"A greatest hits compilation of mental health support": A qualitative study of health professionals' perceptions of modular CBT in pediatric epilepsy services.

OBJECTIVES: The primary aim of this qualitative study was to explore the views of health professionals, with little previous clinical mental health training, of an adapted modular cognitive-behavioral intervention (MATCH-ADTC) for common mental health problems in children and young people with epilepsy. METHODS: Healthcare Professionals (HCPs) and their supervisors were interviewed at the start (n = 23) and end (n = 15) of the six-month training period. The interviews were transcribed verbatim and analyzed using thematic analysis. RESULTS: Three higher order themes with sub-themes were identified: (1) strengths of the MATCH-ADTC content and manual; (2) expectations of the treatment; and (3) improving practice with MATCH-ADTC. Overall impressions of the training and treatment were largely positive, with HCPs viewing MATCH-ADTC as an acceptable treatment for the families that they worked with. HCPs highlighted some challenges in delivering an integrated service, particularly relating to the time commitment involved and their own confidence in delivering the intervention, as many participants did not have a mental health background. CONCLUSIONS: The findings suggested that the intervention and training was acceptable to HCPs working in pediatric epilepsy services, and confidence grew over the six-month training period. Further research is needed to understand how to best train, supervise, and support HCPs in pediatric epilepsy services to deliver mental health treatments.

Cost effectiveness of therapist delivered cognitive behavioural therapy and web-based self-management in irritable bowel syndrome: the ACTIB randomised trial.

BACKGROUND: Telephone therapist delivered CBT (TCBT) and web-based CBT (WCBT) have been shown to be significantly more clinically effective than treatment as usual (TAU) at reducing IBS symptom severity and impact at 12 months in adults with refractory IBS. In this paper we assess the cost-effectiveness of the interventions. METHODS: Participants were recruited from 74 general practices and three gastroenterology centres in England. Interventions costs were calculated, and other service use and lost employment measured and costed for one-year post randomisation. Quality-adjusted life years (QALYs) were combined with costs to determine cost-effectiveness of TCBT and WCBT compared to TAU. RESULTS: TCBT cost £956 more than TAU (95% CI, £601-£1435) and generated 0.0429 more QALYs. WCBT cost £224 more than TAU (95% CI, - £11 to £448) and produced 0.029 more QALYs. Compared to TAU, TCBT had an incremental cost per QALY of £22,284 while the figure for WCBT was £7724. After multiple imputation these ratios increased to £27,436 and £17,388 respectively. Including lost employment and informal care, TCBT had costs that were on average £866 lower than TAU (95% CI, - £1133 to £2957), and WCBT had costs that were £1028 lower than TAU (95% CI, - £448 to £2580). CONCLUSIONS: TCBT and WCBT resulted in more QALYs and higher costs than TAU. Complete case analysis suggests both therapies are cost-effective from a healthcare perspective. Imputation for missing data reduces cost-effectiveness but WCTB remained cost-effective. If the reduced societal costs are included both interventions are likely to be more cost-effective. Trial registration ISRCTN44427879 (registered 18.11.13).

A pilot feasibility study of an unguided, internet-delivered cognitive behavioral therapy program for irritable bowel syndrome.

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.

Patients' Experiences of Telephone-Based and Web-Based Cognitive Behavioral Therapy for Irritable Bowel Syndrome: Longitudinal Qualitative Study.

BACKGROUND: Cognitive behavioral therapy (CBT) is recommended in guidelines for people with refractory irritable bowel syndrome (IBS). However, the availability of CBT is limited, and poor adherence has been reported in face-to-face CBT. OBJECTIVE: Nested within a randomized controlled trial of telephone- and web-delivered CBT for refractory IBS, this qualitative study aims to identify barriers to and facilitators of engagement over time with the interventions, identify social and psychological processes of change, and provide insight into trial results. METHODS: A longitudinal qualitative study was nested in a randomized controlled trial. Repeated semistructured interviews were conducted at 3 (n=34) and 12 months (n=25) post baseline. Participants received telephone-based CBT (TCBT; n=17 at 3 months and n=13 at 12 months) or web-based CBT (WCBT; n=17 at 3 months and n=12 at 12 months). Inductive thematic analysis was used to analyze the data. RESULTS: Participants viewed CBT as credible for IBS, perceived their therapists as knowledgeable and supportive, and liked the flexibility of web-based and telephone-based delivery; these factors facilitated engagement. Potential barriers to engagement in both groups (mostly overcome by our participants) included initial skepticism and concerns about the biopsychosocial nature of CBT, initial concerns about telephone-delivered talking therapy, challenges of maintaining motivation and self-discipline given already busy lives, and finding nothing new in the WCBT (WCBT group only). Participants described helpful changes in their understanding of IBS, attitudes toward IBS, ability to recognize IBS patterns, and IBS-related behaviors. Consistent with the trial results, participants described lasting positive effects on their symptoms, work, and social lives. Reasons and remedies for some attenuation of effects were identified. CONCLUSIONS: Both TCBT and WCBT for IBS were positively received and had lasting positive impacts on participants' understanding of IBS, IBS-related behaviors, symptoms, and quality of life. These forms of CBT may broaden access to CBT for IBS.

Personalised Adherence Support for Maintenance Treatment of Inflammatory Bowel Disease: A Tailored Digital Intervention to Change Adherence-related Beliefs and Barriers.

BACKGROUND AND AIMS: Interventions to improve adherence to medication may be more effective if tailored to the individual, addressing adherence-related beliefs about treatment and overcoming practical barriers to daily use. We evaluated whether an algorithm, tailoring support to address perceptual and practical barriers to adherence, reduced barriers and was acceptable to patients with inflammatory bowel disease [IBD]. METHODS: Participants with IBD, prescribed azathioprine and/or mesalazine, were recruited via patient groups, social media, and hospital clinics and allocated to Intervention or Control Groups. The online intervention comprised messages tailored to address beliefs about IBD and maintenance treatment and to provide advice on overcoming practical difficulties with taking regular medication. The content was personalised to address specific perceptual and practical barriers identified by a pre-screening tool. Validated questionnaires assessed barriers to adherence and related secondary outcomes at baseline and at 1 and 3 months of follow-up. RESULTS: A total of 329 participants were allocated to the Intervention [n = 153] and Control [n = 176] Groups; just under half [46.2%] completed follow-up. At 1 and 3 months, the Intervention Group had significantly fewer concerns about IBD medication [p ≤0.01]; and at three months, fewer doubts about treatment necessity, fewer reported practical barriers, and higher reported adherence [p <0.05]. Relative to controls at follow-up, the Intervention Group were more satisfied with information about IBD medicines, and viewed pharmaceuticals in general more positively. Questionnaires, interviews, and intervention usage indicated that the intervention was acceptable. CONCLUSIONS: Personalised adherence support using a digital algorithm can help patients overcome perceptual barriers [doubts about treatment necessity and medication concerns] and practical barriers to adherence.

Optimising Evidence-Based Psychological Treatment for the Mental Health Needs of Children with Epilepsy: Principles and Methods.

There are potent evidence-based psychological treatments for youth with mental health needs, yet they are rarely implemented in clinical practice, especially for youth with mental health disorders in the context of chronic physical illness such as epilepsy. Implementation science, the study of the translation of research into practice, can promote the uptake of existing effective interventions in routine clinical practice and aid the sustainable integration of psychological treatments with routine health care. The aim of this report was to use four implementation science methods to develop a version of an existing effective psychological treatment for mental health disorders [the Modular Approach to Treatment of Children with Anxiety, Depression or Conduct Problems (MATCH-ADTC)] for use within paediatric epilepsy services: (a) literature search; (b) iterative focus groups underpinned by normalisation process theory; (c) Plan-Do-Study-Act methods; and (d) qualitative patient interviews. Findings: Three modifications were deemed necessary to facilitate implementation in children with both mental health disorders and epilepsy. These were (a) a universal brief psychoeducational component addressing the relationship between epilepsy and mental health; (b) supplementary, conditionally activated interventions addressing stigma, parental mental health and the transition to adulthood; and (c) additional training and supervision. The intervention needed relatively little alteration for implementation in paediatric epilepsy services. The modified treatment reflected the scientific literature and the views of clinicians and service users. The multi-method approach used in this report can serve as a model for implementation of evidence-based psychological treatments for children with mental health needs in the context of other chronic illnesses.

Cognitive behavioural therapy for irritable bowel syndrome: 24-month follow-up of participants in the ACTIB randomised trial.

BACKGROUND: Irritable bowel syndrome (IBS) is common, affecting 10-20% of the adult population worldwide, with many people reporting ongoing symptoms despite first-line therapies. Cognitive behavioural therapy (CBT) is recommended in guidelines for refractory IBS but there is insufficient access to CBT for IBS and uncertainty about whether benefits last in the longer term. Assessing Cognitive behavioural Therapy for IBS (ACTIB) was a large, randomised, controlled trial of two forms of CBT for patients with refractory IBS. ACTIB results showed that, at 12 months, both forms of CBT for IBS were significantly more effective than treatment as usual at reducing IBS symptom severity in adults with refractory IBS. This follow-up study aimed to evaluate 24-month clinical outcomes of participants in the ACTIB trial. METHODS: In the ACTIB three-group, randomised, controlled trial, 558 adults with refractory IBS were randomly allocated to receive either therapist-delivered telephone CBT (telephone-CBT group), web-based CBT with minimal therapist support (web-CBT group), or treatment as usual (TAU group) and were followed up for 12 months. Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite being offered first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and the south of England (UK) between May 1, 2014, and March 31, 2016. Primary outcome measures were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS), assessed in the intention-to-treat (ITT) population with multiple imputation. This study was a non-prespecified naturalistic follow-up and analysis of the participants of the ACTIB trial at 24 months assessing the same outcomes as the original trial. Outcome measures were completed online by participants or a paper questionnaire was posted, or telephone follow-up undertaken. The ACTIB trial is registered with the International Standard Randomised Controlled Trial Number registry, number ISRCTN44427879. FINDINGS: 24-month follow-up of outcomes was achieved for 323 (58%) of 558 participants: 119 (64%) of 186 in the telephone-CBT group, 99 (54%) of 185 in the web-CBT group, and 105 (56%) of 187 in the TAU group. At 24 months, mean IBS-SSS was 40·5 points (95% CI 15·0 to 66·0; p=0·002) lower in the telephone-CBT group and 12·9 points (-12·9 to 38·8; p=0·33) lower in the web-CBT group than in the TAU group. The mean WSAS score was 3·1 points (1·3 to 4·9; p<0·001) lower in the telephone-CBT group and 1·9 points (0·1 to 3·7; p=0·036) lower in the web-CBT group than in the TAU group. A clinically significant IBS-SSS change (≥50 points) from baseline to 24 months was found in 84 (71%) of 119 participants in the telephone-CBT group, in 62 (63%) of 99 in the web-CBT group, and in 48 (46%) of 105 in the TAU group. In total 41 adverse events were reported between 12 to 24 months: 11 in the telephone-CBT group, 15 in the web-CBT group, and 15 in the TAU group. Of these, eight were reported as gastrointestinal related, five as psychological, and six as musculoskeletal. There were no adverse events related to treatment. INTERPRETATION: At 24-month follow-up, sustained improvements in IBS were seen in both CBT groups compared with TAU, although some previous gains were reduced compared with the 12-month outcomes. IBS-specific CBT has the potential to provide long-term improvement in IBS, achievable within a usual clinical setting. Increasing access to CBT for IBS could achieve long-term patient benefit. FUNDING: UK National Institute for Health Research.

Therapist telephone-delivered CBT and web-based CBT compared with treatment as usual in refractory irritable bowel syndrome: the ACTIB three-arm RCT.

BACKGROUND: Irritable bowel syndrome (IBS) affects 10-22% of people in the UK. Abdominal pain, bloating and altered bowel habits affect quality of life and can lead to time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many people suffer ongoing symptoms. Cognitive-behavioural therapy (CBT) is recommended in guidelines for patients with ongoing symptoms but its availability is limited. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of therapist telephone-delivered CBT (TCBT) and web-based CBT (WCBT) with minimal therapist support compared with treatment as usual (TAU) in refractory IBS. DESIGN: This was a three-arm randomised controlled trial. SETTING: This trial took place in UK primary and secondary care. PARTICIPANTS: Adults with refractory IBS (clinically significant symptoms for 12 months despite first-line therapies) were recruited from 74 general practices and three gastroenterology centres from May 2014 to March 2016. INTERVENTIONS: TCBT - patient CBT self-management manual, six 60-minute telephone sessions over 9 weeks and two 60-minute booster sessions at 4 and 8 months (8 hours' therapist time). WCBT - interactive, tailored web-based CBT, three 30-minute telephone sessions over 9 weeks and two 30-minute boosters at 4 and 8 months (2.5 hours' therapist time). MAIN OUTCOME MEASURES: Primary outcomes - IBS symptom severity score (IBS SSS) and Work and Social Adjustment Scale (WSAS) at 12 months. Cost-effectiveness [quality-adjusted life-years (QALYs) and health-care costs]. RESULTS: In total, 558 out of 1452 patients (38.4%) screened for eligibility were recruited - 186 were randomised to TCBT, 185 were randomised to WCBT and 187 were randomised to TAU. The mean baseline Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) was 265.0. An intention-to-treat analysis with multiple imputation was carried out at 12 months; IBS SSS were 61.6 points lower in the TCBT arm [95% confidence interval (CI) 89.5 to 33.8; p < 0.001] and 35.2 points lower in the WCBT arm (95% CI 57.8 to 12.6; p = 0.002) than in the TAU arm (IBS SSS of 205.6). The mean WSAS score at 12 months was 10.8 in the TAU arm, 3.5 points lower in the TCBT arm (95% CI 5.1 to 1.9; p < 0.001) and 3.0 points lower in the WCBT arm (95% CI 4.6 to 1.3; p = 0.001). For the secondary outcomes, the Subject's Global Assessment showed an improvement in symptoms at 12 months (responders) in 84.8% of the TCBT arm compared with 41.7% of the TAU arm [odds ratio (OR) 6.1, 95% CI 2.5 to 15.0; p < 0.001] and 75.0% of the WCBT arm (OR 3.6, 95% CI 2.0 to 6.3; p < 0.001). Patient enablement was 78.3% (responders) for TCBT, 23.5% for TAU (OR 9.3, 95% CI 4.5 to 19.3; p < 0.001) and 54.8% for WCBT (OR 3.5, 95% CI 2.0 to 5.9; p < 0.001). Adverse events were similar between the trial arms. The incremental cost-effectiveness ratio (ICER) (QALY) for TCBT versus TAU was £22,284 and for WCBT versus TAU was £7724. Cost-effectiveness reduced after imputation for missing values. Qualitative findings highlighted that, in the CBT arms, there was increased capacity to cope with symptoms, negative emotions and challenges of daily life. Therapist input was important in supporting WCBT. CONCLUSIONS: In this large, rigorously conducted RCT, both CBT arms showed significant improvements in IBS outcomes compared with TAU. WCBT had lower costs per QALY than TCBT. Sustained improvements in IBS symptoms are possible at an acceptable cost. Suggested future research work is longer-term follow-up and research to translate these findings into usual clinical practice. FUTURE WORK: Longer-term follow-up and research to translate these findings into usual clinical practice is needed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN44427879. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme and will be published in full in Health Technology Assessment; Vol. 23, No. 17. See the NIHR Journals Library website for further project information. The University of Southampton sponsored this study. Funding was received from the NIHR HTA Board and the NIHR Clinical Research Network and support was received from the NIHR Clinical Research Network.

Irritable bowel syndrome (IBS) is a common bowel disorder causing pain, bloating and diarrhoea or constipation, which can affect quality of life. Treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies. However, many patients suffer ongoing distressing symptoms. Guidelines recommend cognitive­behavioural therapy (CBT) for patients with ongoing IBS symptoms. However, access to therapy is limited because of cost and therapist availability. We previously developed web-based CBT (WCBT), which is more accessible, less expensive and requires less therapist time than traditional therapist telephone-delivered CBT (TCBT). The aim of the current trial was to assess the clinical effectiveness and cost-effectiveness of these two approaches. Participants were randomly assigned to TCBT, WCBT or treatment as usual (TAU). The TCBT group received a CBT manual and six 1-hour telephone CBT sessions with trained therapists over 9 weeks and two booster sessions at 4 and 8 months. The WCBT group received access to the interactive CBT website with eight online sessions at home over 9 weeks, with similar content to the therapist CBT, and received three 30-minute therapist telephone-delivered CBT sessions and two boosters at 4 and 8 months. There were 558 adults with ongoing IBS symptoms who took part from 74 general practice surgeries and three hospital clinics in London and the south of England. The main study outcomes were the IBS Symptom Severity Score and the Work and Social Adjustment Scale, which measures people's ability to function and live their lives. The results of these were collected at the start of the study and at 3, 6 and 12 months. Significant improvement in symptoms was found in the two therapy groups compared with TAU at 3, 6 and 12 months. Cost-effectiveness and wider benefits (e.g. ability to cope and mood) also showed positive results, indicating that sustained improvements in IBS symptoms are possible at an acceptable cost.

Assessing telephone-delivered cognitive-behavioural therapy (CBT) and web-delivered CBT versus treatment as usual in irritable bowel syndrome (ACTIB): a multicentre randomised trial.

OBJECTIVE: To evaluate the clinical effectiveness of two modes of cognitive-behavioural therapy (CBT) for IBS compared with treatment as usual (TAU) in refractory IBS. DESIGN: A three-arm randomised controlled trial assessing telephone-delivered CBT (TCBT), web-based CBT (WCBT) with minimal therapist support, and TAU. Blinding participants and therapists was not possible. Chief investigator, assessors and statisticians were blinded. Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and South of England between May 2014 to March 2016. Co-primary outcomes were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS) at 12 months. RESULTS: 558/1452 (38.4%) patients screened for eligibility were randomised: 76% female: 91% white: mean age 43 years. (391/558) 70.1% completed 12 months of follow-up. Primary outcomes: Compared with TAU (IBS-SSS 205.6 at 12 months), IBS-SSS was 61.6 (95% CI 33.8 to 89.5) points lower (p<0.001) in TCBT and 35.2 (95% CI 12.6 to 57.8) points lower (p=0.002) in WCBT at 12 months. Compared with TAU (WSAS score 10.8 at 12 months) WSAS was 3.5 (95% CI 1.9 to 5.1) points lower (p<0.001) in TCBT and 3.0 (95% CI 1.3 to 4.6) points lower (p=0.001) in WCBT. All secondary outcomes showed significantly greater improvement (p≤0.002) in CBT arms compared with TAU. There were no serious adverse reactions to treatment. CONCLUSION: Both CBT interventions were superior to TAU up to 12 months of follow-up. TRIAL REGISTRATION NUMBER: ISRCTN44427879.

Cognitive and Behavioral Differences Between Subtypes in Refractory Irritable Bowel Syndrome.

Irritable bowel syndrome (IBS) is a functional gastrointestinal syndrome consisting of different bowel pattern subtypes: diarrhea predominant (IBS-D), constipation predominant (IBS-C), and alternating (IBS-A). This paper aimed to identify whether (a) psychological factors implicated in the cognitive behavioral model of IBS were differentially associated with bowel pattern subtypes, (b) whether there were differences in symptom severity and work and social adjustment across the IBS-subtypes. Analysis was conducted on baseline data of 557 individuals with refractory IBS recruited into the Assessing Cognitive Therapy in Irritable Bowel (ACTIB) randomized controlled trial. Correlations assessed the associations between psychological factors, stool patterns, symptom severity, and work and social adjustment. Hierarchical regressions identified whether cognitive and behavioral factors were significantly associated with frequency of loose/watery stools, hard/lumpy stools and symptom severity while controlling for affective (anxiety and depression) and demographic factors (age, gender, symptom duration). One-way ANOVAs were conducted to assess differences across Rome III classified subtypes (IBS-A, D and C) in cognitive, behavioral, affective, symptom severity, and adjustment measures. Psychological factors were significantly associated with symptom severity and work and social adjustment. Increased avoidance behavior and unhelpful gastrointestinal (GI) cognitions were significantly associated with higher frequency of loose/watery stools. Increased control behaviors were associated with higher frequency of hard/lumpy stools. Cognitive and behavioral differences were significant across the Rome III classified IBS subtypes. There were no differences in anxiety, depression, overall symptom severity, or work and social adjustment. The results are discussed in terms of their utility in tailoring cognitive behavioral treatments to IBS subtypes.

Patients' perspectives on GP interactions after cognitive behavioural therapy for refractory IBS: a qualitative study in UK primary and secondary care.

BACKGROUND: Previous studies have identified issues with the doctor-patient relationship in irritable bowel syndrome (IBS) that negatively impact symptom management. Despite this, little research has explored interactions between GPs and patients with refractory IBS. National guidelines suggest cognitive behavioural therapy (CBT) as a treatment option for refractory symptoms. AIM: To explore perceptions of interactions with GPs in individuals with refractory IBS after receiving CBT for IBS or treatment as usual (TAU). DESIGN AND SETTING: This qualitative study was embedded within a trial assessing CBT in refractory IBS. Fifty-two participants took part in semi-structured interviews post-treatment in UK primary and secondary care. METHOD: Inductive and/or data-driven thematic analysis was conducted to identify themes in the interview data. RESULTS: Two key themes were identified: perceived paucity of GPs' IBS knowledge and lack of empathy from GPs, but with acknowledgement that this has improved in recent years. These perceptions were described through three main stages of care: reaching a 'last-resort diagnosis'; searching for the right treatment through a trial-and-error process, which lacked patient involvement; and unsatisfactory long-term management. Only CBT participants reported a shared responsibility with their doctors concerning symptom management and an intention to reduce health-seeking behaviour. CONCLUSION: In this refractory IBS group, specific doctor-patient communication issues were identified. Increased explanation of the process of reaching a positive diagnosis, more involvement of patients in treatment options (including a realistic appraisal of potential benefit), and further validation of symptoms could help. This study supports a role for CBT-based IBS self-management programmes to help address these areas and a suggestion that earlier access to these programmes may be beneficial.

Desperately seeking a cure: Treatment seeking and appraisal in irritable bowel syndrome.

OBJECTIVES: Irritable bowel syndrome (IBS) is common and adversely affects patients' quality of life. Multiple potential treatment options exist for patients (and clinicians) to choose from, with limited evidence to inform treatment selection. The aim was to explore how patients with IBS go about seeking and appraising different treatment modalities, with a view to elucidating the psychological processes involved and identifying opportunities to improve clinical practice. DESIGN: Qualitative study nested within a randomized controlled trial of therapist-delivered and web-based cognitive behavioural therapy versus treatment-as-usual for IBS. METHODS: A total of 52 people participated in semi-structured interviews about their prior experiences of treatments for IBS. Transcripts were analysed using inductive thematic analysis. RESULTS: Key themes (desperation for a cure, disappointment at lack of cure, appraising the effects of diverse treatments, and hope for positive effects) clustered around an overarching theme of being trapped within a vicious cycle of hope and despair on treatment seeking. A desperation and willingness drove interviewees to try any treatment modality available that might potentially offer relief. Coming to accept there is no cure for IBS helped interviewees escape the vicious cycle. Treatments were appraised for their effects on symptoms and quality of life while also considering, but rarely prioritizing, other aspects including convenience of the regimen itself, whether it addressed the perceived root causes of IBS, perceived side-effects, and cost. CONCLUSION: Treatment seeking in IBS can be challenging for patients. Supportive discussions with health care professionals about illness perceptions, treatment beliefs, and goals could improve patients' experiences. Statement of contribution What is already known on this subject? Irritable bowel syndrome (IBS) is a highly prevalent chronic relapsing functional gastrointestinal disorder. Studies show few treatment modalities provide complete symptom relief. IBS is associated with emotional and physical distress, and negatively impacts personal, social, and professional aspects of quality of life. What does this study add? Patients appraise IBS treatments for impact on quality of life and treatment characteristics. Developing acceptance and coping strategies helps escape treatment-seeking vicious cycles of hope and despair. Clinicians could better support patients by discussing their illness perceptions, treatment goals, and values.

Positive and negative affect mediate the bidirectional relationship between emotional processing and symptom severity and impact in irritable bowel syndrome.

INTRODUCTION: Individuals with IBS report higher levels of psychological distress compared to healthy controls. Distress has been associated with emotional processing difficulties but studies have not explored how the relationship between distress and emotional processing affects IBS. There is little research on the role of positive affect (PA) in IBS. AIMS: (a) If difficulties in self-reported emotional processing are associated with affect and IBS measures (i.e., symptom severity, interference in life roles) (b1) If affect mediates the relationship between emotional processing and IBS measures (b2) Alternative model: if affect mediates the relationship between IBS and emotional processing (c) If PA moderates the relationship between distress and IBS. METHODS: Participants with a confirmed diagnosis of IBS (n=558) completed a questionnaire including measures of emotional processing (i.e., unhelpful beliefs about negative emotions, impoverished emotional experience), distress, PA, and IBS symptoms/interference. Mediation and moderation analyses were conducted with Maximum Likelihood Estimation. RESULTS: Distress and PA mediated or partly mediated the relationship between unhelpful beliefs about negative emotions/impoverished emotional experience and both IBS measures. The alternative models were also valid, suggesting a two-way relationship between emotional processing and IBS through affect. PA did not moderate the relationship between distress and IBS. CONCLUSION: Future interventions in IBS may benefit from not only targeting the management of physical symptoms and their daily impact but also aspects related to the experience of both negative and positive affect, and the acceptance and expression of negative emotions. Longitudinal studies are needed to confirm causal relationships within the explored models.

The role of high expectations of self and social desirability in emotional processing in individuals with irritable bowel syndrome: A qualitative study.

OBJECTIVES: Although high levels of distress are associated with the onset and severity of Irritable bowel syndrome (IBS), it is unclear how this relates to emotional processing, particularly in relation to maintenance of symptoms and treatment outcome. This qualitative study embedded within a randomized controlled trial aimed to explore how individuals with refractory IBS experience, express, and manage their emotions after either therapist-delivered cognitive behavioural therapy (TCBT) or Web-based CBT (WBCBT) compared to treatment as usual (TAU). DESIGN: Cross-sectional qualitative study. METHODS: Fifty-two semi-structured interviews were conducted at post-treatment with 17 TCBT, 17 WBCBT, and 18 TAU participants. The transcripts were analysed using inductive thematic analysis with grounded theory elements. NVivo 11 was used to compare themes across groups. RESULTS: Across all groups, high expectations of self was a recurring reason for how participants experienced and expressed their emotions. Three themes with subthemes captured how high expectations related to specific aspects of emotional processing: perceived causes of emotions, strategies for coping with emotions (bottling up, avoiding emotions, and active coping strategies), and the perceived interplay between emotions and IBS symptoms. CONCLUSIONS: Patients recognized that their IBS symptoms both triggered and were triggered by negative emotions. However, there was a tendency to bottle up or avoid negative emotions for reasons of social desirability regardless of whether patients had CBT for IBS or not. Future psychological interventions in IBS may benefit from addressing negative beliefs about expressing emotions, promoting assertive emotional expression, and encouraging the experience of positive emotions. Statement of contribution What is already known on this subject? High levels of distress are consistently associated with both the onset and maintenance of IBS symptoms. Little is known about how this relates to the concept of emotional processing. Preliminary findings suggest a positive correlation between poor emotional processing and IBS. However, further studies need to confirm its role in relation to aetiology, maintenance of symptoms, and response to treatment. What does this study add? High expectations of self and social desirability seem to be important aspects shaping the way individuals with IBS experience, express, and manage their emotions. Emotional avoidance and bottling up were reported as key strategies to cope with negative emotions. The study revealed that bottling up is not perceived as an all-or-nothing strategy but can be applied selectively depending on the context. Psychological interventions in IBS may benefit from addressing not only illness-related causes of negative emotions but also personal and social triggers of distress.

The journey between brain and gut: A systematic review of psychological mechanisms of treatment effect in irritable bowel syndrome.

PURPOSE: Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder characterized by abdominal pain and altered bowel habits. It is estimated to affect 10-22% of the UK population. The use of psychological interventions in IBS is increasingly empirically supported, but little is known about the mechanism of psychological treatment approaches. The present systematic review aimed to investigate the mechanisms of psychological treatment approaches applied to IBS. METHODS: The systematic review included studies conducting mediation analysis in the context of psychological interventions for IBS, focusing on the outcomes of symptom severity and/or quality of life (QoL). RESULTS: Nine studies in total were included in the review. Eight of the studies assessed mediation in the context of cognitive behavioural-based interventions, and one study assessed mediation in a mindfulness-based stress reduction intervention. Results indicate that change in illness-specific cognitions is a key process by which psychological treatments may have an effect on the outcomes of symptom severity and QoL. Furthermore, results suggest that whilst GI-specific anxiety may also be a key mechanism of treatment effect, it would appear that general or state anxiety is not. Although less commonly included in mediation analysis, illness-specific behaviours may also have a mediating role. CONCLUSIONS: A mediational model amalgamating the results of studies is proposed to illustrate the findings of the review. The model depicts the process by which psychotherapy changes illness-specific cognitions, behaviours, and anxiety to achieve reduction in symptom severity. Statement of contribution What is already known on this subject? Cognitive behavioural therapy (CBT) is the predominant psychological treatment for irritable bowel syndrome (IBS), although there is some research supporting other treatments such as mindfulness and hypnotherapy. Mediation analysis in the context of psychological treatments for IBS has just begun to explore possible mechanisms of treatment effect especially within CBT studies. Some studies include anxiety in a basic mediation analysis, whilst others include cognitions with inconsistent results for each. What does this study add? Reviews mediators included in mediation analysis and the methods used for mediation analysis Proposes a mediation model informed by the results of the review for future studies to investigate Provides clinical implications for the targeting of cognitions and behaviours rather than general anxiety.

Management of irritable bowel syndrome in primary care: the results of an exploratory randomised controlled trial of mebeverine, methylcellulose, placebo and a self-management website.

BACKGROUND: Many patients with IBS suffer on-going symptoms. The evidence base is poor for IBS drugs but they are widely prescribed and advised in Guidelines. Cognitive Behavioural Therapy (CBT) can be helpful, but availability is poor in the NHS. We developed a web-based CBT self-management programme (Regul8) in partnership with patients and trialled it and common IBS medications in an exploratory factorial RCT to test trial procedures and provide information for a larger trial. METHODS: Patients, 16 to 60 years, with IBS symptoms fulfilling Rome III criteria were recruited via GP practices and randomised to over-encapsulated mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 website conditions: Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website. RESULTS: 135 patients recruited from 26 GP practices. Mean IBS SSS score 241.9 (sd 87.7), IBS-QOL 64 (sd 20) at baseline. 91% follow-up at 12 weeks. Mean IBS SSS decreased by 35 points from baseline to 12 weeks. There was no significant difference in IBS SSS or IBS-QOL score between medication or website groups at 12 weeks, or in medication groups at 6 weeks, or IBS-QOL in website groups at 6 weeks. However, IBS SSS at 6 weeks was lower in the No website group than the website groups (IBS SSS no website =162.8 (95% CI 137.4-188.3), website 197.0 (172.4 - 221.7), Website + telephone support 208.0 (183.1-233.0) p = 0.037). CONCLUSIONS: This exploratory study demonstrates feasibility and high follow-up rates and provides information for a larger trial. Primary outcomes (IBS SS and IBS QOL) did not reach significance at 6 or 12 weeks, apart from IBS SSS being lower in the no-website group at 6 weeks - this disappeared by 12 weeks. Improved Enablement suggests patients with access to the Regul8 website felt better able to cope with their symptoms than the non-website group. Improved SGA score in the Regul8 groups may indicate some overall improvement not captured on other measures. TRIAL REGISTRATION: ClinicalTrials.gov Identifier (NCT number): NCT00934973.

Management of irritable bowel syndrome in primary care: feasibility randomised controlled trial of mebeverine, methylcellulose, placebo and a patient self-management cognitive behavioural therapy website. (MIBS trial).

BACKGROUND: IBS affects 10-22% of the UK population. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current GP treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer ongoing symptoms.A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: In 2005 the NHS costs were nearly £10 million for mebeverine and over £8 million for fibre-based bulking agents. CBT and self-management can be helpful, but poor availability in the NHS restricts their use. We have developed a web-based CBT self-management programme, Regul8, based on an existing evidence based self-management manual and in partnership with patients. This could increase access with minimal increased costs. METHODS/DESIGN: The aim is to undertake a feasibility factorial RCT to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and Regul8, the CBT based self-management website.135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website, thus creating 9 groups. OUTCOMES: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks as the primary outcomes. An intention to treat analysis will be undertaken by ANCOVA for a factorial trial. DISCUSSION: This pilot will provide valuable information for a larger trial. Determining the effectiveness of commonly used drug treatments will help patients and doctors make informed treatment decisions regarding drug management of IBS symptoms, enabling better targeting of treatment. A web-based self-management CBT programme for IBS developed in partnership with patients has the potential to benefit large numbers of patients with low cost to the NHS. Assessment of the amount of email or therapist support required for the website will enable economic analysis to be undertaken.