Clinical trial NCT06920238: Use of a Generative AI (Gen-AI) Chatbot for Anxiety and Depression Among Persons With Cannabis Use
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cannabis Use Disorder
Anxiety
Depression, Anxiety
Depression - Major Depressive Disorder
Keywords: Artifical Intelligence
Generative AI
Generative Artificial Intelligence
Therabot
Therabot-CALM
Cannabis Use Disorder
Anxiety
Depression
Chatbot
Cannabis Use
Drug Abuse
Drug Use
Drug Use Disorder
Interview
Screening
Application
REDCap
post-intervention measures
System Usability Scale
Treatment Acceptability and Adherence Scale
Cannabis Use Disorders Identification Test - Revised
Cannabis Use Disorders Identification Test
Quantity of Cannabis Use Inventory
Patient Health Questionnaire for depression
generalized anxiety disorder screener
DSM-5
Zoom
Lead sponsor: Trustees of Dartmouth College
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-04-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Therabot-CALM Model
Primary purpose: DEVICE_FEASIBILITY

Brief 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

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.

Eligibility 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.

Primary outcomes:
measure: Feasibility
timeFrame: From enrollment to the end of the third interview at around 10 months
measure: Usability
timeFrame: From enrollment to the end of the third interview at around 10 months
measure: Acceptability
timeFrame: From enrollment to the end of the third interview at around 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: 46 Centerra Parkway, Suite 300, Office #333S
state: New Hampshire
Study officials:
affiliation: Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College
name: Nicholas C Jacobson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heinz, M. V., Mackin, D., Trudeau, B., Bhattacharya, S., Wang, Y., Banta, H. A., Jewett, A. D., Salzhauer, A., Griffin, T., & Jacobson, N. C. (2024). Evaluating Therabot: A Randomized Control Trial Investigating the Feasibility and Effectiveness of a Generative AI Therapy Chatbot for Depression, Anxiety, and Eating Disorder Symptom Treatment. OSF. https://doi.org/10.31234/osf.io/pjqmr
citation: Collins AC, Bhattacharya S, Oh JY, Salzhauer A, Taylor CT, Wolitzky-Taylor K, Aupperle RL, Budney AJ, Jacobson NC. Inclusion of Individuals With Lived Experiences in the Development of a Digital Intervention for Co-Occurring Depression and Cannabis Use: Mixed Methods Investigation. JMIR Form Res. 2024 Oct 7;8:e54751. doi: 10.2196/54751.