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Individual or Group Hypnotherapy in the treatment of Irritable Bowel Syndrome in primary and secondary care.

Individual or Group Hypnotherapy in the treatment of Irritable Bowel Syndrome in primary and secondary care. - Imagine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39767
Enrollment
354
Registered
2011-02-15
Start date
2011-05-31
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Interventions

Patients will be randomly allocated to 6 sessions of individual hypnotherapy, 6 sessions of group-hypnotherapy or 6 sessions of educational-supportive therapy in a group (placebo).

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients aged 18-65 years in primary and secondary care , who are diagnosed with IBS (Rome III criteria)

Exclusion criteria

Exclusion criteria: Patients unable to understand the content of the sessions, because of insufficient command of the Dutch language. Patients unable to fill in the questionnaires. Patients unable (for example: too aggressive) or unwilling to function in a group. Patients in whom a` psychiatric condition needs attention first (for example severe depression or psychosis). Patients who have IBS and other chronic bowel diseases, as far as they are already diagnosed, such as ulcerative colitis, Crohn*s disease or coeliac disease. Patients who have undergone major surgery to the lower gastrointestinal tract, such as partial or total colectomy, small bowel resection or partial or total gastrectomy.

Design outcomes

Primary

MeasureTime frame
The primary efficacy parameter is the responder rate for IBS symptoms based on a weekly assessment of Adequate Relief (AR) score.

Secondary

MeasureTime frame
Secondary efficacy parameters are changes in the IBS Symptom Severity Score (IBS-SSS) and Quality of Life (IBS-Qol), cognitions, self-efficacy, psychological complaints and direct and indirect costs of the disease, measured as the costs of visits to doctors and alternative healers, use of medicines and loss of labour productiveness.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)