scholarly journals The HARMONIC trial: Study protocol for a randomised controlled feasibility trial of Shaping Healthy Minds – a modular transdiagnostic intervention for mood, stress and anxiety disorders in adults

2018 ◽  
Author(s):  
Melissa Black ◽  
Caitlin Hitchcock ◽  
Anna Bevan ◽  
Cliodhna O Leary ◽  
James Clarke ◽  
...  
Keyword(s):  
National Health Service ◽  
Randomised Controlled Trial ◽  
Health Service ◽  
National Health ◽  
Controlled Trial ◽  
Self Report ◽  
Feasibility Trial ◽  
Randomised Controlled ◽  
Later Phase ◽  
Phase Trial

Introduction: Anxiety, mood and trauma-related disorders are common, affecting up to 20% of adults. Many of these individuals will experience symptoms of more than one disorder as diagnostically defined. However, most psychological treatments focus on individual disorders and are less effective for those who experience comorbid disorders. The HARMONIC trial introduces a novel transdiagnostic intervention (Shaping Healthy Minds), which synthesises several evidence-based treatment techniques to address the gap in effective interventions for people with complex and comorbid difficulties. This early-phase trial aims to estimate the efficacy and feasibility of the transdiagnostic intervention in preparation for a later-phase randomised controlled trial, and to explore mechanisms of change.Methods/Analysis: We outline a patient-level two-arm randomised controlled trial (HARMONIC) that compares Shaping Healthy Minds to treatment-as-usual (TAU) for individuals aged >18 years (N=50) with co-morbid mood, anxiety, obsessive-compulsive or trauma/stressor disorder diagnoses, recruited from outpatient psychological services within the UK National Health Service. The co-primary outcomes will be 3-month follow-up scores on self-report measures of depressive symptoms, anxiety symptoms, and disability and functional impairment. Secondary outcomes include changes in symptoms linked to individual disorders. We will assess the feasibility and acceptability of Shaping Healthy Minds, the utility of proposed outcome measures, and refine the treatment manuals in preparation for a later-phase trial. Ethics and dissemination: This trial protocol has been approved by the Health Research Authority of the National Health Service of the United Kingdom (East of England, Reference: 16/EE/0095). We anticipate that trial findings will inform future revisions of clinical guidelines for numerous forms of mood, anxiety, and stressor-related disorders. Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations, clinical workshops, and a trial website.

scholarly journals The HARMONIC trial: study protocol for a randomised controlled feasibility trial of Shaping Healthy Minds—a modular transdiagnostic intervention for mood, stressor-related and anxiety disorders in adults

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e024546 ◽  
Author(s):  
Melissa Black ◽  
Caitlin Hitchcock ◽  
Anna Bevan ◽  
Cliodhna O Leary ◽  
James Clarke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Building Blocks ◽  
Self Report ◽  
Mental Wellbeing ◽  
Feasibility Trial ◽  
Randomised Controlled ◽  
The Uk ◽  
Later Phase ◽  
Phase Trial

IntroductionAnxiety, mood and trauma-related disorders are common, affecting up to 20% of adults. Many of these individuals will experience symptoms of more than one disorder as diagnostically defined. However, most psychological treatments focus on individual disorders and are less effective for those who experience comorbid disorders. The Healthy and Resilient Mind Programme: Building Blocks for Mental Wellbeing (HARMONIC) trial introduces a novel transdiagnostic intervention (Shaping Healthy Minds (SHM)), which synthesises several evidence-based treatment techniques to address the gap in effective interventions for people with complex and comorbid difficulties. This early phase trial aims to estimate the efficacy and feasibility of the transdiagnostic intervention in preparation for a later-phase randomised controlled trial, and to explore mechanisms of change.Methods/analysisWe outline a patient-level two-arm randomised controlled trial (HARMONIC) that comparesSHMto treatment-as-usual for individuals aged >18 years (n=50) with comorbid mood, anxiety, obsessive-compulsive or trauma/stressor disorders diagnoses, recruited from outpatient psychological services within the UK National Health Service (NHS). The co-primary outcomes will be 3-month follow-up scores on self-report measures of depressive symptoms, anxiety symptoms, and disability and functional impairment. Secondary outcomes include changes in symptoms linked to individual disorders. We will assess the feasibility and acceptability ofSHM, the utility of proposed outcome measures, and refine the treatment manuals in preparation for a later-phase trial.Ethics and disseminationThis trial protocol has been approved by the Health Research Authority of the NHS of the UK (East of England, Reference: 16/EE/0095). We anticipate that trial findings will inform future revisions of clinical guidelines for numerous forms of mood, anxiety and stressor-related disorders. Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations, clinical workshops and a trial website.Trial registrationNCT03143634; Pre-results.

scholarly journals Slip-resistant footwear reduces slips among National Health Service workers in England: a randomised controlled trial

2021 ◽  
pp. oemed-2020-106914 ◽  
Author(s):  
Sarah Cockayne ◽  
Caroline Fairhurst ◽  
Gillian Frost ◽  
Mark Liddle ◽  
Rachel Cunningham-Burley ◽  
...  
Keyword(s):  
National Health Service ◽  
Randomised Controlled Trial ◽  
Health Service ◽  
Incidence Rate ◽  
National Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomised Controlled

