AI-assisted GNW on Adolescent Emotional Distress

NCT07105137 | Active Not Recruiting

• 1 other identifier: AI-assisted GNW
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

This cluster-randomized controlled trial aims to evaluate the efficacy of an AI-assisted Guided Narrative Writing (AI-GNW) in alleviating emotional distress among adolescents. Classes will be randomized in a 1:1:1 ratio to one of three arms-AI-GNW, a no-feedback GNW (NF-GNW), or a Neutral Writing Group (NWG)-and will complete a three-day writing intervention. On the first day, participants in both GNW conditions will recount a negative experience and reflect on their thoughts and feelings; on the second day, they will focus exclusively on the negative aspects of that experience; and on the third day, they will explore its positive dimensions. In contrast, NWG participants will objectively document their previous day's daily routine. After each session, those in the AI-GNW arm will receive individualized, AI-generated feedback, whereas NF-GNW participants will proceed without feedback.

Conditions

Emotional Disturbance; Emotional Regulation; Insomnia

Keywords

AI-assisted; Expressive writing; Adolesents; Emotional distress; Insomnia

Outcome Measures

Primary Outcomes (2)

• Revised Child Anxiety and Depression Scale (RCADS)

  RCADS is a 25-item scale that includes 15 items for general anxiety and 10 for depression, rated on a 4-point Likert scale (0 = never, 3 = always). Higher scores mean more severe emotional distress

  Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34),3 (day 64), and 6 (day 94) months after the intervention.

• Insomnia Severity Index (ISI)

  ISI is a 7-item, 5-point (0-4) Likert scale. Higher scores mean higher insomnia severity.

  Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34),3 (day 64), and 6 (day 94) months after the intervention.

Secondary Outcomes (3)

• Non-Suicidal Self-Injury Assessment Tool (NSSI-AT)

  Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34),3 (day 64), and 6 (day 94) months after the intervention.

• Suicidal Behaviors Questionnaire-Revised (SBQ-R)

  Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34),3 (day 64), and 6 (day 94) months after the intervention.

• Chinese PTSD Symptom Scale (CPSS)

  Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34),3 (day 64), and 6 (day 94) months after the intervention.

Other Outcomes (6)

• Adverse Childhood Experience Questionnaire (ACE)

  Baseline (day 0)

• Beijing Irritability Scale (BIS)

  Baseline (day 0), post-intervention (day 4), and follow-ups at 1 (day 34),3 (day 64), and 6 (day 94) months after the intervention.

• Positive Childhood Experience Questionnaire (PCE)

  Baseline (day 0)

Study Arms (3)

AI-GNW

EXPERIMENTAL

Behavioral: AI-GNW

NF-GNW

ACTIVE COMPARATOR

Behavioral: NF-GNW

NWG

SHAM COMPARATOR

Behavioral: NWG

Interventions

AI-GNW BEHAVIORAL

This is a three-day writing intervention. Each session lasts 20 minutes. On the first day, participants in both GNW conditions will recount a negative experience and reflect on their thoughts and feelings; on the second day, they will focus exclusively on the negative aspects of that experience; and on the third day, they will explore its positive dimensions. AI-GNW participants would receive AI-generated feedback.

AI-GNW

NF-GNW BEHAVIORAL

guided narrative writing without feedbacks

NF-GNW

NWG BEHAVIORAL

In contrast, NWG participants will objectively document their previous day's daily routine.

NWG

Eligibility Criteria

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

You may qualify if:

• Native speakers of Chinese who are proficient in reading and writing Chinese.
• Signed a informed consent form and voluntarily agreed to participate.
• Owns a smartphone, tablet, or similar electronic device and is able to complete the required questionnaires and writing tasks.

You may not qualify if:

• Prior clinical diagnosis of schizophrenia or any other major psychiatric disorder.
• Presence of severe cognitive impairment, language-expression difficulties, or any other condition that would impede writing ability.
• Participation in another similar psychological intervention or psychotherapy within the past three months.
• Inability to tolerate a group-based intervention setting due to personal health conditions (e.g., serious illness).
• Unwillingness or inability to provide necessary cooperation or to sign the informed consent form.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Haidian, Beijing Municipality, 100871, China

Location

MeSH Terms

Conditions

Affective Symptoms; Emotional Regulation; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Control; Social Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To maintain rigorous protection against bias, allocation to the AI-GNW, NF-GNW, or NWG arms was concealed from participants, interventionists, and those responsible for outcome evaluation. Participants were informed only that they would engage in a writing exercise and were unaware of the nature or content of the feedback provided in the AI-GNW arm. Investigators who facilitated the sessions did not have access to the randomization schedule or to any identifying information about group assignment. Outcomes assessors remained blind to each participant's study arm. This triple-masking procedure ensured that neither expectations nor assessment procedures could differentially influence intervention delivery or measurement of study endpoints.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: August 5, 2025
• Study Start: May 19, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)