Psychological aspects of IBS

Psychosocial factors and stress are related to the maintenance and manifestation of IBS symptoms in many patients.11 Indeed, historically, clinicians felt that IBS was purely a physical manifestation of emotional problems.12 In recent years, the association IBS has with psychological issues has been supported with experimental data. For example, Guthrie et al's13 study involving 107 participants demonstrates that the perception of bowel sensations may relate directly to psychological distress. The literature reports a prevalence of psychological comorbidity ranging anywhere between 50% and 90% for common mental health problems such as anxiety and depression.14 Traumatic events or stressful experiences which shape an individual's life experiences may also play a fundamental role in IBS. Indeed, it is not uncommon for patients with IBS to report some history of physical or sexual abuse.15 ,16 Stressful life events, in general, are associated with symptom onset and severity.17 These psychological factors and the complex manifestation of IBS symptoms are widely acknowledged as a disease process which involves an individual's social environment, physiology and psychology.11 These elements form part of the ‘biopsychosocial model’ which offers a holistic and rational explanation for the presentation and persistence of IBS symptoms in many individuals.

Because the mechanisms of IBS can be explained by a biopsychosocial model, effective treatment approaches may include psychological interventions such as cognitive behavioural therapy (CBT). Best practice guidelines suggest that CBT, hypnotherapy and psychotherapy are useful interventions for patients with IBS.18 CBT is particularly useful for addressing negative thought patterns6 and catastrophising cognitions and avoidant behaviours.19 CBT can also be used to target maladaptive thought processes20 and help patients understand the interactions between their thoughts and their symptoms.21 CBT is well supported empirically as an effective intervention for patients with IBS.22^–24 Although the results of many of these investigations are promising, a recent systematic review identified issues regarding the methodological quality and power of trials which support these interventions.25

Rationale

There is a need for CBT to be further evaluated using robust methods.14 Furthermore, there is a need for future research to evaluate psychological therapies which address concerns regarding treatment provision and accessibility.26 Many patients within the National Health Service (NHS) healthcare system have no routine access to psychological interventions for the treatment of their IBS symptoms. Notwithstanding these concerns, there is encouraging activity within the wider UK healthcare system to suggest that the government and policymakers are beginning to recognise the impact that psychological therapies such as CBT have on improving health and reducing loss of productivity.27 This study will evaluate the feasibility and acceptability of a novel, nurse-delivered, low-intensity CBT, guided self-help intervention for the treatment of IBS. It is hoped that the nursing intervention will provide a feasible mechanism for the delivery of CBT which may be economically viable, more accessible to patients and implementable within the UK healthcare system. Qualitative research performed during the course of this study will provide researchers and funding bodies with essential information on the acceptability and practical application of CBT interventions in patients with IBS.

Study aim

To carry out a feasibility study to explore the use of various CBT treatment delivery mechanisms for patients with IBS within secondary care GI clinics.

Study objectives

• To develop a tailored, nurse-delivered CBT treatment for patients with IBS.

• To examine the number of patients needed to screen in relation to the numbers successfully randomised into the study.

• To gather reasons for patients not wishing to take part in CBT treatment approaches for their IBS.

• To explore the experience of participants undergoing the study's treatment conditions.

• To identify barriers and facilitators to the implementation of the trial interventions within real clinical settings.

• To measure the follow-up and response rates to study questionnaires.

• To describe the range of data with relevant descriptive statistics.

• To test the data collection procedures and time required to collect study data.

Study design

The randomised controlled trial (RCT) is considered one of the most powerful tools used in research to establish new knowledge claims.28 ,29 The proposed RCT will establish the cause and effect relationship between CBT and patient outcomes. A mixed methods research (MMR) approach, underpinned by a pragmatic philosophy, will draw from the strengths of qualitative and quantitative approaches.30 MMR is defined as “collecting, analysing and mixing both quantitative and qualitative data in a single study or series of studies.”31 The growing popularity of MMR approaches would suggest that many researchers now recognise the value of this pragmatic approach.32 MMR provides robust and rigorous approaches to research33 and creates a richer understanding of phenomena.34 Many of the RCTs which have investigated the use of CBT for patients with IBS lack a qualitative research component. This limits our understanding of the suitability and acceptability of these interventions for this group of patients. The incorporation of qualitative methods will ensure the research considers problematic moments and meanings in individuals lives.35 These methods will also contextualise the findings of the research36 and enable trial participants to provide information regarding their responses to quantitative variables.37

Patients

Around 60% of patients referred to GI clinics with lower GI symptoms are diagnosed with IBS.38 Adults (over 18 years of age) have been chosen as the main group of patients for inclusion as IBS is typically associated with the third and fourth decades of life.39 In order to ensure that participants have symptoms consistent with IBS, they will be screened and required to fulfil Rome III criteria. This tool has been developed by the Rome Foundation with a long-standing history of development and a strong evidence base.40 It has been successfully utilised as symptomatic criteria for IBS in a number of RCTs22 ,41 ,42 and is being constantly updated and reviewed in the light of changes in the recent literature.43 Participants with symptoms inconsistent with IBS according to Rome III criteria will be excluded from randomisation.

Inclusion criteria

• Adult male and female patients aged 18 years or older at the time of enrolment.

• Documented medical diagnosis of IBS.

• Patients with IBS which meets Rome III criteria.

• Able to read, write and speak English.

• Able to provide written informed consent.

• Patients with and without concomitant antidepressant use.

• Able to commit to weekly treatment sessions within the intervention arms of the study.

Exclusion criteria

• Already receiving psychological therapy or hypnotherapy.

• Existing diagnosis of bowel disease based on endoscopic or histological criteria (ie, Crohn's disease, ulcerative colitis, coeliac disease).

• Presence or history of structural or surgical diseases of the GI tract (not including appendix or gall bladder surgery).

• Evidence of alcohol or substance misuse.

• An established cause for bowel symptoms other than IBS (ie, medication use).

• The presence of suicidal ideation or self-harm.

• Significant psychiatric comorbidity (schizophrenia, bipolar disorder, obsessive compulsive disorder).

• Currently taking part in other research studies.

Intervention

Many studies which have investigated the use of CBT for patients with IBS utilise high-intensity treatment protocols. Several RCTs have used 10-week treatment programmes,22 ,26 ,44 ,45 with most sessions over 50 min in duration. Some researchers have experimented with much lower intensity treatment methods and have altered delivery mechanisms in order to improve the provision of CBT interventions such as internet CBT.19 However, there is concern regarding the delivery of online interventions relating to confidentiality, a loss of visual and auditory clues during therapy and a lack of suitability for managing crisis situations.46 A recent survey of 658 patients suggests that internet-delivered CBT would be unacceptable to over 40% of those surveyed.47 Other delivery mechanisms include group-based treatments,42 although some authors suggest that individual contact is better suited to tailoring therapy to the needs of the client.48 CBT has been effective when delivered by trained nurses within primary care settings.24 It is therefore possible that similar effects might be achievable if therapy were to be delivered by GI nurses within secondary care utilising a lower intensity, guided self-help treatment approach which could be less time consuming to deliver and further increase access to evidence-based interventions for patients.

Registered nurses working within gastroenterology are well placed to deliver psychotherapeutic interventions to these groups of patients as they are familiar with the complexity of chronic GI symptoms and the impact they have on patients and their daily activities. The preparatory training utilised within this study offers a replicable mechanism for expansion of the professional scope of nursing practice for nurses working with the GI specialty, while increasing access to evidence-based intervention patients may not otherwise receive.

We have adapted the protocol and self-help materials originally developed by Hunt et al19 at the University of Pennsylvania USA, while working in collaboration with service users to maximise the quality and suitability of our nursing intervention. The nursing intervention consists of an initial 60 min assessment session, with five further 30 min treatment sessions over a 6-week treatment period. Participants will work through six guided self-help treatment modules with a nurse therapist, consisting of:

• an introduction to IBS,

• relaxation training,

• the cognitive model of stress management,

• the cognitive model of IBS and behavioural experiments,

• managing avoidance using exposure,

• diet and IBS.

The nurse therapist (ADD) undertook the first two modules of the National Curriculum for the education of Psychological Wellbeing Practitioners49 in order to prepare for the nurse therapist's role. This training consisted of 25 days of university-based teaching sessions and simulated clinical skills training. The therapist completed all assessments for these modules to the nationally accredited assessed standard, but did not access the supervised practice hours within a mental health services placement as this was not felt to be necessary or economically viable for the preparation of the nurse therapist's role for the treatment of IBS.

Comparators

The nursing intervention will be compared to: (A) the services of a fully trained and experienced cognitive behavioural therapist using high-intensity treatment; (B) a six module, CBT-based self-help workbook as a stand-alone intervention; and (C) a treatment as usual (TAU) control condition. Participants in all four treatment conditions will be permitted to continue with the routine medical management of their IBS.

Outcomes

The literature would suggest that an extended period of follow-up is necessary in order for researchers to establish whether the positive treatment effects of CBT diminish over time.25 However, longer follow-up periods are not feasible within the scope of this PhD project and will be the concern of a definitive trial. Similarly, although an important feature of a definitive study may be a cost-effectiveness data collection and analysis, a limitation is that such data will not be collected during this feasibility work. All outcome measures will be assessed at baseline, and at 12 and 26 weeks postrandomisation. The study flow diagram (figure 1) demonstrates the various data collection points throughout the study period.

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Figure 1

Study flow diagram detailing numbers of participants and participant flow through the study-related procedures and follow-up data collection periods. CBT, cognitive behavioural therapy; GSRS-IBS, Gastrointestinal Symptom Rating Scale for irritable bowel syndrome.

Randomisation and blinding

Participants will be allocated to one of four treatment conditions using random permuted blocks. The principal investigator will screen all potential participants and randomise eligible participants using an online randomisation system (see http://www.sealedenvelope.com). All quantitative, postintervention outcome data will be collected by a research assistant blind to the allocation of participants. The study's investigators will be aware of the allocation of study participants.

Sample size

This study is concerned with generating descriptive statistics that will be used to evaluate the feasibility of the proposed methods and not to establish the effectiveness or generalisability of the interventions. A pragmatic decision was made to randomise 60 participants across four treatment conditions. Approximately 15 participants will be assigned to each of the study conditions (see study diagram).

Recruitment and participant selection

Potentially eligible clinic patients will be identified by a member of their care team and given participant information packs or will be sent information relating to the trial via their hospital physician. Participants may express an interest in taking part in the research study by returning a reply slip using a prepaid postage service. Posters will also be deployed on clinic and hospital notice boards. We will also write to potentially eligible participants on our Biomedical Research Unit research database.

Data collection

The quantitative measures will be collected by the principal investigator (ADD) at screening and sent to participants by mail at 12 and 26 weeks postrandomisation. Postintervention outcome data will be returned to a research assistant blind to the allocation of participants. Interview data will be collected by a coinvestigator (EH) not connected to the delivery of the trial interventions.

The qualitative element of the study aims to capture the knowledge which is located in the minds and personal experiences of others.57 Although some authors advocate unstructured interview techniques,58 a semistructured approach will ensure that information relating to the phenomena of interest is obtained.59 Furthermore, the prestructure has provided a mechanism for the involvement of our patient advisory group, which has helped shape the contents of the interview schedule. The structure and content of the interviews was initially developed as a result of the researcher's prior knowledge of GI research and the subject area as a result of a literature review. Interview questions will be used by the interviewer to seek clarification, illustration and further exploration regarding important issues.60 The qualitative element of our study aims to evaluate the experiences of service users undergoing the three trial treatment protocols in order to identify potential barriers and facilitators to the use of the interventions. Five participants from each of the intervention arms of the study will be recruited to qualitative interviews. This study has also received ethical permission to make enquiries into the reasons patients may have for not taking part in the research. It will be made clear that patients are under no obligation to provide this information to the research team. This information will be useful for helping researchers understand barriers to the successful implementation of psychological therapies for IBS within the NHS.

Data analysis

Patient and public involvement

Patient and public involvement (PPI) is defined by the National Institute for Health Research (NIHR) as “research that is done with or by the public and not to, about or for them.”65 Many awarding bodies expect to see evidence of PPI within major grant applications.66 Our research team has developed an excellent working alliance with a group of six patient/public volunteers who have helped shape and improve the design of the study. The patient advisory group has also helped to review study documents and highlight potential barriers to the recruitment and selection of participants. By involving service users in the conduct of the research, it is hoped that equilibrium has been sought in order to address any power imbalances between health professionals and patients.67 It is also hoped that PPI has helped maximise the quality of our nursing intervention.

Ethical issues