AI CompanionshipNCT07858279
How Do Artificially Intelligent Companions Influence Psychological Outcomes?
A study testing AI Companion Interaction in people with AI Companionship, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- AI Companionship
- What is being tested?
- AI Companion Interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2027to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109
Micaela Rodriguez, PhD, 347-407-3589, rodrim@umich.edu
Amie M Gordon, PhD, 707-292-2298, amiemg@umich.edu
About this study
Official title: 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.
- Conditions
- AI Companionship
- Being tested
- AI Companion Interaction
- Keywords
- artificial intelligence, AI chatbot, human-AI interaction, psychological well-being, social connection, loneliness, social interaction
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Companion InteractionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AI Companion | Experimental | 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. Receives: Behavioral: AI Companion Interaction |
| Control | No intervention | Participants will continue their lives as usual and will not be asked to interact with an AI companion during the 10-week study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and weekly through Week 10
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.
Measured: Baseline and weekly through Week 10
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.
Measured: Baseline and weekly through Week 10
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.
Measured: Baseline and weekly through Week 10
Quality of In-Person Interactions
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.
Measured: Baseline and weekly through Week 10
Aggression
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.
Measured: Baseline and every 2 weeks through Week 10
Narcissism
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.
Measured: Baseline and every 2 weeks through Week 10
Traditional Gender Norm Beliefs
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.
Measured: Baseline and every 2 weeks through Week 10
Secondary outcomes (7)
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.
Measured: Baseline and weekly through Week 10
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.
Measured: Baseline and weekly through Week 10
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.
Measured: Baseline and weekly through Week 10
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.
Measured: Baseline and weekly through Week 10
Quality of Online Interactions With Humans
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.
Measured: Baseline and weekly through Week 10
Motivation to Socialize With Others
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.
Measured: Baseline and weekly through Week 10
Perceived Social Support
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.
Measured: Baseline and weekly through Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Aug 2027 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AI CompanionshipStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Micaela Rodriguez, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858279
- Sponsor's protocol ID
- HUM00292543
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-Month Experimental Study of AI Companionship and Its Effects on Well-Being, Social Life, and Interpersonal Attitudes and Behaviors
- ClinicalTrials.gov ID
- NCT07858279
- Acronym / sponsor ID
- HUM00292543
- Conditions
- AI Companionship
- Keywords
- artificial intelligence, AI chatbot, human-AI interaction, psychological well-being, social connection, loneliness, social interaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 1 Aug 2027 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI Companion | Experimental | Behavioral: AI Companion InteractionParticipants 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. |
| Control | No intervention | –Participants will continue their lives as usual and will not be asked to interact with an AI companion during the 10-week study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI Companion InteractionParticipants 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. | Behavioural | AI Companion |
Primary outcome
Loneliness
Time frame: 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.
General Anxiety
Time frame: 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.
Depression
Time frame: 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.
Quantity of In-Person Interactions
Time frame: 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.
Quality of In-Person Interactions
Time frame: 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.
Aggression
Time frame: 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.
Narcissism
Time frame: 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.
Traditional Gender Norm Beliefs
Time frame: Baseline and every 2 weeks through Week 10
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.
7 secondary outcomes
Life Satisfaction
Time frame: Baseline and weekly through Week 10
Emotion Regulation
Time frame: Baseline and weekly through Week 10
Purpose in Life
Time frame: Baseline and weekly through Week 10
Quantity of Online Interactions With Humans
Time frame: Baseline and weekly through Week 10
Quality of Online Interactions With Humans
Time frame: Baseline and weekly through Week 10
Motivation to Socialize With Others
Time frame: Baseline and weekly through Week 10
Perceived Social Support
Time frame: Baseline and weekly through Week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI Companion Interaction in people with AI Companionship, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Micaela Rodriguez, PhD (347-407-3589, rodrim@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: Baseline and weekly through Week 10). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.