Therabot-CALM for Anxiety and Depression

Overseen By Amanda C Collins, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Trustees of Dartmouth College

Disqualifiers: Psychosis, STBs risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how people feel about using Therabot-CALM, an app designed to assist with cannabis use disorder (a pattern of cannabis use that leads to problems) and symptoms of anxiety or depression. The research aims to determine if the app is user-friendly and effective in improving these conditions. Participants will test the app for four weeks and provide feedback. Individuals who regularly use cannabis, experience anxiety or depression, and have internet access might be a good fit for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative app.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Therabot-CALM is safe for users with cannabis use disorder and anxiety and/or depression?

Research has shown that Therabot-CALM, a therapy chatbot, might help reduce symptoms of anxiety and depression. In an earlier study, participants with generalized anxiety experienced an average symptom reduction of 31%, with many moving from moderate to mild anxiety.

While these results are promising, it's important to remember that this trial is still in its early stages, so information about its safety remains limited. However, early trials like this often suggest that the treatment is somewhat well-tolerated, as it has already passed initial lab tests.

In summary, Therabot-CALM has shown potential in reducing anxiety and depression symptoms. Although more information is needed to fully understand its safety, early results are encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Therabot-CALM is unique because it offers a digital, interactive approach to managing anxiety and depression, unlike traditional treatments like medication and cognitive-behavioral therapy. This treatment allows participants to engage with a therapeutic robot as much or as little as they want, providing a customizable and potentially more accessible form of support. Researchers are excited about Therabot-CALM because it could provide immediate, personalized interaction and support, potentially reducing the time it takes for individuals to feel better and improving accessibility for those who might struggle with traditional therapy formats.

What evidence suggests that Therabot-CALM might be an effective treatment for anxiety and depression?

Research has shown that therapy chatbots like Therabot-CALM can help reduce symptoms of anxiety and depression. In one study, users experienced a 31% drop in anxiety symptoms. Another study found a 51% decrease in symptoms of major depressive disorder (MDD) after using Therabot. These chatbots use artificial intelligence to interact with users, offering support and tips for managing mental health. This trial will specifically evaluate the ease and acceptability of using Therabot-CALM. While this trial focuses on usability, past results suggest it could also assist people with cannabis use disorder and related anxiety or depression. ^{1 2 3 6 7}

Who Is on the Research Team?

Nicholas C Jacobson, Ph.D.

Principal Investigator

Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College

Are You a Good Fit for This Trial?

This trial is for individuals with cannabis use disorder who also experience anxiety and/or depression. Participants will be screened, provide feedback on app design, engage with the Therabot-CALM chatbot over four weeks, and discuss their experiences in interviews.

Inclusion Criteria

Meets criteria for current Cannabis Use Disorder (CUD) (CUDIT-R>=12) and Major Depressive Disorder (MDD) (PHQ-9>=10), and/or Generalized Anxiety Disorder (GAD) (GAD-7>=10)

Has reliable access to the internet and a compatible device for Therabot-CALM

Attends the first interview

Exclusion Criteria

Current psychosis as determined by brief psychosis screen

Moderate to High risk of Suicidal Thoughts and Behaviors (STBs) as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) or baseline questionnaires

Current participation in another digital mental health intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

2 virtual visits

Interviews

Participants engage in two virtual 1-hour interviews to provide feedback on app design and suggest features

2 weeks

2 virtual visits

Treatment

Participants engage with Therabot-CALM in a 4-week clinical trial and provide feedback on their app experience

4 weeks

1 virtual visit

Follow-up

Participants complete post-intervention measures and provide feedback on their experience with Therabot-CALM

2 weeks

1 virtual visit

What Are the Treatments Tested in This Trial?

Interventions

• Therabot-CALM

Trial Overview The study tests Therabot-CALM's usability and effectiveness in improving symptoms of anxiety and depression among those using cannabis. It involves initial screening, virtual interviews for app feedback, and a 4-week period of using the chatbot.

How Is the Trial Designed?

Group I: Therabot-CALM Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Trustees of Dartmouth College

Lead Sponsor

Trials

32

Recruited

14,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A computer-aided self-help clinic effectively increased the number of anxious and depressed patients treated per clinician while reducing the time each patient spent with a clinician, without compromising treatment effectiveness.

Patients showed improvement using one of four computer-aided cognitive behavior therapy (CBT) systems for various anxiety and mood disorders, highlighting the potential for these systems to enhance accessibility and reduce stigma associated with mental health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-aided CBT self-help for anxiety and depressive disorders: experience of a London clinic and future directions. Gega, L., Marks, I., Mataix-Cols, D.[2022]

Chatbots can effectively support patients with anxiety and depression, serving as affordable and efficient virtual assistants, especially in areas with limited mental health resources.

Out of 42 studies reviewed, about 60% of chatbots targeted both anxiety and depression, indicating their versatility in addressing multiple mental health issues, while their role in mental health care is expected to grow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chatbot features for anxiety and depression: A scoping review. Ahmed, A., Hassan, A., Aziz, S., et al.[2023]

A survey of 36 NHS e-therapy app developers revealed that a majority of both web (12 out of 13) and smartphone apps (20 out of 34) involved clinical expertise in their development, indicating a focus on safety and efficacy.

Most apps also demonstrated academic involvement and had published research backing their effectiveness, with many incorporating psychological theories, which suggests a commitment to using evidence-based practices in their design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

e-Therapies in England for stress, anxiety or depression: how are apps developed? A survey of NHS e-therapy developers. Bennion, MR., Hardy, GE., Moore, RK., et al.[2020]

Citations

1. home.dartmouth.edu home.dartmouth.edu/news/2025/03/first-therapy-chatbot-trial-yields-mental-health-benefits

First Therapy Chatbot Trial Yields Mental Health Benefits Participants with generalized anxiety reported an average reduction in symptoms of 31%, with many shifting from moderate to mild anxiety, or ...

2. apsa.org apsa.org/are-therapy-chatbots-effective-for-depression-and-anxiety/

Are Therapy Chatbots Effective for Depression and Anxiety ... The therapeutic effectiveness of artificial intelligence-based chatbots in alleviation of depressive and anxiety symptoms in short-course treatments.

3. apaservices.org apaservices.org/practice/business/technology/on-the-horizon/mental-health-chatbot

Study demonstrates utility of GenAI chatbot for treating mental ... At the 8-week follow up, Therabot users reported a 51% reduction in MDD symptoms, a 31% reduction in GAD symptoms, and a 19% reduction in CHR- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06920238

Use of a Generative AI (Gen-AI) Chatbot for Anxiety and ... 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 ...

5. ai.nejm.org ai.nejm.org/doi/abs/10.1056/AIoa2400802

Randomized Trial of a Generative AI Chatbot for Mental ... Therabot users showed significantly greater reductions in symptoms of MDD (mean changes: −6.13 [standard deviation {SD}=6.12] vs. −2.63 [6.03] at 4 weeks; −7.93 ...

6. nytimes.com nytimes.com/2025/04/15/health/ai-therapist-mental-health.html

This Therapist Helped Clients Feel Better. It Was A.I. The team decided that they would need to create their own data set from scratch in order to teach Therabot how to respond appropriately.

7. researchgate.net researchgate.net/publication/381455152_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

(PDF) Evaluating Therabot: A Randomized Control Trial ... This is the first RCT demonstrating the effectiveness of a fully Gen-AI therapy chatbot for treating mental health disorders.