Healing Circuits™ for Inflammatory Bowel Disease

Overseen By Ajani Jeyakumar, HBSc BScN RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TIDHI Innovation Inc.

Disqualifiers: Schizophrenia, Bipolar, Drug abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the impact of Healing Circuits™, a structured mental health support model, on individuals with Inflammatory Bowel Disease (IBD). Participants will be divided into two groups: one will meet with a social worker, while the other will follow an online self-directed curriculum. The goal is to assess how these different methods help manage IBD over 12 months. The trial seeks individuals with IBD who receive ongoing medical care at TIDHI and experience mild to moderate anxiety or depression. As an unphased trial, it offers a unique opportunity to explore innovative mental health support methods for managing IBD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you cannot participate if you plan to change your IBD-related or psychiatric medications within 3 months after screening.

What prior data suggests that the Healing Circuits™ method is safe for IBD patients?

Research on Healing Circuits™ shows that this treatment supports mental health for people with Inflammatory Bowel Disease (IBD). It includes structured therapy sessions to help manage the stress and emotional challenges of living with IBD. Since Healing Circuits™ focuses on mental health support, it does not involve new medications or physical treatments, which usually means fewer risks and side effects.

Previous studies on mental health support therapies like Healing Circuits™ have found them to be well-tolerated. These treatments typically do not report significant negative effects because they do not involve drugs or surgery. Instead, they aim to improve mental well-being, which can positively impact physical health.

In this trial, participants divide into two groups: one with sessions led by a social worker and another with self-directed online modules. Both groups use the same Healing Circuits™ method, known for its structured support. While specific safety data for Healing Circuits™ is limited, mental health therapies are generally considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Healing Circuits™ is unique because it focuses on the mind-body connection through sessions with a social worker using specific methodologies and self-directed online modules. Unlike traditional treatments for inflammatory bowel disease, which often rely on medication to reduce inflammation, this approach emphasizes behavioral and cognitive techniques that might help manage symptoms by reducing stress and improving emotional well-being. Researchers are excited about this trial because it explores a holistic way to support individuals with inflammatory bowel disease, potentially offering a non-pharmacological option that could complement existing treatments and improve overall quality of life.

What evidence suggests that Healing Circuits™ is effective for inflammatory bowel disease?

Research has shown that mental health support is important for managing Inflammatory Bowel Disease (IBD). This trial will evaluate two approaches using the Healing Circuits™ methodology. One group of participants will receive sessions with a social worker based on this methodology, while another group will engage with online modules of a self-directed Healing Circuits™ curriculum. Studies have found that therapy focused on mental health, like Healing Circuits™, might improve the well-being of people with IBD. Healing Circuits™ offers structured mental health support, which could lower stress and enhance quality of life. Although specific data on Healing Circuits™ is limited, similar mental health programs have shown promising results in reducing stress and improving mood. This suggests that Healing Circuits™ may benefit those with IBD. ^{1 6 7 8 9}

Who Is on the Research Team?

Mark Silverberg, MD, PhD

Principal Investigator

TIDHI Innovation Inc.

Marci Reiss, DSW

Principal Investigator

TIDHI Innovation Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. Participants should be interested in a mental health support program called Healing Circuits™.

Inclusion Criteria

IBD patients who plan to have ongoing medical care at TIDHI

GAD7 and/or PHQ9 score of 10 - 15

I can fully participate in all parts of this clinical trial.

Exclusion Criteria

History of illegal drug abuse (excluding marijuana) or alcohol abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures

Serious underlying psychiatric disorder such as schizophrenia or bipolar disorder

I plan to change my IBD medication within 3 months after screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive structured mental health support through Healing Circuits™ for 12 months, either with a social worker or via an online curriculum

12 months

Follow-up

Participants are monitored for changes in anxiety and depression scores after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Healing Circuits™

Trial Overview The study tests the impact of Healing Circuits™ on IBD patients' mental health. One group gets structured support from a social worker, while another uses a self-directed online curriculum over 12 months.

How Is the Trial Designed?

Group I: Sessions with a social worker based on Healing Circuits™ Methodology Experimental Treatment 1 Intervention

Group II: Online modules of a self-directed Healing Circuits™ curriculum Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

TIDHI Innovation Inc.

Lead Sponsor

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Celltrion

Industry Sponsor

Trials

78

Recruited

50,500+

Founded

2002

Headquarters

Incheon, South Korea

Known For

Biosimilar innovations

Top Products

Remsima™, Truxima™, Herzuma™

Citations

1. withpower.com withpower.com/trial/phase-inflammatory-bowel-diseases-6-2025-d7959

Healing Circuits™ for Inflammatory Bowel Disease The purpose of this study is to test the impact of Healing Circuits™; a structured mental health support model on IBD patients.

2. crohnscolitisfoundation.org crohnscolitisfoundation.org/blog/ibd-innovate-2021-accelerating-solutions-ibd

IBD Innovate 2021: Accelerating solutions for people with IBD Researchers have long agreed that being able to repair disease or inflammation in the digestive tract lining (mucosal healing) could reduce IBD ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4391663/

Experiences of healing therapy in patients with irritable bowel ... The aim of this research is to consider patients perceptions and experiences following a course of healing therapy.

4. eureka.patsnap.com eureka.patsnap.com/report-exploring-bioresonance-therapy-s-impact-on-inflammatory-disorders

Exploring Bioresonance Therapy's Impact on Inflammatory ... A double-blind, placebo-controlled study on patients with inflammatory bowel disease found no statistically significant difference in symptom ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/17474124.2025.2508970?src=

Full article: Management of inflammatory bowel disease This article examines the significance of patient-physician communication, disease-specific education, mental health support, exercise, and diet in IBD ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12281438/

Endoscopic healing in pediatric IBD perpetuates ... Endoscopic healing (EH) is the major long-term treatment target for inflammatory bowel diseases (IBDs), mainly achieved by immune-suppressive ...

7. montefioreeinstein.org montefioreeinstein.org/patient-care/services/psychiatry/research/psychiatry-research-institute-prime/nicola-lab-neural-circuits-motivation-arousal

Neural Circuits for Motivation & Arousal Laboratory The Neural Circuits for Motivation and Arousal Laboratory at the Psychiatry Research Institute at Montefiore Einstein (PRIME) is a specialized program ...

8. gut.bmj.com gut.bmj.com/content/early/2025/10/06/gutjnl-2023-330000

Rise of precision medicine: can it deliver on its promise in ... Adopting this dynamic, data-driven approach to treatment adaptation could shift management of IBD from reactive to proactive and substantially improve long-term ...

9. mdpi.com mdpi.com/2077-0383/14/17/6119

Emerging Therapies in Inflammatory Bowel Disease Early results demonstrated reductions in disease activity and improvement in mucosal healing, but outcomes have been mixed, with some studies showing ...