NCT01178593

Brief Summary

This randomised controlled trial (RCT) aimed at assessing the efficacy of hypnotherapy in group sessions (GHT) with a 12-months follow-up.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

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

April 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

2.4 years

First QC Date

August 9, 2010

Last Update Submit

December 11, 2011

Conditions

Irritable Bowel Syndrome

Keywords

IBSRCTpsychologyhypnosispsychotherapygroup therapy

Outcome Measures

Primary Outcomes (1)

  • Irritable Bowel Syndrome - Impact Scale, IBS-IS

    the IBS-Impact-Scale (IBS-IS). The IBS-IS is a disease-specific documentation of the impact of IBS on patients' lives and was developed and validated for use in clinical trials

    May 2008-September 2010

Secondary Outcomes (1)

  • Short-Form 36 (SF-36)

    May 2008-September 2010

Study Arms (2)

Standard Medical Therapy (SMT)

NO INTERVENTION

standard medical treatment (care as usual) with supportive talks

Gut focused hypnotherapy

ACTIVE COMPARATOR

weekly sessions of gut focused hypnotherapy in groups (10 sessions within 12 weeks)

Other: Gut-focused hypnotherapy in group sessions

Interventions

Gut-focused hypnotherapy in group sessionsOTHER

weekly session (45 min) of gut focused hypnotherapy (10 sessions within 12 weeks)

Also known as: hypnosis, gut directed hypnosis, gut directed hypnotherapy, gut focused hypnosis
Gut focused hypnotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with IBS, fulfilling Rome III criteria, and aged between 18 and 70, The time for patients to reach the hospital should not to be longer than one hour

You may not qualify if:

  • pregnancy, bowel surgery, mental retardation, insufficient knowledge of German, a concomitant severe organic and/or psychiatric disease, recently indicated treatment with anti-depressants.-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gabriele Moser, ao. Prof.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ao.Univ.Prof.Dr.med.

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 10, 2010

Study Start

April 1, 2008

Primary Completion

September 1, 2010

Study Completion

July 1, 2011

Last Updated

December 13, 2011

Record last verified: 2011-12