scholarly journals Evaluating a Values-Based Intervention for Adolescence with High Nonclinical Paranoia: A Schools-Based Randomised Control Trial

2021 ◽  
Author(s):  
A. Parker ◽  
J. Kingston
Keyword(s):  
Active Control ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Self Esteem ◽  
Randomised Control Trial ◽  
Intention To Treat ◽  
Low Intensity ◽  
Time Interaction ◽  
Potential Mediator

Abstract Background Paranoia in adolescents is common, but research on attenuating it is scarce. Focusing on values and enhancing value-based acts is a low intensity method for attenuating paranoia in adults. This randomised trial compared a brief (30-min, self-directed) values-plus-goals intervention to an active control for adolescents with high nonclinical paranoia (Paranoia Scale ≥ 53), delivered in schools. The study also investigated the role of self-esteem. Methods Ninety adolescents were randomly assigned to condition. Paranoia (primary outcome) and self-esteem (potential mediator) were assessed at baseline (T1), and two- (T2) and six-weeks (T3) after baseline. Results Results were analysed using intention to treat (ITT) and per protocol (PP) analysis. Using ITT analysis, the Condition*Time interaction was significant (F(2, 168) = 3.98, p = .02), paranoia was significantly lower at T3 following values-plus-goals as compared to control (d = 0.64). Differences were not significant using per protocol analysis (F(2, 106) = 1.61, p = .21). The between group effect size at T3 was (d = 0.61). The Condition*Time interaction for self-esteem was not significant (F(2, 112) = 2.86, p = .06). Conclusions Tentatively, findings suggest that a brief values-plus-goals intervention can reduce paranoia in adolescents relative to an active control.

scholarly journals A partially randomised trial of pretomanid, moxifloxacin and pyrazinamide for pulmonary TB

2021 ◽  
Vol 25 (4) ◽  
pp. 305-314
Author(s):  
C. D. Tweed ◽  
G. H. Wills ◽  
A. M. Crook ◽  
E. Amukoye ◽  
V. Balanag ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Randomised Trial ◽  
Group Differences ◽  
Pulmonary Tb ◽  
Intention To Treat ◽  
Tb Treatment ◽  
Grade 3 ◽  
To Receive ◽  
Ongoing Evaluation ◽  
Post Randomisation

BACKGROUND: Treatment for TB is lengthy and toxic, and new regimens are needed.METHODS: Participants with pulmonary drug-susceptible TB (DS-TB) were randomised to receive: 200 mg pretomanid (Pa, PMD) daily, 400 mg moxifloxacin (M) and 1500 mg pyrazinamide (Z) for 6 months (6Pa200MZ) or 4 months (4Pa200MZ); 100 mg pretomanid daily for 4 months in the same combination (4Pa100MZ); or standard DS-TB treatment for 6 months. The primary outcome was treatment failure or relapse at 12 months post-randomisation. The non-inferiority margin for between-group differences was 12.0%. Recruitment was paused following three deaths and not resumed.RESULTS: Respectively 4/47 (8.5%), 11/57 (19.3%), 14/52 (26.9%) and 1/53 (1.9%) DS-TB outcomes were unfavourable in patients on 6Pa200MZ, 4Pa200MZ, 4Pa100MZ and controls. There was a 6.6% (95% CI –2.2% to 15.4%) difference per protocol and 9.9% (95%CI –4.1% to 23.9%) modified intention-to-treat difference in unfavourable responses between the control and 6Pa200MZ arms. Grade 3+ adverse events affected 68/203 (33.5%) receiving experimental regimens, and 19/68 (27.9%) on control. Ten of 203 (4.9%) participants on experimental arms and 2/68 (2.9%) controls died.CONCLUSION: PaMZ regimens did not achieve non-inferiority in this under-powered trial. An ongoing evaluation of PMD remains a priority.

