A universally delivered CBT based intervention in a Scottish secondary school: a pilot feasibility study

Objectives: To evaluate the feasibility of a universally delivered CBT-based programme for pupils within a Scottish secondary school setting. Design: A pre-post, within and between groups design was utilised. Setting: Religious Moral Citizenship and Education (RMCE) classes in a Scottish secondary school. Participants: Four (n = 103) classes of third year secondary school pupils were arbitrarily allocated to two conditions: RMCE-as usual (RMCE-AU) controls, and LLTTF intervention. Intervention: Living Life to the Full (LLTTF) is a series of Cognitive Behavioural Therapy (CBT)-based booklets and accompanying 8 classes to improve coping skills. An adolescent version of LLTTF was recently developed. This was delivered over nine weeks by school teachers trained in the approach. Outcome measures: The Strengths and Difficulties Questionnaire, Rosenberg Self-Esteem scale, General Self-Efficacy Scale, and Locus of Control scale were administered at baseline and 9 week follow-up. To determine acceptability and utility of the materials course feedback was gathered weekly from the intervention group and a focus group (n=5) was conducted at 3 month follow up. Results: Outcome measures showed no significant improvement in overall wellbeing of those in the intervention group compared with that of the control group. Weekly feedback suggested that the majority of pupils found the materials useful and relevant. Focus group feedback suggested that pupils found the intervention useful, had utilised strategies in everyday life and would welcome recurring provision of such interventions within the school setting. Conclusions: Universally delivered CBT intervention is acceptable and feasible within the secondary school environment. However, objective measurement using standardised tools does not adequately corroborate qualitative feedback from pupils. Issues relating to measurement, study design and implementation of future interventions are discussed.

Mindfulness-Based Cognitive Therapy for older people in a community setting: a mixed methods feasibility study

Rationale: In line with complex intervention development, this research takes a systematic approach to examining the feasibility and acceptability of delivering Mindfulness-Based Cognitive Therapy (MBCT) to older people who experience symptoms of depression. Methods: A mixed methods approach was adopted in line with recommendations made by the MRC Complex Intervention Development framework. Quantitative and qualitative methods were combined by administering questionnaires as well as conducting post intervention interviews. A number of trial feasibility factors were examined such as recruitment and attrition rates. Qualitative data was analysed using Braun and Clarke’s thematic analysis framework. Results: Nine participants started the MBCT intervention and six completed the 8-week programme. The results suggest that MBCT for older people is feasible and acceptable. Participants reported improved mindfulness skills. Participants responded positively to being asked to take part in research and appeared to particularly value the group delivery format of the intervention. Conclusions: MBCT is both feasible and acceptable for older people experiencing symptoms of depression. Further research is required with larger sample sizes to allow for more robust statistical exploration of outcome measures, including mechanisms of change.

The use of Acceptance and Commitment Therapy to address psychological distress experienced by caregivers: a randomised controlled feasibility trial

Background: An extensive research literature has documented the impact of caring for an individual with acquired brain injury (ABI) on caregivers and family members, including role adjustment, psychological distress, social isolation, family tension and coping with the cognitive and behavioural difficulties of the injured person. Given these findings it is important this population have access to services and supports. Acceptance and Commitment Therapy (ACT) is an intervention that helps individuals to accept difficult experiences and commit to behaviour that is consistent with their values. Research into the effectiveness of ACT to support caregivers is at a preliminary stage. Aim: To investigate the feasibility of using ACT to reduce psychological distress and increase psychological flexibility in ABI caregivers. A secondary aim was to gain an understanding of the experience of caregivers in this context and how this can inform the development and delivery of interventions for this population. Method: Phase one was a randomised controlled feasibility trial of an ACT intervention for use with ABI caregivers. The parameters of this study were formulated around the PICO (population, intervention, control, and outcome) framework. Eighteen carers were recruited and randomised to ACT or an enhanced treatment as usual (ETAU) group. ACT was implemented over 3 sessions; and ETAU was implemented over 2 sessions. The General Health Questionnaire, Valuing Questionnaire, Acceptance and Action Questionnaire, Experiential Avoidance of Caregiving Questionnaire and the Flexibility of Responses to Self-Critical Thoughts Scale were administered to both groups at baseline and following the final session. Phase two used a retrospective qualitative design that involved conducting semi-structured interviews with four participants from phase one. Results: ACT and control participants were successfully recruited. Positive feedback was obtained from ACT participants suggesting that the intervention was acceptable. There were no significant differences between the ACT and ETAU groups on outcome measures. However, there were challenges retaining participants and the overall attrition rate was high (44.44%). Therefore a number of participants did not complete the full complement of sessions, which may have impacted on this result. Qualitative results illustrated the challenges this population face including significant adjustments in their life, the emotional impact of having a loved one with a brain injury and trying to adapt to the changes in the injured person. In addition, findings elucidated the types of support that this population would find helpful and the barriers to accessing same. Conclusions: Findings from this study highlight factors that will help the development of this intervention further for a caring population. Recommendations for future implementation include completing some preparatory work with carers before beginning the intervention, consideration of a larger sample and wider recruitment strategy from local services, barriers to attending interventions and the possibility of holding groups in local venues.