ObjectivesAssess the effectiveness of 5* GRIP-rated slip-resistant footwear in preventing slips in the workplace compared to usual footwear (control group).MethodsA multicentre, randomised controlled trial; 4553 National Health Service (NHS) staff were randomised 1:1 to the intervention group (provided with 5* GRIP-rated slip-resistant footwear) or the control group. The primary outcome of incidence rate of self-reported slips in the workplace over 14 weeks was analysed using a mixed-effects negative binomial model. Secondary outcome measures included incidence rate of falls from a slip, falls not from a slip, proportion of participants reporting a slip, fall or fracture and time to first slip and fall.Results6743 slips were reported: 2633 in the intervention group (mean 1.16 per participant, range 0 to 36) and 4110 in the control group (mean 1.80 per participant, range 0 to 83). There was a statistically significant reduction in slip rate in the intervention group relative to the control group (incidence rate ratio (IRR) 0.63, 95% CI 0.57 to 0.70, p<0.001). Statistically significant differences, in favour of the intervention group, were observed in falls from a slip (IRR 0.51, 95% CI 0.28 to 0.92, p=0.03), the proportion of participants who reported a slip (OR 0.58, 95% CI 0.50 to 0.66, p<0.001) or fall (OR 0.73, 95% CI 0.54 to 0.99, p=0.04) and time to first slip (HR 0.73, 95% CI 0.67 to 0.80, p<0.001).ConclusionsThe offer and provision of 5* GRIP-rated footwear reduced slips in NHS staff in the workplace.Trial registration numberISRCTN33051393.

scholarly journals Personalised Hip Therapy: development of a non-operative protocol to treat femoroacetabular impingement syndrome in the FASHIoN randomised controlled trial

2016 ◽  
Vol 50 (19) ◽  
pp. 1217-1223 ◽  
Author(s):  
Peter DH Wall ◽  
Edward J Dickenson ◽  
David Robinson ◽  
Ivor Hughes ◽  
Alba Realpe ◽  
...  
Keyword(s):  
National Health Service ◽  
Randomised Controlled Trial ◽  
Health Service ◽  
Controlled Trial ◽  
Arthroscopic Surgery ◽  
Operative Care ◽  
Pilot Rct ◽  
Randomised Controlled ◽  
The Uk ◽  
Fai Syndrome

IntroductionFemoroacetabular impingement (FAI) syndrome is increasingly recognised as a cause of hip pain. As part of the design of a randomised controlled trial (RCT) of arthroscopic surgery for FAI syndrome, we developed a protocol for non-operative care and evaluated its feasibility.MethodsIn phase one, we developed a protocol for non-operative care for FAI in the UK National Health Service (NHS), through a process of systematic review and consensus gathering. In phase two, the protocol was tested in an internal pilot RCT for protocol adherence and adverse events.ResultsThe final protocol, called Personalised Hip Therapy (PHT), consists of four core components led by physiotherapists: detailed patient assessment, education and advice, help with pain relief and an exercise-based programme that is individualised, supervised and progressed over time. PHT is delivered over 12–26 weeks in 6–10 physiotherapist-patient contacts, supplemented by a home exercise programme. In the pilot RCT, 42 patients were recruited and 21 randomised to PHT. Review of treatment case report forms, completed by physiotherapists, showed that 13 patients (62%) received treatment that had closely followed the PHT protocol. 13 patients reported some muscle soreness at 6 weeks, but there were no serious adverse events.ConclusionPHT provides a structure for the non-operative care of FAI and offers guidance to clinicians and researchers in an evolving area with limited evidence. PHT was deliverable within the National Health Service, is safe, and now forms the comparator to arthroscopic surgery in the UK FASHIoN trial (ISRCTN64081839).Trial registration numberISRCTN 09754699.

scholarly journals Exercise and education for community-dwelling older participants with knee osteoarthritis: a video-linked programme protocol based on a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lin Wang ◽  
Suhang Xie ◽  
Tianjie Bao ◽  
Siyi Zhu ◽  
Qiu Liang ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
Rating Scale ◽  
Controlled Trial ◽  
Pressure Pain Threshold ◽  
Estimating Equation ◽  
Community Dwelling ◽  
Self Report ◽  
Exercise Programmes ◽  
Randomised Controlled

Abstract Background Neuromuscular and quadriceps exercises have been shown to be effective approaches to relieve pain and to improve function for patients with knee osteoarthritis. In this study, we aim to provide an informative feasible model in which therapeutic exercise and education will be undertaken with physiotherapy supervision and instruction via video link. We also aim to explore the relationship between program-induced pain alleviation/functional improvements and reduction in irritability, which might be mediated through program-induced psychosocial benefits. Methods In this proposed two-parallel group (neuromuscular exercise versus quadriceps exercise), single-blinded, randomised controlled trial, participants aged ≥50 years with osteoarthritic knee pain will undergo a 12-week intervention, comprising video-linked education, supervised exercises, and a 12-week follow-up. Seven measurements will be taken to collect longitudinal data. A generalised estimating equation will be used to establish the adjusted difference in effectiveness on pain, function, irritability, and psychosocial outcomes between participants undertaking neuromuscular exercises and those undertaking quadriceps exercises. The primary outcomes are overall average pain in the knee joint during walking, as assessed through the 11-point Numerical Pain Rating Scale, and the Western Ontario and McMaster Universities osteoarthritis index physical function subscale. Furthermore, pressure pain threshold and changes in self-report pain scores pre-, during, and post-exercise were also measured as an indication of irritability. In addition, both the 6-min walk test and a timed up & go test were used to assess walking function performance. Finally, patients’ emotions (e.g., fear and catastrophising), self-trust, needs in terms of disease knowledge, mental resilience, social support and health-related quality of life were investigated. Two four-wave cross-lagged models will be used to investigate directional relationships, aiming to investigate the complex mechanisms concerning the effects of exercise programmes. Discussion Through summarising the study’s strengths and limitations, this study may provide promising insights in terms of exercise therapy optimisation for people with knee osteoarthritis and/or other chronic pain within a psychosocial framework. Trial registration ChiCTR2100041978 (chictr.org.cn), January 10, 2021.

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