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Completed

NCT Number: NCT01248013

Irritable Bowel Syndrome Hypnotherapy

The primary goal of the study was whether gut focused hypnotherapy, in a group format, was successful in reduction of symptoms in patients with irritable bowel syndrome. The secondary goal was to see if any outcome predictors could be determined.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mind Body Digestive Center

New York, 10023, United States

About this study

Patients with Irritable Bowel Syndrome entering a group hypnotherapy program are asked to complete a series of questionnaires at the outset, and repeat a symptom severity scale at intervals over the one year period after termination of treatment. Eligibility was limited to patients with age greater than 20.

Outcome measures were improvement in symptom score. Outcome predictors studied included quality of relationships, measured with a Quality of Relationship Inventory and attribution of IBS to physical or emotional cause, measured with a Mind-Body IBS Questionnaire, both administered before onset of hypnotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of irritable bowel syndrome by Rome II criteria, age 20 and older

Exclusion criteria

  • Age below 20

Treatment and study plan

gut focused hypnotherapy

Behavioral

7 session hypnotherapy protocol designed for irritable bowel syndrome

Primary outcomes

  1. Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome

    Time frame: one year

    assessed by symptom severity scale given before treatment began and after 7 bi-weekly sessions, at 3 months, 6 months and 12 months

  2. Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy.

    Time frame: One year after termination of treatment

    The IBS Symptom Severity Scale has four components, severity of abdominal pain, number of days with pain in past 10 days, abdominal distension, bowel habit and interference with life in general. Maximum score is 500, minimum score is 0. The lower the score, the lower the symptom severity. Participants are considered clinically improved if they have a reduction in score of 50 points or greater.

Secondary outcomes

  1. Outcome Predictors

    Time frame: one year

    to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result

Sponsors and collaborators

Lead sponsor

Mind-Body Digestive Center

Other

Registry information

Official study title

Outcome Effectiveness Predictors of Irritable Bowel Syndrome Hypnotherapy

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Nov 25, 2010
Registry last updated
Jan 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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