DOI: https://doi.org/10.21203/rs.3.rs-2554475/v1
We aimed to develop a Cognitive Behavioral Therapy-based (CBT-based) mobile application and evaluate its effectiveness as a potential solution to the lack of specific treatments for non-patients with irritable bowel syndrome (IBS) in Japan. The participants comprised non-patients with IBS, recruited online and randomly assigned to either the treatment (n = 5) or waitlist control (n = 6) condition. The application was used over two months under a therapist’s guidance. The outcome measures were assessed using the following scales at six time points: Gastrointestinal Symptom Rating Scale (GSRS), Irritable Bowel Syndrome-Quality of Life Questionnaire (IBS-QOL-J), Pain Catastrophizing Scale (PCS-J), Cognitive Scale for Functional Bowel Disorders (CS-FBD), Visceral Sensitivity Index (VSI), and Irritable Bowel Syndrome Behavioral Responses Questionnaire (IBS-BRQ). Group differences were evaluated using mixed-factors analysis of variance. The interaction of intervention condition × time was significant for the CS-FBD, VSI, and IBS-BRQ. However, no statistically significant between-group differences were observed for the GSRS, IBS-QOL-J, and PCS-J scores at different time points. While the application improved symptom-specific cognition and behavior, and gastrointestinal-specific anxiety, it was not effective in improving IBS symptoms and quality of life. There is a need to refine the implementation of behavioral techniques and adjust the pace of application use according to each patient's understanding and symptoms.
Irritable bowel syndrome (IBS) is a functional bowel disorder characterized by abdominal pain or discomfort, or both (Longstreth et al., 2006). According to the Rome Ⅳ criteria, the latest diagnostic criteria for IBS, the prevalence rate of IBS in Japan is approximately 2.2% (ranging from 1.6–2.7%; Sperber et al., 2021). The diverse symptoms of IBS, which can range from mild to severe, are bothersome and associated with high medical costs and low work efficacy (Drossman et al., 2011; Faresjö et al., 2019; Nellesen et al., 2013). Some can live out their lives normally and experience symptoms only in specific situations, for example, while commuting to school in a crowded train in the morning, before a presentation, or during a meeting. Others cannot tolerate their pain and consequently miss work (Buono et al., 2017). Moreover, the more severe the symptoms, the higher the comorbidities, such as anxiety and depression, leading to lower quality of life (QOL; Lackner et al., 2014). Patients with IBS are classified into four subtypes based on their predominant stool patterns: constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), mixture of constipation and diarrhea (IBS-M), and unclassified (Longstreth et al., 2006). A potential reason for this diversity is the corresponding variety of psychological features (van Tilburg et al., 2013), such as symptom-specific cognition, avoidance behaviors, and gastrointestinal safety behaviors (Sugaya et al., 2012; Windgassen, Moss-Morris, Goldsmith, et al., 2019).
Japanese treatment guidelines for IBS recommend three steps: diet therapy and lifestyle modifications, gut targeted psychopharmacological therapy, and specific psychotherapy (Fukudo et al., 2021). Cognitive behavioral therapy (CBT) is the most effective form of specific psychotherapy with long-term efficacy in alleviating IBS symptoms (Black et al., 2020). Studies have elucidated the mechanisms behind the effectiveness of CBT for IBS (Windgassen et al., 2017) and established that symptom-specific cognition could be a possible factor in exacerbating IBS symptoms (Windgassen, Moss-Morris, Goldsmith, et al., 2019). Recently, Internet-based CBT (ICBT) has been developed, constituting the provision of CBT via email and other online means, and its efficacy as a cost-effective method in relieving IBS has been tested (Sampaio et al., 2019). Additionally, Ljótsson et al. (2010) and Ljótsson et al. (2011) showed that ICBT was more effective in alleviating IBS symptoms for participants in the treatment group as compared to those in the control condition.
