Comparison of Effects Between Gut Directed Hypnotherapy Provided Either Individually or in a Group Setting for Patients With Irritable Bowel Syndrome (IBS) a Randomized Controlled Study.

Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome



Sponsors


Source

Sahlgrenska University Hospital, Sweden

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment
who are referred to a specialist unit for hypnotherapy are consecutively included in the
study. The patients are randomized to either individual or group treatment given by a nurse
trained in hypnotherapy. The treatment consists of eight sessions of gut directed hypno
therapy during twelve weeks. Effects are measured by validated questionnaires at baseline and
at various time points during the treatment period as well as after the completion of the
treatment.

Detailed Description

Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment
who are referred to a specialist unit for hypnotherapy are consecutively included in the
study. Firstly, the patients are invited to a meeting with the nurse for information about
the study, check for eligibility and to sign the written informed consent. Exclusion criteria
that could influence GI symptoms such as organic GI disease, severe psychiatric comorbidity
and pregnancy are controlled for. The patients are randomized to either individual or group
treatment given by a nurse trained in hypnotherapy and cognitive behavioral therapy. The
randomization is organized and performed in blocks by an external unit connected to the
University in order to be accurate. The treatment consists of eight sessions of gut directed
hypnotherapy during twelve weeks. A standardized protocol is used and is the same both in the
group setting as well as in the individual treatment arm. In each group approximately eight
patients are included. Every session lasts for one hour. Outcome measures in the study are GI
symptom severity, GI-specific anxiety, psychological distress and health related quality of
life. These effects are measured by validated questionnaires at baseline and at various time
points during the treatment period as well as after the completion of the treatment and
during follow-up.

Overall Status

Active, not recruiting

Start Date

2011-08-15

Completion Date

2025-12-31

Primary Completion Date

2018-12-31

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change of Gastrointestinal symptom severity
Up to ten years

Enrollment

100

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

Non-pharmacological treatment

Arm Group Label

Individual hypnotherapy

Group hypnotherapy



Eligibility

Criteria

Inclusion Criteria:

- IBS according to Rome III criteria

Exclusion Criteria:

- Organic GI disease

Gender

All

Minimum Age

18 Years

Maximum Age

67 Years

Healthy Volunteers

No


Verification Date

2018-03-01

Lastchanged Date

2018-03-01

Firstreceived Date

2018-02-07

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Sahlgrenska University Hospital, Sweden

Investigator Full Name

Magnus Simrén

Investigator Title

Professor, MD


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Individual hypnotherapy

Arm Group Type

Active Comparator

Description

Treatment given on a individual basis, face to face.


Arm Group Label

Group hypnotherapy

Arm Group Type

Active Comparator

Description

Treatment given in a group setting, face to face.



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

February 7, 2018

Study First Submitted Qc

February 7, 2018

Study First Posted

February 13, 2018

Last Update Submitted

March 1, 2018

Last Update Submitted Qc

March 1, 2018

Last Update Posted

March 2, 2018


ClinicalTrials.gov processed this data on March 02, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2018 ICH GCP