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NCT Number: NCT07436117

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Roehampton

London, SW15 4JD, United Kingdom

Location status: Recruiting

Location contact

Laura M Vowels, PhD

CONTACT

[email protected]

+447858024296

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remi, AI avatar-led cognitive behavioural therapy intervention

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

    • Absenteeism In the past month, approximately how many days of work did you miss due to your mental health? [Numeric response]

  3. 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]

  4. 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)

  5. 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)

  6. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Laura M Vowels, PhD

CONTACT

[email protected]

+447858024296

Sponsors and collaborators

Lead sponsor

University of Roehampton

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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