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InstitutionalizationAuroraNCT07494110

Aurora: AI-Based Narrative Intervention to Support Emotional Well-Being in Clinical and Non-Clinical Populations

A study testing chatbot-mediated supportive care intervention in people with Institutionalization and Elderly, run by Universitat Autonoma de Barcelona at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Institutionalization, Elderly, Mental Health
What is being tested?
chatbot-mediated supportive care intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesSpain
Study dates
12 Feb 2026to 1 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • ---
Show all 26Show fewer
  • 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.
  • ---

Who cannot join

  • 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.
  • ---
Show all 24Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Albert Feliu-Soler Associate Professor Serra Húnter Fellow, PhD contact

+34935812778

albert.feliu@uab.cat

Jaime Navarrete Postdoctoral Researcher, PhD contact

+34 936 615 208 ext. 12734

jaime.navarrete@sjd.es

Spain2 sites, 2 recruiting
  • Llar Residència Gràcia(Grup ATRA)

    Barcelona, Barcelona, 08012

    Meritxell Alcaraz, MSc, +34 93 461 57 62, dir.llargracia@smgracia.org

    Not yet recruiting
  • Department of Clinical and Health Psychology; Universitat Autònoma de Barcelona

    Cerdanyola del Vallès, Barcelona, 08193

    Albert Feliu-Soler Associate Professor Serra Húnter Fellow, PhD, +34 93 581 2778, albert.feliu@uab.cat

    Recruiting

Other trials in Spain

About this study

Official title: Aurora: Evaluation of an AI-Based Narrative Intervention for Emotional Well-Being, Identity Processes, and Recovery-Oriented Outcomes in Clinical and Non-Clinical Populations

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.

Read the 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.

Being tested
chatbot-mediated supportive care intervention
Keywords
artificial intelligence, digital mental health, human-computer interaction, recovery, identity, autobiographical narrative, life story, reminiscence, wellbeing, storytelling, residential care, older adults, chatbot intervention, mental health
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chatbot-mediated supportive care interventionBehavioural

    Also called Aurora, Aurora AI-Assisted Narrative Reconstruction Chatbot

    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.

Study groups in NCT07494110
Study groupRoleWhat they receive
Single-session - Healthy adultsExperimentalHealthy adults complete one Aurora session (single exposure) for platform refinement and usability assessment.
Receives: Behavioral: chatbot-mediated supportive care intervention
Four-hour program - Adults with DSM-5 diagnosed mental disorder in residential careExperimentalAdults (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.
Receives: Behavioral: chatbot-mediated supportive care intervention
Four-hour program - Healthy older adults (≥65 years)ExperimentalHealthy 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.
Receives: Behavioral: chatbot-mediated supportive care intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (4)
  1. Positive Affect (I-PANAS-SF - Positive Affect subscale - baseline to 1-week follow-up change)

    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.

    Measured: Change from baseline at 1 week after end of intervention.

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

    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.

    Measured: Change from baseline at 1 week after end of intervention.

  3. Mental well-being (WEMWBS)

    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.

    Measured: Change from baseline at 1 week after end of intervention.

  4. Recovery-related outcomes aligned with CHIME framework

    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.

    Measured: Change from baseline at 1 week after end of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start12 Feb 2026
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Non-randomized parallel assignment with sequential implementation of three study arms.
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07494110
Sponsor's protocol ID
2025LLAV00080
Other IDs
2025LLAV00080
Acronym
Aurora
Status last verified
Mar 2026
First submitted
18 Dec 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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).

Questions about this trial

What is this clinical trial studying?

A study testing chatbot-mediated supportive care intervention in people with Institutionalization and Elderly, run by Universitat Autonoma de Barcelona at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Albert Feliu-Soler Associate Professor Serra Húnter Fellow, PhD (+34935812778, albert.feliu@uab.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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