AI-GF-GNW on Prolonged Grief Reactions

NCT07589088 | Not Yet Recruiting

• 1 other identifier: AI-assisted Grief-Focused GNW
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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. 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

Prolonged Grief Symptoms; Depression - Major Depressive Disorder; Artificial Intelligence (AI); Anxiety; Disabilities

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)

Secondary Outcomes (2)

• Generalized Anxiety Disorder (GAD-7)

  Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)

• WHO Disability Assessment Schedule-short version(WHODAS 2.0)

  Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)

Study Arms (3)

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

Interventions

AI-Assisted Grief-Focused Guided Narrative Writing BEHAVIORAL

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.

AI-GF-GNW

No-Feedback Guided Narrative Writing BEHAVIORAL

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.

NF-GF-GNW

Free Writing BEHAVIORAL

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.

FWG

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Yinyin Zang, PhD

CONTACT

+86-010-62756953; yinyin.zang@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 15, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)