“Enjoy your baby” Internet-based CBT for mothers with babies: a feasibility randomised control trial

Background: Postnatal depression is a global health problem with lasting effects on the family. Government policy is focussed on early intervention and increasing access to psychological therapies. There is a growing evidence base for the use of computerised CBT packages and this study investigated the feasibility of a CBT-based self-help internet intervention for new mothers. Objective: To assess the ability to recruit mothers, deliver an internet course, obtain follow-up data and evaluate what mothers think of the course. Design: A feasibility randomised control design was used to compare a waiting list control group (delayed access= DA) to the Enjoy Your Baby course (immediate access= IA). Measures were administered at baseline and 8 week follow-up. Methods: Adverts were placed in the Metro freesheet, on charity web pages, on social media, posters were put up in the community, and leaflets were handed out at mother and baby groups. Participants had to be 18 years old or over with a child less than 18 months old. The IA arm was given access to the course straight away. After 8 weeks all participants were asked to recomplete the original measures and those in the IA arm also gave feedback on the course. Participants in the DA arm were given access after recompleting the questionnaires. Due to a lack of follow-up data a small discussion group was conducted. Intervention: The course contains 4 core modules including helping mothers understand why they feel the way they do and helping them build closeness to their babies. Additional modules, worksheets and homework tasks were available. The DA group were given a list of additional support resources and services, and encouraged to seek additional help if required. All participants received weekly automated emails for 12 weeks as they worked through the course. It was not possible to deliver individualised support. 34 Results: Despite using a number of recruitment strategies, recruitment was lower and slower than anticipated, and attrition was high. 41 women, primarily recruited via the internet, were randomised (IA n=21, DA n=20). No significant differences were observed between participants in either arm at baseline and no statistically significant differences were identified when the demographics and baseline measures of participants who logged-on to the course were compared to those who did not, or when participants who completed follow-up measures were compared to those who did not. Pre and post intervention scores on the EPDS approached statistical significance (P=.059, r=.444) favouring the intervention arm. The discussion group suggested strengths of the course and recommended areas for improvement, including making the course more mobile friendly. Conclusion: Internet interventions show promise; however it is difficult to recruit mothers, engagement is low and attrition high. A number of recommendations are made and a further pilot or an internal pilot of a larger substantive study should be conducted to confirm recruitment and retention. Trial ID: ISRCTN90927910.

Results of a feasibility study: barriers and facilitators in implementing the Sherbrooke model in France.

International audience

Feasibility study to inform the design of a UK multi-centre randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis of the leg

Background: This paper describes the results of a feasibility study for a randomised controlled trial (RCT). Methods: Twenty-nine members of the UK Dermatology Clinical Trials Network (UK DCTN) expressed an interest in recruiting for this study. Of these, 17 obtained full ethics and Research & Development (R&D) approval, and 15 successfully recruited patients into the study. A total of 70 participants with a diagnosis of cellulitis of the leg were enrolled over a 5-month period. These participants were largely recruited from medical admissions wards, although some were identified from dermatology, orthopaedic, geriatric and general surgery wards. Data were collected on patient demographics, clinical features and willingness to take part in a future RCT. Results: Despite being a relatively common condition, cellulitis patients were difficult to locate through our network of UK DCTN clinicians. This was largely because patients were rarely seen by dermatologists, and admissions were not co-ordinated centrally. In addition, the impact of the proposed exclusion criteria was high; only 26 (37%) of those enrolled in the study fulfilled all of the inclusion criteria for the subsequent RCT, and were willing to be randomised to treatment. Of the 70 participants identified during the study as having cellulitis of the leg (as confirmed by a dermatologist), only 59 (84%) had all 3 of the defining features of: i) erythema, ii) oedema, and iii) warmth with acute pain/tenderness upon examination. Twenty-two (32%) patients experienced a previous episode of cellulitis within the last 3 years. The median time to recurrence (estimated as the time since the most recent previous attack) was 205 days (95% CI 102 to 308). Service users were generally supportive of the trial, although several expressed concerns about taking antibiotics for lengthy periods, and felt that multiple morbidity/old age would limit entry into a 3-year study. Conclusion: This pilot study has been crucial in highlighting some key issues for the conduct of a future RCT. As a result of these findings, changes have been made to i) the planned recruitment strategy, ii) the proposed inclusion criteria and ii) the definition of cellulitis for use in the future trial.

