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

NCT07436117 | Recruiting

• 1 other identifier: PSYC 25-523
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

• Absenteeism

  First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.

• Productivity

  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

  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

  First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.

Study Arms (2)

AI-avatar led CBT course

EXPERIMENTAL

Behavioral: Remi, AI avatar-led cognitive behavioural therapy intervention

Treatment as usual

NO INTERVENTION

Interventions

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: 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

AI-avatar led CBT course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roehampton: lead

Study Sites (1)

University of Roehampton

London, SW15 4JD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Laura M Vowels, PhD

CONTACT

+447858024296; laura.vowels@roehampton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 27, 2026
• Study Start: October 7, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

GB (1)