Irritable Bowel SyndromeNCT01279382
Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)
A study testing Hypnotherapy (HYP), Relaxation training (RT) and Care as usual (CON) in people with Irritable Bowel Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In this trial, the effects of two psychological interventions - i.e. hypnotherapy and relaxation training - are compared with care as usual in IBS treatment. The investigators hypothesized that hypnotherapy is most effective in reducing complaints in IBS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Hypnotherapy (HYP), Relaxation training (RT) and Care as usual (CON)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2002to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Irritable bowel syndrome (Rome II)
- Presence of complaints < 12 months
Who cannot join
- Gastrointestinal disorders, other than IBS
- Previous psychotherapeutic treatment for IBS
- Severe psychological comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiviteit Van Hypnotherapie Bij Prikkelbare Darmsyndroom (Effectiveness of Hypnotherapy in Irritable Bowel Syndrome)
In this trial, the effects of two psychological interventions - i.e. hypnotherapy and relaxation training - are compared with care as usual in IBS treatment. The investigators hypothesized that hypnotherapy is most effective in reducing complaints in IBS.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Hypnotherapy (HYP), Relaxation training (RT), Care as usual (CON)
- Keywords
- Symptoms, Psychological status, Hypnotherapy, Relaxation training
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotherapy (HYP)Behavioural
Hypnotherapy was given to a subgroup of patients as intervention in IBS treatment
Relaxation training (RT)Behavioural
RT was given to a subgroup of patients as intervention in IBS treatment
Care as usual (CON)Other
CON was given to a subgroup of patients as control intervention in IBS treatment
| Study group | Role | What they receive |
|---|---|---|
| Care as usual (CON) | Other | CON was given to a subgroup of patients as control treatment in IBS treatment Receives: Other: Care as usual (CON) |
| Hypnotherapy (HYP) | Other | HYP was given to a subgroup of patients as intervention in IBS treatment Receives: Behavioral: Hypnotherapy (HYP) |
| Relaxation training (RT) | Other | RT was given to a subgroup of patients as intervention in IBS treatment Receives: Behavioral: Relaxation training (RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean symptom score (MSS)
Secondary outcomes (1)
Psychological measures, i.e. anxiety and depression (HADS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2002
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Ad Masclee, Prof. Dr., Principal investigator, Head of dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279382
- Sponsor's protocol ID
- P113/99
- Status last verified
- Jan 2011
- First submitted
- 17 Jan 2011
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiviteit Van Hypnotherapie Bij Prikkelbare Darmsyndroom (Effectiveness of Hypnotherapy in Irritable Bowel Syndrome)
- ClinicalTrials.gov ID
- NCT01279382
- Acronym / sponsor ID
- P113/99
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Symptoms, Psychological status, Hypnotherapy, Relaxation training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Jan 2006
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this trial, the effects of two psychological interventions - i.e. hypnotherapy and relaxation training - are compared with care as usual in IBS treatment. The investigators hypothesized that hypnotherapy is most effective in reducing complaints in IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Care as usual (CON) | Other | Other: Care as usual (CON)CON was given to a subgroup of patients as control treatment in IBS treatment |
| Hypnotherapy (HYP) | Other | Behavioral: Hypnotherapy (HYP)HYP was given to a subgroup of patients as intervention in IBS treatment |
| Relaxation training (RT) | Other | Behavioral: Relaxation training (RT)RT was given to a subgroup of patients as intervention in IBS treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Irritable bowel syndrome (Rome II)
- Presence of complaints < 12 months
Key exclusion criteria (3 listed)
- Gastrointestinal disorders, other than IBS
- Previous psychotherapeutic treatment for IBS
- Severe psychological comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnotherapy (HYP)Hypnotherapy was given to a subgroup of patients as intervention in IBS treatment | Behavioural | Hypnotherapy (HYP) |
| Relaxation training (RT)RT was given to a subgroup of patients as intervention in IBS treatment | Behavioural | Relaxation training (RT) |
| Care as usual (CON)CON was given to a subgroup of patients as control intervention in IBS treatment | Other | Care as usual (CON) |
Primary outcome
Mean symptom score (MSS)
1 secondary outcome
Psychological measures, i.e. anxiety and depression (HADS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
- effect of relaxation training in IBS treatmentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ad Masclee, Prof. Dr. principal investigator
Head of dept
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotherapy (HYP), Relaxation training (RT) and Care as usual (CON) in people with Irritable Bowel Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean symptom score (MSS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2011.