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Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral. They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. Both programs include mindfulness training, education about how excessive avoidant and control behaviors maintain IBS symptoms, and changing of these behaviors to live a richer life. One of the programs also includes instructions on how to perform systematic exposure. The hypothesis of the study is while both groups will show improvement in terms of IBS symptom severity and quality of life, the addition of systematic exposure will lead to more improvement in symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT without exposure | Active Comparator |
| |
| CBT with exposure | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy without exposure | Behavioral | 10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, and guided behavioral change aiming to increase quality of life and flexibility. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptom rating scale | 1 week before randomization | |
| Gastrointestinal symptom rating scale | 10 weeks after randomization (i.e. after conclusion of treatment) | |
| Gastrointestinal symptom rating scale | 36 weeks after randomization (i.e. 6 months after conclusion of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) | 1 week before randomization | |
| Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) | 10 weeks after randomization (i.e. after conclusion of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brjánn Ljótsson, PhD | Karolinska Institutet | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34256715 | Derived | Wallen H, Lindfors P, Andersson E, Hedman-Lagerlof E, Hesser H, Lindefors N, Svanborg C, Ljotsson B. Return on investment of internet delivered exposure therapy for irritable bowel syndrome: a randomized controlled trial. BMC Gastroenterol. 2021 Jul 13;21(1):289. doi: 10.1186/s12876-021-01867-6. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Cognitive Behavioral Therapy with exposure | Behavioral | 10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, guided behavioral change aiming to increase quality of life and flexibility, and systematic exposure to IBS symptoms and aversive situations. |
|
| Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) | 36 weeks after randomization (i.e. 6 months after conclusion of treatment) |
| Visceral Sensitivity Index (VSI) | 1 week before randomization |
| Visceral Sensitivity Index (VSI) | 10 weeks after randomization (i.e. after conclusion of treatment) |
| Visceral Sensitivity Index (VSI) | 36 weeks after randomization (i.e. 6 months after conclusion of treatment) |
| D004066 | Digestive System Diseases |