Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000698774
Ethics application status
Approved
Date submitted
27/04/2022
Date registered
13/05/2022
Date last updated
13/05/2022
Date data sharing statement initially provided
13/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating the efficacy of an app-delivered gut-directed hypnotherapy program in patients with irritable bowel syndrome
Scientific title
A randomised controlled trial evaluating the efficacy of an app-delivered gut-directed hypnotherapy program in patients with irritable bowel syndrome
Secondary ID [1] 307012 0
None
Universal Trial Number (UTN)
U1111-1277-7589
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome 326132 0
Condition category
Condition code
Oral and Gastrointestinal 323509 323509 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
App-delivered gut-directed hypnotherapy and psycho-education using voice recording and readings which will take approximately 20 minutes per day for participants to complete across the 6 week duration of the study. The gut-directed hypnotherapy and psycho-education are resources already available through the Nerva app and involve education of around Irritable Bowel Syndrome and calming hypnotherapy sessions to help relax the patient. Participants will receive weekly text messages at the end of the week to remind them to continue completing the programfor the 6 weeks on the intervention and additionally at 6 months to complete follow up surveys.
Intervention code [1] 323455 0
Treatment: Devices
Comparator / control treatment
App-delivered psycho-education which has the same readings/ education as in the intervention group, but not gut-directed hypnotherapy and will take around 10 minutes per day for participants to complete across the 6 week study. These are the same readings that are available on the Nerva app and educate the participants about various information relating to Irritable Bowel Syndrome. The control participants will also receive reminder weekly text messages to continue completing the sessions for the 6 weeks on the intervention and additionally at 6 months to complete follow up surveys.
Control group
Active

Outcomes
Primary outcome [1] 331194 0
Change in gastrointestinal symptoms related to irritable bowel syndrome assessed by validated questionnaire - Irritable Bowel Syndrome - quality of life (IBS-QOL)
Timepoint [1] 331194 0
Baseline, Week 6 post intervention commencement (primary endpoint) and 6 months post finishing intervention
Primary outcome [2] 331260 0
Change in gastrointestinal symptoms related to irritable bowel syndrome assessed by validated questionnaire - IBS-symptom Severity Scale (IBS-SSS)
Timepoint [2] 331260 0
Baseline, Week 2, 4, and 6 post intervention commencement (primary endpoint) and 6 months post finishing intervention
Primary outcome [3] 331261 0
Change in gastrointestinal symptoms related to irritable bowel syndrome assessed by questionnaire - IBS Visual analogue scale (IBS-VAS)
Timepoint [3] 331261 0
Baseline, Week 1, 2, 3, 4, 5, and 6 post intervention commencement (primary endpoint) and 6 months post finishing intervention.
Secondary outcome [1] 409134 0
Changes in psychological symptoms as assessed by validated questionnaires - Hospital Anxiety and Depression Scale (HADS)
Timepoint [1] 409134 0
Baseline, Week 1, 2, 3, 4, 5, and 6 post intervention commencement and 6 months post finishing intervention
Secondary outcome [2] 409135 0
Changes in validated questionnaire Depression Anxiety Stress Scale (DASS) answers
Timepoint [2] 409135 0
Baseline, Week 1, 2, 3, 4, 5, and 6 post intervention commencement and 6 months post finishing intervention
Secondary outcome [3] 409341 0
Changes in validated questionnaire Symptoms Check List-90-R (SCL-90-R) answers
Timepoint [3] 409341 0
Baseline, Week 1, 2, 3, 4, 5, and 6 post intervention commencement and 6 months post finishing intervention
Secondary outcome [4] 409342 0
Changes in validated questionnaire Patient Health Questionnaire 4 (PHQ-4) answers
Timepoint [4] 409342 0
Baseline, Week 1, 2, 3, 4, 5, and 6 post intervention commencement and 6 months post finishing intervention

Eligibility
Key inclusion criteria
Participants must meets the ROME IV criteria for Irritable Bowel Syndrome
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnancy
• Alcoholism
• Inability to understand the content of the sessions, because of insufficient command of the English language
• Inability to fill out the questionnaires
• Psychiatric condition (for example, severe depression, PTSD or psychosis)
• A combination of IBS and other chronic bowel diseases, such as ulcerative colitis, Crohn’s disease or coeliac disease
• Major surgery to the lower gastrointestinal tract, such as partial or total colectomy, small bowel resection or partial or total gastrectomy
• Past or present radiotherapy to the abdomen

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)
Randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation - blocks of 122
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/05/2022
Actual
Date of last participant enrolment
Anticipated
4/11/2022
Actual
Date of last data collection
Anticipated
4/05/2023
Actual
Sample size
Target
244
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24738 0
United States of America
State/province [1] 24738 0

Funding & Sponsors
Funding source category [1] 311321 0
Commercial sector/Industry
Name [1] 311321 0
Mindset Health Pty Ltd.
Country [1] 311321 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University, Department of Gastroenterology, Level 6 Alfred Centre, 99 Commercial Road, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 312699 0
None
Name [1] 312699 0
Address [1] 312699 0
Country [1] 312699 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310823 0
Monash University Human Research Ethics Commitee
Ethics committee address [1] 310823 0
Wellington Road, Clayton, VIC, 3800
Ethics committee country [1] 310823 0
Australia
Date submitted for ethics approval [1] 310823 0
Approval date [1] 310823 0
23/03/2022
Ethics approval number [1] 310823 0

Summary
Brief summary
The aim of the current study is to compare the effects of the Nerva gut-directed hypnotherapy (GDH) program to psychoeducation (control) on gastrointestinal symptoms and psychological indices in patients with irritable bowel syndrome (IBS).
It is hypothesised that participants randomised to the Nerva GDH program will see greater degrees of improvement in terms of overall and individual gastrointestinal symptoms and psychological indices compared to those who receive psychoeducation (control).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118990 0
Dr Emma Halmos
Address 118990 0
Department of Gastroenterology, Level 6 Alfred Centre, 99 Commercial Road, Melbourne VIC 3004
Country 118990 0
Australia
Phone 118990 0
+61 03 9903 0233
Fax 118990 0
Email 118990 0
emma.halmos@monash.edu
Contact person for public queries
Name 118991 0
Ms Ellie Anderson
Address 118991 0
Department of Gastroenterology, Level 6 Alfred Centre, 99 Commercial Road, Melbourne VIC 3004
Country 118991 0
Australia
Phone 118991 0
+61 400199981
Fax 118991 0
Email 118991 0
ellen.anderson@monash.edu
Contact person for scientific queries
Name 118992 0
Ms Ellie Anderson
Address 118992 0
Department of Gastroenterology, Level 6 Alfred Centre, 99 Commercial Road, Melbourne VIC 3004
Country 118992 0
Australia
Phone 118992 0
+61 400199981
Fax 118992 0
Email 118992 0
ellen.anderson@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.