Use of a Generative AI (Gen-AI) Chatbot for Anxiety and Depression Among Persons With Cannabis Use
NCT ID: NCT06920238
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2025-04-13
2025-12-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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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.
Therabot-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.
Interventions
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Therabot-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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Current psychosis (as determined by brief psychosis screen).
* Current participation in another digital mental health intervention.
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Trustees of Dartmouth College
OTHER
Responsible Party
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Nicholas Jacobson
Associate Professor
Principal Investigators
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Nicholas C Jacobson, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College
Locations
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46 Centerra Parkway, Suite 300, Office #333S
Lebanon, New Hampshire, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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
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.
Other Identifiers
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STUDY00033219
Identifier Type: -
Identifier Source: org_study_id
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