NIHRDataInsights/HRCSData huggingface dataset:
Title: Optimising Individualised prescribing with therapeutic drug Monitoring for Antipsychotics (OptIMA)
Funder: Department of Health (England)

Abstract: Therapeutic drug monitoring (TDM), comprising measurement of an individual’s drug plasma levels to avoid toxic or subtherapeutic levels, enables minimal dose prescribing for drugs with wide biovariability. TDM is rarely used for antipsychotics despite consensus guidelines recommending it for olanzapine and risperidone. Study 1: Aim - to explore how, and on what basis, psychiatrists titrate antipsychotic dose for acute psychosis. I will conduct a cross-sectional postal quantitative study of 100 consultant psychiatrists using a newly-designed questionnaire to explore aspects regarding antipsychotic titration and perspectives on TDM. Study 2: Aim - to develop and pilot clinically acceptable methods for TDM for olanzapine/ risperidone with rapid feedback to clinicians with a dose management algorithm. I will conduct a logistics confirmation small scale open study for 30 inpatients with psychosis, prescribed olanzapine/ risperidone who will have rapid feedback TDM.Study 3: Aim- to conduct a randomised controlled trial for olanzapine comparing TDM with treatment as usual. 170 participants, admitted to inpatient wards in the past fortnight, and treated with olanzapine for schizophrenia/ schizoaffective disorder will be randomised. Baseline measures include predictors of drug biovariability and clinical parameters. The intervention is TDM, entailing a blood-test conducted 7-14 days after clinician drug initiation, with rapid results and an interpretation algorithm. Medication decisions will be by the participant’s clinician. The primary outcome at 12-week follow-up is (change in) olanzapine dose.Ultimately, I predict that individualised TDM-guided dose reduction will lead to morbidity reduction from side effects, improved clinical outcomes with drug continuation, and decreased drug costs.


Research activity codes: 5.1 PHARMACEUTICALS;6.1 PHARMACEUTICALS
Health categories: MENTAL HEALTH
Title: Rationalisation of antipsychotic drug use in older people, using [18F]-Fallypride PET
Funder: Department of Health (England)

Abstract: Older people are extremely susceptible to the side effects of antipsychotic drugs, including falls, sedation, tremor and a greater risk of stroke. There is an urgent clinical need to understand why this is the case, to guide treatment strategies. This study aims to utilise brain imaging techniques that measure the action of antipsychotic drugs in the brain to explore mechanisms of heightened sensitivity in people with dementia and schizophrenia with onset in later life, and translate these findings into direct patient benefit. The first aim is to establish whether, for a given (low) dose of the commonly used antipsychotic drug amisulpride, a greater action at brain sites is seen in people with dementia compared to people with schizophrenia or healthy older people. The second aim is to investigate and compare the relationship between drug dosage, action at brain sites and clinical response (symptom reduction and side effect profile) during the first 8 weeks of amisulpride treatment in the 2 patient groups. Information obtained from these studies will be used to establish the smallest drug dosage and optimum dose range of drugs like amisulpride required to reduce symptoms without causing side effects, with the aim of informing and guiding dosage strategies.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;6.1 PHARMACEUTICALS
Health categories: MENTAL HEALTH
Title: Prediction of Risk of Relapse of Pscychosis - Examining the Interaction Between Genes and Substance Use (PREDICT)
Funder: Department of Health (England)

Abstract: In this fellowship, I propose to examine whether comorbid cannabis use increases the risk of relapse in patients with pre-existing psychotic disorder after controlling for potential confounding factors (such as the effects of other illicit substances, non-adherence to medication, baseline severity of illness, exposure to stressful life events etc.) and whether it is possible to reliably predict on the basis of genetic testing which patients with pre-existing psychotic disorder will experience a relapse of their illness following recent cannabis use. Further, in a related study, I also plan to examine whether comorbid cannabis use increases the risk of violence in patients with pre-existing psychotic disorder and whether it is possible to predict on the basis of genetic testing, which patients with psychosis are likely to become violent if they use illicit drugs like cannabis. I will test the following hypotheses: Primary hypotheses- 1) Patients with psychosis who continue to use cannabis are at greater risk of relapse of their psychotic illness compared to those without ongoing cannabis use. 2) The risk of relapse is greater in those patients with psychosis and ongoing cannabis use, who also carry the risk variants of genes that we and others have identified as being linked to a greater sensitivity to the effects of cannabis, compared to those who do not carry the risk variant. I will also explore whether: 1) Patients with psychosis who continue to use cannabis are at greater risk of violent behaviours compared to those without ongoing cannabis use. 2) The risk of violence is greater in those patients with psychosis and ongoing cannabis use, who also carry the risk variants certain genes.


