Irritable Bowel Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALgut focused hypnotherapy
7 session hypnotherapy protocol designed for irritable bowel syndrome
Sponsors
Mind-Body Digestive Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of irritable bowel syndrome by Rome II criteria, age 20 and older
Exclusion criteria
* Age below 20
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome | 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 |
| Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy. | 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
| Measure | Time frame | Description |
|---|---|---|
| Outcome Predictors | one year | to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 89 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | Group Hypnotherapy for Irritable Bowel Syndrome |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants |
| Age Continuous | 45.9 years STANDARD_DEVIATION 14.4 |
| Region of Enrollment United States | 89 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 89 |
| serious Total, serious adverse events | 0 / 89 |
Outcome results
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
Time frame: one year
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.
Time frame: One year after termination of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group Hypnotherapy for Irritable Bowel Syndrome | Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy. | 60 percentage of participants |
Secondary
Outcome Predictors
to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result
Time frame: one year