- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Micaela Rodriguez, PhD
- Номер телефона: 347-407-3589
- Электронная почта: rodrim@umich.edu
Места учебы
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48109
- University of Michigan
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Контакт:
- Micaela Rodriguez, PhD
- Номер телефона: 347-407-3589
- Электронная почта: rodrim@umich.edu
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Контакт:
- Amie M Gordon, PhD
- Номер телефона: 707-292-2298
- Электронная почта: amiemg@umich.edu
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Главный следователь:
- Micaela Rodriguez, PhD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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. |
|
Без вмешательства: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Loneliness
Временное ограничение: Baseline and weekly through Week 10
|
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
|
|
General Anxiety
Временное ограничение: Baseline and weekly through Week 10
|
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
|
|
Depression
Временное ограничение: Baseline and weekly through Week 10
|
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
Временное ограничение: Baseline and weekly through Week 10
|
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
|
|
Quality of In-Person Interactions
Временное ограничение: Baseline and weekly through Week 10
|
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
Временное ограничение: Baseline and every 2 weeks through Week 10
|
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
|
|
Narcissism
Временное ограничение: Baseline and every 2 weeks through Week 10
|
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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Life Satisfaction
Временное ограничение: Baseline and weekly through Week 10
|
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
Временное ограничение: Baseline and weekly through Week 10
|
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
Временное ограничение: Baseline and weekly through Week 10
|
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
Временное ограничение: 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
Временное ограничение: Baseline and weekly through Week 10
|
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
Временное ограничение: Baseline and weekly through Week 10
|
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
Временное ограничение: Baseline and weekly through Week 10
|
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
|
Соавторы и исследователи
Спонсор
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HUM00292543
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .