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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07436117
Enrollment
50
Registered
2026-02-27
Start date
2025-10-07
Completion date
2026-06-30
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief 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. 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.

Interventions

BEHAVIORALRemi, 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

Sponsors

University of Roehampton
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Depression (PHQ-9)First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.

Secondary

MeasureTime frameDescription
Anxiety (GAD-7)First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
AbsenteeismFirst 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? \[Numeric response\]
ProductivityFirst 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) \[Sliding scale or numeric response\]
Concentration at WorkFirst 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)
Relationships with ColleaguesFirst 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)
Job SatisfactionFirst 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)

Countries

United Kingdom

Contacts

CONTACTLaura M Vowels, PhD
laura.vowels@roehampton.ac.uk+447858024296

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026