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Testing an AI emotional support companion for university students' psychological wellbeing and mental health

Effectiveness of Kai AI Companion compared to traditional therapeutic approaches for improving psychological wellbeing among university students experiencing mild-to-moderate emotional distress: A comprehensive two-experiment randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61075527
Enrollment
1148
Registered
2025-05-12
Start date
2025-05-10
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Psychological Distress, PTSD Symptoms, Substance Use Mental and Behavioural Disorders

Interventions

Experiment 1: The study comprises three arms: 1. Kai AI Companion (Experimental): Participants will use Kai, a digital AI companion, daily for three months. Kai offers empathetic, affirming, and non-j

Sponsors

Reichman University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Experiment 1 - Participant inclusion criteria: 1. University students aged 18-35 years 2. Self-reported mild-to-moderate emotional distress (anxiety, sadness, stress) 3. Fluent in Hebrew 4. Access to smartphone or computer with internet 5. Willing to provide informed consent 6. Available to participate in weekly group sessions (for those assigned to group intervention) Experiment 2 - Participant inclusion criteria: 1. University students aged 18-35 years 2. Self-reported mild-to-moderate emotional distress (anxiety, sadness, stress) 3. Fluent in Hebrew 4. Access to smartphone or computer with internet 5. Willing to provide informed consent 6. Eligible for university counseling services 7. Not previously enrolled in university counseling services

Exclusion criteria

Exclusion criteria: Experiment 1 - Participant exclusion criteria: 1. Active suicidal ideation or psychiatric crisis 2. Currently receiving psychotherapy or psychiatric medication 3. Diagnosed with severe mental disorder (psychosis, bipolar disorder) 4. Unable to commit to 12-week intervention period 5. Previous participation in similar group intervention programs Experiment 2 - Participant exclusion criteria: 1. Active suicidal ideation or psychiatric crisis 2. Currently receiving psychotherapy or psychiatric medication 3. Diagnosed with severe mental disorder (psychosis, bipolar disorder) 4. Previous participation in university counseling services within the past year 5. Current enrollment in other intervention studies

Design outcomes

Primary

MeasureTime frame
1.Life Satisfaction measured using the Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS) at baseline and 3 months 2.Anxiety measured using the Generalized Anxiety Disorder-7 (GAD-7) at baseline and 3 months 3.Depression measured using the Patient Health Questionnaire (PHQ-9) at baseline and 3 months 4.Well-Being measured using the WHO-5 Well-Being Index at baseline and 3 months 5.PTSD Symptoms measured using the PCL-5 (4-item version) at baseline and 3 months 6.Substance Use measured using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) at baseline and 3 months

Secondary

MeasureTime frame
1. Help-Seeking Intention measured using the General Help Seeking Questionnaire at baseline and 3 months 2. Engagement with Kai measured by number of messages sent throughout intervention period 3. Perceptions of Kai's Supportive Qualities measured using an adapted version of Cash's Perceptions of Counselor Behavior scale at 3 months

Countries

Israel

Contacts

Public ContactAnat Shoshani
ashoshani@runi.ac.il+972 9 9602887

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 1, 2026