Gut-directed Hypnotherapy for IBS in Ehlers-Danlos Syndrome

Overseen By Misbah Salim Salim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Lower bowel disease, Major GI surgery, Serious mental illness, others

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

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if gut-directed hypnotherapy can help manage symptoms of Irritable Bowel Syndrome (IBS) in individuals with Ehlers-Danlos Syndrome or Generalized Hypermobility Spectrum Disorders. Participants will receive either standard medical treatment or standard treatment plus eight sessions of hypnotherapy, a deep relaxation method focused on easing gut discomfort. Researchers seek to discover if hypnotherapy leads to improved IBS symptoms, better quality of life, and reduced stress. This trial suits individuals diagnosed with both IBS and either Ehlers-Danlos Syndrome or a similar connective tissue disorder who are already on stable IBS medication. As an unphased trial, it offers a unique opportunity to explore new therapeutic options for managing IBS symptoms.

What prior data suggests that gut-directed hypnotherapy is safe for managing IBS in individuals with EDS or G-HSD?

Research has shown that gut-directed hypnotherapy is generally safe for people with IBS (Irritable Bowel Syndrome). Studies indicate it can ease symptoms without causing major side effects. One review found that this therapy improved pain symptoms more effectively than other IBS treatments. Most patients tolerated the therapy well, with few reports of negative effects.

Since this trial includes people with Ehlers-Danlos Syndromes, it's important to note that the therapy has been used in similar groups without major safety concerns. Participants usually feel calm and relaxed during sessions, making the process comfortable. Overall, gut-directed hypnotherapy is considered safe for IBS patients, including those with conditions like Ehlers-Danlos Syndromes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Gut-directed hypnotherapy is unique because it offers a mind-body approach to treating IBS in patients with Ehlers-Danlos Syndrome, which is not typically addressed by standard medical therapies. While traditional treatments like dietary changes and medications focus on physical symptoms, hypnotherapy targets the gut-brain axis, aiming to improve abdominal comfort and normalize gut function through relaxation and mental suggestions. Researchers are excited about this method because it has the potential to complement existing therapies by addressing the psychological and neurological aspects of IBS, which might lead to more comprehensive symptom relief.

What evidence suggests that gut-directed hypnotherapy is effective for IBS in Ehlers-Danlos Syndrome?

This trial will compare Standard Medical Therapy with Standard Medical Therapy plus Gut-Directed Hypnotherapy for IBS in Ehlers-Danlos Syndrome. Studies have shown that gut-focused hypnotherapy can improve IBS symptoms, especially pain. Research indicates that many patients experience relief from IBS symptoms after this treatment. Specifically, the Manchester group found that six sessions of gut-focused hypnosis significantly improved IBS symptoms. Additionally, remote sessions of this therapy have proven effective and well-received. Although keeping patients engaged may pose challenges, this therapy shows promise for those dealing with difficult gut-brain disorders like IBS. ^{1 4 5 6 7}

Who Is on the Research Team?

Louis Liu

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for individuals with Ehlers-Danlos Syndromes or Generalized Hypermobility Spectrum Disorders who also have Irritable Bowel Syndrome. They must be on a stable IBS medication dose for 4 weeks before joining and able to understand English well. People with certain bowel diseases, major gut surgery history, serious mental illness, cognitive issues, or heavy alcohol use cannot participate.

Inclusion Criteria

I have been diagnosed with Ehlers-Danlos Syndrome or Generalized Hypermobility Spectrum Disorder.

My doctor diagnosed me with Irritable Bowel Syndrome.

I have been on a stable dose of my IBS medication for at least 4 weeks.

Exclusion Criteria

Patients with a known history of serious mental illness (e.g., schizophrenia, dissociative identity disorder)

I have cognitive issues that affect my understanding.

Patients with limited comprehension of English or hearing difficulty who would not be able to understand the verbal instructions for clinical hypnosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard medical therapy, with some receiving additional gut-directed hypnotherapy over eight weekly sessions

9 weeks

3 visits (in-person), 8 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Gut-directed hypnotherapy

Trial Overview The study tests if gut-directed hypnotherapy plus standard medical therapy improves IBS symptoms in patients with EDS/G-HSD compared to standard therapy alone. Participants will either receive regular doctor visits or the same visits plus eight sessions of hypnotherapy aimed at relaxing the gut and improving its function.

How Is the Trial Designed?

Group I: Standard Medical Therapy plus Gut-Directed Hypnotherapy Experimental Treatment 2 Interventions

In addition to Standard Medical Therapy, participants randomized to this arm will attend 8 sessions of gut-directed hypnotherapy by a trained behavioral therapist. The treatment protocol developed for the proposed study was adapted from the empirically-supported Manchester Protocol for gut-directed hypnotherapy. At each visit, a voluntary, pleasant, and dream-like state of deep relaxation will be induced and suggestions made for greater relaxation, abdominal comfort, and normalization of gut function. The first session will be 90 minutes in duration and the remaining sessions will be 60 minutes. At the first session, participants will be provided with 30 minutes of education on the nature of the gut-brain axis and hypnotherapy before they undergo hypnotherapy.

Group II: Standard Medical Therapy Experimental Treatment 1 Intervention

Standard Medical Treatment will be administered by board certified gastroenterologists through the EDS Clinic gastroenterology clinical care pathway. Therapies will be individualized to the participants' current symptoms and severity of symptoms as per current clinical guidelines for management of IBS. Potential therapies that may be administered include dietary changes, supplemental fibre, and pharmacotherapy (including neuromodulators) as appropriate.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40179285/

Gut-Directed Hypnotherapy for Irritable Bowel Syndrome Conclusion: Gut-directed hypnotherapy may improve global symptoms of IBS. In particular, GDH improved pain symptoms compared to other standard ...

2. ctv.veeva.com ctv.veeva.com/study/rct-of-gut-directed-hypnotherapy-in-ehlers-danlos-syndromes-and-generalized-hypermobility-spectrum-d

RCT of Gut-directed Hypnotherapy in Ehlers-Danlos ... This randomized, controlled trial (RCT) will evaluate the effectiveness of gut-directed hypnotherapy for management of Irritable Bowel ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11095959/

Gut-Directed Hypnotherapy May Pose Specific Challenges ... While gut-directed hypnotherapy is effective for refractory disorders of gut-brain interaction, the required internal awareness and vulnerability may be ...

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1389911/full

Gut-directed hypnosis and hypnotherapy for irritable bowel ... The Manchester group has demonstrated in a RCT with 444 patients that six sessions of gut-directed hypnosis led to similar levels of improvement ...

5. gut.bmj.com gut.bmj.com/content/gutjnl/71/Suppl_1/A183.2.full.pdf

Abstracts Conclusion Remote gut-directed hypnotherapy for IBS has been well received by patients and has been effective in pro- viding effective treatment ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06297785

Online, Gut-directed Hypnotherapy for Patients With ... Adult IBS patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups.

7. withpower.com withpower.com/trial/phase-gastrointestinal-dysfunction-3-2024-81614

Gut-directed Hypnotherapy for IBS in Ehlers-Danlos ... This randomized, controlled trial (RCT) will evaluate the effectiveness of gut-directed hypnotherapy for management of Irritable Bowel Syndrome (IBS) in ...