Funaba Misako, Kawanishi Hitomi, Fujii Yasushi, Higami Koyo, Tomita Yoshitoshi, Maruo Kazushi, Sugawara Norio, Oe Yuki, Kura Satsuki, Horikoshi Masaru, Ohara Chisato, Kikuchi Hiroe, Ariga Hajime, Fukudo Shin, Sekiguchi Atsushi, Ando Tetsuya
Department of Behavioral Medicine, National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Japan.
Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Front Psychiatry. 2021 Sep 9;12:673939. doi: 10.3389/fpsyt.2021.673939. eCollection 2021.
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder, which severely impairs the quality of life of patients. Treatment of refractory IBS patients is needed, but it is not yet widely available. Therefore, we previously developed a Japanese version of cognitive behavioral therapy with interoceptive exposure (CBT-IE) involving 10 face-to-face sessions to treat refractory IBS patients. To disseminate this treatment of IBS in places where therapists are limited, we further developed a hybrid CBT-IE program with complementary video materials that include psychoeducation and homework instructions so that patients can prepare for face-to-face sessions in advance at home and the session time can be shortened, thereby reducing the burden on both patient and therapist. In this study, we conducted a trial to evaluate the feasibility, efficacy, and safety of the hybrid CBT-IE program for Japanese IBS patients. The study was a single-arm, open-label pilot clinical trial. A total of 16 IBS patients were included in the study and 14 patients completed the intervention, which consisted of 10 weekly individual hybrid CBT-IE sessions. We performed an intention to treat analysis. The primary outcome measure for the efficacy of the intervention was a decrease in the severity of IBS symptoms. The feasibility and safety of the intervention were examined by the dropout rate and recording of adverse events, respectively. The dropout rate of the hybrid CBT-IE was comparable to that of our previous CBT-IE with only face-to-face sessions and no adverse events were recorded. The severity of IBS symptoms within-group was significantly decreased from the baseline to mid-treatment [Hedges' g = -0.98 (-1.54, -0.41)], post-treatment [Hedges' g = -1.48 (-2.09, -0.88)], 3-month follow-up [Hedges' g = -1.78 (-2.41, -1.14)], and 6-month follow-up [Hedges' g = -1.76 (-2.39, -1.13)]. Our results suggest that the hybrid CBT-IE is effective and could be conducted safely. To confirm the effectiveness of the hybrid CBT-IE, it is necessary to conduct a multicenter, parallel-design randomized control trial. [https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041376], identifier [UMIN000036327].
肠易激综合征（IBS）是一种功能性胃肠疾病，严重损害患者的生活质量。难治性IBS患者需要治疗，但目前尚未广泛应用。因此，我们之前开发了一种日语版的包含内感受暴露的认知行为疗法（CBT-IE），包括10次面对面治疗，用于治疗难治性IBS患者。为了在治疗师有限的地区推广这种IBS治疗方法，我们进一步开发了一种混合CBT-IE项目，配有补充视频材料，包括心理教育和家庭作业指导，以便患者可以在家提前为面对面治疗做准备，从而缩短治疗时间，减轻患者和治疗师的负担。在本研究中，我们进行了一项试验，以评估混合CBT-IE项目对日本IBS患者的可行性、疗效和安全性。该研究是一项单臂、开放标签的试点临床试验。共有16名IBS患者纳入研究，14名患者完成了干预，干预包括每周1次，共10次的个体混合CBT-IE治疗。我们进行了意向性分析。干预疗效的主要结局指标是IBS症状严重程度的降低。分别通过脱落率和不良事件记录来检查干预的可行性和安全性。混合CBT-IE的脱落率与我们之前仅进行面对面治疗的CBT-IE相当，且未记录到不良事件。组内IBS症状严重程度从基线到治疗中期[Hedges' g = -0.98（-1.