However, a considerable number of people with IBS symptoms remain undiagnosed by gastroenterologists even though their symptoms meet the criteria (Ringström et al., 2007). Known as “non-patients with IBS,” they exist on a psychosocial continuum between patients and normal individuals (Drossman et al., 1988). However, the symptoms that non-patients experience are not significantly different from IBS patients’, and they suffer from severe pain as well. Fujii and Nomura (2008) showed that approximately 30% of IBS non-patients may become IBS patients within a timeframe as early as three years after experiencing symptoms. Some possible reasons for not seeking a diagnosis include not perceiving bowel symptoms as an illness that requires medical care, having insufficient information about effective treatments for IBS, availability of CBT only in specific centers in Japan, and long waiting lists to see specialists. Moreover, CBT has not been attempted for non-patients with IBS because psychotherapy has been established as the third step of the treatment process or adapted for refractory patients (individuals with IBS who do not respond to pharmacological treatments after 12 months) and those who develop chronic symptoms (NICE, 2015). Further, there is insufficient data to optimize clinical trials because no treatment has been developed for non-patients.
Endo (2007) and Endo et al. (2010) studied children and adolescents in Japan and reported that none of the students in their study had been diagnosed with IBS or received treatment even though the onset of IBS often occurs at a young age (Yamamoto et al., 2015). Moreover, according to a study of pediatrician visits in Japan, many patients who complained about IBS symptoms were associated with school absenteeism and experienced difficulty in going out (Fujii et al., 2021). Thus, treatment methods that consider psychosocial factors unique to Japan need to be established.
The purpose of this study was to address the problems experienced by IBS non-patients in Japan—the low accessibility of CBT and inadequacy of treatment options available. Additionally, there is room to strengthen the effect of ICBT interventions for IBS, which involve an automatic message system, visualization of data, and assistance with homework related to the treatment. Given this context, using a mobile application appears to be the most suitable approach. Accordingly, we developed a mobile application for non-patients with IBS, which has higher accessibility than the conventional methods of providing CBT.
Moreover, CBT for IBS usually includes multiple treatment modalities that lead to longer treatment durations and higher costs. Hence, we focus on symptom-specific cognition as the exacerbation factor; to the best of our knowledge, this is a novel aspect of our intervention for IBS. The application used included original cognitive restructuring strategies to ease the comprehension of CBT, psychoeducation, and exposure, which are also in line with previous studies (Kawanishi et al., 2019).
Individuals who thought they might have IBS symptoms were recruited online via Twitter between July 4 and 31, 2021. The inclusion criteria were as follows: 1) meeting the Rome Ⅳ criteria, 2) having never received an official diagnosis of IBS, 3) not currently undergoing treatment for IBS, 4) aged over 18 years, and 5) scoring over 70 points on the Cognitive Scale for Functional Bowel Disorders (CS-FBD) and Irritable Bowel Syndrome Behavioral Responses Questionnaire (IBS-BRQ). The exclusion criteria were as follows: 1) exhibiting the alarm symptoms (rectal bleeding, unintentional weight loss, and fever) and 2) having undergone colonoscopy or colonography due to suspected organic disease in their medical history (Black et al., 2012).
This study was approved by the Research Ethics Committee of Meisei University on June 29, 2021 [Reference no.: 2021-026]. The study was conducted according to the principles listed in the Declaration of Helsinki. Informed consent was obtained from the participants. Prior to the study, the participants agreed with our contract, which assured voluntary participation; that is, they could opt out of the study at any point without any repercussions. Furthermore, they were required to inform the researchers of any instance of discomfort or ill-health that may occur during the study period. Additionally, they were aware that they could consult the therapists (the first and last authors, KK and YF) whenever necessary.
The GSRS measures a wide range of gastrointestinal symptoms. However, it was originally designed to measure symptoms among patients with IBS and peptic ulcers. The GSRS measures five dimensions, including reflux, abdominal pain, indigestion, diarrhea, and constipation. The 15 items are rated on a seven-point Likert scale, ranging from 1 (no discomfort) to 7 (very severe discomfort). On adding all the items, a higher score indicates a higher severity of symptoms (Hongou et al. 1999).
The original Irritable Bowel Syndrome-Quality of Life Questionnaire (IBS-QOL) was developed by Drossman et al. (2000). Kanazawa et al. (2007) translated the IBS-QOL into Japanese (IBS-QOL-J) and verified its psychometric properties. The questionnaire measures how QOL is affected by IBS symptoms via eight subscales: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual concerns, and relationships. It comprises 34 items rated on a five-point scale, ranging from 0 (not at all) to 4 (a great deal). The raw scores can be converted into scaled scores, ranging from 0 to 100; higher scores indicate better QOL.
The original Pain Catastrophizing Scale (PCS) was developed by Sullivan et al. (1995) and translated into Japanese (PCS-J) by Matsuoka and Sakano (2007). The PCS and PCS-J have shown good psychometric soundness. The instrument comprises 13 items that measure catastrophizing thoughts pertaining to pain. The items are assessed using a five-point Likert scale, ranging from 0 (not at all) to 4 (all the time). It encompasses three subscales: rumination (e.g., “I keep thinking about how badly I want the pain to stop”), helplessness (e.g., “I feel I can’t stand it anymore”), and magnification (e.g., “I wonder whether something serious may happen”).
The CS-FBD is a psychometrically sound measure for maladaptive cognitions pertaining to bowel symptoms. It comprises 25 items rated on a seven-point Likert scale, ranging from 1 (strongly disagree) to 7 (totally agree). The total scores range from 25 to 175, with higher scores indicating the presence of several maladaptive cognitions pertaining to bowel symptoms (Toner et al., 1998).
The VSI is a psychometrically sound measure of the anxiety associated with gastrointestinal symptoms and sensations (Labus et al., 2004). Gastrointestinal-specific anxiety (GSA) is an important factor for evaluating perceived symptom severity among patients with IBS (Jerndal et al., 2010). It is a unidimensional 15-item instrument; the items are rated on a six-point Likert scale, ranging from 0 (not at all) to 5 (strongly agree). The total scores range from 0 to 75, with higher scores indicating severe anxiety pertaining to gastrointestinal symptoms.
The IBS-BRQ consists of 26 items measuring unhelpful behaviors pertaining to IBS symptoms. The items are rated on a seven-point Likert scale ranging from 1 (never) to 7 (always). Higher scores indicate the presence of several unhelpful behaviors. The IBS-BRQ comprises two subscales, assessing avoidance and control behavior; these behaviors could be targeted for treatment via ICBT (Reme et al., 2010).
The authors designed the application based on the modules of CBT for IBS. (Craske et al., 2011). The application includes three primary components—psychoeducation, cognitive restructuring, and exposure (Fig. 1)—which are the basic elements usually included in CBT practices for IBS. In this application, the order in which the content are accessed and utilized is important, and we hypothesized the following sequence: 1) psychoeducation conveys how cognition and behavior are related to IBS symptoms, 2) cognitive restructuring helps users practice how to regulate their thoughts when they face a situation where their symptoms might occur, and 3) exposure allows users to confirm that the terrible situation that they envisaged would not occur and that the adaptive cognitions are true. Thus, the treatment via the application proceeded in a step-wise manner.
The psychoeducational component—titled “IBS no ohanashi” (which translates to “explanations about IBS”)—comprised six lessons (delivered via 63 pages, as PDF files): information about IBS symptoms (lesson 1); deciphering associations between thoughts (cognition), feelings (emotions), and reactions (behavior), and the development of the vicious cycle of pain associated with IBS symptoms (lesson 2); effects of cognitive bias on the pain associated with IBS symptoms and strategies to break the vicious cycle by challenging maladaptive cognition (lesson 3); effectiveness and facilitation of exposure (lesson 4); summary of psychoeducation and preventive methods (lesson 5); and dispelling misunderstandings based on common myths and beliefs (shared as a bonus page to prevent misunderstanding and confusion regarding the information included in the application). Participants could access these lessons (except lesson 5 and the bonus page) whenever they wished. Participants answered a quiz via Google Forms after they read each section for the first time to ensure that they understood the contents.
The cognitive restructuring component was titled “ninchi no work” (which means “cognitive restructuring work”). Our application was focused on the symptoms' specific cognitions, and hence, included an original method of cognitive restructuring. To manifest the main point of cognitive restructuring, which is to diversify or fulfill objective perspectives and magnify the mobile application’s effect as a self-help method, we developed an original technique involving more than 100 example situations and four choices for each situation. These situations are commonly observed among non-patients with IBS in Japan. The choices were divided into two types: adaptive and maladaptive solutions. For maladaptive cognitions, we considered the cognitions commonly misunderstood as being adaptive by the patients. The participants were asked to specify to what extent they agreed with the four specified options for each question, on a scale of 0 to 100. If they answered incorrectly, as denoted by the percentage score conforming to maladaptive cognitions, they had to continue answering until the option aligning with the adaptive cognition was chosen. We intended to enhance the participants’ thinking abilities such that they could deal with their symptoms when faced with similarly triggering situations.
The third component—titled “exposure”—was divided into two steps. First, we established an anxiety hierarchy via the application. The application displays examples of plausible IBS symptoms that non-patients commonly experience in their daily lives. The participants chose five anxiety-arousing symptoms with which they wished to cope (via exposure). They could also create their own anxiety hierarchy using the application. Second, the application guided them through exposure therapy and maintained a recorded their work on it. Before their encounter with the situations listed in the anxiety hierarchy, participants recorded their cognitions by selecting one of the four alternatives. After completion of the exposure therapy, they recorded the transformation in their anxiety (by using their fingers to draw a graph) and cognition, and evaluated the exposure therapy by awarding themselves points. The anxiety and achievement self-assessments of exposure, as captured by the app, are shown in Fig. 1.
The first author (KK) sent messages to the participants as daily reminders of their tasks for the respective day; however, the author did not require the participants to respond unless they had any questions. These messages were aimed at sustaining the participants’ motivation for treatment. Participants were allowed to contact the author via Instagram at any time between 10 am and 10 pm (except on Thursdays). Following the completion of the assigned tasks, the participants were required to send the message “done” to the researcher. Furthermore, they were requested to read the manual if they faced trouble while manipulating the application.
The participants followed the given instructions for using the application. In the first step (psychoeducation), they read each section and answered the corresponding quiz via Google Forms. Before engaging in the tasks in the second step (cognitive restructuring), the participants watched an instructional video on YouTube and met with the author for less than 30 minutes online. In the second step, the participants answered 136 questions over 27 days (five questions per day). If they were unable to decipher a question, they were allowed to review it. Before engaging in the tasks in the third step (exposure), the participants watched two YouTube videos; one explained the content and procedures of the section and instructions for generating the anxiety hierarchy, and the other explained the steps for practicing exposure exercises using the mobile application. The participants engaged in the exposure exercises for 26 days (Table 1).
| Week 1 | Psychoeducation | Understanding the vicious cycle of exacerbation of IBS symptoms. |
|---|---|---|
| Week 2 | Psychoeducation Cognitive restructuring | Understanding the connection between cognition and IBS symptoms and the vicious cycle of IBS. Learning about various perspectives and ideas to break the vicious cycle of IBS. |
| Week 3 | Psychoeducation Cognitive restructuring | Learning the importance of exposure therapy for improving IBS symptoms and how to act in situations where IBS symptoms might occur by using the application. Learning about various perspectives and ideas to break the vicious cycle of IBS. |
| Week 4 | Cognitive restructuring Developing the anxiety hierarchy | Learning about various perspectives and ideas to break the vicious cycle of IBS. Selecting situations where IBS symptoms might occur and determining ways to overcome them. |
| Week 5 | Exposure | Being exposed to and challenging the situations in a particular order. |
| Week 6 | ||
| Week 7 | ||
| Week 8 | ||
| Week 9 | Psychoeducation | Learning about ways to deal with IBS symptoms after completing the use of the application. Learning about ways to prevent a recurrence. |
| Summarization | ||
| Note: IBS: irritable bowel syndrome | ||
We used the waitlisted participants as a control condition. The participants in the control group used the application during the post-treatment period, after the treatment group had completed the assessment.
