Back to resultsFace-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome (FORTITUDE)
Primary Purpose
Irritable Bowel Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Face-to-face hypnotherapy
Online hypnotherapy
Online psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility Criteria
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
Sites / Locations
- Medisch Centrum LeeuwardenRecruiting
- Gelderse ValleiRecruiting
- Maastricht University Medical CenterRecruiting
- Jeroen Bosch Ziekenhuis
- BernhovenRecruiting
- Martini ZiekenhuisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Face-to-face hypnotherapy
Online hypnotherapy
Online psychoeducation
Arm Description
12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
12 weeks treatment with online hypnotherapy
12 weeks treatment with online psychoeducation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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]
Indirect costs
determined by Productivity Cost Questionnaire (PCQ) (savings from increased work productivity)
Direct costs
determined by Medical Consumption Questionnaire (MCQ) (savings from reduced medical resource use)
General Quality of life (by EQ-5D)
Determined by the Euro-Quality of Life - 5 domains (EQ-5D-5L) (change from baseline)
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]
Use of over the counter medication and rescue medication
As reported via digital diary (mobile phone application)
Number and severity of side effects
As reported via digital diary (mobile phone application)
Expectation
Response rates in relation to patient expectation prior to the start of treatment
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]
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]
Full Information
NCT ID
NCT03899779
First Posted
February 13, 2019
Last Updated
September 2, 2020
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03899779
Brief Title
Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
285 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Face-to-face hypnotherapy
Arm Type
Active Comparator
Arm Description
12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
Arm Title
Online hypnotherapy
Arm Type
Experimental
Arm Description
12 weeks treatment with online hypnotherapy
Arm Title
Online psychoeducation
Arm Type
Active Comparator
Arm Description
12 weeks treatment with online psychoeducation
Intervention Type
Other
Intervention Name(s)
Face-to-face hypnotherapy
Intervention Description
12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
Intervention Type
Other
Intervention Name(s)
Online hypnotherapy
Intervention Description
12 weeks treatment with online hypnotherapy
Intervention Type
Other
Intervention Name(s)
Online psychoeducation
Intervention Description
12 weeks treatment with online psychoeducation
Primary Outcome Measure Information:
Title
Abdominal pain response rate after 12 weeks of treatment
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Degree of relief response rate after 12 weeks of treatment
Description
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.
Time Frame
12 weeks
Title
Improvement of symptom severity
Description
determined by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) by 50 points or more [IBS-SSS, minimum score 0, maximum score 500]
Time Frame
16 weeks
Title
Indirect costs
Description
determined by Productivity Cost Questionnaire (PCQ) (savings from increased work productivity)
Time Frame
16 weeks and after 6 months and 1 year follow-up
Title
Direct costs
Description
determined by Medical Consumption Questionnaire (MCQ) (savings from reduced medical resource use)
Time Frame
16 weeks and after 6 months and 1 year follow-up
Title
General Quality of life (by EQ-5D)
Description
Determined by the Euro-Quality of Life - 5 domains (EQ-5D-5L) (change from baseline)
Time Frame
16 weeks and after 6 months and 1 year follow-up
Title
IBS related Quality of life (by IBS-QoL)
Description
Determined by IBS Quality of Life (IBS-QoL) (change from baseline) [IBS-QoL, minimum score: 0, maximum score 100]
Time Frame
16 weeks and after 6 months and 1 year follow-up
Title
Use of over the counter medication and rescue medication
Description
As reported via digital diary (mobile phone application)
Time Frame
12 and 16 weeks
Title
Number and severity of side effects
Description
As reported via digital diary (mobile phone application)
Time Frame
12 and 16 weeks
Title
Expectation
Description
Response rates in relation to patient expectation prior to the start of treatment
Time Frame
16 weeks
Title
Response rates in relation to comorbid anxiety
Description
Assessed with the use of the Generalized Anxiety Disorder-7 (GAD-7). [GAD-7 minimum score: 0, maximum score: 21]
Time Frame
16 weeks and after 6 months and 1 year follow-up
Title
Response rates in relation to comorbid depression
Description
Assessed with the use of the Patient Health Questionnaire-9 (PHQ-9). [PHQ-9 minimum score: 0, maximum score: 21]
Time Frame
16 weeks and after 6 months and 1 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anke Snijkers, MD
Phone
0031433882952
Email
fortitude-intmed@maastrichtuniversity.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Keszthelyi, MD, PhD
Email
daniel.keszthelyi@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.A.M. Masclee, Prof., MD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
State/Province
Friesland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A.S. de Ruiter
Facility Name
Gelderse Vallei
City
Ede
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B.J.M. Witteman
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Keszthelyi
Facility Name
Jeroen Bosch Ziekenhuis
City
Den Bosch
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. van Hee
Facility Name
Bernhoven
City
Uden
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B.J.T. Haarhuis
Facility Name
Martini Ziekenhuis
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L.A. van der Waaij
12. IPD Sharing Statement
Learn more about this trial
Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome
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