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

Trial Summary

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 data supports the effectiveness of the treatment Therabot-CALM for anxiety and depression?

Research shows that chatbot-delivered psychotherapy, similar to Therabot-CALM, significantly improves symptoms of depression and anxiety. A meta-analysis of 11 trials found that this type of therapy can be an effective alternative treatment for these conditions. ^{1 2 3 4 5}

How is the treatment Therabot-CALM for anxiety and depression different from other treatments?

Therabot-CALM is unique because it likely involves a chatbot or virtual assistant component, which provides on-demand support for anxiety and depression, making it accessible and efficient, especially when human resources are limited. This approach differs from traditional therapies by offering real-time personal assistance and potentially integrating features from e-therapies and computer-aided self-help. ^{2 5 6 7 8}

What is the purpose of 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

Research Team

Nicholas C Jacobson, Ph.D.

Principal Investigator

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

Eligibility Criteria

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)

Attends the first interview

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Computer-aided CBT self-help for anxiety and depressive disorders: experience of a London clinic and future directions. [2022]

2. England 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. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Chatbot-Delivered Psychotherapy for Adults With Depressive and Anxiety Symptoms: A Systematic Review and Meta-Regression. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Trier Treatment Navigator (TTN) in action: Clinical case study on data-informed psychological therapy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

E-therapies in England for stress, anxiety or depression: what is being used in the NHS? A survey of mental health services. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Chatbot features for anxiety and depression: A scoping review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Pragmatic evaluation of computer-aided self-help for anxiety and depression. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Long-term goals in the management of acute and chronic anxiety disorders. [2022]