A Phase I Single-Arm Trial to Test the Use of a Generative AI (Gen-AI) Chatbot for Anxiety and Depression Among Persons With Cannabis Use Disorder (CUD)
Trustees of Dartmouth College
Summary
The goal of this clinical trial is to learn if Therabot-CALM (Cannabis, Anxiety, Low Mood) has acceptability among users and could work to improve the symptoms of persons with cannabis use disorder and anxiety and/or depression. The main question it aims to answer is: What is the usability, feasibility, and acceptability of Therabot-CALM in persons with Cannabis Use Disorder and Anxiety and/or Depression? Participants will * Take a screening questionnaire * Participate in two virtual 1-hour interviews to provide feedback on app design and suggest features. * Engage with Therabot-CALM in a 4-week clinical trial and provide feedback on their app experience in a third virtual interview
Description
Participants will complete a two-stage screening process via REDCap to determine their eligibility for enrollment. Participants who meet criteria and provide informed consent will be enrolled and participate in three interviews and the 4-week clinical trial. After the first interview, researchers will fine-tune Therabot-CALM based on feedback received during the interview. After the second interview, experts by experience (EBEs) will engage with Therabot-CALM at least once per day for 4 weeks. After the clinical trial period, participants will receive an email with a link to complete the post…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Is 18 years or older. * Meet criteria for current CUD (CUDIT-R\>=12) and MDD (PHQ-9\>=10), and/or GAD (GAD-7\>=10). * Have reliable access to the internet and a compatible device for Therabot-CALM. * Have willingness and capacity to provide informed consent and commit to participating in all assessments and interventions during the study. * Attend the first interview. Exclusion Criteria: * Moderate to High risk of STBs as determined by the C-SSRS or baseline questionnaires. * Current psychosis (as determined by brief psychosis screen). * Current participation in anothe…
Interventions
- DeviceTherabot-CALM
Therabot is a generative-AI-driven mobile app designed to provide mental health treatment. The feasibility of Therabot-CALM, an adapted Therabot application, is being tested for the future use of treating co-occurring substance use disorders and anxiety and/or depression. The primary purpose of this study is application feasibility.
Location
- 46 Centerra Parkway, Suite 300, Office #333SLebanon, New Hampshire