A pilot study of a Cognitive Behavioral Therapy (CBT) Application for Irritable Bowel Syndrome (IBS)

JRCT ID: jRCTs032230498

Registered date:08/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: irritable bowel syndrome
• Date of first enrollment: 08/12/2023
• Target sample size: 20
• Study type: Interventional

Intervention(s)

In this study, the efficacy of a CBT program using a smartphone app (the App) for IBS is evaluated. The App, under development by MICIN Co., Ltd., consists of a patient-side app and a doctor-side app and falls under the category of unapproved medical device programs both domestically and internationally.
The CBT program using this app includes psychological education, relaxation (diaphragmatic breathing, autogenic training), exposure therapy, and summarization and relapse prevention content. Each content consists of learning, implementation, and symptom input, and subjects undergo the program step by step. Specifically, psychological education and relaxation are tackled in the first two weeks, then it transitions to exposure therapy, and lastly, it focuses on summarization and relapse prevention. The entire usage period is assumed to be three months.
The main content of the app, the exposure therapy, is a behavioral technique in cognitive behavioral therapy. It's incorporated into the CBT program because it's effective as a treatment for situations where one avoids certain situations due to IBS symptoms. For the groundwork of the therapy using exposure therapy, psychological education and relaxation are incorporated, and summarization and relapse prevention are set for therapeutic consolidation. Moreover, to easily implement exposure therapy, initially, an anxiety hierarchy (a list from mild to intense anxiety situations, each rated with the most intense anxiety situation being 100 points and scored in increments of 10) is created, and starts from the mild anxiety situations.
Research subjects access the exclusive page of the app from the web browser of their smartphones and engage in CBT using the app at least once a day. The patient-side app is equipped with 1) learning content display function, 2) messaging function, 3) function to display the judgment results of changes in target activities after exposure therapy, and 4) recording content display function. Also, doctors access the exclusive page of the app from a computer or tablet web browser and check feedback messages from the app based on the subject's implementation status at least during consultations. Therefore, the doctor-side app is equipped with the record display function and judgment result display function for research subjects. Through these functions, research subjects can implement effective CBT themselves, and doctors can provide appropriate feedback.
Benefits to the research subjects from undergoing the CBT program are expected improvements in IBS symptoms. Symptom improvement refers to improvements in IBS severity, mental health, and QOL. Given the nature of CBT using an app, significant side effects are unlikely.
Results obtained from this study, using the planned app, will not only enable patients to understand their symptoms and condition but also to adopt continuous coping methods, thereby expecting to improve patients' QOL. Also, doctors can easily obtain patient information, including daily life and psychological state, and check the patient's behavior changes under daily life. It's believed that even without specialized knowledge, care from a psychological perspective can be done at home, and effective and optimal guidance/treatment can be provided during consultations even within limited consultation time.

Outcome(s)

• Primary Outcome: Change in the IBSSI-J score from baseline at 12 weeks

Secondary Outcome

(1) Change in the IBSSI-J score from baseline at 4 and 8 weeks.
(2) Change in the IBS-QOL-J score from baseline at 4, 8, and 12 weeks.
(3) Change in the EQ-5D-5L score from baseline at 4, 8, and 12 weeks.
(4) Change in the HADS score from baseline at 2, 4, 8, and 12 weeks.
(5) Change in daily symptom records (number of symptoms per day, maximum severity of symptoms in a day) from baseline at 2, 4, 8, and 12 weeks.
(6) Adherence (quantitative evaluation during the study period: login rate, daily symptom recording rate, relaxation technique execution recording rate.).
(7) Usability (qualitative & quantitative evaluation based on post-study questionnaire).
(8) Treatment satisfaction (qualitative & quantitative evaluation based on post-study questionnaire).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

(1) Individual diagnosed with IBS based on the Rome IV criteria.
(2) Those who, despite initiating the first-stage treatment (diet therapy/behavioral modification, gastrointestinal motility modifiers, probiotics, bulking polymer, 5-HT3 antagonists, intestinal secretagogues, etc.) or the second-stage treatment (administration of psychotropic drugs, etc.) as outlined in the "Evidence-based clinical practice guidelines for irritable bowel syndrome 2020" (The Japanese Society of Gastroenterology), have not seen sufficient improvement in symptoms (falling between 3-7 on the Global Improvement Scale) after 8 weeks or more.
(3) Those who possess a smartphone capable of using the application and is able to operate this application.
(4) Age: Those aged between 18 and 75 at the time of consent acquisition.
(5) Gender: Not specified.
(6) Those who, after receiving a thorough explanation about the study, have given their informed written consent of their own free will.
(7) Individuals able to attend outpatient visits according to the research schedule.

Exclude criteria

(1) Patients who are pregnant or may become pregnant.
(2) Patients who have a malignant tumor or other disease that should be prioritized over treatment of irritable bowel syndrome
(3) Patients who, at the time of consent acquisition, have participated in another clinical trial or clinical research within the past 3 months.
(4) Other patients whom the principal investigator or co-investigator deems unsuitable for participation in this study

Related Information

• Primary Sponsor: Yoshiuchi Kazuhiro