Research activity codes: 2.1 BIOLOGICAL AND ENDOGENOUS FACTORS
Health categories: MENTAL HEALTH
Title: Group Mindfulness Based Therapy for distressing voices: a pragmatic randomized controlled trial
Funder: Department of Health (England)

Abstract: Background Mindfulness-based psychological interventions are being used across the US and UK for people with a range of long-term physical and mental health conditions. Prof. Paul Chadwick is the international pioneer in developing a mindfulness-based group therapy specifically adapted for people with psychosis. With his research team, Prof. Chadwick has produced strong pilot data supporting mindfulness-based therapy (MBT) groups for psychosis. The proposed study is the first of its kind to robustly evaluate outcomes of an MBT group for people distressed by hearing voices. The intention is to increase the range of evidence-based psychological therapies available to this often marginalised client group. Aims This study will evaluate the effectiveness of MBT groups for people distressed by voices using a pragmatic RCT design. In the first instance, the priority is to establish whether or not MBT groups are more effective than treatment as usual (TAU) as this question has yet to be addressed. This study therefore compares outcomes between MBT groups (plus TAU) with TAU on measures of psychological health, distress, control and recovery. Outcomes will address the question of effectiveness and have the potential to increase the range of psychological therapies available to this group of people. Plan of Investigation Approximately 144 service users will be recruited from community mental health teams in Sussex and Hampshire. Inclusion criteria will stipulate that the person has: 1) been experiencing drug resistant and distressing voices for the preceding one year period; and 2) an ICD 10 (research criteria) diagnosis of schizophrenia or schizo-affective disorder. Participants will be randomly allocated to either a 12-session MBT group (plus TAU) or TAU. Service user defined goals for recovery as well as measures of psychological health, distress and personal control will be assessed at baseline, post-group and six-month follow-up for all participants. Potential Impact Pilot data suggests that MBT groups for distressing voices can have a positive benefit on participants’ psychological health, distress and sense of personal control. This data was corroborated by the post-group qualitative exploration of group members’ experiences. We hypothesise that participants receiving group MBT will report significantly better outcomes than participants in the control condition. If found to be effective, manualised group MBT will also assist NHS Trusts in making psychological therapies available to more service users who have a diagnosis of schizophrenia.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH
Title: Assessing the feasibility of implementing and evaluating a new problem solving model for patients at risk of self-harm and suicidal behaviour in prison
Funder: Department of Health (England)

Abstract: We will conduct three inter-related studies in four prisons in the North of England. We will train all wing staff in the basics of problem-solving and assess the impact using a multiple interrupted time series design with a range of outcome measures derived from routinely collected prison data. We will develop an economic protocol to estimate the associated NHS costs. We will train specialist staff in the use of problem-solving to help with the management of individual prisoners at risk and we will assess the feasibility of collecting individual, prison-based and NHS service outcomes before, during, after, and at 4 months following participants after release from prison. We will use qualitative methods to evaluate the feasibility and acceptability of the prison-based training, and to identify potential barriers to its wider implementation in the prison service.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: MENTAL HEALTH
Title: Electroconvulsive therapy: a qualitative study of the experiences of patients and their carers, as part of www.healthtalkonline.org.
Funder: Department of Health (England)

Abstract: This qualitative study aims to elicit detailed accounts of the experiences of ECT. Using in-depth narrative interviews we will investigate a wide range of experiences from service users and carers. This method is ideally situated to explore the subtleties, possible contradictions, reasoning and positioning of ECT within wider life histories. This is a qualitative study and therefore does not seek to test a hypothesis (although it may generate hypotheses for future research). We aim to establish and present matierial depicting the RANGE of experiences and perspectives of patients and carers, not their FREQUENCY. The main question we seek to answer is: what are the experiences and perspectives of service users and carers who have undergone ECT? Within this, there are many subsidiary questions, some of which are predictable and some of which will arise unexpectedly. The sampling, interviewing and analysis processes are designed to bring out new themes during the interviews and to focus on those that are of importance to the users and carers. The first, narrative, part of the interview is led by the interviewee and so they dictate the way they position ECT within their account. The second part is semi-structured to ensure a broad range of topics areas are covered. A minimum range of themes to be covered across the sample will be identified by literature review and an Advisory Panel. These themes may include, but will not be limited to, the following: the image of ECT, the place of ECT within their treatment regime and wider life history, reactions of others to ECT, experience of compulsory treatment, the impact of ECT, deciding whether or not to have ECT and information sources they used, effects of ECT on memory, what the treatment itself was like, use in mania, schizophrenia pregnancy, use with older people, getting information, messages to others considering ECT, messages to health professionals.


Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: MENTAL HEALTH
Title: Addressing social anxiety in adults who stutter: A pilot study.
Funder: Department of Health (England)

Abstract: Background There are over 350,000 adults who stutter (AWS) in the UK, many of whom experience social anxiety and social phobia that impact negatively on their education, work and quality of life. These conditions can be addressed using Cognitive Behaviour Therapy (CBT), but CBT is not effective for every client, and SLT service provision of CBT for AWS is very variable across the country and in some cases non-existent. An alternative therapy, Cognitive Bias Modification (CBM), has the potential to be as effective as, and better value for money than, CBT. As it can be delivered via a computer terminal it does not require the attendance of highly-trained staff. The proposed research would pilot a protocol for delivering CBM to AWS, to inform the design of a subsequent, more comprehensive RCT. Aims This pilot project aims to (1) Perform an exploratory trial to evaluate the usefulness of a Cognitive Bias Modification intervention for social anxiety in adults who stutter; (2) Examine the views and experiences of adults who stutter with regard to the acceptability of the intervention and the conduct of subsequent research into it, and (3) Gather data for the development of a definitive RCT to further examine the effectiveness and cost-effectiveness of the intervention as a means of improving outcomes for adults who stutter. Plan of Investigation An exploratory RCT (Attention Training versus Placebo Control) will be carried out. Attention training and placebo will be delivered online. Participants will be 40 adults who stutter who meet the DSM-IV criteria for a diagnosis of social anxiety. Measures of psychological well-being and speech fluency will be collected (i) prior to commencement of the intervention, (ii) one week after its completion, and (iii) four months later. Data collection points have been selected to permit comparison with other studies. Attitudes to the intervention will be investigated via questionnaire. Outcome measures: Social anxiety; speech fluency; EQ5D. Potential Impact The proposed intervention has already been shown to be efficacious with people with generalized social anxiety, but neither its efficacy in reducing social anxiety related to stuttering, nor any attendant effects on speech fluency (which might occur because of the correlation between these two variables) have been evaluated. If this intervention is efficacious for this client group, and is acceptable to users, it has the potential to provide a treatment that is extremely cost-effective and that can be carried out online, either in the user's home or at another convenient location such as a GP's surgery. A key output of the study will be a well-defined protocol for a more definitive Phase III trial.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH
Title: Pilot Evaluation of a Brief Family Domains Intervention for Parents of Children Referred with Emotional and Behavioural Problems
Funder: Department of Health (England)

Abstract: Background Young children with emotional and behavioural problems are at greatly increased risk for later mental health problems Effective early intervention is therefore essential. Progress, especially through parent training programmes now widely available in the NHS, has been substantial. However parent training programmes only target limited aspects of parenting, and drop outs and poor outcomes are still common. Improvements in treatment need to take account of the way in which emotions and behaviours are dysregulated in children with mental health problems, and of the range of parental responses required to promote better regulation. Recent evidence suggests that very brief interventions can be as effective as lengthier treatments. Aims The aim of the study is to evaluate, in children referred with mental health problems, the impact on parenting and child outcomes of a one session psychoeducational group offered as the first intervention following referral. This ‘Family Domains Review’ will provide parents with a way of understanding parent-child relationships, to enable them to re-evaluate their children’s emotions and behaviours, both those associated with their mental health problems, and others important to the development of resilience. In turn this will increase their ability to respond in ways that promote effective management of emotions and regulation of behaviours. A further aim is to provide a basis for the development of an approach suitable for widespread application, for example through on-line learning. Plan of Investigation A Phase 2 pilot randomized controlled trial for 150 parents of children aged 4 – 8 years, referred to an inner-city child and adolescent mental health service (CAMHS). They will be randomized in the ratio 2:1 (100 intervention) no more than 4 weeks prior to their first clinical appointment. Parents will either have a one session Family Domains Review group or will wait for their first appointment in the usual way. Child adjustment and parental criticism of the child will be measured before and after the group in the intervention arm (and at two equivalent points in the control group), and after 3 months. Parental perceptions of the intervention will be assessed quantitatively and qualitatively, and service usage measured. Potential Impact If the intervention is effective it has the potential to be offered universally in child and adolescent mental health services (CAMHS) to reduce emotional and behavioural problems, to reduce service usage, and to enhance the effectiveness of subsequent clinical interventions. It is a psychoeducational approach well suited to application through non-clinical trainers, and on-line help for parents and children, and hence impact mored widely in the NHS and beyond. ????


