Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS) | NCT01279382

Studies
Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)

NCT01279382

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Jan 19, 2011Estimated

Enrollment

112Actual

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome

Interventions

Hypnotherapy (HYP)
Relaxation training (RT)
Care as usual (CON)

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Not provided

Completion Date

Jan 2006

First Submitted Date

Jan 17, 2011

First Submission Date that Met QC Criteria

Jan 18, 2011

First Posted Date

Jan 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2011

Last Update Posted Date

Jan 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypnotherapy (HYP)	Behavioral	Hypnotherapy was given to a subgroup of patients as intervention in IBS treatment	Hypnotherapy (HYP)

Measure	Description	Time Frame
Mean symptom score (MSS)

Measure	Description	Time Frame
Psychological measures, i.e. anxiety and depression (HADS)

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ad Masclee, Prof. Dr.	Head of dept	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LUMC - Leiden		Leiden			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006990	Hypnosis
D012064	Relaxation Therapy

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D011613	Psychotherapy

Browse Leaves

Not provided

Browse Branches

Not provided