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Cognitive Behavior Therapy (CBT) Compared to Stress Management for Irritable Bowel Syndrome

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Karolinska Institute

Status

Completed

Conditions

Irritable Bowel Syndrome

Treatments

Behavioral: Cognitive behavior therapy
Behavioral: Stress management

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks.

Approximately 200 patients will be included in the study and randomized to either condition.

The study hypothesis is that CBT will be superior to stress management on the main outcome measure, which is IBS symptom severity measured over 4 weeks.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Cognitive behavior therapy
Experimental group
Treatment:
Behavioral: Cognitive behavior therapy
Stress management
Active Comparator group
Treatment:
Behavioral: Stress management

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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