Digital Support for Inflammatory Bowel Disease

Overseen By David T Rubin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Severe motion sickness, Seizures, Pregnant, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a digital wellness app using AI (artificial intelligence) and VR (virtual reality) can assist individuals with inflammatory bowel disease (IBD) who also experience mild to moderate anxiety or depression. The main goal is to determine if the mental health support session delivered through the app is safe, user-friendly, and effective in managing symptoms. Ideal participants include those with IBD, such as Crohn's Disease or Ulcerative Colitis, who experience anxiety or depression and can speak English. As an unphased study, this trial provides a unique opportunity to explore innovative digital therapies for mental health support.

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 prior data suggests that this digital wellness application is safe for IBD patients with anxiety or depression?

Research shows that digital mental health tools, such as smartphone apps and virtual reality, are increasingly used to treat mental health issues. Studies have examined their safety and ease of use.

Digital wellness apps are generally considered safe, with few side effects, as they do not involve medications or surgeries, making them a low-risk option for many.

However, this study is in its early stages and focuses on assessing the app's practicality and safety for individuals with inflammatory bowel disease (IBD) who also experience anxiety or depression.

Previous research in digital mental health suggests that most people can use these tools without issues. Yet, since this study is in its early phase, more information is needed to fully understand the app's safety and effectiveness for IBD patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Support for Mental Health Intervention for patients with Inflammatory Bowel Disease (IBD) because it uniquely addresses mental health aspects through a digital platform. Unlike traditional treatments for IBD, which typically focus on physical symptoms with medications like anti-inflammatories or immunosuppressants, this approach targets the mental health challenges such as anxiety and depression that often accompany IBD. By providing support digitally, it offers a convenient and accessible way for patients to manage their mental health, potentially improving overall quality of life without the side effects associated with conventional medications.

What evidence suggests that this digital wellness application is effective for mental health support in IBD patients?

Research has shown that digital tools like AI and VR apps can help manage anxiety and depression by creating experiences similar to therapy. Studies have found that these apps can lessen symptoms of anxiety and depression. This trial will evaluate a digital support app specifically for patients with inflammatory bowel disease (IBD) who self-report mild to moderate levels of anxiety or depression. Although this app is still being tested, early findings suggest it could be a safe and effective way to improve mental well-being for individuals with long-term conditions like IBD. ^{1 2 4 6 7}

Who Is on the Research Team?

David T Rubin, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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

Non-English speakers

Having had a seizure in the past year

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Digital Support for Mental Health 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.

How Is the Trial Designed?

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+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

Published Research Related to This Trial

Digital health applications in mental health care for immigrants and refugees show promise, with participants reporting satisfaction and improvements in symptoms of anxiety, depression, and PTSD across 16 reviewed studies.

Despite their effectiveness, ethical standards in the implementation and reporting of these digital health applications are lacking, and challenges such as stigma and technology literacy hinder their scalability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Health Applications in Mental Health Care for Immigrants and Refugees: A Rapid Review. Liem, A., Natari, RB., Jimmy, ., et al.[2021]

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]

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]

Digital technology can significantly improve mental healthcare by providing better access to information and services, as well as enabling real-time monitoring of patient data for enhanced clinical management.

There is a critical need for more research and collaboration between patients and clinicians to evaluate these digital tools effectively, ensuring they meet real needs and improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technological innovations in mental healthcare: harnessing the digital revolution. Hollis, C., Morriss, R., Martin, J., et al.[2022]

The Patients First initiative uses the CareSense platform to combine patient-reported outcomes with biological monitoring, allowing for real-time feedback on symptoms like stress, anxiety, and depression, which enhances patient engagement and care delivery.

This project is pioneering in integrating digital therapeutics and providing video resources to primary care providers, enabling them to respond effectively when patients show signs of symptom severity, marking a significant advancement in psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Psychiatric Care Through Integrated Digital Technologies. Fowler, JC., Madan, A., Bruce, CR., et al.[2023]

Digital mental health applications (DMHAs) have been shown to provide a modest reduction in anxiety (effect size g = 0.31) and depressive symptoms (effect size g = 0.35) based on a meta-analysis of randomized controlled trials, indicating their potential as effective interventions.

Several factors, such as treatment duration and participant characteristics, influence the effectiveness of DMHAs, suggesting that careful consideration is needed for their implementation in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of stand-alone digital mental health applications for anxiety and depression: A meta-analysis of randomized controlled trials. Seegan, PL., Miller, MJ., Heliste, JL., et al.[2023]

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]

A systematic review of 12 studies found that immersive virtual reality (VR) interventions can effectively target various symptom domains of schizophrenia spectrum disorders, showing positive treatment effects with minimal adverse effects.

Currently, there is a notable lack of research on augmented reality (AR) technologies in treating schizophrenia, highlighting a significant gap in the exploration of this potential therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of immersive extended reality (XR) interventions on different symptom domains of schizophrenia spectrum disorders. A systematic review. Holopainen, R., Tiihonen, J., Lähteenvuo, M.[2023]

A comprehensive overview of 246 reviews highlights the effectiveness of various digital and technological interventions for mental health and wellbeing, emphasizing the predominance of psychotherapeutic approaches using computers and smartphones.

Smartphone applications primarily focus on self-help, while extended reality technologies are emerging as a significant area of research, indicating a diverse landscape of interventions that can enhance care and user involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technological and Digital Interventions for Mental Health and Wellbeing: An Overview of Systematic Reviews. De Witte, NAJ., Joris, S., Van Assche, E., et al.[2022]

The study involved 255 adults using the Woebot LIFE app over 8 weeks, revealing that while many participants lived in medically underserved areas (MUAs) or mental health provider shortage areas (MHPSAs), there were no significant differences in app use, satisfaction, or mental health outcomes based on these statuses.

Participants from MUAs showed higher baseline depressive symptoms and reported stronger therapeutic alliance scores, particularly in goal-setting and bonding, suggesting that digital mental health interventions like Woebot LIFE may be beneficial for vulnerable populations in managing their mental health.

NCBI (Pubmed)

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. Forman-Hoffman, VL., Pirner, MC., Flom, M., et al.[2023]

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]

Citations

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Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/537315

Digital Support for Mental Health Intervention in Patients ... This is a small, exploratory study that will investigate using an artificial intelligence (AI) and virtual reality (VR), digital wellness application (app) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12079407/

Digital mental health: evidence, apps, AI, VR The expanding domain of digital mental health is transitioning beyond traditional telehealth to incorporate smartphone apps, virtual reality, and generative ...

4. trial.medpath.com trial.medpath.com/clinical-trial/dfea44e38b67cf2a/nct06575660-digital-support-mental-health-intervention-inflammatory-bowel-disease

Digital Support for Mental Health Intervention in Patients With ... This is a small, exploratory study that will investigate using an artificial intelligence (AI) and virtual reality (VR), digital wellness applica...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06575660/digital-support-for-mental-health-intervention-in-patients-with-inflammatory-bowel-disease

Digital Support for Mental Health Intervention in Patients ... This is a small, exploratory study that will investigate using an artificial intelligence (AI) and virtual reality (VR), digital wellness ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/537315

Digital Support for Mental Health Intervention in Patients ... 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 ...

7. withpower.com withpower.com/trial/digital-support-for-inflammatory-bowel-disease-c764c

Digital Support for Inflammatory Bowel Disease 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 ...