Face-to-face hypnotherapy
Other12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
NCT Number: NCT03899779
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.
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Notify Me16 year–75 year
All sexes
Interventional
Not applicable
Gelderse Vallei, Ede, Gelderland, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 12 weeks
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
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: 16 weeks
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 and after 6 months and 1 year follow-up
determined by Productivity Cost Questionnaire (PCQ) (savings from increased work productivity)
Time frame: 16 weeks and after 6 months and 1 year follow-up
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
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
Determined by IBS Quality of Life (IBS-QoL) (change from baseline) [IBS-QoL, minimum score: 0, maximum score 100]
Time frame: 12 and 16 weeks
As reported via digital diary (mobile phone application)
Time frame: 12 and 16 weeks
As reported via digital diary (mobile phone application)
Time frame: 16 weeks
Response rates in relation to patient expectation prior to the start of treatment
Time frame: 16 weeks and after 6 months and 1 year follow-up
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
Assessed with the use of the Patient Health Questionnaire-9 (PHQ-9). [PHQ-9 minimum score: 0, maximum score: 21]
Maastricht University Medical Center
Other
Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome, According to a Non-inferiority Design. Three-armed Randomized Controlled Trial.
Acronym: FORTITUDE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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