A randomised controlled trial of triple antiplatelet therapy (Aspirin, Clopidogrel and Dipyridamole) in the secondary prevention of stroke: safety, tolerability and feasibility

Background: Aspirin, dipyridamole and clopidogrel are effective in secondary vascular prevention. Combination therapy with three antiplatelet agents might maximise the benefit of antiplatelet treatment in the secondary prevention of ischaemic stroke. Methodology/Principal Findings: A randomised, parallel group, observer-blinded phase II trial compared the combination of aspirin, clopidogrel and dipyridamole with aspirin alone. Adult patients with ischaemic stroke or transient ischaemic attack (TIA) within 5 years were included. The primary outcome was tolerability to treatment assessed as the number of patients completing randomised treatment. Recruitment was halted prematurely after publication of the ESPRIT trial (which confirmed that combined aspirin and dipyridamole is more effective than aspirin alone). 17 patients were enrolled: male 12 (71%), mean age 62 (SD 13) years, lacunar stroke syndrome 12 (71%), median stroke/TIA onset to randomisation 8 months. Treatment was discontinued in 4 of 9 (44%) patients receiving triple therapy vs. none of 8 taking aspirin (p = 0.08). One recurrent stroke occurred in a patient in the triple group who was noncompliant of all antiplatelet medications. The number of patients with adverse events and bleeding complications, and their severity, were significantly greater in the triple therapy group (p,0.01). Conclusions/Significance: Long term triple antiplatelet therapy was asociated with a significant increase in adverse events and bleeding rates, and their severity, and a trend to increased discontinuations. However, the patients had a low risk of recurrence and future trials should focus on short term therapy in high risk patients characterised by a very recent event or failure of dual antiplatelet therapy.

Point-of-care lactate and creatinine analysis for sick obstetric patients at Queen Elizabeth Central Hospital in Blantyre, Malawi: A feasibility study

Background: To achieve good outcomes in critically ill obstetric patients, it is necessary to identify organ dysfunction rapidly so that life-saving interventions can be appropriately commenced. However, timely access to clinical chemistry results is problematic, even in referral institutions, in the sub-Saharan African region. Reliable point-of-care tests licensed for clinical use are now available for lactate and creatinine. Aim: We aimed to assess whether implementation of point-of-care testing for lactate and creatinine is feasible in the obstetric unit at the Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi, by obtaining the opinions of clinical staff on the use of these tests in practice. Methods: During a two-month evaluation period nurse-midwives, medical interns, clinical officers, registrars, and consultants were given the opportunity to use StatStrip® and StatSensor® (Nova Biomedical, Waltham, USA) devices, for lactate and creatinine estimation, as part of their routine clinical practice in the obstetric unit. They were subsequently asked to complete a short questionnaire. Results: Thirty-seven questionnaires were returned by participants: 22 from nurse-midwives and the remainder from clinicians. The mean satisfaction score for the devices was 7.6/10 amongst clinicians and 8.0/10 amongst nurse-midwives. The majority of participants stated that the obstetric high dependency unit (HDU) was the most suitable location for the devices. For lactate, 31 participants strongly agreed that testing should be continued and 24 strongly agreed that it would influence patient management. For creatinine, 29 strongly agreed that testing should be continued and 28 strongly agreed that it would influence their patient management. Twenty participants strongly agreed that they trust point-of-care devices. Conclusions: Point-of-care clinical chemistry testing was feasible, practical, and well received by staff, and was considered to have a useful role to play in the clinical care of sick obstetric patients at this referral centre.

Feasibility of An Online Survey Examining the Physical Activity Patterns Among South Asian Adults Residing In the United States

Background: Physical inactivity is a major risk factor for cardiovascular disease and diabetes among South Asians (SAs) - Bangladeshi, Bhutanese, Indian, Maldivian, Nepali, Pakistani, and Sri Lankan. Methods: An online survey was used to determine the feasibility of examining physical activity (PA) levels of SAs living in the US. The Social Ecological Model was the theoretical basis for identifying individual-level, social environmental, and physical environmental factors that impact PA. Results: Ethnicity, intention, self-efficacy, and perceived health benefits of PA were significantly associated with being physically active. Facilitators to PA included achieving improved health; while barriers were lack of time to exercise, unfamiliarity with PA, and nonexistent gender-specific PA facilities. Conclusions: This study showed that online surveys can be a promising tool for data collection among SAs. Health promotion programs should include education on the benefits of PA, and provide culturally sensitive facilities that support PA, especially for SA women.

Feasibility of resting-state microstates neurofeedback

Despite major progress, currently available treatment options for patients suffering from schizophrenia remain suboptimal. Antipsychotic medication is one such option, and is helpful in acute phases of the disease. However, antipsychotics cause significant side-effects that often require additional medication, and can even trigger the discontinuation of treatment. Taken together, along with the fact that 20-30% of patients are medication-resistant, it is clear that new medical care options should be developed for patients with schizophrenia. Besides medication, an emerging option to treat psychiatric symptoms is through the use of neurofeedback. This technique has proven efficacy for other disorders and, more importantly, has also proven to be feasible in patients with schizophrenia. One of the major advantages of this approach is that it allows for the influence of brain states that otherwise would be inaccessible; i.e. the physiological markers underlying psychotic symptoms. EEG resting-state microstates are a very interesting electrophysiological marker of schizophrenia symptoms. Precisely, a specific class of resting-state microstates, namely microstate class D, has consistently been found to show a temporal shortening in patients with schizophrenia compared to controls, and this shortening is correlated with the presence positive psychotic symptoms. Under the scope of biological psychiatry, appropriate treatment of psychotic symptoms can be expected to modify the underlying physiological markers accompanying behavioral manifestations of a disease. We reason that if abnormal temporal parameters of resting-state microstates seem to be related to positive symptoms in schizophrenia, regulating this EEG feature might be helpful as a treatment for patients. The goal of this thesis was to prove the feasibility of microstate class D contribution self-regulation via neurofeedback. Given that no other study has attempted to regulate microstates via neurofeedback, we first tested its feasibility in a population of healthy subjects. In the first paper we describe the methodological characteristics of the neurofeedback protocol and its implementation. Neurofeedback performance was assessed by means of linear mixed effects modeling, which provided a complete profile of the neurofeedback’s training response within and between-subjects. The protocol included 20 training sessions, and each session contained three conditions: baseline (resting-state) and two active conditions: training (auditory feedback upon self-regulation performance) and transfer (self-regulation with no feedback). With linear modeling we obtained performance indices for each of them as follows: baseline carryover (baseline increments time-dependent) and learning and aptitude for each of the active conditions. Learning refers to the increase/decrease of the microstate class D contribution, time-dependent during each active condition, and aptitude refers to the constant difference of the microstate class D contribution between each active condition and baseline independent of time. The indices provided are discussed in terms of tailoring neurofeedback treatment to individual profiles so that it can be applied in future studies or clinical practice. In our sample of participants, neurofeedback proved feasible, as all participants at least showed positive results in one of the aforementioned learning indices. Furthermore, between-subjects we observed that the contribution of microstate class D across-sessions increased by 0.42% during baseline, 1.93% during training trials, and 1.83% during transfer. This range is expected to be effective in treating psychotic symptoms in patients. In the second paper presented in this thesis, we explored the possible predictors of neurofeedback success among psychological variables measured with questionnaires. An interesting finding was the negative correlation between “motivational incongruence” and some of the neurofeedback performance indices. Even though this finding requires replication, we discuss it in terms of the interfering effects of incompatible psychological processes with neurofeedback training requirements. In the third paper, we present a meta-analysis on all available studies that have related resting-state microstate abnormalities and schizophrenia. We obtained medium effect sizes for two microstate classes, namely C and D. Combining the meta-analysis results with the fact that microstate class D abnormalities are correlated with the presence of positive symptoms in patients with schizophrenia, these results add further support for the training of this precise microstate. Overall, the results obtained in this study encourage the implementation of this protocol in a population of patients with schizophrenia. However, future studies will have to show whether patients will be able to successfully self-regulate the contribution of microstate class D and, if so, whether this regulation will have an impact on symptomatology.

