19 January 2021
IBD and hypnosis trial
Update 11 August 2021: Recruitment for this trial has now ended.
The Royal Adelaide Hospital IBD Service, in conjunction with Deakin University and with input from the University of Adelaide, is currently running a trial on hypnotherapy for patients with Crohn’s Disease. This is a randomized, controlled pilot and feasibility trial of adjunctive gut-directed hypnotherapy. Hypnotherapy is currently used as an effective treatment for people with function gastrointestinal disorders (such as Irritable Bowel Syndrome), but little has been done into its usefulness for people with IBD.
Who is eligible?
Patients are eligible if they:
- Have been diagnosed with Crohn’s Disease.
- Can provide confirmation of active disease.
There are certain exclusions, such as patients with:
- major psychiatric disorders,
- personality disorders,
- history of complex trauma, or
- dissociative symptoms.
Patients currently in, or about to commence, a clinical trial, or those facing surgery, are also not suitable.
What is expected of patients in the trial?
Patients who choose to participate will be randomly allocated to one of two groups – the intervention group or the control group. Both groups will continue to receive their usual medical therapy as prescribed by the IBD doctor.
All participants will be asked to attend five virtual assessments over approximately 14 months. This will include online questionnaires (measuring mental health and quality of life) and background data (e.g. demographic and disease data).
Patients in the intervention group will also receive a seven-week course of virtual gut-directed hypnotherapy. This will be administered by a qualified hypnotherapist, via telehealth. The hypnotherapy involves relaxing and listening to suggestions for improve bowel health.
What are the benefits of participating?
Participants in the trial may not directly benefit from being involved. Potential benefits include receiving hypnotherapy, which may improve medical therapy, mental health and/or quality of life. Those in the control group may benefit from extra clinician-patient interactions.
A possible benefit across both group sis the opportunity to be a part of a highly novel trial (one of the first in the world) and health advance research into the usefulness of psychologist care and interventions for people with Crohn’s Disease.
Participation is voluntary
This is a research project and participation is voluntary; you do not have to be involved. Your medical care will not be affected in any way if you do not participate. You may withdraw from the project at any time after you have commenced.
Your participation in the study is strictly confidential and will not be disclosed to anyone outside the IBD Service without your agreement. Your clinical data will be stored securely and confidentially on a password protected electronic dataset at the Royal Adelaide Hospital; a de-identified version will be accessible only to the research team. Your data will be used to investigate the feasibility of a larger clinical trial on this topic and explore preliminary patient outcomes. Any information that is published will be done in a way that protects your identity.
T Lores, Royal Adelaide Hospital / Deakin University
Prof JM Andrews, Royal Adelaide Hospital
Dr A Mikocka-Walus, Deakin University
Dr S Evans, Deakin University
Prof A Chur-Hansen, University of Adelaide
C Goess, Royal Adelaide Hospital|
L Smith, Royal Adelaide Hospital
L Bibb, The Queen Elizabeth Hospital
Questions can be directed to:
- Taryn Lores: 08 7074 2199
- Prof Jane Andrews: 08 7074 2182
- A/Prof Antonina Mikocka-Walus: 03 9246 8575
Want to get involved?
If you’d like to get involved in the study speak to your IBD SA gastroenterologist.
Contributed by Taryn Lores