- Fecal Incontinence
|A pilot feasibility study of an unguided, internet-delivered cognitive behavioral therapy program for irritable bowel syndrome
Neurogastroenterol Motil. 2021 Nov;33(11):e14108. doi: 10.1111/nmo.14108. Epub 2021 Mar 21.
Jocelynn T Owusu 1, Alice Sibelli 1, Rona Moss-Morris 2, Miranda A L van Tilburg 3 4 5, Rona L Levy 5, Megan Oser 1
1Mahana Therapeutics, Inc, San Francisco, CA, USA.
2Department of Psychology, King's College London, UK.
3College of Pharmacy & Health Sciences, Campbell University, Buies Creek, NC, USA.
4Department of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
5School of Social Work, University of Washington, Seattle, WA, USA.
Background: Irritable bowel syndrome (IBS) is linked with lower health-related quality of life. Cognitive behavioral therapy (CBT) designed for IBS management can improve outcomes but further research of more accessible implementations of this treatment approach for IBS is needed. This study assessed the feasibility of a web-delivered CBT program among adults with IBS to apply to a future clinical trial.
Methods: Twenty-five participants were randomized to receive an unguided web-based, CBT program for IBS. The primary outcome was changes in IBS symptom severity (IBS Symptom Severity Scale [IBS-SSS]). Secondary outcomes included IBS-specific CBT therapeutic mechanisms of change (GI-specific anxiety, unhelpful IBS behaviors, and GI-focused cognitions) and changes in depressive (Patient Health Questionnaire-9 [PHQ-9]) and anxiety (Generalized Anxiety Disorder-7 scale [GAD-7]) symptom severity.
Key results: Among participants randomized to receive web-based CBT, the average baseline IBS-SSS score was 296.3 (SD=100.9). IBS symptom severity significantly improved at 2-month (p < 0.001) and 3-month follow-up (p < 0.0001); the within-group effect size between baseline and 3-month follow-up IBS-SSS scores was large (d = 1.14) and 63.6% experienced a clinically meaningful improvement (ie, ≥50-point IBS-SSS score reduction). GI-specific anxiety symptoms and cognitions significantly improved at 2-month follow-up, as did unhelpful IBS safety behaviors. Additionally, clinically meaningful improvement was observed in depressive and anxiety symptoms at 3-month follow-up among participants with symptoms above the clinical threshold (ie, PHQ-9 ≥ 10 and GAD-7 ≥ 10, respectively) at baseline.
Conclusions & inferences: These preliminary findings warrant a larger trial to investigate an unguided, web-based CBT for IBS symptom management that is powered to detect between-group treatment effects.