Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— FORTITUDE  

Official title:

Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome, According to a Non-inferiority Design. Three-armed Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03899779
• Other study ID #: NL67607.068.18
• Secondary ID: 852001924METC18-
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: August 2022

Study information

• Verified date: September 2020
• Source: Maastricht University Medical Center
• Contact: Anke Snijkers, MD
• Phone: 0031433882952
• Email: fortitude-intmed[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Psychological therapies are effective in reducing irritable bowel syndrome (IBS) symptom severity and increasing quality of life and are recommended for the management of IBS by guidelines. Evidence appears strongest for the efficacy of hypnotherapy as psychological treatment. However, therapist-led interventions are time consuming and relatively costly. Approaches based on e-health are cost saving and appear more attractive to patients as no visits to a therapist are necessary. Therefore, the investigators plan to conduct a multicentre randomised controlled trial to examine whether the effectiveness of online hypnotherapy is non-inferior compared to individual face-to-face hypnotherapy delivered by a therapist, according to current FDA guidelines. Online psychoeducation will be used as control condition. In addition, the investigators hypothesize that treatment with online hypnotherapy is a more cost-effective therapy than face-to-face hypnotherapy in IBS patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 285
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

Inclusion criteria:

• Age 16-65 years

• A diagnosis of IBS according to the Rome IV criteria

• In the presence of alarm symptoms, such as rectal blood loss, weight loss, anemia, first onset of symptoms above 50 years of age, patients will be first referred for further investigation by their treating physician to exclude organic disorders, conform current Dutch guidelines for IBS.

• Women in fertile age must use contraception or be postmenopausal for at least two years.

Exclusion criteria:

• Insufficient command of the Dutch language

• No access to internet

• Evidence of current anxiety and/or depression disorder as defined by a score =10 on the GAD-7 and/or PHQ-9 questionnaire. In this case it is conceivable that the IBS symptoms are strongly related to psychopathology for which different treatment might be more appropriate.

• History of ulcerative colitis, Crohn's disease, coeliac disease or significant liver 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

• Current pregnancy or lactation

• Using of psychoactive medication in case there's no stable dose for at least 3 months prior to inclusion

• Use of over-the-counter or prescription antidiarrheals, analgesics and laxatives (only be allowed as specific rescue medication)

• Hypnotherapy treatment received in the last 3 months prior to inclusion

• Using more than 20 units of alcohol per week

• Using drugs of abuse

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• Face-to-face hypnotherapy
12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
• Online hypnotherapy
12 weeks treatment with online hypnotherapy
• Online psychoeducation
12 weeks treatment with online psychoeducation

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Ziekenhuis	Den Bosch	Noord-Brabant
Netherlands	Gelderse Vallei	Ede	Gelderland
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden	Friesland
Netherlands	Maastricht University Medical Center	Maastricht	Limburg
Netherlands	Bernhoven	Uden	Noord-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal pain response rate after 12 weeks of treatment	A responder is defined as a patient who experiences at least a 30 percent decrease in the weekly average of worst daily abdominal pain (measured daily, on an 11 point NRS) compared to baseline weekly average in at least 50 percent of the weeks in which the treatment in given.	12 weeks
Secondary	Degree of relief response rate after 12 weeks of treatment	A responder is defined as a patient who experiences a weekly relief of 1 or 2 (on a 7 point NRS) in at least 50 percent of the weeks in which treatment is given.	12 weeks
Secondary	Improvement of symptom severity	determined by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) by 50 points or more [IBS-SSS, minimum score 0, maximum score 500]	16 weeks
Secondary	Indirect costs	determined by Productivity Cost Questionnaire (PCQ) (savings from increased work productivity)	16 weeks and after 6 months and 1 year follow-up
Secondary	Direct costs	determined by Medical Consumption Questionnaire (MCQ) (savings from reduced medical resource use)	16 weeks and after 6 months and 1 year follow-up
Secondary	General Quality of life (by EQ-5D)	Determined by the Euro-Quality of Life - 5 domains (EQ-5D-5L) (change from baseline)	16 weeks and after 6 months and 1 year follow-up
Secondary	IBS related Quality of life (by IBS-QoL)	Determined by IBS Quality of Life (IBS-QoL) (change from baseline) [IBS-QoL, minimum score: 0, maximum score 100]	16 weeks and after 6 months and 1 year follow-up
Secondary	Use of over the counter medication and rescue medication	As reported via digital diary (mobile phone application)	12 and 16 weeks
Secondary	Number and severity of side effects	As reported via digital diary (mobile phone application)	12 and 16 weeks
Secondary	Expectation	Response rates in relation to patient expectation prior to the start of treatment	16 weeks
Secondary	Response rates in relation to comorbid anxiety	Assessed with the use of the Generalized Anxiety Disorder-7 (GAD-7). [GAD-7 minimum score: 0, maximum score: 21]	16 weeks and after 6 months and 1 year follow-up
Secondary	Response rates in relation to comorbid depression	Assessed with the use of the Patient Health Questionnaire-9 (PHQ-9). [PHQ-9 minimum score: 0, maximum score: 21]	16 weeks and after 6 months and 1 year follow-up