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH
Title: Development and preliminary evaluation of a Medication Review Tool for people taking antipsychotic medication
Funder: Department of Health (England)

Abstract: Background Recent policy guidance highlights the need to support people with long-term psychiatric conditions to take a greater role in discussions and decisions about their medication. This is consistent with a recovery oriented approach to mental health care. Greater involvement in medication decisions should also focus prescribing on service users' priorities, thus reducing the extensive over-prescribing of antipsychotics, improving adherence, reducing unecessary side effects, and improving satisfaction with care. Aims This research aims to develop a Medication Review Tool for people who are taking antipsychotic drugs to help them to weigh up the pros and cons of drug treatment and communicate their experiences and desires more clearly to prescribers. Specific aims are 1) to conduct qualitative research to explore service users' experiences of taking antipsychotic medication and their views on the current decision making practice in relation to medication 2) To develop a Medication Review Tool 3) To conduct a pilot study of the Tool with people with schizophrenia and schizoaffective disorder in community mental health services to assess the feasibilty of conducting a full randomised controlled trial Plan of Investigation The first part of the project will consist of a qualitative study of service users' views about taking antipsychotic medication, and their involvement in decisions-making. A preliminary Medication Review Tool will be designed and there will be a further consultation with users, carers and prescribers to finalise the design. The tool will be made available for download on a website with links to information about psychiatric drugs. The Tool will be evaluated in a pilot cluster randomised trial in community mental health teams and Early Intervention in Psychosis services. The primary outcome will be participation in discussions about medication. Attitudes to drug treatment, general satisfaction, symptoms, adherence, side effects and prescribing patterns will also be evaluated. Potential Impact The costs of poor adherence with antipsychotic drugs is estimated to be high, and over treatment also incurs costs in terms of unnecessary side effects, impairment and suffering. Helping service users to take a more active and informed part in discussions and decisions about drug treatment should improve adherence and help reduce the over-use of these drugs. Improving adherence will benefit patients in terms of reducing rates of relapse and readmission to hospital, and also reduce demands on carers and the NHS. Reducing the over-use of antipsychotic drugs will reduce iatrogeneic effects, which will improve patients' quality of life, and reduce the costs of treatment of drug-induced side effects, which can be considerable.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH
Title: Randomised controlled trial of modified cognitive behaviour therapy for non-cardac chest pain (COPIC - COgnitive therapy for Pain In the Chest)
Funder: Department of Health (England)

Abstract: Background Chest pain is one of the most common reasons for attending an Accident & Emergency Department . This is understandable as cardiac conditions often present with chest pain and many sufferers require emergency interventions to save life. However, only a minority of patients presenting with chest pain have a demonstrated physical cause for their conditions and the remainder are often inadequately managed, and who often receive a combination of support and reassurance that may reinforce rather than resolve the problems We have developed a modification of cognitive behaviour therapy for chest pain (CBT-CP), administered mainly by trained general nurses, with preliminary evidence of efficacy, and need to test its value formally in a randomised controlled trial. Aims (i) to carry out a two-arm parallel randomised controlled trial of either 1-2 or 3-6 sessions of cognitive behaviour therapy (CBT) or standard treatment (ST) in patients presenting with non-cardiac chest pain (who have presented at least once before in the previous year), and who have not had sufficient physical pathology to explain their symptoms, at cardiology settings at one general hospital (KIngs Mill Hospital) (ii) to measure outcome both in terms of reduction of symptoms of health related anxiety, medically unexplained symptoms, social funtioning, generalised anxiety and depression, and quality of life at 6m and 12m (iii) to measure all health service related costs in the 6 months before randomisation and at 6 month intervals subsequently for 12months. ???? Plan of Investigation This is a randomised parallel arm controlled trial of interventions for patients with non-cardiac chest pain. It has two arms, one of standard support and reassurance (control arm) and the other of either 1-2 or between 3 and 6 sessions, depending on the assessmen of the severity of the problem at first assessment, of an adapted form of cognitive behaviour therapy for non-cardiac chest pain administered by a trained medical team. Patients will be stratified by gender and be randomised using a minimisation procedure with equal allocation to the two arms of the trial. Potential Impact The National Health Service could gain in two different ways if the trial demonstrated value of this new adapted form of cognitive behaviour therapy. A significant source of morbidity - persistent, recurring and anxiety-provoking chest pain - would be alleviated with major gains to quality of life and satisfaction, and there would also be a reduction of health service presentations in both primary and secondary care. This would not be likely to be achieved easily, because the resources needed to provide the service would have to be obtained, If this treatment is successful a strong case could be made for further teams to be trained in the same way.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH