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

Universitat Autonoma de Barcelona55 enrolled

Overview

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.

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.

Interventions

chatbot-mediated supportive care interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

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

Secondary Outcomes

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.

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

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.

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

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.

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

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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts