Using a chatbot to help with anxiety and depression in people with cannabis use disorder
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)
This study tests whether a chatbot can help people with cannabis use disorder who also struggle with anxiety and depression feel better over four weeks.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Trustees of Dartmouth College Academic / other |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT06920238 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the acceptability and effectiveness of Therabot-CALM, a generative AI chatbot designed to assist individuals with cannabis use disorder who also experience anxiety and depression. Participants will undergo a screening process and engage in three virtual interviews, providing feedback on the chatbot's design and functionality. Over a four-week period, they will interact with Therabot-CALM and complete various assessments to measure usability and symptom improvement. The study aims to refine the chatbot based on user feedback and assess its impact on mental health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who meet the criteria for cannabis use disorder and have symptoms of anxiety and/or depression.
Not a fit: Patients with moderate to high risk of suicidal thoughts or behaviors, current psychosis, or those participating in another digital mental health intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel, accessible tool for managing anxiety and depression in individuals with cannabis use disorder.
How similar studies have performed: While the use of AI in mental health interventions is emerging, this specific approach with Therabot-CALM is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 another digital mental health intervention.
Where this trial is running
Lebanon, New Hampshire
- 46 Centerra Parkway, Suite 300, Office #333S — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Nicholas C Jacobson, Ph.D. — Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College
- Study coordinator: Michael V Heinz, MD
- Email: michael.v.heinz@hitchcock.org
- Phone: (603) 277-9110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.