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Internet-delivered CBT for Irritable Bowel Syndrome

Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01171053
Enrollment
86
Registered
2010-07-28
Start date
2008-06-30
Completion date
2010-06-30
Last updated
2010-07-28

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

Conditions

Irritable Bowel Syndrome

Keywords

Cognitive behavior therapy, Internet, Cost-effectiveness, Irritable bowel syndrome

Brief summary

The aim of this study is to investigate the efficacy of a 10 week Internet-delivered CBT treatment for patients diagnosed with IBS. The patients' work with the treatment and is supported through online contact with a therapist. Approximately 86 patients will be included in the study and randomized to either condition. All included patients are assessed one week before the treatment starts. After 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months follow-up after treatment. Patients in treatment condition are hypothesized to experience significant reduction IBS symptoms, societal costs and quality of life compared to patients on waiting list.

Interventions

Internet-delivered cognitive behavioral therapy with therapist support.

Weekly therapist support without CBT-interventions

Sponsors

Region Stockholm
CollaboratorOTHER_GOV
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of IBS given by physician * At screening fulfilling Rome III-criteria for IBS

Exclusion criteria

* Severe depression * Suicidal ideation * Presence of unexplained IBS alarm symptoms

Design outcomes

Primary

MeasureTime frameDescription
Gastrointestinal symptomsOne week before the treatment startsGastrointestinal Symptom rating scale (GSRS)

Secondary

MeasureTime frameDescription
Health economic dataOne week before the treatment startsTrimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry. In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured.
Quality of lifeOne week before the treatment startsThe Irritable Bowel Syndrome Quality of Life Instrument
Gastrointestinal symptom-specific anxietyOne week before the treatment startsVisceral Sensitivity Index
Depressive symptomsOne week before the treatment startsThe Montgomery Åsberg Depression Rating Scale
Functional impairments in work, social and family lifeOne week before the treatment startsSheenan Disability Scale (DSD)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026