NCT01279382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2011

First QC Date

January 17, 2011

Last Update Submit

January 18, 2011

Conditions

Irritable Bowel Syndrome

Keywords

SymptomsPsychological statusHypnotherapyRelaxation training

Outcome Measures

Primary Outcomes (1)

  • Mean symptom score (MSS)

Secondary Outcomes (1)

  • Psychological measures, i.e. anxiety and depression (HADS)

Study Arms (3)

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

Hypnotherapy (HYP)BEHAVIORAL

Hypnotherapy was given to a subgroup of patients as intervention in IBS treatment

Hypnotherapy (HYP)
Relaxation training (RT)BEHAVIORAL

RT was given to a subgroup of patients as intervention in IBS treatment

Relaxation training (RT)
Care as usual (CON)OTHER

CON was given to a subgroup of patients as control intervention in IBS treatment

Care as usual (CON)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Irritable bowel syndrome (Rome II)
  • Presence of complaints \< 12 months

You may not qualify if:

  • Gastrointestinal disorders, other than IBS
  • Previous psychotherapeutic treatment for IBS
  • Severe psychological comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LUMC - Leiden

Leiden, Netherlands

Location

Related Links

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

HypnosisRelaxation Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesBehavior Therapy

Study Officials

  • Ad Masclee, Prof. Dr.

    Head of dept

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2011

First Posted

January 19, 2011

Study Start

January 1, 2002

Study Completion

January 1, 2006

Last Updated

January 19, 2011

Record last verified: 2011-01

Locations

NL(1)