scholarly journals PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e023562 ◽  
Author(s):  
Deirdre Hayes-Ryan ◽  
Karla Hemming ◽  
Fionnaula Breathnach ◽  
Amanda Cotter ◽  
Declan Devane ◽  
...  
Keyword(s):  
Growth Factor ◽  
Maternal Morbidity ◽  
Primary Outcome ◽  
Mode Of Delivery ◽  
Randomised Trial ◽  
Placental Growth Factor ◽  
Randomised Control Trial ◽  
Stepped Wedge ◽  
Cluster Randomised ◽  
Maternity Hospitals

IntroductionWomen presenting with suspected pre-eclampsia are currently triaged on the basis of hypertension and dipstick proteinuria. This may result in significant false positive and negative diagnoses resulting in increased morbidity or unnecessary intervention. Recent data suggest that placental growth factor testing may be a useful adjunct in the management of women presenting with preterm pre-eclampsia. The primary objective of this trial is to determine if the addition of placental growth factor testing to the current clinical assessment of women with suspected preterm pre-eclampsia, is beneficial for both mothers and babies.Methods and analysisThis is a multicentre, stepped wedge cluster, randomised trial aiming to recruit 4000 women presenting with symptoms suggestive of preterm pre-eclampsia between 20 and 36+6 weeks’ gestation. The intervention of an unblinded point of care test, performed at enrolment, will quantify maternal levels of circulating plasma placental growth factor. The intervention will be rolled out sequentially, based on randomisation, in the seven largest maternity units on the island of Ireland. Primary outcome is a composite outcome of maternal morbidity (derived from the modified fullPIERS model). To ensure we are not reducing maternal morbidity at the expense of earlier delivery and worse neonatal outcomes, we have established a co-primary outcome which will examine the effect of the intervention on neonatal morbidity, assessed using a composite neonatal score. Secondary analyses will examine further clinical outcomes (such as mode of delivery, antenatal detection of growth restriction and use of antihypertensive agents) as well as a health economic analysis, of incorporation of placental growth factor testing into routine care.Ethics and disseminationEthical approval has been granted from each of the seven maternity hospitals involved in the trial. The results of the trial will be presented both nationally and internationally at conference and published in an international peer-reviewed journal.Trial registration numberNCT02881073.

scholarly journals Optimising outcomes of exercise and corticosteroid injection in patients with subacromial pain (impingement) syndrome: a factorial randomised trial

2020 ◽  
pp. bjsports-2019-101268
Author(s):  
Edward Roddy ◽  
Reuben O Ogollah ◽  
Raymond Oppong ◽  
Irena Zwierska ◽  
Praveen Datta ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Corticosteroid Injection ◽  
Randomised Trial ◽  
Clinical Effectiveness ◽  
Impingement Syndrome ◽  
Ultrasound Guided ◽  
Exercise Interventions ◽  
Intention To Treat ◽  
Registration Number ◽  
And Function

ObjectivesTo compare the clinical effectiveness of (1) physiotherapist-led exercise versus an exercise leaflet, and (2) ultrasound-guided subacromial corticosteroid injection versus unguided injection for pain and function in subacromial pain (formerly impingement) syndrome (SAPS).MethodsThis was a single-blind 2×2 factorial randomised trial. Adults with SAPS were randomised equally to one of four treatment groups: (1) ultrasound-guided corticosteroid injection and physiotherapist-led exercise, (2) ultrasound-guided corticosteroid injection and an exercise leaflet, (3) unguided corticosteroid injection and physiotherapist-led exercise and (4) unguided corticosteroid injection and an exercise leaflet. The primary outcome was the Shoulder Pain and Disability Index (SPADI), collected at 6 weeks, 6 and 12 months and compared at 6 weeks for the injection interventions and 6 months for the exercise interventions by intention to treat.ResultsWe recruited 256 participants (64 treatment per group). Response rates for the primary outcome were 94% at 6 weeks, 88% at 6 months and 80% at 12 months. Greater improvement in total SPADI score was seen with physiotherapist-led exercise than with the exercise leaflet at 6 months (adjusted mean difference −8.23; 95% CI −14.14 to -2.32). There were no significant differences between the injection groups at 6 weeks (−2.04; −7.29 to 3.22), 6 months (−2.36; −8.16 to 3.44) or 12 months (1.59; −5.54 to 8.72).ConclusionsIn patients with SAPS, physiotherapist-led exercise leads to greater improvements in pain and function than an exercise leaflet. Ultrasound guidance confers no additional benefit over unguided corticosteroid injection.Trial registration numberISRCTN42399123.

