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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laura M Vowels, PhD
- Phone Number: +447858024296
- Email: laura.vowels@roehampton.ac.uk
Study Locations
-
-
-
London, United Kingdom, SW15 4JD
- Recruiting
- University of Roehampton
-
Contact:
- Laura M Vowels, PhD
- Phone Number: +447858024296
- Email: laura.vowels@roehampton.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Treatment as usual
|
|
|
Experimental: AI-avatar led CBT course
|
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:
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
|
|
|
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.
|
1. Absenteeism In the past month, approximately how many days of work did you miss due to your mental health?
[Numeric response]
|
First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
|
|
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]
|
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
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)
|
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
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)
|
First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
|
|
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)
|
First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSYC 25-523
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.