AI-GF-GNW on Prolonged Grief Reactions
9. Mai 2026 aktualisiert von: Yinyin Zang, PhD, Peking University
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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
126
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Yinyin Zang, PhD
- Telefonnummer: +86-010-62756953
- E-Mail: yinyin.zang@pku.edu.cn
Studienorte
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China
- Peking University
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: AI-GF-GNW
|
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.
|
|
Experimental: NF-GF-GNW
|
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.
|
|
Aktiver Komparator: FWG
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Prolonged Grief Disorder-13-Revision (PG-13-R)
Zeitfenster: 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.
|
Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)
|
|
Patient Health Questionnaire (PHQ-9)
Zeitfenster: 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.
|
Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Generalized Anxiety Disorder (GAD-7)
Zeitfenster: 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.
|
Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)
|
|
WHO Disability Assessment Schedule-short version(WHODAS 2.0)
Zeitfenster: 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.
|
Baseline (0 Day), post-treatment assessment (5 Day), follow-up assessment (35 Day)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
25. Mai 2026
Primärer Abschluss (Geschätzt)
1. Mai 2027
Studienabschluss (Geschätzt)
1. Mai 2027
Studienanmeldedaten
Zuerst eingereicht
9. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Mai 2026
Zuerst gepostet (Tatsächlich)
15. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- AI-assisted Grief-Focused GNW
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .