AzTrials
AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

Search all trials

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
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

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.

Micaela Rodriguez, PhD contact

347-407-3589

rodrim@umich.edu

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

Other trials in United States

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.

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 groups in NCT07858279
Study groupRoleWhat they receive
AI CompanionExperimentalParticipants 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
ControlNo interventionParticipants 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.

  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.

    Measured: Baseline and weekly through Week 10

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)
  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.

    Measured: Baseline and weekly through Week 10

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted5 Oct 2026
  2. Study start1 Aug 2027 (estimated)
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

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)
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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in