The CIRCuiTS study (Implementation of cognitive remediation in early intervention services): protocol for a randomised controlled trial
DiscussionIt has already been established that cognitive remediation improves cognitive function in people with schizophrenia. Successful implementation in mental health services has the potential to change the recovery trajectory of individuals with schizophrenia-spectrum disorders. However, the best mode of implementation, in terms of efficacy, service user and team preference, and cost-effectiveness is still unclear. The CIRCuiTS trial will provide guidance for a large-scale roll-out of CRT to mental health services where cognitive difficulties impact recovery and resilience.Trial registrationISRCTN,ISRCTN14678860, Regi...
Source: Trials - March 15, 2018 Category: Research Source Type: clinical trials

Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial
DiscussionIf FITNET-NHS is found to be feasible and acceptable (internal pilot) and effective and cost-effective (full trial), its provision by the NHS has the potential to deliver substantial health gains for the large number of young people suffering from CFS/ME but unable to access treatment because there is no local specialist service. This trial will provide further evidence evaluating the delivery of online CBT to young people with chronic conditions.Trial registrationISRCTN registry, registration number:ISRCTN18020851. Registered on 4 August 2016. (Source: Trials)
Source: Trials - February 22, 2018 Category: Research Source Type: clinical trials

United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial
DiscussionThe three treatments being compared are the most frequently used in secondary care in the NHS, but there is uncertainty about which one works best and at what cost. UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults.Trial registrationInternational Standard Randomised Controlled Trial Register, ID:ISRCTN48804508. Registered on 25 July 2014. (Source: Trials)
Source: Trials - December 22, 2017 Category: Research Source Type: clinical trials

PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial
DiscussionThe trial will provide a preliminary estimate of potential efficacy of PERFECT-ER versus standard care; assess service delivery variation, inform primary and secondary outcome selection, generate estimates of recruitment and retention rates, data collection difficulties, and completeness of outcome data and provide an indication of potential economic benefits. The process evaluation will enhance knowledge of implementation delivery and receipt.Trial registrationISRCTN,99336264. Registered on 5 September 2016. (Source: Trials)
Source: Trials - December 4, 2017 Category: Research Source Type: clinical trials

Coping with Unusual ExperienceS for 12 –18 year olds (CUES+): a transdiagnostic randomised controlled trial of the effectiveness of cognitive therapy in reducing distress associated with unusual experiences in adolescent mental health services: study protocol for a randomised controlled trial
DiscussionThe CUES+ study will contribute to the currently limited child-specific evidence base for psychological interventions for UEDs occurring in the context of psychosis or any other mental health presentation.Trial registrationInternational Standard Randomised Controlled Trials, ID:ISRCTN21802136. Prospectively registered on 12 January 2015. Protocol V3 31 August 2015 with screening amended. (Source: Trials)
Source: Trials - December 4, 2017 Category: Research Source Type: clinical trials

TIGA-CUB – manualised psychoanalytic child psychotherapy versus treatment as usual for children aged 5–11 years with treatment-resistant conduct disorders and their primary carers: study protocol for a randomised controlled feasibility trial
DiscussionTIGA-CUB will provide important information on the feasibility and potential challenges of undertaking a confirmatory RCT to evaluate the effectiveness and cost-effectiveness  of mPCP.Trial registrationCurrent Controlled Trials, ID:ISRCTN86725795. Registered on 31 May 2016.   (Source: Trials)
Source: Trials - September 15, 2017 Category: Research Source Type: clinical trials

Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study
This study aims to address these problems, using established methodo logy to develop a core outcome set for use in future clinical trials of orthodontic interventions in children and young people.Methods/designThis is a mixed-methods study incorporating four distinct stages. The first stage will include a scoping review of the scientific literature to identify primary and secondary outcome measures that have been used in previous orthodontic clinical trials. The second stage will involve qualitative interviews and focus groups with orthodontic patients aged 10 to 16  years to determine what outcomes are important to them....
Source: Trials - August 4, 2017 Category: Research Source Type: clinical trials

Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Ankylosing Spondylitis, in the Portuguese National Health Service
Conditions:   Crohn's Disease;   Ulcerative Colitis;   Rheumatoid Arthritis;   Psoriatic Arthritis;   Psoriasis and Ankylosing Spondylitis Intervention:   Sponsor:   AbbVie Not yet recruiting - verified July 2017 (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 18, 2017 Category: Research Source Type: clinical trials