NCT07380685

Brief Summary

Clinical nurses are frequently exposed to high emotional demands due to heavy workloads, time pressure, patient suffering, and the interpersonal complexity of clinical care. These stressors may contribute to compassion fatigue, burnout, reduced resilience, and decreased occupational well-being. However, timely and accessible psychological support is often limited in busy clinical environments, and many nurses may hesitate to seek help due to stigma, time constraints, or limited resources. This study is a prospective, randomized, controlled, parallel-group interventional trial designed to evaluate the feasibility and effectiveness of an on-demand, human-centered emotional support intervention delivered through a LINE-based GPT assistant. The AI assistant provides real-time supportive conversations, reflective prompts, stress-coping guidance, and resilience-enhancing strategies tailored specifically for clinical nurses, offering a private and easily accessible support resource. Eligible clinical nurses (target sample size: 100-120) are randomly assigned to either an Intervention Group, which interacts with the AI assistant, or a Control Group, which receives non-interactive static messages, over a four-week intervention period. Primary outcomes include changes in compassion fatigue, burnout, and compassion satisfaction, as measured by the Professional Quality of Life Scale (ProQOL). Secondary outcomes include changes in resilience (Brief Resilience Scale), general self-efficacy (General Self-Efficacy Scale), and perceived stress (Perceived Stress Scale-10). The results of this study are expected to provide evidence on the feasibility and potential effectiveness of AI-based emotional support as a scalable and accessible tool to promote psychological well-being among clinical nurses, thereby informing future digital mental health interventions in healthcare settings.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
May 2026Sep 2026

First Submitted

Initial submission to the registry

December 8, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2026

Last Updated

March 11, 2026

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

December 8, 2025

Last Update Submit

March 9, 2026

Conditions

Keywords

AI-based supportive interventionChatGPTLINE platformClinical NursingEmotional ResilienceOccupational BurnoutCompassion FatigueDigital Mental HealthSelf-EfficacyPerceived Stress

Outcome Measures

Primary Outcomes (1)

  • Change in Compassion Fatigue, Burnout, and Compassion Satisfaction (ProQOL)

    Compassion fatigue, burnout, and compassion satisfaction will be assessed using the Professional Quality of Life Scale (ProQOL), a validated self-report instrument consisting of three subscales: Compassion Fatigue, Burnout, and Compassion Satisfaction. Each subscale score ranges from 10 to 50. Higher scores on the Compassion Fatigue and Burnout subscales indicate worse outcomes. Higher scores on the Compassion Satisfaction subscale indicate better outcomes. Scores will be collected at baseline and at the end of the 4-week intervention period to evaluate changes associated with the AI emotional support intervention compared with the control condition.

    Baseline and Week 4

Secondary Outcomes (3)

  • Change in Resilience (Brief Resilience Scale, BRS)

    Baseline and Week 4

  • Change in General Self-Efficacy (GSE)

    Baseline and Week 4

  • Change in Perceived Stress (PSS-10)

    Baseline and Week 4

Other Outcomes (1)

  • AI Engagement Metrics (Message Frequency and Interaction Patterns)

    Throughout the 4-week intervention period

Study Arms (2)

Interactive LINE GPT Emotional Support

EXPERIMENTAL

Arm Description: Participants in this arm receive daily interactive emotional support messages delivered through a LINE-based GPT assistant. They may engage in two-way conversations with the AI assistant to discuss work-related stress, emotions, and coping strategies. The interactive AI support is available throughout the 4-week intervention period.

Behavioral: Interactive LINE GPT Emotional Support

Static Supportive Messages

ACTIVE COMPARATOR

Participants in this arm receive daily static supportive messages delivered via LINE, matched in theme to the intervention group but without any interactive or AI-generated components. These messages provide general emotional support without enabling conversation or personalized responses. Participants receive the static messages for the full 4-week intervention period.

Behavioral: Static Supportive Messages

Interventions

Participants receive daily non-interactive supportive messages via LINE. Message themes match those in the intervention arm (e.g., stress awareness, emotional well-being) but contain no AI-generated responses or interactive components. Participants receive one static message per day for 4 weeks.

Static Supportive Messages

Participants receive daily interactive emotional support messages delivered through a LINE-based GPT assistant. The AI system provides two-way conversations, reflective prompts, and coping suggestions related to work stress and emotional well-being. The intervention is available on demand throughout the 4-week study period.

Interactive LINE GPT Emotional Support

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 20 to 65 years.
  • Currently employed as clinical nursing staff in the participating institution, including inpatient wards or intensive care units.
  • Able to read Traditional Chinese and receive daily messages via LINE or Email.
  • Willing to participate and able to provide written informed consent.
  • Expected to remain employed in the clinical unit for the full 4-week study period (not planning resignation or extended leave).

You may not qualify if:

  • Refusal or inability to provide informed consent.
  • Unable to receive daily messages through LINE or Email (e.g., no smartphone or internet access).
  • Currently undergoing psychiatric treatment or in the acute phase of major physical/mental illness, where participation may interfere with clinical care.
  • Cognitive or communication impairments that prevent understanding of study material or completion of questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Occupational StressBurnout, PsychologicalCompassion FatigueBurnout, Professional

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorMental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Yiting Huang, RN, Master

CONTACT

Chen-Chih Chung, Co-Investigator, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking was implemented. This is a cluster-randomized, parallel-group behavioral intervention in which both participants and investigators are aware of whether they receive interactive AI emotional support messages or static non-interactive messages. Outcomes are assessed using self-administered questionnaires.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a randomized, controlled, parallel-group study utilizing stratified cluster randomization. Clinical nursing units (e.g., MICU, General Ward) serve as the clusters and are stratified by work intensity (High, Medium, Low). Within each stratum, clusters are randomly assigned (1:1 ratio) to either the Intervention Group (receiving interactive LINE GPT support) or the Control Group (receiving static messages). Participants remain in their assigned arm for the entire 4-week intervention period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2025

First Posted

February 2, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 28, 2026

Study Completion (Estimated)

September 25, 2026

Last Updated

March 11, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the study involves sensitive information from clinical nursing staff, including psychological measures and message-based interactions, which cannot be fully de-identified without risk of re-identification. The approved IRB protocol does not include provisions for external data sharing.