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Trial registered on ANZCTR


Registration number
ACTRN12620000348954
Ethics application status
Approved
Date submitted
6/03/2020
Date registered
12/03/2020
Date last updated
12/03/2020
Date data sharing statement initially provided
12/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Hypnotherapy for patients with Crohn’s disease
Scientific title
Adjunctive gut-directed hypnotherapy for patients with Crohn’s disease: A randomised controlled pilot trial
Secondary ID [1] 300732 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 316554 0
Condition category
Condition code
Oral and Gastrointestinal 314792 314792 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being trialed is a course of adjunctive gut-directed hypnotherapy (provided in addition to usual medical therapy), delivered individually in person by a trained hypnotherapist (enrolled nurse with a Diploma in Clinical Hypnosis) at the Royal Adelaide Hospital. 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).
Intervention code [1] 317054 0
Treatment: Other
Comparator / control treatment
The control group comprises of patients with Crohn's disease who will receive their usual medical therapy but no adjunctive hypnotherapy.
Control group
Active

Outcomes
Primary outcome [1] 323152 0
Recruitment feasibility as measured by % potential participants successfully recruited, % declined, % excluded for each criterion
Timepoint [1] 323152 0
once recruitment has been completed (30 participants entered the trial)
Primary outcome [2] 323153 0
Acceptability of intervention as measured by % participants who completed all hypnotherapy sessions (adherence) and assessment appointments, % who completed home-based practice as recommended (measured with participant diary), % adverse reactions (e.g. dizziness, sudden anxiety or other strong emotions, measured by participant self-report and direct observation by hypnotherapist), % drop-out, subjective rating of satisfaction (1-4) of intervention and likelihood of participating again, and open participant feedback
Timepoint [2] 323153 0
After final participant's post-intervention assessment
Primary outcome [3] 323154 0
Acceptability of study procedures as measured by subjective rating of satisfaction (1-4), % successful completion of questionnaires, missing data at a minimum rate, % adhered completely to protocol
Timepoint [3] 323154 0
After final participant's 12 month follow-up assessment
Secondary outcome [1] 380963 0
Change in mean depression, anxiety and stress scores assessed using the Depression, Anxiety and Stress Scale (DASS-21) questionnaire
Timepoint [1] 380963 0
Baseline, post-intervention, and at 3 months, 6 months and 12 months post-intervention
Secondary outcome [2] 380964 0
Change in mean quality of life scores assessed using the AQol-8D
Timepoint [2] 380964 0
Baseline, post-intervention, and at 3 months, 6 months and 12 months post-intervention
Secondary outcome [3] 380966 0
Change in Crohn's disease activity assessed using the Crohn's Disease Activity Index (CDAI) as well as C-Reactive Protein (CRP), faecal-calprotectin or endoscopic or radiologic investigation
Timepoint [3] 380966 0
Baseline, post-intervention, and at 3 months, 6 months and 12 months post-intervention
Secondary outcome [4] 380967 0
Change in bowel symptom severity assessed using the Bowel Symptom Severity Scale (BSSS)
Timepoint [4] 380967 0
Baseline, post-intervention, and at 3 months, 6 months and 12 months post-intervention
Secondary outcome [5] 381005 0
Changes in stress as measured by biomarker alpha-amylase (measured with saliva assay)
Timepoint [5] 381005 0
Baseline, post-intervention, and at 3 months, 6 months and 12 months post-intervention

Eligibility
Key inclusion criteria
Participants 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study Coordinator will randomly allocate participants to condition and allocate a study code so that their data can be stored in a de-identified manner, and the primary investigate will remain blind to the condition allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16071 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 29583 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 305181 0
Charities/Societies/Foundations
Name [1] 305181 0
Crohn's & Colitis Australia
Address [1] 305181 0
Head Office
Level 1, Suite 4
363 Caberwell Road
Camberwell, VIC 3124
Country [1] 305181 0
Australia
Funding source category [2] 305182 0
Charities/Societies/Foundations
Name [2] 305182 0
Health Services Charitable Gifts Board
Address [2] 305182 0
240 Waymouth Street
Adelaide SA 5000
Country [2] 305182 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network
Address
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 305537 0
University
Name [1] 305537 0
Deakin University
Address [1] 305537 0
221 Burwood Highway
Burwood VIC 3125
Country [1] 305537 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305539 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 305539 0
North Terrace
Adelaide SA 5000
Ethics committee country [1] 305539 0
Australia
Date submitted for ethics approval [1] 305539 0
Approval date [1] 305539 0
04/12/2019
Ethics approval number [1] 305539 0

Summary
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 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. 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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100718 0
Ms Taryn Lores
Address 100718 0
Royal Adelaide Hospital
Port Road
Adelaide SA 5000
Country 100718 0
Australia
Phone 100718 0
+61870742199
Fax 100718 0
Email 100718 0
taryn.lores2@sa.gov.au
Contact person for public queries
Name 100719 0
Ms Taryn Lores
Address 100719 0
Royal Adelaide Hospital
Port Road
Adelaide SA 5000
Country 100719 0
Australia
Phone 100719 0
+61870742199
Fax 100719 0
Email 100719 0
taryn.lores2@sa.gov.au
Contact person for scientific queries
Name 100720 0
Ms Taryn Lores
Address 100720 0
Royal Adelaide Hospital
Port Road
Adelaide SA 5000
Country 100720 0
Australia
Phone 100720 0
+61870742199
Fax 100720 0
Email 100720 0
taryn.lores2@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect patient privacy and confidentiality
What supporting documents are/will be available?
No other documents available
Summary results
No Results