Data were analyzed using mixed-factors analysis of variance with the intervention condition (treatment/control) and time (the time points reflected the durations from pre-treatment to the third follow-up; time points from pre-treatment to Follow-up 2 were measured every month, and the Follow-up 3 measurement was taken two months after Follow-up 2) as independent variables and the primary (GSRS and IBS-QOL-J scores) and secondary (PCS-J, CS-FBD, VSI, and IBS-BRQ scores) outcome measures as dependent variables. Analyses were carried out using the R software (version 4.1.0)
Of the 49 individuals who were recruited via Twitter, 11 (Mage = 22.73 years, SD = 4.22 years; nine women) met the inclusion criteria; that is, they met the Rome IV diagnostic criteria and obtained scores greater than 70 on the CS-FBD and IBS-BRQ. Of the 11 participants included in the study, seven (63.6%) presented with IBS-M, three (27.2%) had IBS-D, and one (9.0%) had IBS-C. Further, they did not meet the exclusion criteria. One individual had been diagnosed with IBS (based on the Rome Ⅲ criteria) when he was 18 years old and was prescribed medication for a year. Another individual’s doctor suspected that she had IBS and prescribed her medication (mepenzolate bromide).
The participants were randomly allocated to the two groups (Fig. 2). Of the 11 participants, five were assigned to the treatment condition; of these, four had IBS-M and one had IBS-C during the pre-treatment period. Further, six participants were assigned to the waitlist control condition; of these, three had IBS-D and three had IBS-M during the pre-treatment period.
| Experimental group | Waitlist control | ||
|---|---|---|---|
| Age (SD) | 23.2 (5.38) | 2.33 (2.29) | |
| Sex | Female | 4 | 5 |
| Male | 1 | 1 | |
| IBS Subtype | |||
| Constipation | 1 | 0 | |
| Diarrhea | 0 | 3 | |
| Mixed | 4 | 3 | |
The IBS subtype was assessed at the pre-treatment period. SD: standard deviation
The results pertaining to the outcomes are presented in Table 3. The main effects of the intervention condition (F[1, 9] = 3.09, p = 0.11) and interaction effect of intervention condition × time (F[4, 36] = .18, p = .95) on GSRS scores were not statistically significant. However, the main effect of time on GSRS scores was statistically significant (F[4, 36] = 2.99, p = .03, η2G = .19). The result of multiple comparisons performed using the Bonferroni method on the main effect of time was not statistically significant.
| Main Effect | Intervention condition × time | Effect size | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Experimental group (n = 5) | Waitlist control (n = 6) | group | duration | ||||||||||||||||
| Outcome | Pre-treatment | Mid-treatment | Post-treatment | Follow-up 1 | Follow-up 2 | Follow-up 3 | Pre-treatment | Mid-treatment | Post-treatment | Follow-up 1 | Follow-up 2 | Follow-up 3 | F | F | F | η2G | |||
| GSRS | Mean (SD) | 37.40 (13.53) | 38.40 (11.15) | 34.20 (11.51) | 33.60 (6.34) | 26.40 (7.86) | 22.60 (5.50) | 48.83 (13.35) | 53.50 (20.05) | 48.33 (17.58) | 43.33 (18.08) | 40.83 (12.64) | 40.83 (23.97) | 3.09 | 2.99* | .18 | .19 | ||
| IBS-QOL-J | Mean (SD) | 51.80 (9.87) | 50.60 (18.18) | 55.51 (18.46) | 60.44 (25.13) | 58.82 (24.27) | 67.69 (22.06) | 48.67 (16.24) | 39.00 (17.92) | 42.72 (19.72) | 43.98 (18.49) | 55.76 (15.37) | 62.04 (25.22) | .77 | 2.35 | 1.03 | .06 | ||
| CS-FBD | Mean (SD) | 110.00 (15.38) | 80.00 (33.98) | 72.80 (29.23) | 78.40 (46.00) | 75.60 (39.05) | 56.00 (27.78) | 92.50 (29.02) | 113.17 (28.39) | 107.67 (33.53) | 103.50 (34.58) | 89.00 (29.39) | 88.67 (39.95) | .87 | 2.32 | 5.23** | .07 | ||
| VSI | Mean (SD) | 46.40 (11.11) | 36.40 (17.78) | 32.60 (17.19) | 34.00 (25.40) | 28.20 (23.28) | 26.00 (24.36) | 39.50 (12.96) | 49.33 (10.63) | 49.67 (10.17) | 46.83 (13.12) | 37.50 (12.66) | 35.50 (16.81) | .91 | 3.19* | 4.00** | .08 | ||
| PCS-J | Mean (SD) | 74.40 (25.28) | 57.20 (15.68) | 63.80 (26.70) | 62.20 (31.05) | 63.40 (38.60) | 53.80 (33.45) | 69.50 (26.62) | 73.00 (30.25) | 79.33 (22.03) | 72.00 (25.32) | 60.67 (25.78) | 62.00 (30.85) | .20 | .77 | 1.06 | .02 | ||
| IBS-BRQ | Mean (SD) | 106.60 (16.12) | 74.60 (20.20) | 68.40 (20.83) | 77.80 (30.14) | 72.20 (26.29) | 58.40 (20.06) | 76.83 (30.12) | 107.00 (23.20) | 106.17 (24.72) | 103.67 (29.13) | 85.00 (28.83) | 83.67 (36.90) | 1.42 | 1.09 | 6.84*** | .10 | ||
| *p < .05, **p < .01, ***p < .001, SD: standard deviation, GSRS: Gastrointestinal Symptom Rating Scale, IBS-QOL-J: Japanese Version of the Irritable Bowel Syndrome-Quality of Life Questionnaire, CS-FBD: Cognitive Scale for Functional Bowel Disorders, VSI: Visceral Sensitivity Index, PCS-J: Japanese Version of the Pain Catastrophizing Scale, IBS-BRQ: Irritable Bowel Syndrome Behavioral Responses Questionnaire | |||||||||||||||||||
Furthermore, the main effects of the intervention condition (F[1, 9] = .77, p = .40), time (F[4, 36] = 2.35, p = .07, η2G = .06), and interaction effect of intervention condition × time (F[4, 36] = 1.03, p = .40) on IBS-QOL-J scores were not statistically significant.
Additionally, there were no significant main effects of intervention group (F[1, 9] = .87, p = .38) and time (F[4, 36] = 2.32, p = .08) on cognitive biases (assessed via CS-FBD scores). However, the interaction effect of intervention condition × time (F[4, 36] = 5.23, p = .00, η2G = .07) on CS-FBD scores were statistically significant. The results of multiple comparisons performed using the Bonferroni method on the experimental group were not statistically significant.
In contrast, the main effect of time (F[4, 36] = 3.19, p = .02) and interaction effect of intervention condition × time (F[4, 36] = 4.00, p = .01, η2G = .08) on GSA (assessed via VSI scores) were statistically significant. However, the results of multiple comparisons performed using the Bonferroni method on the experimental group showed that the scores of VSI were not statistically significant and there were no significant main effects of intervention group (F[1, 9] = .91, p = .37) on VSI scores.
