How Do Artificially Intelligent Companions Influence Psychological Outcomes?
ConditionAI Companionship
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
AI Companion Interaction
BehavioralParticipants 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.
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: AI CompanionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Loneliness
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.
Time frame
Baseline and weekly through Week 102
General Anxiety
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.
Time frame
Baseline and weekly through Week 103
Depression
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.
Time frame
Baseline and weekly through Week 104
Quantity of In-Person Interactions
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.
Time frame
Baseline and weekly through Week 10Secondary outcomes
1
Life Satisfaction
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.
Time frame
Baseline and weekly through Week 102
Emotion Regulation
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.
Time frame
Baseline and weekly through Week 103
Purpose in Life
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.
Time frame
Baseline and weekly through Week 104
Quantity of Online Interactions With Humans
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.
Time frame
Baseline and weekly through Week 10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Yale University
Collaborator
Source ClinicalTrials.gov
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