- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07494110
Aurora: AI-Based Narrative Intervention to Support Emotional Well-Being in Clinical and Non-Clinical Populations (Aurora)
Aurora: Evaluation of an AI-Based Narrative Intervention for Emotional Well-Being, Identity Processes, and Recovery-Oriented Outcomes in Clinical and Non-Clinical Populations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pre-human development (in silico; not part of the clinical trial):
Prior to human participation, the Aurora system underwent an in-silico preparatory phase focused on content coherence and emotional safety using synthetic user profiles. Simulated interactions were reviewed by licensed mental health professionals to identify potential safety concerns and inform iterative refinements of the supportive narrative process. This preparatory work did not involve human participants and is not part of the clinical trial.
Human participants (clinical trial):
The study uses a sequential, non-randomized, three-arm interventional design with a total anticipated sample of 55 participants.
Arm 1: Healthy adults (single-session arm; n=20) Following informed consent, participants complete a single guided interaction with Aurora to generate a brief personal narrative. Outcomes include pre-session expectations, pre-post session affect (I-PANAS-SF), perceived usefulness and user experience, usability (System Usability Scale, SUS), satisfaction, and qualitative feedback.
Arm 2: Adults with DSM-5 diagnosed mental disorder in residential care (4-hour intervention arm; n=15) Following informed consent, participants complete four guided sessions over two weeks (two sessions per week, 1 hour per session). Outcomes include pre-session expectations, pre-post session affect (I-PANAS-SF) for each session, perceived usefulness and user experience, usability (SUS), satisfaction, qualitative feedback, and pre-post intervention self-report measures of mental well-being and recovery-related constructs. Ecological momentary assessment (EMA) is conducted during the 1-week pre-intervention period, the 2-week intervention period, and the 1-week post-intervention follow-up period.
Arm 3: Healthy older adults (aged 65 years and older; 4-hour intervention arm; n=20) Following informed consent, participants complete two guided sessions over two weeks (one session per week, 2 hours per session). Outcomes include pre-session expectations, pre-post session affect (I-PANAS-SF) for each session, perceived usefulness and user experience, usability (SUS), satisfaction, qualitative feedback, and pre-post intervention self-report measures of mental well-being and recovery-related constructs. Ecological momentary assessment (EMA) is conducted during the 1-week pre-intervention period, the 2-week intervention period, and the 1-week post-intervention follow-up period.
Data security and compliance:
All interactions occur in a secure professional environment. Textual data are pseudonymized during transcription and fully anonymized at the end of the project. Optional audio recordings are stored on encrypted offline devices and deleted after integration into the participant's life book. The study complies with applicable data protection and regulatory frameworks, including GDPR (EU 2016/679), LOPDGDD 3/2018, the EU AI Act (2024/1689), and institutional ethics guidelines.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Albert Feliu-Soler Associate Professor Serra Húnter Fellow, PhD
- Phone Number: +34935812778
- Email: albert.feliu@uab.cat
Study Contact Backup
- Name: Jaime Navarrete Postdoctoral Researcher, PhD
- Phone Number: 12734 +34 936 615 208
- Email: jaime.navarrete@sjd.es
Study Locations
-
-
Barcelona
-
Barcelona, Barcelona, Spain, 08012
- Not yet recruiting
- Llar Residència Gràcia(Grup ATRA)
-
Contact:
- Meritxell Alcaraz, MSc
- Phone Number: +34 93 461 57 62
- Email: dir.llargracia@smgracia.org
-
Cerdanyola del Vallès, Barcelona, Spain, 08193
- Recruiting
- Department of Clinical and Health Psychology; Universitat Autònoma de Barcelona
-
Contact:
- Albert Feliu-Soler Associate Professor Serra Húnter Fellow, PhD
- Phone Number: +34 93 581 2778
- Email: albert.feliu@uab.cat
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
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.
Ability to engage in guided interaction and provide feedback.
Able and willing to provide informed consent; when applicable, provision of legal guardian consent plus participant assent.
Willingness to participate in all study procedures.
---
Arm 3: Healthy Older Adults (≥65 Years; 4-hour Intervention)
Age 65 years or older at screening.
No self-reported diagnosis of a serious mental disorder (for example, psychotic disorder or bipolar disorder).
Sufficient ability to read and understand Spanish to participate in study procedures.
Adequate cognitive and communication abilities to engage in guided interaction and complete questionnaires.
Able and willing to provide written informed consent.
---
Exclusion Criteria
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.
Explicit refusal to participate.
Imminent discharge or transfer that would prevent completion of the intervention or post-assessment.
---
Arm 3: Healthy Older Adults
Self-reported diagnosis of a serious mental disorder (for example, psychotic disorder or bipolar disorder).
Moderate or high acute suicide or self-harm risk at screening.
Current acute medical or psychiatric condition that would compromise safe participation.
Significant cognitive, communication, or comprehension impairment that would interfere with participation.
Explicit refusal to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single-session - Healthy adults
Healthy adults complete one Aurora session (single exposure) for platform refinement and usability assessment.
|
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.
Other Names:
|
|
Experimental: Four-hour program - Adults with DSM-5 diagnosed mental disorder in residential care
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.
|
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.
Other Names:
|
|
Experimental: Four-hour program - Healthy older adults (≥65 years)
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive Affect (I-PANAS-SF - Positive Affect subscale-pre-post session change)
Time Frame: Change from immediately before to immediately after each session, up to 2 weeks.
|
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)
Time Frame: Change from immediately before to immediately after each session, up to 2 weeks.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive Affect (I-PANAS-SF - Positive Affect subscale - baseline to 1-week follow-up change)
Time Frame: Change from baseline at 1 week after end of intervention.
|
Positive affect will be assessed using the Positive Affect (PA) subscale of the I-PANAS-SF.
Participants will rate their affect "over the past week."
The endpoint is the change in PA from baseline to immediately post-intervention in Arms 2 and 3. Higher scores indicate higher positive affect.
|
Change from baseline at 1 week after end of intervention.
|
|
Negative Affect (I-PANAS-SF - baseline to 1-week follow-up change)
Time Frame: Change from baseline at 1 week after end of intervention.
|
Negative affect will be assessed using the Negative Affect (NA) subscale of the I-PANAS-SF, adapted to assess affect over the past week.
The endpoint is the change in NA from baseline (pre-intervention) to 1-week follow-up after completion of the intervention in Arms 2 and 3. Higher scores indicate higher negative affect.
|
Change from baseline at 1 week after end of intervention.
|
|
Mental well-being (WEMWBS)
Time Frame: Change from baseline at 1 week after end of intervention.
|
Mental well-being will be assessed using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS; total score).
Higher scores indicate greater mental well-being.
The endpoint is change from baseline at 1 week after end of intervention in Arms 2 and 3.
|
Change from baseline at 1 week after end of intervention.
|
|
Recovery-related outcomes aligned with CHIME framework
Time Frame: Change from baseline at 1 week after end of intervention.
|
Recovery-related outcomes will be assessed using an ad hoc self-report measure aligned with the CHIME framework.
The measure includes six constructs (3 items each): social connectedness, hope, self-concept clarity, valued living, general self-efficacy, and self-esteem.
A total composite score will be computed.
Higher scores indicate more favorable recovery-related outcomes.
The endpoint is the change from baseline (pre-intervention) to 1-week follow-up after completion of the intervention in Arms 2 and 3.
|
Change from baseline at 1 week after end of intervention.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usability (System Usability Scale, SUS)
Time Frame: Immediately after session (Arm 1); 1 week after end of intervention (Arms 2 and 3)
|
Usability will be assessed using the System Usability Scale (SUS).
The SUS is a 10-item self-report measure of perceived usability.
Total scores range from 0 to 100, with higher scores indicating better perceived usability.
In Arm 1, the SUS will be administered immediately after the single session.
In Arms 2 and 3, the SUS will be administered at follow-up, 1 week after the end of the intervention.
|
Immediately after session (Arm 1); 1 week after end of intervention (Arms 2 and 3)
|
|
User experience and satisfaction
Time Frame: Immediately after session (Arm 1); 1 week after end of intervention (Arms 2 and 3)
|
User experience and satisfaction will be assessed using study-specific self-report items covering expectations, perceived usefulness, and satisfaction/opinion.
In Arm 1, this measure will be administered immediately after the single session.
In Arms 2 and 3, it will be administered at follow-up, 1 week after the end of the intervention.
|
Immediately after session (Arm 1); 1 week after end of intervention (Arms 2 and 3)
|
|
Ecological Momentary Assessment (EMA)
Time Frame: Twice daily from 1 week before intervention to 1 week after end of intervention.
|
Ecological momentary assessment (EMA) will be conducted in Arms 2 and 3. Participants will complete brief assessments twice daily across three predefined periods: (1) a 1-week pre-intervention baseline period, (2) the 2-week intervention period, and (3) a 1-week post-intervention follow-up period.
EMA will include brief momentary items assessing affect, valued action, self-efficacy/empowerment, connectedness/hope, and psychological flexibility, capturing real-time (momentary) experiences.
|
Twice daily from 1 week before intervention to 1 week after end of intervention.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025LLAV00080 (Other Identifier: AGAUR; Convocatòria d'Indústria del Coneixement, 2025, Modalitat A, Llavor)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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