization to measure health status and functional disability across six core domains over the past 30 days. 12 questions are scored on a Likert scale of 1-5 with 1 being no difficulty and 5 being extreme difficulty.
Measured: Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start25 May 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial Intelligence (AI)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (estimated)
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
- NCT07589088
- Sponsor's protocol ID
- AI-assisted Grief-Focused GNW
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Assisted Grief-Focused Guided Narrative Writing for Subclinical Prolonged Grief Disorder in Bereaved Chinese Adolescents: A Three-Arm Parallel Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07589088
- Acronym / sponsor ID
- AI-assisted Grief-Focused GNW
- Conditions
- Artificial Intelligence (AI), Prolonged Grief Symptoms, Depression - Major Depressive Disorder, Anxiety, Disabilities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 25 May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 May 2026 (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.
Prolonged Grief Disorder (PGD) is a severe, disabling condition characterized by intense yearning and difficulty accepting the reality of loss, which significantly impairs the academic and psychosocial functioning of bereaved adolescents. While Grief-Focused Cognitive Behavioral Therapy (GF-CBT) is effective, its high cost and resource-intensive nature limit its accessibility for adolescents in mainland China. Grief-Focused Guided Narrative Writing (GF-GNW) offers a scalable, low-cost alternative that facilitates memory integration.
Furthermore, integrating Artificial Intelligence (AI) to provide personalized, structured feedback has the potential to simulate therapist functions and enhance intervention efficacy. However, the specific efficacy of AI-assisted feedback in this context remains empirically unvalidated.
This parallel randomized controlled trial aims to examine the effectiveness of AI-assisted GF-GNW (AI-GF-GNW) in treating Chinese adolescents (aged 10-19) with subclinical PGD, compared to a no-feedback NF-GF-GNW group and a free writing group. Primary outcomes include PGD symptom severity, while secondary outcomes assess depression, anxiety, and daily functioning. We hypothesize that both active intervention arms will significantly alleviate PGD and related symptoms compared to the free writing group, and that the AI-GF-GNW group will demonstrate a significantly greater reduction in symptoms and functional impairment than the NF-GF-GNW group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AI-GF-GNW | Experimental | Behavioral: AI-Assisted Grief-Focused Guided Narrative Writing |
| NF-GF-GNW | Experimental | Behavioral: No-Feedback Guided Narrative Writing |
| FWG | Active comparator | Behavioral: Free Writing |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Junior and senior high school students currently studying in Chinese Mainland, aged 10-19;
- Between 6 and 60 months prior to the experimental period, experienced the death of a significant family member or close friend or close friend;
- The total symptom score of PG-13-R is between 20-29 points;
- Ability to write and understand written guidelines, to use the mobile phone to interact with AI;
- Consent to participate in the study.
Key exclusion criteria (5 listed)
- Diagnosed or previously diagnosed with mental illness
- The bereavement time does not meet the time window
- PG-13-R score is not within the range
- At present, there is suicidal ideation or recent severe self harm behavior (Reynolds' Suicidal Ideation Questionnaire, SIQ-JR-4>0), and a crisis intervention hotline is provided when necessary.
- Has received other grief counseling or is currently taking psychiatric medication within the past month
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-Assisted Grief-Focused Guided Narrative WritingParticipants will independently complete the intervention writing tasks via the H5 platform. Participants were required to complete a 6-day, 3-session narrative writing task. Each session requires more than 20 minutes of uninterrupted writing. Session 1 requires describing the specific details and feelings of the bereavement event; Session 2 requires describing the negative impact of the event and one's own negative feelings; Session 3 requires a description of the positive impact of the event and one's own positive feelings, with a one-day interval between each session, synchronized with the NF-GF-GNW group. When participants complete and submit their writing, they will immediately receive a response generated by the AI large language model. Participants are not allowed to engage in any additional interaction with the AI large language model other than submitting writing content and receiving feedback. | Behavioural | AI-GF-GNW |
| No-Feedback Guided Narrative WritingAll processes are the same as the AI-GF-GNW group, except that when participants complete their writing and submit, the platform will only display a "submission successful" prompt and will not provide any feedback on the writing content. | Behavioural | NF-GF-GNW |
| Free WritingParticipants in the FWG will not receive structured guidance, and are only required to write freely about their loss experiences. The writing sessions will follow the same schedule and duration as the other groups. | Behavioural | FWG |
Primary outcome
Prolonged Grief Disorder-13-Revision (PG-13-R)
Time frame: Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)
PG-13-R is a standardized diagnostic tool designed to assess the severity of prolonged grief disorder symptoms over the past month. The instrument consists of 10 questions scored on a 5-point Likert scale, alongside 2 true/false questions and 1 open-ended question assessing functional impairment and duration.Who gets 30 points or higher will be considered as clinical prolonged grief reactions.
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)
PHQ-9 is a brief, validated screening tool used to measure the severity of depression symptoms in adolescents over the past two weeks. 9 questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
2 secondary outcomes
Generalized Anxiety Disorder (GAD-7)
Time frame: Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)
WHO Disability Assessment Schedule-short version(WHODAS 2.0)
Time frame: Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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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.
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-Assisted Grief-Focused Guided Narrative Writing, No-Feedback Guided Narrative Writing and Free Writing in people with Artificial Intelligence (AI) and Prolonged Grief Symptoms, 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 5 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: opening soon, as of the sponsor's last update on 15 May 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yinyin Zang, PhD (+86-010-62756953, yinyin.zang@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged Grief Disorder-13-Revision (PG-13-R) (time frame: Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)). The study lists 2 primary outcomes in all. 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 15 May 2026; AzTrials last refreshed its copy on 4 Nov 2026.