Use of a Generative AI (Gen-AI) Chatbot for Anxiety and Depression Among Persons With Cannabis Use
Purpose
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
Conditions
- Cannabis Use Disorder
- Anxiety
- Depression, Anxiety
- Depression - Major Depressive Disorder
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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 another digital mental health intervention.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Therabot-CALM Model
- Primary Purpose
- Device Feasibility
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Therabot-CALM |
Participants will engage in three one-hour interviews and a 4-week clinical trial where they may interact with Therabot-CALM as much or as little as they want. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Trustees of Dartmouth College
Detailed 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-intervention measures delivered via REDCap, including the System Usability Scale (SUS), Treatment Acceptability and Adherence Scale (TAAS), Cannabis Use Disorders Identification Test - Revised (CUDIT-R), the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU), the 9-item Patient Health Questionnaire for depression (PHQ-9), and the 7-item generalized anxiety disorder screener for DSM-5 (GAD-7). Participants will then be asked to return for a third interview to provide feedback on their experience with Therabot-CALM. Researchers will use the IDEAS (Innovate, Develop, Evaluate, Adapt, Scale) Impact Framework to plan and conduct three, one-on-one interviews with a trained research assistant (RA). Each interview script will be developed using the IDEAS Impact Framework and follow a semi-structured design, such that the RA will follow a set of questions, with as-needed probing for follow-up. Interviews will be recorded via a virtual platform.
