An interventional study of Remi, AI avatar-led cognitive behavioural therapy intervention in Depression, sponsored by University of Roehampton. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by University of Roehampton · Not applicable, Interventional, and Treatment
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 50 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University of Roehampton is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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
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.
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
1\. Absenteeism In the past month, approximately how many days of work did you miss due to your mental health? \[Numeric response\]
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
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) \[Sliding scale or numeric response\]
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
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)
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
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)
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
Job Satisfaction Overall, how satisfied have you felt with your job in the past month? (0 = Not satisfied at all, 10 = Completely satisfied)
Time frame: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
Plan to share: Undecided
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University of Roehampton