Digital Support for Inflammatory Bowel Disease

Recruiting in Palo Alto (17 mi)

Overseen by David T Rubin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Chicago

Disqualifiers: Severe motion sickness, Seizures, Pregnant, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This is a small, exploratory study that will investigate using an artificial intelligence (AI) and virtual reality (VR), digital wellness application (app) to deliver a mental health support session in outpatient and hospitalized patients with inflammatory bowel disease (IBD) and co-existing symptoms of mild to moderate anxiety or depression. The purpose of this study is to explore if a mental health support session using the app is feasible, safe, and acceptable to IBD patients and whether it could possibly help with physical and comorbid psychological symptoms of these patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on using a digital app for mental health support, so it's likely you can continue your current treatments, but please confirm with the study team.

What data supports the effectiveness of the treatment Digital Support for Mental Health Intervention, Digital Wellness Application, AI-VR Mental Health Support App, XAIA for Inflammatory Bowel Disease?

Research shows that digital mental health technologies, like smartphone apps and virtual reality, are promising for improving mental health and well-being. These technologies have been effective in managing conditions like anxiety and depression, suggesting they could also support mental health in people with Inflammatory Bowel Disease. ^{1 2 3 4 5}

Is the digital support treatment generally safe for humans?

Research on digital health technologies, including smartphone apps and virtual reality, shows they are generally safe and well-received by users, with positive outcomes reported for mental health conditions. However, there are concerns about data privacy and the need for better ethical standards in their implementation. ^{1 2 6 7 8}

How is the Digital Support for Mental Health Intervention treatment unique for inflammatory bowel disease?

The Digital Support for Mental Health Intervention is unique because it uses a digital wellness application with AI and virtual reality to support mental health, which is not a standard approach for treating inflammatory bowel disease. This treatment leverages technology to address mental health aspects, potentially improving overall well-being and quality of life for patients. ^{3 8 9 10 11}

Research Team

David T Rubin, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for outpatients or hospitalized patients with Inflammatory Bowel Disease (IBD), such as Ulcerative Colitis or Crohn's Disease, who also have mild to moderate anxiety or depression. Specific eligibility criteria are not provided.

Inclusion Criteria

English-speaking

Patients with score of 5-14 on General Anxiety Disorder-7 (GAD-7) questionnaire or 5-19 on Patient Health Questionnaire-9 (PHQ-9) within 3 months

Able to provide written consent

Exclusion Criteria

The presence of a facial/head deformity that will prohibit comfortably wearing of a VR headset

I am not willing or able to participate in the study.

Non-English speakers

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants engage in a single AI-VR mental health support session using the XAIA app

1 day

1 visit (in-person or virtual)

Follow-up

Participants' experiences and opinions are collected through surveys and semi-structured interviews

1 day

1 visit (in-person or virtual)

Treatment Details

Interventions

• Digital Support for Mental Health Intervention (Behavioral Intervention)

Trial Overview The study explores the use of an AI and VR digital wellness app for mental health support sessions in IBD patients. It aims to assess feasibility, safety, acceptability, and potential benefits on physical and psychological symptoms.

Participant Groups

Group I: Patients with IBD who self-report mild to moderate levels of anxiety or depression Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

David E. Cohen

Cedars-Sinai Medical Center

Chief Medical Officer

MD and PhD in Physiology and Biophysics from Harvard University

Peter L. Slavin

Cedars-Sinai Medical Center

Chief Executive Officer

MD from Harvard Medical School, MBA from Harvard Business School

Findings from Research

Digital mental health technologies, including smartphone apps and virtual reality, are becoming increasingly important in mental health care, offering accessible and scalable interventions that can enhance traditional treatment methods.

Current evidence suggests these technologies show promise in self-managing psychological well-being and early intervention for various mental health conditions, but further efforts are needed to address implementation challenges in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The growing field of digital psychiatry: current evidence and the future of apps, social media, chatbots, and virtual reality. Torous, J., Bucci, S., Bell, IH., et al.[2023]

Mobile health apps have shown promise in reducing symptoms of depression and anxiety, as well as suicidal thoughts, supported by recent meta-analyses.

Despite their potential, barriers such as data governance issues, clinical safety concerns, low user engagement, and integration challenges with traditional healthcare systems hinder widespread adoption, prompting the development of innovative models like 'digital clinics' to enhance accessibility and personalization in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone apps for the treatment of mental health conditions: status and considerations. Huckvale, K., Nicholas, J., Torous, J., et al.[2021]

A pan-Canadian survey revealed that individuals affected by mental health conditions prioritize digital tools that help them navigate both physical and digital mental healthcare systems.

Respondents expressed a strong preference for digital mental health tools that are integrated into their overall care, highlighting the importance of cohesive support in managing mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planning for the Future of Digital Mental Health in Canada: Priorities of Canadians Affected by Mental Health Conditions. Shen, N., Kassam, I., Boparai, N., et al.[2022]

AI-based chatbots, like Happify Health's Anna, are emerging as promising tools in digital mental health interventions (DMHIs) for diagnostics, symptom management, and behavior change, highlighting their potential effectiveness and usability.

Future research should focus on understanding user perceptions of AI, individual differences in responses, and ethical considerations to enhance the integration and impact of AI in mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificially intelligent chatbots in digital mental health interventions: a review. Boucher, EM., Harake, NR., Ward, HE., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Technological and Digital Interventions for Mental Health and Wellbeing: An Overview of Systematic Reviews. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

The growing field of digital psychiatry: current evidence and the future of apps, social media, chatbots, and virtual reality. [2023]

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

Efficacy of stand-alone digital mental health applications for anxiety and depression: A meta-analysis of randomized controlled trials. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Technological innovations in mental healthcare: harnessing the digital revolution. [2022]

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

Improving Psychiatric Care Through Integrated Digital Technologies. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of immersive extended reality (XR) interventions on different symptom domains of schizophrenia spectrum disorders. A systematic review. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Smartphone apps for the treatment of mental health conditions: status and considerations. [2021]

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

Digital Health Applications in Mental Health Care for Immigrants and Refugees: A Rapid Review. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Planning for the Future of Digital Mental Health in Canada: Priorities of Canadians Affected by Mental Health Conditions. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Artificially intelligent chatbots in digital mental health interventions: a review. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Engagement, Satisfaction, and Mental Health Outcomes Across Different Residential Subgroup Users of a Digital Mental Health Relational Agent: Exploratory Single-Arm Study. [2023]