- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07858279
How Do Artificially Intelligent Companions Influence Psychological Outcomes?
An Eight-Month Experimental Study of AI Companionship and Its Effects on Well-Being, Social Life, and Interpersonal Attitudes and Behaviors
This randomized longitudinal study examines how interacting with an artificially intelligent (AI) companion affects psychological well-being, social experiences, and interpersonal attitudes and behaviors over time. A total of 1,200 U.S. adults will be randomly assigned to either interact with an AI companion (via the Replika app) for 10 weeks or continue life as usual. Participants will complete online surveys at baseline, throughout the 10-week study period, and at 1-, 3-, and 6-month follow-ups. The study will examine both potential benefits and risks of AI companionship, including effects on psychological well-being, social connection, and interpersonal attitudes and behaviors.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Micaela Rodriguez, PhD
- Número de teléfono: 347-407-3589
- Correo electrónico: rodrim@umich.edu
Ubicaciones de estudio
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
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Contacto:
- Micaela Rodriguez, PhD
- Número de teléfono: 347-407-3589
- Correo electrónico: rodrim@umich.edu
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Contacto:
- Amie M Gordon, PhD
- Número de teléfono: 707-292-2298
- Correo electrónico: amiemg@umich.edu
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Investigador principal:
- Micaela Rodriguez, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Living in the United States
- 18 years of age or older
- Own a smartphone
- No prior experience interacting with AI companions, defined as AI designed for ongoing, personal, or social interaction (e.g., for emotional support, companionship, or relationship-like experiences). This does not include use of tools such as ChatGPT or Claude for work-related tasks or information.
Exclusion Criteria:
- Any suicidal ideation, defined as a response other than "not at all" to the suicidal ideation item of the Patient Health Questionnaire-9 (PHQ-9)
- Severe depression, defined as a total PHQ-9 score of 20 or greater
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: AI Companion
Participants will create an AI companion using Replika and will be asked to interact with their AI companion for at least one hour per week for 10 consecutive weeks. |
Participants assigned to the AI condition will download Replika, an AI companion application, and create a personalized AI companion. Participants will be instructed to interact with their AI companion for at least one hour per week for 10 consecutive weeks. They may interact with their AI companion as much as they would like beyond the required one hour per week. |
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Sin intervención: Control
Participants will continue their lives as usual and will not be asked to interact with an AI companion during the 10-week study period. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Loneliness
Periodo de tiempo: Baseline and weekly through Week 10
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Loneliness will be assessed using the 3-item UCLA Loneliness Scale, adapted to refer to the last week. Participants rate how often they felt they lacked companionship, felt left out, and felt isolated from others on a scale from 1 (hardly ever) to 3 (often). Higher scores indicate greater loneliness. |
Baseline and weekly through Week 10
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General Anxiety
Periodo de tiempo: Baseline and weekly through Week 10
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General anxiety will be assessed using the 2-item Generalized Anxiety Disorder scale (GAD-2), adapted to refer to the last week. Participants rate how often they felt nervous, anxious, or on edge and were unable to stop or control worrying from 0 (not at all) to 3 (nearly every day). Higher scores indicate greater anxiety. |
Baseline and weekly through Week 10
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Depression
Periodo de tiempo: Baseline and weekly through Week 10
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Depression will be assessed using the 2-item Patient Health Questionnaire (PHQ-2), adapted to refer to the last week. Participants rate how often they experienced little interest or pleasure in doing things and felt down, depressed, or hopeless from 0 (not at all) to 3 (nearly every day). Higher scores indicate greater depressive symptoms. |
Baseline and weekly through Week 10
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Quantity of In-Person Interactions
Periodo de tiempo: Baseline and weekly through Week 10
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Quantity of in-person social interaction will be assessed using three face-valid items developed for this study. Items assess the frequency of getting together with friends or family in person during the last week, the number of different people spoken to in person on a typical day, and overall in-person social activity during the last week. Higher responses indicate greater quantity of in-person social interaction. |
Baseline and weekly through Week 10
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Quality of In-Person Interactions
Periodo de tiempo: Baseline and weekly through Week 10
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Quality of in-person social interactions will be assessed using three items from the UBC State Social Connection Scale, adapted to refer to in-person interactions during the last week. Participants rate the extent to which they felt close to people, felt a sense of belonging, and felt a strong bond with others from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater quality of in-person social interactions. |
Baseline and weekly through Week 10
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Aggression
Periodo de tiempo: Baseline and every 2 weeks through Week 10
