Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS)

NCT ID: NCT06297785

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2025-05-30

Brief Summary

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Adult IBS patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups. The primary outcome measure was change in gastro-intestinal symptom severity. Secondary outcomes are GI-specific anxiety, general anxiety and depression, quality of life, and extracolonic symptom severity. Usability of the digital platform as well as patient treatment satisfaction will also be assessed.

Detailed Description

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IBS patients with symptoms refractory to standard treatment and who were referred to a specialist unit for hypnotherapy, will be included in the study consecutively. The patients will receive gut-directed hypnotherapy given by a nurse trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. Effects of treatment will be measured by validated questionnaires at baseline and at various time points during the treatment period, as well as after the completion of the treatment at follow-up 6 months, 1 and 2 years after treatment.

Conditions

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IBS - Irritable Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nurse-delivered, gut-directed hypnotherapy

Group Type OTHER

Gut-directed hypnotherapy

Intervention Type BEHAVIORAL

Gut-directed hypnotherapy for patients with irritable bowel syndrome (IBS). Gut-directed hypnotherapy (8 sessions), will be given online in a group setting.The hypnosis treatment is administered by a nurse specially trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. The treatment is based on the North Carolina protocol. Patients will assess gastro-intestinal symptom severity before, during and after treatment, as well as at follow-up.

Interventions

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Gut-directed hypnotherapy

Gut-directed hypnotherapy for patients with irritable bowel syndrome (IBS). Gut-directed hypnotherapy (8 sessions), will be given online in a group setting.The hypnosis treatment is administered by a nurse specially trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. The treatment is based on the North Carolina protocol. Patients will assess gastro-intestinal symptom severity before, during and after treatment, as well as at follow-up.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* IBS diagnosis

Exclusion Criteria

* Organic GI disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Magnus Simrén

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magnus Simrén

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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Mag-Tarmlab, Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2022-03997-01

Identifier Type: -

Identifier Source: org_study_id

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