Feasibility study and flow scheduling optimization of a multi-product pipeline system

The first goal of this study is to analyse a real-world multiproduct onshore pipeline system in order to verify its hydraulic configuration and operational feasibility by constructing a simulation model step by step from its elementary building blocks that permits to copy the operation of the real system as precisely as possible. The second goal is to develop this simulation model into a user-friendly tool that one could use to find an “optimal” or “best” product batch schedule for a one year time period. Such a batch schedule could change dynamically as perturbations occur during operation that influence the behaviour of the entire system. The result of the simulation, the ‘best’ batch schedule is the one that minimizes the operational costs in the system. The costs involved in the simulation are inventory costs, interface costs, pumping costs, and penalty costs assigned to any unforeseen situations. The key factor to determine the performance of the simulation model is the way time is represented. In our model an event based discrete time representation is selected as most appropriate for our purposes. This means that the time horizon is divided into intervals of unequal lengths based on events that change the state of the system. These events are the arrival/departure of the tanker ships, the openings and closures of loading/unloading valves of storage tanks at both terminals, and the arrivals/departures of trains/trucks at the Delivery Terminal. In the feasibility study we analyse the system’s operational performance with different Head Terminal storage capacity configurations. For these alternative configurations we evaluated the effect of different tanker ship delay magnitudes on the number of critical events and product interfaces generated, on the duration of pipeline stoppages, the satisfaction of the product demand and on the operative costs. Based on the results and the bottlenecks identified, we propose modifications in the original setup.

Measuring the impact of illness perception on NHS audiology service usage in presbycusis patients – a feasibility study

Objective: Coping behaviour in adult hearing loss is still not well understood. Despite the high prevalence of hearing loss in those over 65, many people do not seek help for hearing loss. The common sense model of illness perceptions suggests that illness perceptions are a strong predictor of adapted coping behaviours, including help-seeking and take-up of treatments. This study aimed to determine the feasibility of using the brief illness perceptions questionnaire (bIPQ) to measure the impact of illness perception in predicting usage of NHS audiology services. Study design: Twenty-four volunteers were recruited from a standard NHS audiology outpatient clinic and illness perception was measured using the bIPQ. Two different recruitment strategies were explored and compared in terms of recruitment and retention rates. Comprehensibility of the questionnaire was assessed by Think Aloud Analysis in a subset of participants, while possible risks and burdens were monitored in structured telephone interviews. Results: The questionnaire is a comprehensive and quick tool to measure individual illness perception at minimal cost. We suggested minor adaptations of three questionnaire items to increase comprehension. Participants preferred to complete the questionnaire after their appointment at the clinic facilities rather than at home prior to their hearing assessment appointment. There were no identified risks or burdens to participants in this study. Conclusions: This approach met our criteria for feasibility. Understanding the impact of illness perception on patients’ coping behaviour in presbycusis could improve treatment outcomes and increase patient satisfaction, while promoting a more efficient and individualized audiology service.

Feasibility study of a gripper with thermally controlled stiffness of compliant jaws

This paper proposes a simple and compact compliant gripper, whose gripping stiffness can be thermally controlled to accommodate the actuation inaccuracy to avoid or reduce the risk of breaking objects. The principle of reducing jaw stiffness is that thermal change can cause an initial internal compressive force along each compliant beam. A prototype is fabricated with physical testing to verify the feasibility. It has been shown that when a voltage is applied, the gripping stiffness effectively reduces to accommodate more inaccuracy of actuation, which allows delicate or small-scale objects to be gripped.

From client's dreams to achievable projects: An expert system for determining web site feasibility

This paper presents a web based expert system application that carries out an initial assessment of the feasibility of a web project. The system allows detection of inconsistency problems before design starts, and suggests correcting actions to solve them. The developed system presents important advantages not only for determining the feasibility of a web project but also by acting as a means of communication between the client company and the web development team, making the requirements specification clearer.

Economic feasibility analysis of the implementation of a high value-added molecule extraction system in an olive oil mill

The production of olive oil generates several by-products that can be seen as an additional business opportunity. Among them are the olive pits, already used for heat and/or electricity generation in some mills. They contain compounds that are commercially very interesting and, if recovered, contribute to the sustainability of the olive mills. The work presented in this paper is a preliminary evaluation of the economic feasibility of implementing a system based on a batch prototype with 1 m3 for the extraction of high value-added bioactive molecules from olive pits that are separated during the production of virgin olive oil. For the analysis, a small representative olive mill in Portugal was considered and the traditional Discounted Cash Flow Method was applied. Based on the assumptions made, the simple payback for implementation a system for the extraction of value-added molecules from the olive pits is around 7 years.