NIHRDataInsights/HRCSData huggingface dataset:
Title: Cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care: a randomised controlled trial
Funder: Department of Health (England)

Abstract: Patients with treatment resistant depression in primary care (defined as those who have significant depressive symptoms following at least 6 weeks treatment with antidepressant medication at an adequate dose) will be invited to participate in this randomised controlled trial. Those who give written informed consent will be randomised to (1) usual care i.e. pharmacological treatment and clinical management or (2) CBT in addition to usual care. All patients will be taking antidepressant medication at the time of randomisation. Those randomised to CBT will receive a course of 12 sessions with (up to) a further 6 sessions if deemed clinically appropriate by the therapist. Each session will last 50 minutes. Outcome will be measured at 6 months and 12 months post-randomisation with the Beck Depression Inventory (BDI). The primary outcome is the BDI score at 6-months post-randomisation specifically a binary variable representing response defined as a reduction in depressive symptoms of at least 50% compared to baseline. Secondary outcomes will include remission of symptoms quality of life and use of antidepressants together with outcomes measured at 12-months post-randomisation. A follow-up of the CoBalT study participants is currently on-going in order to determine whether the intervention is effective in reducing depressive symptoms and improving quality of life over the long-term (approximately 4 years post-randomisation) compared with usual care alone and whether this strategy is cost-effective.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.1 PHARMACEUTICALS
Health categories: MENTAL HEALTH
Title: The Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) Trial
Funder: Department of Health (England)

Abstract: Depression is a major health problem. The majority of people with depression receive care from their GP. However lots of people experiencing depression would also like to receive a talking treatment (counselling or psychotherapy). Cognitive Behaviour Therapy (CBT) seems to be the most effective type of talking treatment for depression but is not always immediately available in the NHS. Recently therapists have developed a form of CBT that can be delivered by computer which might make it easier to access this form of treatment. We call this computerised CBT. There are different computerised packages some of which are freely available and others which have to be paid for by the NHS. At the moment we do not know which of these works best for NHS patients with depression. The purpose of this study is to compare two (one free-to-use and one commercial) CBT packages to see if there are any additional benefits of offering this treatment to the care that people already receive from their GP. We will also examine whether the commercial package is better than the free-to-use package and whether the extra cost is justified. To answer these questions we will randomly allocate 600 participants to receive either usual GP care alone usual GP care plus a commercial CBT package or usual GP care plus a free-to-use package. We will compare how people fare and the costs of the different options. We will recruit participants via their GP Practice in four centres (York Sheffield Bristol and Manchester) and follow them up for two years. It is also unclear how acceptable this form of treatment is for people with depression. We will examine this issue and how it should be delivered in the NHS by discussions with NHS staff and the patients participating in the trial.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH
Title: Financial incentives to improve adherence to anti-psychotic maintenance medication in non-adherent patients - a cluster randomised controlled trial: FIAT (Financial Incentives for Adherence to Treatment)
Funder: Department of Health (England)

Abstract: BackgroundVarious clinical interventions have been tested to achieve adherence in non-adherent patients with psychotic disorders however there is no consistent evidence for any intervention to significantly improve medication adherence in this population. The effectiveness of financial incentives in improving adherence to a range of treatments has been demonstrated; however there are few research studies on the use of financial incentives to achieve medication adherence for people living in the community with a severe mental illness. AimTo establish the effectiveness and cost effectiveness of using financial incentives to improve adherence to anti-psychotic maintenance medication in patients with poor adherence with whom all conventional methods to achieve adherence have failed.MethodIn a cluster randomised controlled trial 34 assertive outreach teams will be randomly allocated to either the intervention group where patients will be offered a financial incentive for each anti-psychotic depot medication they receive over a 12 month period or the control group where all patients will receive treatment as usual.Sample136 patients with severe mental illness who use assertive outreach services and who have problems adhering to antipsychotic depot medication. All conventional methods to achieve adherence must have failed for these patients.Outcome measuresWe will measure adherence levels global clinical improvement number of voluntary and involuntary hospital admissions number of attempted and completed suicides incidents of physical violence number of police arrests number of days spent in work/training/education subjective quality of life and satisfaction with medication in both the intervention and control groups. We will also aim to establish the cost effectiveness of financial incentives.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH
Title: Antidepressant Controlled Trial of Negative symptoms in Schizophrenia (ACTIONS)
Funder: Department of Health (England)

Abstract: The negative symptoms of schizophrenia represent an important dimension of psychopathology and reflect the absence or diminution of normal behaviours and functions. They include deficiencies in emotional responsiveness drive and emotional and social engagement. Persistent negative symptoms are held to account for much of the long-term morbidity and poor functional outcome in patients with established schizophrenia but if they prove resistant to antipsychotic medication there is a very limited evidence base regarding specific treatments. The aim of this double-blind placebo-controlled trial is to establish the clinical and cost effectiveness of an SSRI antidepressant citalopram in the management of negative symptoms of schizophrenia over a year. The study sample will be adults with an OPCRIT diagnosis of schizophrenia clinically stable for 3 months with a consistent antipsychotic regimen and characterised by persistent negative symptoms to a criterion level of severity. The study will be submitted for adoption by the Mental Health Research Network (MHRN) and conducted at seven centres: Bristol North London West London South London Manchester Oxford and Southampton. Consenting participants will be randomly assigned to be additional treatment with either citalopram (20mg/day for the first 4 weeks followed by 40mg per day for the remainder of the study period) or identical placebo. 360 patients will be recruited over an 18-month period and each participant followed-up for 12 months. All outcomes scales will be administered at baseline and subsequently 3 9 and 12 months. Primary outcomes will be quality-of-life at 3 and 12 months and negative symptoms Secondary outcomes will include the EuroQol EQ-5D for health economics. Symptoms will be comprehensively assessed and other measures will assess social function medication side effects treatment adherence and cognition. The statistical analysis of the data will be guided by the CONSORT statement on reporting clinical trials.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: MENTAL HEALTH
Title: Amisulpride augmentation in clozapine-unresponsive schizophrenia (AMICUS)
Funder: Department of Health (England)

Abstract: This 12-week placebo-controlled RCT will be conducted in secondary care specifically mental health services at four UK centres. The health technology to be assessed is the augmentation of clozapine treatment with another second-generation antipsychotic amisulpride which will be compared with placebo: 400mg amisulpride or 1 matching placebo capsule for the first 4 weeks then the option of titrating up to 800mg amisulpride or 2 matching placebo capsules for the remaining 8 weeks. The study will be double-blind with medication supplied as identical capsules containing either 400mg amisulpride or placebo. The optimum dose of clozapine at entry and subsequent augmentation will be achieved through a flexible dosing regimen whereby treating psychiatrists will be able to flexibly alter dose regimens to maximise clinical risk-benefit ratios; there will be opportunities for clinical titration of clozapine dose at two and six weeks. Any direct pharmacokinetic effect on clozapine levels will be assessed by pre- and post-augmentation plasma levels of clozapine samples being taken at baseline and at the end of the 12 weeks. Recommended pharmacovigilance procedures will be followed. Clinicians will be asked not to prescribe any additional medication during the course of the study and will be reminded of the drugs with potential adverse interactions as mentioned in the SPCs for clozapine and amisulpride. Medication adherence will be assessed by pill count and clozapine/norclozapine plasma level ratio. Therapeutic improvement will be assessed in terms of overall symptom severity but also using broader clinically-relevant outcome measures of social and occupational function and target symptoms and/or behaviours as well as overall health status and utility. Side effects will be systematically assessed. The costs and outcomes for a cost effectiveness acceptability and net benefit analysis will also be measured. The primary economic measure will be the incremental cost effectiveness ratio of clozapine augmentation estimated as the net cost of clozapine augmentation divided by net QALY of clozapine augmentation. Twenty-four months will be allowed for recruitment of participants plus 3 months for the final follow-up assessments.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: MENTAL HEALTH
Title: Effectiveness and Cost-Effectiveness of Body Psychotherapy in the Treatment of Negative Symptoms of Schizophrenia. A multi-centre randomised controlled trial
Funder: Department of Health (England)

Abstract: The overall objective of the study is to improve the treatment of negative symptoms of patients with schizophrenia through testing a novel treatment method. The trial tests whether body psychotherapy (BPT) is effective and cost effective in the treatment of negative symptoms of schizophrenia as compared to a non-specific intervention of physical activity. In a randomised controlled trial a total of 248 patients in working age with an established diagnosis of schizophrenia and marked negative symptoms will be randomly allocated to participating in either BPT or pilates groups. Both interventions will be delivered in groups of 8 patients with 20 sessions over a period of 10 weeks. Pilates groups will provide physical activity and non-specific attention in groups but not the specific components of BPT. The primary outcome are negative symptoms as measured on PANSS. Secondary outcomes are general psychopathology quality of life social functioning treatment satisfaction and the objective social situation of the patients. We will also test whether any effects of the intervention hold true over a six month follow up period and assess the cost-effectiveness of BPT. If successful the trial will provide evidence for the effectiveness of a new and relatively inexpensive group treatment for a very challenging group of patients which can be widely implemented in the NHS.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH
Title: Collaborative care and active surveillance for screen-positive elders with sub-clinical depression: a pilot study and definitive and randomised evaluation - the CASPER trial
Funder: Department of Health (England)

Abstract: Depression accounts for the greatest burden of disease among all mental health problems and is expected to become the second-highest amongst all general health problems by 2020. By the age of 75 1 in 7 older people meet formal diagnostic criteria for depression. Efforts to ameliorate the burden of illness and personal suffering associated with depression in the elderly have focussed on those with more severe depressive syndromes. Less attention has been paid to those with mild disorders/sub-threshold depressive syndromes but these patients also suffer impairments in their quality of life and level of functioning. There is currently no clear evidence-based guidance regarding treatment for this patient group. The vast majority of depression in the elderly is managed entirely in primary care without recourse to specialist mental health services. A range of individual treatments have been shown to be effective in the management of clinical depression in the elderly including anti-depressants and psychosocial interventions. However a repeated observation amongst those with depression has been the failure to integrate these effective elements of care into routine primary care services.The current study brings together 3 established elements (screening for depression collaborative care and low intensity psychological intervention) to see whether collaborative care reduces depression symptom severity in older adults in a cost-effective manner compared withholder adults who are managed by usual GP care. This intervention does not involve the use of anti-depressants which are generally not effective in this group.The study will randomly allocate 500 participants to receive either usual GP care alone or collaborative care plus usual GP care. We will assess depressive symptoms using the PHQ-9. We will recruit participants via their GP practice in 3 centres (York Leeds and Hull). We will follow-up participants for 12 months.Collaborative care and low intensity psychological intervention is currently not routinely offered therefore it is unclear how acceptable this form of treatment is. The study will examine this issue and how it should be delivered by discussions with participants and those delivering collaborative care.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: MENTAL HEALTH
Title: Psychoeducation with problem solving (PEPS) therapy for adults with personality disorder: A pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manualised intervention to improve social functioning
Funder: Department of Health (England)

Abstract: Personality disorder is a type of mental health problem that happens when a person has a pattern of belief and behaviour which causes them distress and difficulties. Personality disorder is very common affecting around 4 in every 100 people in the UK. There is not a lot of information about what treatments are helpful for people with personality disorder. The purpose of the PEPS trial is to evaluate the effectiveness of a treatment for people with personality disorder called psycho-education with problem solving (PEPS) therapy. PEPS therapy is a complex cognitive-behavioural intervention that integrates individual and group therapies. PEPS therapy aims to inform participants about their personality disorder diagnosis discuss its effects and teach strategies for solving interpersonal problems The PEPS trial is a two-arm parallel group randomised controlled trial which will compare the effectiveness of PEPS therapy with the treatment that people with personality disorder would usually receive from community mental health teams Participants will be recruited from NHS Trusts providing mental health care within the UK. The primary outcome is social functioning at one year post-treatment follow-up assessed by the Social Functioning Questionnaire. In addition the trial will look at NHS service use quality of life anxiety and depression referrers assessment of functioning and the clients assessment of problems


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH
Title: A randomised trial to increase the uptake of smoking cessation services using personal targeted risk information and taster sessions
Funder: Department of Health (England)

