Gender differences in the experience of interstitial cystitis/bladder pain syndrome.

Aims: This study assessed gender differences in a debilitating urologic pain condition, interstitial cystitis/bladder pain syndrome (IC/BPS). We aimed to (1) evaluate how pain, symptom, and distress profiles of IC/BPS may differ between genders and (2) obtain in-depth firsthand accounts from patients to provide additional insight into their experiences that may explain potential gender differences. Methods: A mixed methods approach combined validated patient-reported outcome measures with a single timepoint 90-min focus group. Tests of summary score group differences between men and women were assessed across questionnaires measuring urologic symptoms, pain, emotional functioning, and diagnostic timeline. Qualitative analysis applied an inductive-deductive approach to evaluate and compare experiences of living with IC/BPS Group narratives were coded and evaluated thematically by gender using the biopsychosocial model, providing insight into the different context of biopsychosocial domains characterizing the male and female experience of IC/BPS. Results: Thirty-seven participants [women (n = 27) and men (n = 10)] completed measures and structured focus group interviews across eight group cohorts conducted from 8/2017 to 3/2019. Women reported greater pain intensity (p = 0.043) and extent (p = 0.018), but not significantly greater impairment from pain (p = 0.160). Levels of psychological distress were significantly elevated across both genders. Further, the duration between time of pain symptom onset and time to diagnosis was significantly greater for women than men (p = 0.012). Qualitative findings demonstrated key distinctions in experiences between genders. Men appeared not to recognize or to deter emotional distress while women felt overwhelmed by it. Men emphasized needing more physiological treatment options whilst women emphasized needing more social and emotional support. Interactions with medical providers and the healthcare system differed substantially between genders. While men reported feeling supported and involved in treatment decisions, women reported feeling dismissed and disbelieved. Conclusion: The findings indicate different pain experiences and treatment needs between genders in persons experiencing urologic pain and urinary symptoms, with potential intervention implications. Results suggest gender health inequality in medical interactions in this urologic population needing further investigation.

Psychosocial factors associated with pain and health-related quality of life in Endometriosis: A systematic review.

BACKGROUND AND OBJECTIVE: Endometriosis is associated with pain and impaired health-related quality of life (HRQoL). Psychosocial factors have been associated with pain and HRQoL in other conditions, suggesting their potential relevance in Endometriosis. However, the role of psychosocial factors in this population has not been systematically explored yet. This systematic review aims to explore the association of psychosocial factors with pain intensity/severity and HRQoL in women with Endometriosis. DATABASES AND DATA TREATMENT: Observational and experimental studies that explored the association of psychosocial factors with pain and HRQoL in women with Endometriosis were eligible. The following databases were searched: Medline, Embase, Cochrane library, Web of Science, PsychInfo and Cumulative index of nursing and allied health literature. The methodological quality was assessed, and findings were synthesized using narrative synthesis. RESULTS: Twenty-seven studies were eligible for inclusion, which included 5419 women with Endometriosis. Catastrophising and anxiety were the factors most consistently associated with greater pain, whilst depression, anxiety and stress were related to worse HRQoL. Findings regarding depression and pain were mixed, and research on social factors was limited. CONCLUSIONS: This systematic review highlights the role of psychosocial factors in Endometriosis. Anxiety, depression and catastrophising are suggested as potential treatment targets. The review also indicates the lack of research on other potentially important psychosocial factors, such as avoidance, perceived injustice and social support. SIGNIFICANCE: This systematic review explored the role of psychosocial factors in Endometriosis, suggesting that these are associated with pain and health-related quality of life (HRQoL). Among the psychosocial factors included, anxiety, depression and catastrophising were the factors most often associated with pain and HRQoL in Endometriosis. These findings highlight the need to target psychological factors in the treatment of women with Endometriosis.

A Novel Digital Self-management Intervention for Symptoms of Fatigue, Pain, and Urgency in Inflammatory Bowel Disease: Describing the Process of Development.

BACKGROUND: Empirical studies and systematic reviews have demonstrated the role of biological, cognitive, behavioral, and emotional factors in fatigue, pain, and urgency in inflammatory bowel disease (IBD). Behavioral management that addresses the cognitive, behavioral, and emotional factors offered alongside medical treatment is seldom available to people with IBD. Digital interventions provide a potentially scalable and cost-effective way of providing behavioral support to patients. OBJECTIVE: This paper aimed to describe the process of developing a supported digital self-management intervention for fatigue, pain, and urgency in IBD using theory and evidence-based approaches and stakeholder input. METHODS: The Medical Research Council framework for complex health interventions and a person-based approach were used to guide intervention development, consulting with 87 patients with IBD and 60 nurses. These frameworks informed the selection and use of a theoretical model that subsequently guided cognitive behaviorally based intervention content. They also guided the design of tailored digital intervention pathways for individuals with IBD that matched the predominant symptoms. RESULTS: A transsymptomatic cognitive behavioral framework of symptom perpetuation was developed for the symptoms of fatigue, pain, and urgency in IBD. A logic model was used to define the intervention techniques. Patient feedback and qualitative interviews refined the website content and functionalities, including the use of visual aids, email reminders, and graphical tracking of symptoms. Nurse focus groups informed the volume and delivery model of the therapist facilitator support. Ratings of acceptability out of 10 following feasibility testing (31/87, 36%) demonstrated accessibility (scoring 9.43, SD 1.040), ease (scoring 8.07, SD 3.205), clarity, and the relevant tone of the intervention. The final intervention comprised 12 web-based sessions (8 core and 4 symptom-specific), with one 30-minute facilitator phone call following session 1 and subsequent on-site messaging. CONCLUSIONS: The use of theory and integration of stakeholders' views throughout informed the development of an evidence-based digital intervention for fatigue, pain, and urgency in IBD. This is the first web-based self-management intervention designed to address these multiple symptoms with the aim of improving the quality of life and reducing the symptom burden of IBD. The intervention is being tested in a large multicenter randomized controlled trial. TRIAL REGISTRATION: ISRCTN Registry ISRCTN71618461; https://www.isrctn.com/ISRCTN71618461.

Developing an Online Program for Self-Management of Fatigue, Pain, and Urgency in Inflammatory Bowel Disease: Patients' Needs and Wants.

BACKGROUND: Inflammatory bowel disease (IBD) is a lifelong relapsing-remitting condition, characterized by troublesome symptoms including fatigue, pain, and bowel urgency. These symptoms can persist even in clinical remission and have a debilitating impact on social, work-related and intimate domains of life. Symptom self-management can be challenging for some patients, who could potentially benefit from an online self-management tool. AIMS: We aimed to understand patients' symptom self-management strategies and preferred design for a future online symptom self-management intervention. METHODS: Using exploratory qualitative methods, we conducted focus group and individual interviews with 40 people with IBD recruited from UK clinics and from community-dwelling members of the Crohn's and Colitis UK charity; data were collected using a digital audio recorder, and transcribed and anonymized by a third party (professional) transcriber. We used framework analysis for focus group data and thematic analysis for interview data. RESULTS: The data provided three core themes: ways of coping; intervention functionality; and intervention content. Participants attempt to manage all three symptoms simultaneously, recognizing the combined influence of factors such as food, drink, stress, and exercise on all symptoms. They wanted an accessible online intervention functioning across several platforms, with symptom and medication management, and activity-tracking features. CONCLUSIONS: Patients reported numerous ways of self-managing symptoms of fatigue, pain, and urgency/incontinence related to IBD and expressed their needs for content, design, and functionality of the proposed intervention. Based on this and existing intervention development literature, the IBD-BOOST online self-management intervention has now been developed and is undergoing testing.

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).

Patient Strategies for Managing the Vicious Cycle of Fatigue, Pain and Urgency in Inflammatory Bowel Disease: Impact, Planning and Support.

BACKGROUND: Inflammatory bowel disease (IBD) causes inter-related symptoms of fatigue, pain and urgency which can persist in remission. AIM: To understand how people with IBD experience and self-manage these symptoms and to inform the future development of an online self-management programme. METHODS: Using exploratory qualitative methods, we recruited participants from clinic and community settings. Focus groups, conducted across the UK, were audio-recorded and professionally transcribed. Transcripts were analysed over four rounds using framework analysis. Eight patients were consulted to agree the final structure of data and themes. RESULTS: Seven focus groups were held; five gave useable data. Twenty-six participants (15 female; ages 21-60 years; disease duration 2-40 years) with Crohn's disease (n = 10), ulcerative colitis (n = 14) and IBD-unclassified (n = 2) attended one of these five focus groups. Three core themes emerged: The Negative Impact of Symptoms, Positively Taking Control and Seeking and Receiving Support. The persistent, often stark impact of multiple co-existing symptoms on physical and emotional wellbeing can force unwanted adjustments and limitations in working, social and intimate arenas of life. Unpredictable symptoms are challenging and impact each other in negative vicious cycles. Managing diet, pacing, accepting background levels of fatigue, pain and urgency, seeking support, exercising and attending to mental wellbeing, are all perceived as helpful in self-managing symptoms. CONCLUSION: Fatigue, pain and urgency are troublesome for patients, especially in combination, suggesting that these should be addressed simultaneously by clinicians. Participants reported several strategies for self-management, providing patient-focused evidence to inform future development of a self-management intervention programme.

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.

Cognition, Emotion, and the Bladder: Psychosocial Factors in bladder pain syndrome and interstitial cystitis (BPS/IC).

PURPOSE OF REVIEW: To review findings from empirical studies assessing the role of psychosocial factors in bladder pain syndrome and interstitial cystitis (BPS/IC). RECENT FINDINGS: There is a high rate of psychosocial comorbidity in BPS/IC, including elevated levels of anxiety and depression. Recent studies assessing the role of illness perceptions in BPS/ICrelate poorer illness perceptions to more unhelpful illness coping patterns. Conversely, positive illness perceptions including self-efficacy in illness management are associated with more adaptive coping behaviors such as exercising and acceptance. New research is investigating the role of trauma in BPS/ICand the impact of suicidality. There is a paucity of psychosocial interventions for BPS/ICover the last 5 years. The three small-scale studies reviewed included a mindfulness-based stress reduction (MBSR) intervention tailored for BPS/IC, a brief self-management intervention designed to increase patient knowledge and symptom management techniques and a 90-minute interview aimed at increasing awareness about physiological-affective relationship in IC.

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.

Key mechanisms of cognitive behavioural therapy in irritable bowel syndrome: The importance of gastrointestinal related cognitions, behaviours and general anxiety.

BACKGROUND: Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterised by abdominal pain and altered bowel movements. Cognitive behavioural therapy (CBT) has been shown to be effective in reducing symptom severity in IBS and enhancing quality of life/functioning. The present study sought to identify how CBT achieves change in these outcomes. METHOD: Secondary analysis was conducted on 149 patients with irritable bowel syndrome who had been randomised to cognitive behavioural therapy plus an antispasmodic medication or antispasmodic alone. Single and sequential mediation was modelled using structural equation modelling. Gastrointestinal (GI) related avoidance behaviour, safety behaviour, cognitions and general anxiety were included as mediators. RESULTS: GI safety behaviours, cognitions and general anxiety mediated treatment effect on the outcomes of symptom severity and work and social adjustment. Avoidance behaviour was not a significant mediator for either outcome. Sequential mediation models indicated that unhelpful GI related cognitions reduced before anxiety did, and this sequential path (R➔GI related cognitions➔anxiety➔outcome) was significant for both symptom severity (b = -0.22, CI [-0.40 to -0.90], p = .005) and work and social adjustment (b = -0.26, CI [-0.44 to -0.11], p = .003) where 'R' is randomisation. Reduction in GI safety behaviours also preceded reduction in anxiety. This sequence (R ➔GI safety behaviours➔anxiety➔outcome) was significant for both symptom severity (b = -0.11, CI [-0.24 to -0.01], p = .049) and work and social adjustment (b = -0.12, CI [-0.23 to -0.03], p = .03). CONCLUSION: Results suggest that it is important for psychological treatments to target IBS specific factors for change.

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.

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.

Non-pharmacological interventions to reduce ICU-related psychological distress: a systematic review.

INTRODUCTION: Patients frequently suffer stress in intensive care units (ICUs) and many develop serious psychological morbidity after discharge. Little is known about the nature and efficacy of interventions to reduce ICU-related distress. There is growing evidence that administering sedative drugs can be harmful. Therefore we carried out a systematic review of non-pharmacological interventions to reduce ICU-related distress. EVIDENCE ACQUISITION: A systematic search was conducted using Medline, Embase, Psychinfo, Cinahl and the Web of Science. Included studies evaluated the effect of non-pharmacological interventions to reduce ICU stress. Study populations were adults in mixed or general ICUs. Outcomes were stress or psychological distress in or after the ICU, using self-report or physiological measures. No meta-analysis was possible due to heterogeneity, therefore studies were arranged according to intervention type, and outcomes examined together with risk of bias criteria. EVIDENCE SYNTHESIS: Twenty-three studies were eligible, including 15 randomized controlled trials. Non-pharmacological interventions included music therapy (11 studies), mind-body practices (5) and psychological interventions (7). 12 studies showed a beneficial effect. However only three of the 12 had a low risk of bias, and many studies in the review were under-powered to detect an effect. Only 5 studies measured a medium/long term psychological outcome such as PTSD or depression at 2-12 months. CONCLUSIONS: Evidence indicates that non-pharmacological approaches to reducing ICU distress, in particular psychological interventions, may be beneficial. The evidence base would be strengthened by the implementation of fully-powered studies using robust designs, that measure longer-term outcomes.