DepressionNCT07436117
Evaluating the Impact AI Avatar-led Mental Health Interventions for Keeping Employees in Work
A study testing Remi, AI avatar-led cognitive behavioural therapy intervention in people with Depression, run by University of Roehampton at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Remi, AI avatar-led cognitive behavioural therapy intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Oct 2025to 30 Jun 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Roehampton
London, SW15 4JD
Laura M Vowels, PhD, +447858024296, laura.vowels@roehampton.ac.uk
About this study
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.
- Conditions
- Depression
- Being tested
- Remi, AI avatar-led cognitive behavioural therapy intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remi, AI avatar-led cognitive behavioural therapy interventionBehavioural
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:
- Session 1-2: Psychoeducation on depression and the role of CBT.
- Session 3-4: Cognitive restructuring techniques to challenge negative thought patterns.
- 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
| Study group | Role | What they receive |
|---|---|---|
| AI-avatar led CBT course | Experimental | Not described Receives: Behavioral: Remi, AI avatar-led cognitive behavioural therapy intervention |
| Treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression (PHQ-9)
Measured: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Secondary outcomes (6)
Anxiety (GAD-7)
Measured: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Absenteeism
- Absenteeism In the past month, approximately how many days of work did you miss due to your mental health? [Numeric response]
Measured: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Productivity
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]
Measured: 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
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)
Measured: 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
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)
Measured: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Job Satisfaction
Job Satisfaction Overall, how satisfied have you felt with your job in the past month? (0 = Not satisfied at all, 10 = Completely satisfied)
Measured: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start7 Oct 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Vowels, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436117
- Sponsor's protocol ID
- PSYC 25-523
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact AI Avatar-led Mental Health Interventions for Keeping Employees in Work
- ClinicalTrials.gov ID
- NCT07436117
- Acronym / sponsor ID
- PSYC 25-523
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Feb 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-avatar led CBT course | Experimental | Behavioral: Remi, AI avatar-led cognitive behavioural therapy intervention |
| Treatment as usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Remi, AI avatar-led cognitive behavioural therapy interventionThe 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 | Behavioural | AI-avatar led CBT course |
Primary outcome
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
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 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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 Remi, AI avatar-led cognitive behavioural therapy intervention in people with Depression, run by University of Roehampton at 1 site in United Kingdom.
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 3 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: looking for participants now, as of the sponsor's last update on 27 Feb 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 Kingdom. 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 Laura M Vowels, PhD (+447858024296, laura.vowels@roehampton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 27 Feb 2026.