Abstract: Recent figures show a reduction in smoking prevalence but there is no room for complacency smoking remains a major cause of ill health and mortality. Most smokers say they want to quit but only a tiny proportion make use of the free Smoking Cessation Services provided by the NHS. This research will evaluate in a randomized trial a two-pronged intervention to increase the number of people attending the services. We will recruit 60 general practices through the PCRN in areas that are representative of the English smoking cessation service. All smokers aged 16 and over identified from their medical records in participating practices will be sent a brief questionnaire to update their smoking status and to assess their dependence motivation to quit previous attendance at NHS services and to seek consent to participate in the trial. Current smokers who consent and are eligible will be randomized to: a) the Control Group to receive a generic letter advertising the NHS service and inviting them to contact the service for an appointment;b) the Intervention Group to receive i) a brief personalized tailored letter from the GP offering risk information using information about general health status and chronic conditions from the patients medical records and data from the assessment; and ii) an invitation and appointment to attend a Come and Try it taster session to find out more about the services run by advisors from the local service. Attendees will be encouraged to sign up to a group or one-to-one session at convenient time. Participants who fail to attend will receive a further invitation and appointment 3 months later to encourage attendance. Research interviewers will conduct follow-up interviews 6-months after randomisation by telephone to assess attendance at the services current smoking status daily cigarette consumption reasons for non-attendance and barriers to attendance in all participants.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: MENTAL HEALTH
Title: A randomised trial of nicotine patch preloading for smoking cessation
Funder: Department of Health (England)

Abstract: Background: Standard smoking cessation support advises smokers not to use nicotine replacement therapy (NRT) whilst still smoking before their quit day. However this could be beneficial for a number of reasons. For example it may decondition the link between smoking and associated environmental cues it may familiarise smokers with NRT so they use it most effectively post-quit and/or it may cause aversion and therefore may make smoking less desirable. Evidence for the beneficial effect of nicotine preloading has proved inconclusive.Design/Methods: We will conduct a multi-centre pragmatic randomised controlled trial of four week nicotine patch treatment pre-quit day alongside standard NHS stop smoking service (SSS) versus standard NHS SSS support without pre-quit patch. Participants will be recruited through GP practices and through an existing smoking cessation clinic. Support will be in the form of one-to-one clinic visits and the standard support will be provided by the NHS.Outcomes/Follow-up: Follow-ups will take place 1 week 4 weeks 6 months and 12 months after each participant’s quit day. The primary outcome will be six month validated prolonged abstinence. Additional abstinence outcomes will be 4 week and 12 month prolonged abstinence and point prevalence 4 week 6 month and 12 month abstinence. Markers of potential mediators such as changes in carbon monoxide and cigarettes per day aversion dependence smoking reward urges to smoke confidence in quitting and motivation to change will also be measured. A health economic analysis will be carried out.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;6.1 PHARMACEUTICALS
Health categories: MENTAL HEALTH
Title: The feasibility of using a manualised Social Stories training toolkit to alleviate challenging behaviour and social difficulties exhibited by children with Autism Spectrum Disorder in mainstream schools: a cluster randomised controlled trial with nested qualitative and cost-effectiveness study
Funder: Department of Health (England)

Abstract: Social Stories for autism represents a complex intervention. This technology is not yet sufficiently evolved such that it would be premature to design and conduct a full scale randomised controlled trial at this stage. The aim of our study is to build upon previous research to develop a manualised Social Stories intervention for use with children with Autism Spectrum Disorder (ASD) in mainstream schools that has the effect of reducing challenging behaviour. We will conduct a feasibility study which will inform the design of a full Randomised Controlled Trial (RCT) that includes a justification and description of appropriate costs outcomes and parameters to include cost effectiveness. In line with the Medical Research Council (MRC) complex interventions framework we will first meet the following aims to ensure our trial is successful and informative to the HTA and the NHS:Preclinical theory: A systematic review examining the use of Social Stories and other social stories in autism spectrum disorders with particular reference to an outcome of reducing challenging behaviour in mainstream school aged children.Phase I: A qualitative analysis with user interviews and a user focus group to gather information relating to the optimum design and use of Social Stories in children and young people with autism spectrum disorders. We will also form an expert writing panel and develop a manualised toolkit (including a training package) of appropriate Social Stories for use in mainstream school children and young people. Phase II: A feasibility study in the form of a randomised controlled trial comparing the manualised Social Stories intervention with an attention control (demonstrating recruitment delivery of the intervention and successful follow up). In doing so we will establish the acceptability and utility of the manualised Social Stories intervention to parents and carers and identify parameters outcomes and cost effectiveness from the feasibility study in order to inform a future full scale RCT.


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