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NCT Number: NCT07589088

AI-GF-GNW on Prolonged Grief Reactions

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.

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Key information

Conditions

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

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Generalized Anxiety Disorder (GAD-7)

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

    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.

  2. WHO Disability Assessment Schedule-short version(WHODAS 2.0)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yinyin Zang, PhD

CONTACT

[email protected]

+86-010-62756953

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

AI-Assisted Grief-Focused Guided Narrative Writing for Subclinical Prolonged Grief Disorder in Bereaved Chinese Adolescents: A Three-Arm Parallel Randomized Controlled Trial.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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