Evaluating the Impact AI Avatar-led Mental Health Interventions for Keeping Employees in Work

February 20, 2026 updated by: Laura Vowels, University of Roehampton

This study will examine whether an artificial intelligence (AI) avatar-led mental health programme can help employees experiencing symptoms of depression. The programme delivers structured, self-guided psychological support over several short sessions that participants complete online over a period of several weeks.

Approximately 50-80 adults will take part. Participants will be randomly assigned either to start the AI programme immediately or to continue with their usual support and access the programme later. All participants will complete questionnaires before and after the study period to assess changes in mood, anxiety, and work functioning. Some participants will also be invited to take part in brief interviews to share their experiences of using the programme.

The aim of the study is to evaluate whether this AI-based intervention can improve mental health and workplace functioning, and to assess how acceptable and safe it is for use in a working population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants will be eligible if they currently experience symptoms of depression (score above 5 on the PHQ-9)
  • Participants should be aged 18 or above.
  • Participants need to be resident in the UK.

Exclusion Criteria:

  • Participants with frequent thoughts of suicide/self-harm will be excluded (scoring above 2 on Question 9 of the PHQ-9 "Thoughts that I would be dead or hurting myself in some way")
  • Participants who are currently undergoing other forms of therapy will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as usual
Experimental: AI-avatar led CBT course
Behavioral: Remi, AI avatar-led cognitive behavioural therapy intervention

The InsideOut AI programme for low mood is based on principles of Cognitive Behavioral Therapy (CBT), adapted into a self-paced, avatar-led format. Participants in the intervention group will complete six sessions over a four to six-week period, each lasting 10-15 minutes.

The sessions will cover the following key components:

  1. Session 1-2: Psychoeducation on depression and the role of CBT.
  2. Session 3-4: Cognitive restructuring techniques to challenge negative thought patterns.
  3. Session 5-6: Coping behavioural strategies for managing low mood and preventing relapse. The programme is designed to be fully automated, with personalised feedback provided by the AI avatar based on participants' responses and progress. Throughout the programme, participants will also complete self-check-ins to track their mood and identify progress.

Engagement and adherence to the programme will be monitored through the platform's data analytics, allowing us to track session completion rates and user int

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression (PHQ-9)
Time Frame: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety (GAD-7)
Time Frame: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Absenteeism
Time Frame: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
1. Absenteeism In the past month, approximately how many days of work did you miss due to your mental health? [Numeric response]
First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Productivity
Time Frame: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Productivity In the past month, on the days you worked, how productive did you feel you were on average? (0% = Not productive at all; 100% = Fully productive) [Sliding scale or numeric response]
First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Concentration at Work
Time Frame: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Concentration at Work In the past month, how much difficulty did you have concentrating on your work tasks due to your mental health? (0 = No difficulty at all, 10 = Extremely severe difficulty)
First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Relationships with Colleagues
Time Frame: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Relationships with Colleagues In the past month, how much did your mental health negatively affect your interactions or relationships with colleagues at work? (0 = Not at all, 10 = Extremely severely)
First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Job Satisfaction
Time Frame: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Job Satisfaction Overall, how satisfied have you felt with your job in the past month? (0 = Not satisfied at all, 10 = Completely satisfied)
First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roehampton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSYC 25-523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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