NCT07494110 Aurora: AI-Based Narrative Intervention to Support Emotional Well-Being in Clinical and Non-Clinical Populations

Eligibility & Interventions

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This trial targets 55 participants in total. It began in 2026-02-12 with a primary completion date of 2026-04-01.

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.

Eligibility Criteria

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.

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