NCT07494110

Brief Summary

Aurora is an interdisciplinary project evaluating a chatbot-mediated supportive care intervention designed to promote emotional expression, autobiographical meaning-making, identity processes, and emotional well-being through guided narrative reconstruction. The Aurora system provides a structured, person-centered storytelling process supported by generative AI and human facilitation. Under the supervision of a trained facilitator (licensed mental health professional), participants engage in guided reminiscence and storytelling sessions to co-create a personalized "life book." The chatbot is not a diagnostic or treatment tool; rather, it is intended to support emotional expression, narrative reconstruction, and recovery-oriented processes. The study includes three non-randomized arms implemented sequentially: (1) a single-session arm of healthy adults focused on acceptability, usability, and emotional safety; (2) a four-hour intervention arm of adults with DSM-5 diagnosed mental disorders in residential care; and (3) a four-hour intervention arm of healthy older adults aged 65 years and older. Quantitative outcomes assess affect, mental well-being, and recovery-related constructs. Additional measures include usability, satisfaction, and qualitative feedback. Ecological momentary assessment (EMA) is conducted in Arms 2 and 3.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 12, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

December 18, 2025

Last Update Submit

March 19, 2026

Conditions

Keywords

artificial intelligencedigital mental healthhuman-computer interactionrecoveryidentityautobiographical narrativelife storyreminiscencewellbeingstorytellingresidential careolder adultschatbot interventionmental health

Outcome Measures

Primary Outcomes (2)

  • Positive Affect (I-PANAS-SF - Positive Affect subscale-pre-post session change)

    Positive affect will be assessed using the Positive Affect (PA) subscale of the International Positive and Negative Affect Schedule - Short Form (I-PANAS-SF). Participants will rate their affect "right now." The endpoint is the change in PA from immediately before to immediately after each session across all treatment arms. Higher scores indicate higher positive affect.

    Change from immediately before to immediately after each session, up to 2 weeks.

  • Negative Affect (I-PANAS-SF - Negative Affect subscale - pre-post session change)

    Negative affect will be assessed using the Negative Affect (NA) subscale of the International Positive and Negative Affect Schedule - Short Form (I-PANAS-SF). Participants will rate their affect "right now." The endpoint is the change in NA from immediately before to immediately after each session across all treatment arms. Higher scores indicate higher negative affect.

    Change from immediately before to immediately after each session, up to 2 weeks.

Secondary Outcomes (4)

  • Positive Affect (I-PANAS-SF - Positive Affect subscale - baseline to 1-week follow-up change)

    Change from baseline at 1 week after end of intervention.

  • Negative Affect (I-PANAS-SF - baseline to 1-week follow-up change)

    Change from baseline at 1 week after end of intervention.

  • Mental well-being (WEMWBS)

    Change from baseline at 1 week after end of intervention.

  • Recovery-related outcomes aligned with CHIME framework

    Change from baseline at 1 week after end of intervention.

Other Outcomes (3)

  • Usability (System Usability Scale, SUS)

    Immediately after session (Arm 1); 1 week after end of intervention (Arms 2 and 3)

  • User experience and satisfaction

    Immediately after session (Arm 1); 1 week after end of intervention (Arms 2 and 3)

  • Ecological Momentary Assessment (EMA)

    Twice daily from 1 week before intervention to 1 week after end of intervention.

Study Arms (3)

Single-session - Healthy adults

EXPERIMENTAL

Healthy adults complete one Aurora session (single exposure) for platform refinement and usability assessment.

Behavioral: chatbot-mediated supportive care intervention

Four-hour program - Adults with DSM-5 diagnosed mental disorder in residential care

EXPERIMENTAL

Adults (aged ≥18 years) with a DSM-5 diagnosed mental disorder, residing in long-term mental health residential care facilities, complete a four-session guided narrative program over two weeks (two sessions per week, 1 hour per session) with facilitation by a licensed mental health professional.

Behavioral: chatbot-mediated supportive care intervention

Four-hour program - Healthy older adults (≥65 years)

EXPERIMENTAL

Healthy older adults (aged ≥65 years), with no self-reported diagnosis of a serious mental disorder, complete a two-session guided narrative program over two weeks (one session per week, 2 hours per session) with facilitation by a licensed mental health professional.

