Use of a Generative AI (Gen-AI) Chatbot for Anxiety and Depression Among Persons With Cannabis Use

Trustees of Dartmouth College

Status and phase: Enrolling; Phase 1

Conditions: Cannabis Use Disorder; Depression, Anxiety; Anxiety; Depression - Major Depressive Disorder

Treatments: Device: Therabot-CALM

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06920238

5P30DA029926-14 (U.S. NIH Grant/Contract)

STUDY00033219

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Therabot-CALM

Experimental group

Description:

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.

Treatment:

Device: Therabot-CALM