Clinical trial NCT01171053: Internet-delivered CBT for Irritable Bowel Syndrome
Official title: Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Cognitive behavior therapy
Internet
Cost-effectiveness
Irritable bowel syndrome
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2010-07-28
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Gastrointestinal symptoms
timeFrame: One week before the treatment starts
measure: Gastrointestinal symptoms
timeFrame: 10 weeks after the treatment started
measure: Gastrointestinal symptoms
timeFrame: 3 months after the treatment ended
measure: Gastrointestinal symptoms
timeFrame: One year after the treatment ended
Secondary outcomes:
measure: Health economic data
timeFrame: One week before the treatment starts
measure: Health economic data
timeFrame: 10 weeks after the treatment started
measure: Health economic data
timeFrame: 3 months after the treatment ended
measure: Health economic data
timeFrame: One year after the treatment ended
measure: Quality of life
timeFrame: One week before the treatment starts
measure: Quality of life
timeFrame: 10 weeks after the treatment started
measure: Quality of life
timeFrame: 3 months after the treatment ended
measure: Quality of life
timeFrame: One year after the treatment ended
measure: Gastrointestinal symptom-specific anxiety
timeFrame: One week before the treatment starts
measure: Gastrointestinal symptom-specific anxiety
timeFrame: 10 weeks after the treatment started
measure: Gastrointestinal symptom-specific anxiety
timeFrame: 3 months after the treatment ended
measure: Gastrointestinal symptom-specific anxiety
timeFrame: One year after the treatment ended
measure: Depressive symptoms
timeFrame: One week before the treatment starts
measure: Depressive symptoms
timeFrame: 10 weeks after the treatment started
measure: Depressive symptoms
timeFrame: 3 months after the treatment ended
measure: Depressive symptoms
timeFrame: One year after the treatment ended
measure: Functional impairments in work, social and family life
timeFrame: One week before the treatment starts
measure: Functional impairments in work, social and family life
timeFrame: 10 weeks after the treatment started
measure: Functional impairments in work, social and family life
timeFrame: 3 months after the treatment ended
measure: Functional impairments in work, social and family life
timeFrame: One year after the treatment ended
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Internetpsykatrienheten, M46, Psykiatri sydväst
Study officials:
affiliation: Karolinska Institutet
name: Nils Lindefors, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ljotsson B, Falk L, Vesterlund AW, Hedman E, Lindfors P, Ruck C, Hursti T, Andreewitch S, Jansson L, Lindefors N, Andersson G. Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome--a randomized controlled trial. Behav Res Ther. 2010 Jun;48(6):531-9. doi: 10.1016/j.brat.2010.03.003. Epub 2010 Mar 16.