Condition category
Digestive System
Date applied
14/04/2011
Date assigned
17/06/2011
Last edited
16/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Carla Flik

ORCID ID

Contact details

Julius Center
Health Sciences and Primary Care
University Medical Center
Sratenum 6.131
Universiteitsweg 100
Utrecht
3584 CG
Netherlands
+31 88 756 8494
c.e.flik@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL30698.041.10

Study information

Scientific title

Individual or group hypnotherapy in the treatment of irritable bowel syndrome in primary and secondary care

Acronym

IMAGINE

Study hypothesis

1. At the end of therapy, patients in the hypnotherapy condition will report more adequate relief than in the educational supportive therapy condition (placebo treatment)
2. Hypnotherapy offered in a group format, is as effective as individual hypnotherapy

Ethics approval

Medical Ethical Committee of the University Hospital Utrecht, 23/02/2011, METC-Protocol No. 10-201/O

Study design

Randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Gastroenterology

Intervention

Patients will be randomly allocated to one of the following:
1. Six sessions of individual hypnotherapy (every 14 days)
2. Six sessions of hypnotherapy in a group consisting of 6 patients (every 14 days)
3. Six sessions of educational-supportive therapy (every 14 days) in a group consisting of 6 patients

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Responder rate for IBS symptoms based on a weekly assessment of Adequate Relief (AR) score.

Secondary outcome measures

1. Changes in the IBS Symptom Severity Score (IBS-SSS) and Quality of life (IBS-Qol)
2. Cognitions, self-efficacy, psychological complaints and direct and indirect costs of the disease, measured as the costs of visits to doctors and alernative healers, use of medicines and loss of labour productiveness

Overall trial start date

01/05/2011

Overall trial end date

01/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18-65 years
2. In primary and secondary care
3. Diagnosed with IBS (Rome III criteria)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

354

Participant exclusion criteria

1. Patients unable to understand the content of the sessions, because of insufficient command of the Dutch language
2. Patients unable to fill in the questionnaires
3. Patients unable (for example: too agressive) or unwilling to function in a group
4. Patients in whom a psychiatric condition needs attention first (for example severe depression or psychosis)
5. Patients who have IBS in addition to other chronic bowel diseases, as far as they are already diagnosed, such as ulcerative colitis, Crohn's disease or coeliac disease
6. Patients who have undergone major surgery to the lower gastrointestinal tract, such as partial or total colectomy, small bowel resection or partial or total gastrectomy

Recruitment start date

01/05/2011

Recruitment end date

01/05/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Julius Center, Health Sciences and Primary Care
Utrecht
3584 CG
Netherlands

Sponsor information

Organisation

University Medical Center Utercht (Netherlands)

Sponsor details

c/o Mrs Carla E. Flik
Julius Center
Health Sciences And Primary Care
University Medical Center
Stratenum 6.131
Universiteitsweg 100
Utrecht
3584 CG
Netherlands
+31 88 756 8494
c.e.flik@umcutrecht.nl

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Medical Center Utrecht (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 result in http://www.ncbi.nlm.nih.gov/pubmed/22185606

Publication citations

Additional files

Editorial Notes

16/03/2016: Publication reference added.