Behavioral: chatbot-mediated supportive care intervention

Interventions

Aurora is a guided narrative reconstruction chatbot combining structured storytelling and reminiscence with an AI-based conversational system and support from a trained facilitator. Participants co-create a personalized life narrative ("life book") with written content and optional audio contributions (with explicit consent). Sessions occur in a secure professional environment and are supervised by licensed mental health professionals to ensure emotional safety. Aurora is not a diagnostic tool and is intended to promote emotional expression, recovery-oriented processes, and emotional well-being. The intervention is delivered in structured guided sessions. Arm 1 receives a single-session version for refinement and usability assessment, whereas Arms 2 and 3 receive a 4-hour intervention delivered over two weeks. The total intervention dose is equivalent across Arms 2 and 3. Session structure differs to accommodate participant characteristics.

Also known as: Aurora, Aurora AI-Assisted Narrative Reconstruction Chatbot
Four-hour program - Adults with DSM-5 diagnosed mental disorder in residential careFour-hour program - Healthy older adults (≥65 years)Single-session - Healthy adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arm 1: Healthy Adults (Single-Session Intervention)
  • Age 18 years or older at screening.
  • Sufficient ability to read and understand Spanish to follow study instructions and complete questionnaires.
  • Ability to engage in a brief guided interaction and complete self-report measures.
  • Able and willing to provide written informed consent.
  • \---
  • Arm 2: Adults with DSM-5 Diagnosed Mental Disorder in Residential Care (4-hour Intervention)
  • Age 18 years or older at screening.
  • Currently residing in a participating long-term mental health residential care facility and expected to remain there for the duration of the intervention and post-assessment period.
  • Documented diagnosis of a mental disorder according to DSM-5 criteria, confirmed by the treating clinician.
  • Minimal clinical stability at baseline, defined as all of the following:
  • Clinically stable in the judgment of the treating clinician.
  • No requirement for acute psychiatric hospitalization or crisis intervention in the previous 4 weeks.
  • Clinical Global Impression - Improvement (CGI-I) score between 3 and 5 inclusive during the 4 weeks prior to enrollment, indicating relative clinical stability.
  • Sufficient ability to understand spoken and written Spanish to participate in study procedures.
  • +11 more criteria

You may not qualify if:

  • Arm 1: Healthy Adults
  • Current acute medical or psychiatric condition that would compromise safe participation or data validity.
  • Moderate or high acute suicide or self-harm risk at screening.
  • Significant cognitive, communication, or comprehension impairment that would interfere with participation.
  • Explicit refusal to participate.
  • \---
  • Arm 2: Adults with DSM-5 Diagnosed Mental Disorder in Residential Care
  • Current acute psychiatric decompensation requiring crisis-level care.
  • Moderate or high acute suicide or self-harm risk at screening or baseline.
  • High risk of clinically significant emotional harm from autobiographical life review, defined as treating clinician judgment that narrative or reminiscence work is contraindicated due to one or more of the following:
  • Severe clinical destabilization within the past 3 months.
  • Trauma-related re-experiencing symptoms.
  • Marked dissociative symptoms.
  • Inability to provide informed consent, with no legal representative available when required, or lack of participant assent when applicable.
  • Significant cognitive, communication, or comprehension impairment without available supports.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Llar Residència Gràcia(Grup ATRA)

Barcelona, Barcelona, 08012, Spain

NOT YET RECRUITING

Department of Clinical and Health Psychology; Universitat Autònoma de Barcelona

Cerdanyola del Vallès, Barcelona, 08193, Spain

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Albert Feliu-Soler Associate Professor Serra Húnter Fellow, PhD

CONTACT

Jaime Navarrete Postdoctoral Researcher, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Non-randomized parallel assignment with sequential implementation of three study arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor - Serra Húnter Fellow

Study Record Dates

First Submitted

December 18, 2025

First Posted

March 27, 2026

Study Start

February 12, 2026

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to the sensitive nature of the data, which include mental health information and autobiographical narrative content from a vulnerable population. Data use is restricted to the approved study objectives under the conditions of the ethics committee approval and applicable data protection regulations (GDPR).

Locations