On catastrophizing thoughts (assessed via PCS-J scores), there were no significant main effects of intervention group (F[1, 9] = .20, p = .67) or time (F[4, 36] = 77, p = .55). Similarly, the interaction effect of intervention condition × time on PCS-J scores was not statistically significant (F[4, 36] = 1.06, p = .39, η2G = .02).
Analogously, the interaction effect of intervention condition × time (F[4, 36] = 6.84, p = .00, η2G = .10) on avoidance and control behaviors pertaining to IBS symptoms (assessed via IBS-BRQ scores) showed significant improvement. The results of multiple comparisons performed using the Bonferroni method on the experimental group showed that the score was significantly lower at the mid- (p = .04) and post-treatment (p = .03) periods compared to the waitlist group. However, there were no significant main effects of intervention group (F[1, 9] = 1.42, p = .26) or time (F[4, 36] = 1.09, p = .26).
This research encompassed three distinct features. Firstly, it proposed the utilization of CBT as the initial treatment approach for non-patients with IBS. Secondly, it involved the development and evaluation of a mobile application aimed at modifying the cognitions of IBS non-patients through the implementation of CBT techniques. Lastly, it aimed to enhance the efficacy of ICBT interventions for IBS by using a mobile application.
The results showed no significant improvements in IBS symptoms, measured by the GSRS and participants’ QOL measured by the IBS-QOL-J post-intervention. Non-patients with IBS often experience symptoms in specific situations, such as during crowded commutes and before important presentations, rather than throughout their lives. As a result, the efficacy of our intervention may be circumscribed to specific situations or contexts for these individuals. Additionally, participants strictly adhered to the provided instructions and refrained from reviewing the treatment protocol at their own discretion, even though it was permitted. Only one participant reviewed the psychoeducation component, and none revisited cognitive restructuring exercises while undergoing exposure therapy. Furthermore, when working on exposure therapy, participants completed the therapy once per day, rather than repeatedly attempting to reduce their anxiety through multiple exposures. This resulted in a sense of obligation rather than voluntary engagement in the treatment process when using the app. Moreover, given that non-patients with IBS have never undergone treatment for the symptoms, they may lack insight into the entirety of the treatment process and simply engage with the app daily without a comprehensive understanding.
Further exploration and refinement of treatment options for non-patients with IBS are necessary. This includes evaluating whether the efficacy of our mobile application using CBT may be undermined by factors such as lifestyle and diet not being adequately addressed, or if additional treatment components beyond psychoeducation, cognitive restructuring, and exposure are needed.
Throughout the pre-treatment to post-treatment period, which spanned from weeks 1–4, participants engaged in psychoeducation and cognitive restructuring, resulting in a notable decrease in symptom-specific behavior as measured by the IBS-BRQ. Accordingly, the interaction effects of intervention condition × time (F[4, 36] = 5.23, p = .00, η2G = .07) on CS-FBD and GSA assessed via VSI scores (F[4, 36] = 4.00, p = .01, η2G = .08) were significant. This indicated that our implemented method of cognitive restructuring was effective. Our application provided adaptive thoughts for situations in which individuals experienced symptoms of IBS. Consequently, a substantial number of adaptive cognitions were acquired without much effort, despite the participants being new to CBT. One participant noted that when experiencing bowel discomfort, she was able to apply the cognitive restructuring techniques and utilize the adaptive cognitions provided by the application by recalling the exercises. During the cognitive restructuring process, participants were instructed to imagine real-life situations, which may have had an effect akin to exposure therapy. This may have contributed to a reduction in GSA scores in addition to exposure sessions. Indeed, we propose that non-patients with IBS exhibit various cognitions specific to their symptoms. Prior studies have established a link between pain catastrophizing and GSA with IBS symptoms and have yet to explore other forms of cognition. Our application's cognitive restructuring work included exemplars drawn from cognitions that have not been widely explored. As a result, symptom-specific cognitions were improved, thereby suggesting the potential for other cognitions, such as dichotomous thinking, disqualifying the positive, and magnification and minimization, to be linked to IBS symptoms. Given the demonstrated efficacy of behavioral avoidance and GSA in affecting subsequent changes in symptoms (Hesser et al., 2018), further examination of the underlying mechanisms of ICBT, to better understand and address the absence of symptom improvement in this study, is imperative.
