Trial Outcomes & Findings for Irritable Bowel Syndrome Hypnotherapy (NCT NCT01248013)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

89 participants

Primary outcome timeframe

one year

Results posted on

2011-01-06

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	89
Overall Study Irritable Bowel Syndrome Hypnotherapy	75
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	14

Baseline Characteristics

Irritable Bowel Syndrome Hypnotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group Hypnotherapy for Irritable Bowel Syndrome n=89 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age Continuous	45.9 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	89 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group Hypnotherapy for Irritable Bowel Syndrome n=89 Participants 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.
Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy.	60 percentage of participants

SECONDARY outcome

Timeframe: one year

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

Outcome measures

Outcome data not reported

Adverse Events

Group Hypnotherapy for Irritable Bowel Syndrome

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Charles D. Gerson, M.D.

Mind-Body Digestive Center

Phone: 212 496 6161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place