Health TrialsbyHealthPanel

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

ConditionsCannabis Use DisorderAnxietyDepression, AnxietyDepression - Major Depressive Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrustees of Dartmouth College

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Therabot-CALM

    Device

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Therabot-CALMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility

Feasibility of the application is measured by engagement rates of participants. Engagement rates will be quantified based on the frequency and duration of interactions with the application during the clinical trial period.

Time frame
From enrollment to the end of the third interview at around 10 months
2

Usability

Usability is measured by participant responses on the System Usability Scale (SUS). The SUS score will range from 0 to 100, where higher scores indicate better usability.

Time frame
From enrollment to the end of the third interview at around 10 months
3

Acceptability

Acceptability is measured by the Treatment Acceptability and Adherence Scale (TAAS), the Likert-style satisfaction rating scale to assess satisfaction with Therabot-CALM. The TAAS scale will range from 0 to 100, where higher scores indicate higher acceptability. The Likert-style satisfaction rating scale will range from 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.

Time frame
From enrollment to the end of the third interview at around 10 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Trustees of Dartmouth College

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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