AI-Assisted Grief-Focused Guided Narrative Writing for Subclinical Prolonged Grief Disorder in Bereaved Chinese Adolescents: A Three-Arm Parallel Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Prolonged Grief Disorder-13-Revision (PG-13-R)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
AI-GF-GNW
干预措施: AI-Assisted Grief-Focused Guided Narrative Writing (Behavioral)
NF-GF-GNW
干预措施: No-Feedback Guided Narrative Writing (Behavioral)
FWG
干预措施: Free Writing (Behavioral)
结局指标
主要结局
Prolonged Grief Disorder-13-Revision (PG-13-R)
时间窗: 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)
时间窗: 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.
次要结局
- 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))
研究者
Yinyin Zang, PhD
Principal Investigator
Peking University