The ELECTRIC Trial
The ELECTRIC trial, which is funded by NIHR HTA Programme, will investigate the clinical effectiveness of a programme of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and the associated costs and consequences. 500 participants with urinary incontinence will be recruited from care homes in Scotland and England and will be randomised to a programme of TPTNS or sham stimulation. The primary outcome is volume of urinary incontinence leaked over a 24 hour period at 6 weeks post randomisation.
The ELECTRIC statistical analysis plan can be downloaded here.
The EMPOWER Trial
The EMPOWER trial, funded by the NIHR HTA Programme and the Australian Government National Health and Medical Research Council, will evaluate the EMPOWER App against treatment as usual, using a multicentre, two arm, parallel group, cluster randomised controlled design involving eight purposively selected Community Mental Health Services (6 in Glasgow and 2 in Melbourne). Eligible patients are adults with a diagnosis of Schizophrenia-related disorder who have either been admitted to a psychiatric in-patient service at least once in the previous two years for relapse of psychosis or have received crisis intervention in the previous two years for a relapse of psychosis. The primary outcome is relapse over a 12 month follow-up period.
The EMPOWER statistical analysis plan is available for download here.
Click the links for Appendix A and Appendix B.
The FOCUS Trial
The FOCUS trial is assessing whether cognitive behaviour therapy (CBT) is an effective treatment for individuals who have experience of psychosis and whose symptoms have been unresponsive to the anti-psychotic medication ‘clozapine’. Greater Manchester West Mental Health NHS Foundation Trust, details on the trial can be found here:
The FOCUS statistical analysis plan is available for download here
The FOCUS economic evaluation protocol is available for download here
Let's Talk
Let’s Talk is a feasibility randomised controlled trial that is conducted across two UK sites, Greater Manchester, and Northeast London. Participants are randomly allocated to either the Let’s Talk peer-delivered intervention plus treatment as usual (TAU), or TAU alone; randomisation is in the 1:1 ratio. Participants are aged 16+, have a schizophrenia diagnosis or meet operational entry criteria for an Early Intervention in Psychosis Service, are under the care of a mental health service, can provide informed consent and have at least moderate levels of internalised stigma and disclosure. Exclusion criteria are a primary diagnosis of alcohol or substance dependency, moderate to severe learning disability, organic psychosis, non-English speaking where this prevents engagement with informed consent and completion of interviews and immediate risk to self or others. The intervention is peer-delivered and addresses mental health stigma and discrimination. The intervention is manualised and has a workbook to support sessions. The aims of the intervention are: to support participants to weigh up the pros and cons of disclosing mental health experiences, teach safe ways to disclose, support a participant to develop their own narrative regarding their mental health experiences in a manner that supports disclosure goals, explore resources that address stigmatising beliefs about psychosis and to support self-affirming beliefs that counter stigma. Up to 10-weeks of the Let’s Talk intervention, delivered by a peer support worker, are available plus one booster session. The primary outcome are feasibility of recruitment, retention, and uptake of the intervention with pre-specified red, amber, green progression criteria. Secondary outcome measures include measures of stigma, recovery, depression, anxiety, quality of life, empowerment, service user and health status. The comparator is treatment as usual (TAU) which is NHS statutory secondary care adult mental health services including care coordination. Assessments are conducted by a research assistant blind to allocation at baseline, 2.5-months, and 6-months. Recruitment commenced on 01/09/2021 and ended on 31/01/2023.
The Let's Talk statistical analysis plan is available to download here.
The LIFT Trial
The LIFT trial, funded by Arthritis Research UK, is a multi-centre, three-arm randomised controlled trial testing usual care alone versus usual care with additional adapted cognitive behavioural approach (CBA) or personalised exercise programme (PEP) therapies.
Approximately 375 participants will be randomly assigned to either a course of usual care and CBA or PEP or usual care alone. Those in the CBA and PEP groups will receive a course of treatment involving 7 sessions delivered by telephone/ internet-based audio/video call. A booster session will be conducted 22 weeks after the start date of treatment. The interventions will be delivered centrally, by either telephone or Skype. Follow-up data will be collected from all participants at 10 weeks, 26 weeks and 54 weeks after randomisation. The primary outcome measures are fatigue severity and impact. Secondary outcome measures include quality of life, pain, psychological distress and work ability.
The LIFT statistical analysis plan is available for download here
The MAPS Trial
Psychosis is a mental health problem that causes people to perceive or interpret things differently from those around them. Common symptoms of psychosis are unusual beliefs (delusions) and hallucinations (most often, hearing voices). Antipsychotics are the standard medication for these problems and are often helpful but can have serious side effects. There is also evidence that talking therapies (such as cognitive behaviour therapy (CBT) or family intervention) can help reduce symptoms and prevent relapse. The guidelines suggest that treatment options should include the possibility of choice between CBT, antipsychotic medication or both. However, more research is needed to see how well psychological treatment works when used alone, compared with antipsychotic medication and compared with psychological treatment and antipsychotic medication combined. The first stage to better understanding what is most helpful is to conduct a small study to see if young people and their families want to take part in this kind of research and to find out what they think of taking part. This will show whether a larger study should be done and the best way to do it. Managing Adolescent first episode Psychosis: a feasibility Study (MAPS) has been funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme to answer the question of whether it is feasible to conduct a study to examine the effectiveness of psychological therapy, antipsychotic medication or a combination of the two, in adolescents with first episode psychosis. ISRCTN Registry number: ISRCTN80567433.
The MAPS statistical analysis plan is available for download here
The PUrE Trial
PUrE is a research study collecting information on the different ways of treating lower pole kidney stones. PUrE stands for the Percutaneous nephrolithotomy, flexible Ureterorenoscopy and Extracorporeal shockwave lithotripsy for lower pole kidney stone.
The PUrE statistical analysis plan is available for download here
The OPEN Trial
The OPEN trial, funded by the NIHR HTA Programme, was a multicentre randomised trial comparing open urethroplasty with endoscopic urethrotomy in men with recurrent bulbar urethral strictures. The trial aimed to recruit 210 men. The primary outcome was the area under curve (AUC) for serial repeated measurement of International Consultant on Incontinence Modular Questionnaire Male Form (ICIQ-Male SF) questionnaire over 24 months following randomisation.
The OPEN statistical analysis plan can be downloaded here (SAP_V2_signed).. An additional statistical analysis plan was requested by the NIHR HTA Programme during the course of the trial and it is available here (SAPAdditional_v1.1_Signed).
The SHARPS Trial
The SHARPS trial will test whether relationships with Peer Navigators can improve mental health and quality of life of people experiencing homelessness and substance use problems. Peer Navigators will be based in services run by The Salvation Army. We will invite people who are experiencing homelessness and problem substance use from services based in 20 cities and towns in England and Scotland to participate. Peer Navigators will provide practical and emotional support to 25 clients for up to 12 months to help them to make changes in their lives. The co-primary outcomes measured at 12-months are the mental health measure PHQ-ADS and quality of life ICECAP-A.
The SHARPS statistical analysis plan is available to download here.