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Aggression will be assessed using an adapted 12-item Buss-Perry Aggression Questionnaire Short Form. Participants rate statements about their thoughts and behaviors over the past two weeks from 1 (extremely uncharacteristic of me) to 6 (extremely characteristic of me). Items are summed to create a composite score, with higher scores indicating greater aggression. |
Baseline and every 2 weeks through Week 10
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Narcissism
Periodo de tiempo: Baseline and every 2 weeks through Week 10
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Narcissism will be assessed using the 8-item Narcissistic Personality Inventory Short Form. For each item, participants choose between paired statements, with the less narcissistic response scored 1 and the more narcissistic response scored 2. Items are summed to create a composite score, with higher scores indicating greater narcissism. |
Baseline and every 2 weeks through Week 10
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Traditional Gender Norm Beliefs
Periodo de tiempo: Baseline and every 2 weeks through Week 10
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Traditional gender norm beliefs will be assessed using the 9-item G-NORM Scale Injunctive Norm Subscale. Participants rate statements concerning traditional gender roles from 1 (strongly disagree) to 5 (strongly agree). Items are summed to create a composite score, with higher scores indicating greater traditional gender norm beliefs. |
Baseline and every 2 weeks through Week 10
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Life Satisfaction
Periodo de tiempo: Baseline and weekly through Week 10
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Life satisfaction will be assessed using the 3-item Satisfaction With Life Scale (SWLS-3). Participants rate their current agreement with statements about their life being close to ideal, having excellent life conditions, and being satisfied with their life from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater life satisfaction. |
Baseline and weekly through Week 10
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Emotion Regulation
Periodo de tiempo: Baseline and weekly through Week 10
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Emotion regulation difficulties will be assessed using the Strategies Subscale of the Difficulties in Emotion Regulation Scale (DERS) Short Form, adapted to refer to the last week and to use past-tense wording. Participants rate three items concerning difficulty recovering or regulating emotions when upset from 1 (almost never) to 5 (almost always). Higher scores indicate greater difficulty regulating emotions. |
Baseline and weekly through Week 10
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Purpose in Life
Periodo de tiempo: Baseline and weekly through Week 10
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Purpose in life will be assessed using the 5-item Presence of Meaning Subscale of the Meaning in Life Questionnaire. Participants rate their current sense of meaning and purpose from 1 (absolutely untrue) to 7 (absolutely true). One negatively worded item is reverse scored. Higher scores indicate greater presence of meaning and purpose in life. |
Baseline and weekly through Week 10
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Quantity of Online Interactions With Humans
Periodo de tiempo: Baseline and weekly through Week 10
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Quantity of online social interaction with humans will be assessed using three face-valid items developed for this study. Items assess the frequency of talking to friends or family online during the last week, the number of different people spoken to online on a typical day, and overall online social activity during the last week. Higher responses indicate greater quantity of online social interaction. |
Baseline and weekly through Week 10
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Quality of Online Interactions With Humans
Periodo de tiempo: Baseline and weekly through Week 10
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Quality of online social interactions with humans will be assessed using three items adapted from the UBC State Social Connection Scale. Participants rate the extent to which they felt close to people, felt a sense of belonging, and felt a strong bond with others during their online interactions in the last week from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater quality of online social interactions. |
Baseline and weekly through Week 10
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Motivation to Socialize With Others
Periodo de tiempo: Baseline and weekly through Week 10
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Motivation to socialize will be assessed using four items from the State Motivation to Foster Social Connection Scale, including two items assessing motivation to socialize with new people and two assessing motivation to socialize with existing connections. Items are rated from 1 (strongly disagree) to 7 (strongly agree), with higher scores indicating greater motivation to socialize with others. |
Baseline and weekly through Week 10
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Perceived Social Support
Periodo de tiempo: Baseline and weekly through Week 10
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Perceived social support will be assessed using four items from the Interpersonal Support Evaluation List assessing emotional, informational, and instrumental support. Participants rate each statement from 1 (definitely false) to 4 (definitely true), with higher scores indicating greater perceived social support. |
Baseline and weekly through Week 10
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HUM00292543
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified individual participant-level survey data collected during the study will be made publicly available. Direct identifiers will be removed prior to sharing. AI companion conversation transcript data will not be made publicly available
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .