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Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome

Primary Purpose

IBS - Irritable Bowel Syndrome

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypnotherapy
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IBS - Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • IBS according to Rome III criteria

Exclusion Criteria:

  • Organic GI disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Individual hypnotherapy

    Group hypnotherapy

    Arm Description

    Treatment given on a individual basis, face to face.

    Treatment given in a group setting, face to face.

    Outcomes

    Primary Outcome Measures

    Change of Gastrointestinal symptom severity
    Measured with Irritable Bowel Syndrome- severity scoring system (IBS-SSS). The questionnaire measures severity of GI symptoms and consists of five questions where each score ranges from 0 to 100. A total score of all five questions is calculated ranging from 0 to 500. The higher the score the more severe the GI symptoms.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 7, 2018
    Last Updated
    October 24, 2022
    Sponsor
    Sahlgrenska University Hospital, Sweden
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03432078
    Brief Title
    Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    August 15, 2011 (Actual)
    Primary Completion Date
    December 31, 2019 (Actual)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sahlgrenska University Hospital, Sweden

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    IBS - Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Individual hypnotherapy
    Arm Type
    Active Comparator
    Arm Description
    Treatment given on a individual basis, face to face.
    Arm Title
    Group hypnotherapy
    Arm Type
    Active Comparator
    Arm Description
    Treatment given in a group setting, face to face.
    Intervention Type
    Other
    Intervention Name(s)
    Hypnotherapy
    Intervention Description
    Non-pharmacological treatment
    Primary Outcome Measure Information:
    Title
    Change of Gastrointestinal symptom severity
    Description
    Measured with Irritable Bowel Syndrome- severity scoring system (IBS-SSS). The questionnaire measures severity of GI symptoms and consists of five questions where each score ranges from 0 to 100. A total score of all five questions is calculated ranging from 0 to 500. The higher the score the more severe the GI symptoms.
    Time Frame
    Up to ten years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    67 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: IBS according to Rome III criteria Exclusion Criteria: Organic GI disease

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35505463
    Citation
    Lovdahl J, Tornblom H, Ringstrom G, Palsson OS, Simren M. Randomised clinical trial: individual versus group hypnotherapy for irritable bowel syndrome. Aliment Pharmacol Ther. 2022 Jun;55(12):1501-1511. doi: 10.1111/apt.16934. Epub 2022 May 3.
    Results Reference
    derived

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    Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome

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