Evaluating the Impact AI Avatar-led Mental Health Interventions for Keeping Employees in Work
ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Roehampton
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Remi, AI avatar-led cognitive behavioural therapy intervention
BehavioralThe 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
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: AI-avatar led CBT courseExperimental treatment 1 intervention
Group B: Treatment as usualNo intervention 0 interventions
Trial outcomes
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
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov