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

Sponsor: University of Roehampton

NCT ID: NCT07436117

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Remi, AI avatar-led cognitive behavioural therapy intervention (behavioural)
How long the study runs
Study runs about 8 months (dates as stated)
About the drug or intervention
Remi, AI avatar-led cognitive behavioural therapy intervention — behavioural: The InsideOut AI programme for low mood is based on principles of Cognitive Behavioral Therapy (CBT), adapted into a self-paced, avatar-led format.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
50
Started
2025-10-07
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for depression
  • • NA - 50 participants
  • • This study will examine whether an artificial intelligence (AI) avatar-led mental health programme can help employees experiencing symptoms of depression

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with depression

Where?

  • • London - University of Roehampton

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Depression

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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 take part

  • ✗Participants with frequent thoughts of suicide/self-harm will be excluded (scoring above 2 on Question 9 of the...
  • ✗Participants who are currently undergoing other forms of therapy will be excluded.
See the full criteria
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.

Where Is This Study? (1 UK site)

University of Roehampton

London SW15 4JD, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Laura M Vowels, PhD

Sponsor contact

CONTACT

+447858024296 laura.vowels@roehampton.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-02