NCT01171053

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
Last Updated

July 28, 2010

Status Verified

July 1, 2010

Enrollment Period

2 years

First QC Date

July 26, 2010

Last Update Submit

July 27, 2010

Conditions

Irritable Bowel Syndrome

Keywords

Cognitive behavior therapyInternetCost-effectivenessIrritable bowel syndrome

Outcome Measures

Primary Outcomes (4)

  • Gastrointestinal symptoms

    Gastrointestinal Symptom rating scale (GSRS)

    One week before the treatment starts

  • Gastrointestinal symptoms

    Gastrointestinal Symptom rating scale (GSRS)

    10 weeks after the treatment started

  • Gastrointestinal symptoms

    Gastrointestinal Symptom rating scale (GSRS)

    3 months after the treatment ended

  • Gastrointestinal symptoms

    Gastrointestinal Symptom rating scale (GSRS)

    One year after the treatment ended

Secondary Outcomes (20)

  • Health economic data

    One week before the treatment starts

  • Health economic data

    10 weeks after the treatment started

  • Health economic data

    3 months after the treatment ended

  • Health economic data

    One year after the treatment ended

  • Quality of life

    One week before the treatment starts

  • +15 more secondary outcomes

Study Arms (2)

Attention control

PLACEBO COMPARATOR

Weekly support from therapist without CBT-interventions

Behavioral: Therapist support

Internet CBT

EXPERIMENTAL

Internet-delivered cognitive behavioral therapy with therapist support

Behavioral: Internet-delivered CBT

Interventions

Internet-delivered CBTBEHAVIORAL

Internet-delivered cognitive behavioral therapy with therapist support.

Internet CBT
Therapist supportBEHAVIORAL

Weekly therapist support without CBT-interventions

Attention control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internetpsykatrienheten, M46, Psykiatri sydväst

Stockholm, 141 86, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 20362976RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Nils Lindefors, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2010

First Posted

July 28, 2010

Study Start

June 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 28, 2010

Record last verified: 2010-07

Locations

SE(1)