None listed
Conditions
Brief summary
Crohn's disease (CD) is a type of inflammatory bowel disease (IBD) - a chronic gastrointestinal disorder - associated with high disease burden and psychological comorbidity. Gut-directed hypnotherapy may be a type of psychological intervention useful for people with CD, as it has been well-researched as a treatment for functional gastrointestinal (GI) disorders (particularly Irritable Bowel Syndrome) with considerable evidence for reduced symptom burden and improved mental health. In the IBD literature however, hypnotherapy has received very little attention, with most research comprising case studies, and no previous trials conducted specifically with CD patients. This pilot trial will investigate the feasibility of conducting a future randomised controlled trial (RCT) of virtual adjunctive gut-directed hypnotherapy for patients with CD. Participants will be randomised to one of two groups: Control group will receive medical treatment as usual (TAU); Intervention group will receive usual medical therapy plus adjunctive gut-directed hypnotherapy delivered via telehealth. Primary outcomes are study feasibility endpoints (e.g. recruitment rates, intervention completion and acceptability, and acceptability of study procedures). Participants will complete assessments at five time-points (in line with pre-treatment, post-treatment, and follow-up three-, six- and 12 months post-treatment) to measure potential changes in disease activity, mental health and quality of life (secondary measures). This research will be a collaborative project between the Central Adelaide Local Health Network and Deakin University, and will contribute to the PhD of the Principal Investigator (PI: TL).
Interventions
The intervention being trialed is a course of adjunctive gut-directed hypnotherapy (provided in addition to usual medical therapy), delivered individually by a trained hypnotherapist (registered nurse with a Diploma in Clinical Hypnosis). The intervention will be delivered virtually via telehealth platform Coviu so that participants do not have to attend the Royal Adelaide Hospital for the treatment. The intervention will follow the Standardised Hypnotherapy Protocol for Inflammatory Bowel Disease (Keefer & Palsson, 2008), which comprises 7 x 40 minute sessions of hypnotherapy delivered weekly, with additional audio provided for home-based practice after the second session (recommended practice 3-5x week; participants will be asked to keep a record of their home-based practice).
Sponsors
Study design
Eligibility
Inclusion criteria
Participants recruited from the RAH IBD Service must be: -aged 18 years or older -have a formal diagnosis of Crohn’s disease made by a gastroenterologist -have active disease, as indicated by (within the last month): ---faecal-calprotectin > 250, OR ---reactive protein > 15, OR ---confirmed by endoscopic or radiologic investigation AND ---score on Crohn’s Disease Activity Index (CDAI) > 150 Participants recruited from the community must be: -aged 18 years or older -have a formal diagnosis of Crohn’s disease made by a gastroenterologist
Exclusion criteria
Patients will be excluded if they have any of the following: -a diagnosis of UC or indeterminate colitis made by a gastroenterologist -inability to read and understand the English language sufficiently -a diagnosis of a serious mental disorder (e.g. post-traumatic stress disorder, schizophrenia, bipolar disorder), personality disorder (e.g. borderline personality disorder), dissociative symptoms, and/or history of complex trauma