Primary objective:To compare the efficacy of online hypnotherapy versus face-to-face according to a non-inferiority design for the treatment of IBS.Hypothesis: Hypnotherapy delivered in the form of online exercises has non-inferior efficacy to face-…
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
According to FDA recommendation:
1. Abdominal pain response rate after 12 weeks of treatment.
a. 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
- Degree of relief response rate after 12 weeks of treatment, according to EMA
recommendation: *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.*
- Response rate directly after completion of the 12-week treatment period
- Improvement of symptom severity as determined by the IBS-SSS by 50 points or
more
- Longitudinal change in IBS-SSS at baseline (run-in), t=12 weeks, t=16 weeks,
t=6 months follow-up and t=1 year follow-up
- Cost-utility, as determined by calculations incorporating total treatment
costs and changes in EQ-5D-5L (QALYs gained) and MCQ/PCQ results (savings from
reduced medical resource use and increased work productivity respectively)
- Quality of life, as determined by the EQ-5D-5L and IBS-QoL (change from
baseline)
- Use of OTC and rescue medication
- Adherence to therapy
- Response rates in relation to patient expectation prior to the start of
treatment
- Response rates in relation to comorbid anxiety and/or depression- Number and severity of adverse events
Background 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, we 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, we hypothesize
that treatment with online hypnotherapy is a more cost-effective therapy than
face-to-face hypnotherapy in IBS patients. and more cost saving.
Study objective
Primary objective:
To compare the efficacy of online hypnotherapy versus face-to-face according to
a non-inferiority design for the treatment of IBS.
Hypothesis: Hypnotherapy delivered in the form of online exercises has
non-inferior efficacy to face-to-face hypnotherapy delivered by a
hypnotherapist for the treatment of IBS.
Secondary objectives:
1. To compare the efficacy of hypnotherapy vs. online psychoeducation
2. To evaluate the cost-effectiveness of face-to-face hypnotherapy as compared
to online exercises of hypnotherapy
3. To evaluate the effect of treatment after discontinuation
4. To evaluate the effect of treatment on quality of life
5. To evaluate the use of OTC and rescue medication
6. To evaluate the adherence to therapy
7. To evaluate the response rates in relation to patient expectation prior to
the start of treatment
8. To evaluate the response rates in relation to comorbid anxiety and/or
depression
Study design
A randomised controlled clinical trial with three parallel study arms (online
psychoeducation, face-to-face hypnotherapy and online hypnotherapy) for 12
weeks with a follow up of 1 year.
Intervention
Group 1 will receive 12 weeks treatment with online psychoeducation, group 2
will receive 12 weeks treatment with individual face-to-face hypnotherapy (6
individual, bi-weekly sessions), group 3 will receive 12 weeks treatment with
online hypnotherapy.
Study burden and risks
Subjects may be confronted with certain inconveniences. There are three
(digital) visits (screening visit, randomisation visit and post-treatment
visit). The screening will take up to 1 hour, including different
questionnaires and a pregnancy test for women of fertile age. During the run-in
period patients are asked to report their daily symptom scores with the use of
an electronic diary (mobile phone application), this takes approximately 30
seconds each day. A similar smartphone application has previously been
developed for IBS trials by investigators from the study group (PERSUADE study,
NL 56000.068.16 / METC 162009), completion of the questionnaire does not result
in substantial interference with everyday life. During the treatment period,
participants are asked to report daily symptom scores using the same mobile
phone application as during the run-in period, and complete three
questionnaires electronically each week. Participants in the online
psychoeducation group will be requested to use the online instrument for 15-30
minutes per day for 5 days a week. Participants randomized to face-to-face
hypnotherapy will receive treatment that is delivered in a series of 6,
bi-weekly 45-minute sessions in which patients receive protocol-based
structured hypnotherapy. In addition, these participants are asked to exercise
at home, for 15-30 minutes per day for 5 days a week, using a CD or other
electronic data storage equipment provided by their therapist. Participants in
the online hypnotherapy group will be requested to do home-work exercises using
the online instrument for 15-30 minutes per day for 5 days a week.
During the post-treatment measurement and follow-up participants several
questionnaires have to be completed at several time-points. In total, to
complete all the questionnaires during the study period take several hours.
Participants in each group may experience relief of IBS symptoms. We don*t
expect any side effects. Side effects of hypnotherapy can occur in participants
with any psychiatric condition, we will screen for anxiety and depression with
the GAD-7 and PHQ-9 questionnaires during the screening visit, subjects which
scores corresponds with moderate anxiety and depression are excluded from the
study.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Age 16-75 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.(15)
- 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, supported by a detailed interview
by the investigator. 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 in case there*s no stable dose during the study period
- Hypnotherapy treatment received in the last 3 months prior to inclusion
- Using more than 20 units of alcohol per week
- Using drugs of abuse
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinicaltrials.gov registratie under review |
| CCMO | NL67607.068.18 |