scholarly journals Cast versus functional brace in the rehabilitation of patients treated for an ankle fracture: protocol for the UK study of ankle injury rehabilitation (AIR) multicentre randomised trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e027242 ◽  
Author(s):  
Rebecca Samantha Kearney ◽  
Rebecca McKeown ◽  
Siobhan Stevens ◽  
Nicholas Parsons ◽  
Helen Parsons ◽  
...  
Keyword(s):  
Ankle Fracture ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Operative Management ◽  
Plaster Cast ◽  
Reference Case ◽  
Intention To Treat ◽  
Functional Brace ◽  
Registration Number ◽  
The Uk

IntroductionEach year in the UK over 120 000 people fracture their ankle. It is not known what the best rehabilitation strategy is for these people. Traditionally standard care has involved immobilisation in a plaster cast but an alternative is a functional brace, which can be removed to allow early movement. This paper details the protocol for a multicentre randomised trial of plaster cast immobilisation versus functional bracing for patients with an ankle fracture.Methods and analysisWe will recruit adults with a fractured ankle, for which the treating clinician would consider plaster cast to be a reasonable management option. Randomisation will be on a 1:1 basis, stratified by centre, operative or non-operative management and age. Participants will be allocated to either plaster cast or a functional brace, both treatments are widely used. To have 90% power to detect a difference of 10 points on the primary outcome (Olerud and Molander Ankle Score) at the primary outcome time point (16 weeks), we need to randomise a minimum of 478 people. Quality of life and resource use will be collected at 6, 10, 16, 24 weeks and 12, 18, 24 months. The differences between treatment groups will be assessed on an intention-to-treat basis. The economic evaluation will adhere to the recommendations of the National Institute for Health and Care Excellence reference case.Ethics, registration and disseminationNational Research Ethic Committee approved this study on 4 July 2017 (17/WM/0239). The first site opened to recruitment 9 October 2017. The results of this trial will be submitted to a peer-reviewed journal and will inform clinical practice.Trial registration numberISRCTN15537280; Pre-results.

Social and Temporal Comparisons as Moderators of Psychological Resources Associations With Wellbeing

2016 ◽  
Vol 37 (2) ◽  
pp. 96-104 ◽  
Author(s):  
Hasida Ben-Zur
Keyword(s):  
Life Satisfaction ◽  
Positive Affect ◽  
Subjective Wellbeing ◽  
Social Comparisons ◽  
Self Esteem ◽  
Psychological Resources ◽  
Low Levels ◽  
Age Range ◽  
General Wellbeing

Abstract. The current study investigated the associations of psychological resources, social comparisons, and temporal comparisons with general wellbeing. The sample included 142 community participants (47.9% men; age range 23–83 years), who compared themselves with others, and with their younger selves, on eight dimensions (e.g., physical health, resilience). They also completed questionnaires assessing psychological resources of mastery and self-esteem, and three components of subjective wellbeing: life satisfaction and negative and positive affect. The main results showed that high levels of psychological resources contributed to wellbeing, with self-enhancing social and temporal comparisons moderating the effects of resources on certain wellbeing components. Specifically, under low levels of mastery or self-esteem self-enhancing social or temporal comparisons were related to either higher life satisfaction or positive affect. The results highlight the role of resources and comparisons in promoting people’s wellbeing, and suggest that self-enhancing comparisons function as cognitive coping mechanisms when psychological resources are low.

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