Catastrophizing, as assessed by the PCS-J, did not demonstrate significant improvement. Individuals with IBS frequently engage in catastrophic thinking, perceiving it as a means of mitigating the pain associated with their symptoms, and thus these cognitions may be persistent (Chilcot & Moss-Morris, 2013). Our cognitive restructuring included several maladaptive thoughts that were observed among non-patients; however, it focused more on the secondary products of IBS-related maladaptive thoughts (e.g., if I leave this conference room, colleagues would be upset because of my attitude) than on patients’ thoughts toward pain (e.g., this pain will never disappear). Therefore, it is possible that the examples provided did not adequately address catastrophic thoughts related to pain, which is essential for reducing symptoms of IBS, or the number was insufficient to facilitate modification of thought. To gain a deeper understanding of the cognitions associated with symptoms of IBS, it is necessary to accumulate data on patients' cognitive processes during symptomatic episodes and analyze the correlation between these cognitions and the symptoms themselves.
The dropout rate was 0%. Since a major concern about ICBT interventions is the high dropout rate (Ljótsson et al., 2011), the present result is noteworthy. Our application provided messages with illustrations, and the data inputted were displayed graphically. These steps may have encouraged participants to want to understand the CBT treatment and remain motivated through the process. However, in this study, the therapist (KK) guided the participants through the application. The relationship between therapists and patients is an important factor in improving IBS symptoms (Lackner & Jaccard, 2021), even though ICBT has an influence with or without the therapist’s guidance (Ahl et al., 2013). Further examination of self-administered treatments for non-patients with IBS would be crucial in promoting the widespread implementation of such treatment options.
An evaluation of the efficacy of a mobile application utilizing CBT was conducted among non-patients with IBS. Results revealed that it was successful in ameliorating symptom-specific cognitions and behaviors, which are crucial factors in the improvement of IBS symptoms. However, it was not effective in enhancing the quality of life or bowel symptoms, despite the magnitude of the effect sizes being sufficient for treating IBS symptoms (GSRS: η2G = .19; IBS-QOL-J: η2G = .06). Further research is needed to address these findings.
First, to establish a more robust evidence base for the effectiveness of CBT-based smartphone interventions, randomized controlled trials with adequately large sample sizes are necessary. This should include a diverse range of participants, such as individuals across different age groups, outpatients with IBS, and patients who have not responded to previous treatment methods.
Second, the application instructions must be adapted considering the psychological features, especially cognitions, of non-patients with IBS. In this study, one participant with IBS-D reported improvement in symptom severity and QOL. Each IBS subtype has different psychological features, which leads to different symptoms; for example, patients with IBS-D display more avoidance behaviors than other subtypes (Windgassen et al., 2019). Thus, based on psychological assessments, certain content should be reviewed repeatedly or practiced with dedicated focus, for example, repeatedly working on the cognitive restructuring of catastrophizing or conducting longer durations of exposure therapy to generalize the cognitions learned through the application. Accumulating such findings about our application can help establish a specialized treatment for non-patients with IBS. The current state of professional treatment for non-patients with IBS in Japan is inadequate in comparison to their large population. Furthermore, there are issues of stigma and limited access to psychotherapy. Our proposed application aims to address these shortcomings and necessitates further research to be conducted regarding its clinical applications and the prevalence of IBS in Japan.
Competing Interests
The authors have no competing interests to declare that are relevant to the content of this article.
Research Involving Human Participants and/or Animals
This experiment, which involved human participants, was approved by the Research Ethics Committee of Meisei University on June 29, 2021 [Reference no.: 2021-026].
Informed Consent
Informed consent was obtained from the participants.