A randomized clinical trial of the Unified Protocol for Transdiagnostic treatment of emotional and gastrointestinal symptoms in patients with irritable bowel syndrome: evaluating efficacy and mechanism of change

Mohsenabadi, Hamid; Zanjani, Zahra; Shabani, Mohammad Javad; Arj, Abbas

doi:10.1016/j.jpsychores.2018.07.003

Cited by 26Gastrointestinal motility and disordersAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesPersonality Disorders and Psychopathology

A randomized clinical trial of the Unified Protocol for Transdiagnostic treatment of emotional and gastrointestinal symptoms in patients with irritable bowel syndrome: evaluating efficacy and mechanism of change

Mohsenabadi, Hamid, Zanjani, Zahra, Shabani, Mohammad Javad, Arj, Abbas·2018·Journal of Psychosomatic Research

DOI 10.1016/j.jpsychores.2018.07.003

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Abstract

Objective The aim of this randomized controlled trial was to evaluate the efficacy of Unified Protocol (UP) for transdiagnostic treatment of psychological problems, such as anxiety, depression, and stress, and treating the intensity of gastrointestinal symptoms in individuals with Irritable Bowel Syndrome (IBS). Another aim of the study was to test whether emotion regulation mediates the effect of UP.Methods Among 91 patients diagnosed with IBS (using ROME III criteria), 64 patients were eligible to participate in the study based on the inclusion/exclusion criteria. These patients were randomly assigned to either an intervention group (n = 32) that participated in 12 weekly UP treatment sessions or to a wait-list control group (n = 32). All patients completed the Depression, Anxiety, and Stress Scale (DASS-42), Emotion Regulation Questionnaire (ERQ), and Gastrointestinal Symptoms Rating Scale (GSRS) pre- and post-intervention. The data were analyzed with SPSS 20.0 software.Results The results of intention-to-treat (ITT) analysis indicated a significant decrease in depression, anxiety, stress, and gastrointestinal symptoms, as well as significant improvements in emotion regulation scores in the intervention group post intervention. All results were significant at P < .001. Mediation analyses indicated that changes in emotion regulation mediated the effect of UP on changes in emotional and gastrointestinal symptoms.Conclusion UP was effective and influential in emotion regulation among the intervention group and caused a decline in emotional and gastrointestinal symptoms. Hence, this intervention is promising, but larger RCTs are needed to more investigate its efficacy. Future studies could also examine the efficacy of the UP in other medical conditions with co-occurring psychological conditions. The study is registered at the irct.ir database under registration number IRCT2017010431765N1.

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Authors: Mohsenabadi, H., Zanjani, Z., Shabani, M. J., & Arj, A.
Affiliations: Kashan University of Medical Sciences (IR)
Corresponding author: Zanjani, Zahra
ORCID: Mohsenabadi, Hamid
Zanjani, Zahra
Shabani, Mohammad Javad
Arj, Abbas
Venue: Journal of Psychosomatic Research
Publisher: Elsevier BV
Published: 2018-10
Volume: 113
Pages: 8-15
ISSN: 0022-3999 (ISSN-L)
DOI: 10.1016/j.jpsychores.2018.07.003
OpenAlex: W2884349560
Cited by: 26
References: 60
Citations by year: 2026: 3 · 2025: 4 · 2024: 4 · 2023: 3 · 2022: 4 · 2021: 4 · 2020: 1 · 2019: 3
FWCI: 1.93
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Journal of Psychosomatic Research (publishedVersion)
PubMed (publishedVersion)
Funders: Kashan University of Medical Sciences (GR-9599)
Topics: Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
Social Sciences › Psychology › Clinical Psychology › Personality Disorders and Psychopathology
Keywords: Unified Protocol, transdiagnostic treatment, irritable bowel syndrome, emotion regulation, anxiety, depression, stress, gastrointestinal symptoms, psychological comorbidity, mediation analysis, psychotherapy efficacy
MeSH terms: Adult, Female, Humans, Male, Treatment Outcome, Irritable Bowel Syndrome

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A randomized clinical trial of the Unified Protocol for Transdiagnostic treatment of emotional and gastrointestinal symptoms in patients with irritable bowel syndrome: evaluating efficacy and mechanism of change

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