Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gut focused hypnotherapy | Behavioral | 7 session hypnotherapy protocol designed for irritable bowel syndrome |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome | assessed by symptom severity scale given before treatment began and after 7 bi-weekly sessions, at 3 months, 6 months and 12 months | one year |
| Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy. | 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. | One year after termination of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome Predictors | to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result | one year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mind Body Digestive Center | New York | New York | 10023 | United States |
There was no control group assignment in this preliminary study which was designed to see if hypnotherapy, already proven effective in individual treatment was effective when using a group format.
Patients were recruited at their initial visit to an IBS treatment center, on a purely voluntary basis into a group hypnotherapy program, from 2005 to 2009. 75 patients were entered into the study. Another 14 filled out initial questionnaires but then declined to enter treatment or dropped out after 1 or 2 sessions.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group Hypnotherapy for Irritable Bowel Syndrome | IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group Hypnotherapy for Irritable Bowel Syndrome | IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome | assessed by symptom severity scale given before treatment began and after 7 bi-weekly sessions, at 3 months, 6 months and 12 months | Not Posted | one year | ||||||||||||
| Secondary | Outcome Predictors | to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result | Not Posted | one year |
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Hypnotherapy for Irritable Bowel Syndrome | IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings. |
Not provided
Not provided
Subjects who dropped out did so for reasons of inconvenience of scheduling attendance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles D. Gerson, M.D. | Mind-Body Digestive Center | 212 496 6161 | cgerson@yahoo.com |
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary | Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy. | 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. | Posted | Number | percentage of participants | One year after termination of treatment |
|
|
|
| 0 |
| 89 |
| 0 |
| 89 |
Not provided
Not provided
| D004066 | Digestive System Diseases |