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NCT01279382 Clinical Trial

Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)

Irritable Bowel Syndrome Clinical Trial

Official title:
Effectiviteit Van Hypnotherapie Bij Prikkelbare Darmsyndroom (Effectiveness of Hypnotherapy in Irritable Bowel Syndrome)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01279382
Other study ID # P113/99
Secondary ID
Status Completed
Phase N/A
First received January 17, 2011
Last updated January 18, 2011
Start date January 2002
Est. completion date January 2006

Study information
Verified date January 2011
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority The Netherlands: Commissie Medische Ethiek (CME), Leiden
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 112
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Irritable bowel syndrome (Rome II)

- Presence of complaints < 12 months

Exclusion Criteria:

- Gastrointestinal disorders, other than IBS

- Previous psychotherapeutic treatment for IBS

- Severe psychological comorbidity

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Hypnotherapy (HYP)
Hypnotherapy was given to a subgroup of patients as intervention in IBS treatment
• Relaxation training (RT)
RT was given to a subgroup of patients as intervention in IBS treatment
Other:
• Care as usual (CON)
CON was given to a subgroup of patients as control intervention in IBS treatment

Locations
Country Name City State
Netherlands LUMC - Leiden Leiden

Sponsors (1)
Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean symptom score (MSS)
Secondary Psychological measures, i.e. anxiety and depression (HADS)
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