scholarly journals A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Vladimir Carli ◽  
Danuta Wasserman ◽  
Gergö Hadlaczky ◽  
Nuhamin Gebrewold Petros ◽  
Sara Carletto ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Physiological Data ◽  
Control Group ◽  
Evidence Based ◽  
Treatment As Usual ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Abstract Background Depressive symptoms are common in individuals suffering from severe somatic conditions. There is a lack of interventions and evidence-based interventions aiming to reduce depressive symptoms in patients with severe somatic conditions. The aim of the NEVERMIND project is to address these issues and provide evidence by testing the NEVERMIND system, designed to reduce and prevent depressive symptoms in comparison to treatment as usual. Methods The NEVERMIND study is a parallel-groups, pragmatic randomised controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The NEVERMIND system comprises a smart shirt and a user interface, in the form of a mobile application. The system is a real-time decision support system, aiming to predict the severity and onset of depressive symptoms by modelling the well-being condition of patients based on physiological data, body movement, and the recurrence of social interactions. The study includes 330 patients who have a diagnosis of myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants are randomised in blocks of ten to either the NEVERMIND intervention or treatment as usual as the control group. Clinical interviews and structured questionnaires are administered at baseline, at 12 weeks, and 24 weeks to assess whether the NEVERMIND system is superior to treatment as usual. The endpoint of primary interest is Beck Depression Inventory II (BDI-II) at 12 weeks defined as (i) the severity of depressive symptoms as measured by the BDI-II. Secondary outcomes include prevention of the onset of depressive symptoms, changes in quality of life, perceived stigma, and self-efficacy. Discussion There is a lack of evidence-based interventions aiming to reduce and prevent depressive symptoms in patients with severe somatic conditions. If the NEVERMIND system is effective, it will provide healthcare systems with a novel and innovative method to attend to depressive symptoms in patients with severe somatic conditions. Trial registration DRKS00013391. Registered 23 November 2017.

Longer-Term Clinical and Economic Benefits of Offering Acupuncture to Patients with Chronic Low Back Pain Assessed as Suitable for Primary Care Management – 3 Month Clinical Outcomes from a Controlled Trial of 241 Patients

2002 ◽  
Vol 20 (2-3) ◽  
pp. 121-137
Author(s):  
H Macpherson ◽  
K Thomas ◽  
J Brazier ◽  
M Fitter ◽  
L Thorpe ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Bodily Pain ◽  
Control Group ◽  
Low Back ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Objectives To undertake a pragmatic randomised controlled trial to test the hypothesis that a population of patients with persistent low back pain, when given access to an acupuncture service, gain more relief from pain than those offered usual management only, for equal or less cost. Methods The study is a pragmatic randomised controlled trial (n=241). Suitable patients are identified by their general practitioners. Patients randomised to the experimental arm are offered the option of referral for up to 10 individualised treatments from one of six qualified acupuncture practitioners. The control group continues to receive usual management from their general practitioner. The primary scale used for measuring change is the Bodily Pain (SF–36) at 3 months and 12 months post randomisation. The main outcome is cost-effectiveness at 12 months. Results A total of 43 general practitioners participated in the trial and 241 patients were randomised. All patients randomised to the option of acupuncture chose to receive treatment. Clinical outcomes at 3 months show that the SF-36 Bodily Pain scores improved by 29.4 and 24.9 points in the acupuncture and normal management group respectively (p=0.125). Patients in the acupuncture group reported lower levels of worry at three months (p<0.001). Conclusions It is possible to conduct a large pragmatic randomised controlled trial of acupuncture in a primary care setting. Acupuncture is seen as an acceptable treatment by patients with low back pain. Clinical outcomes at three months suggest that the acupuncture group are in less pain than the control group.

scholarly journals Postcards from the EDge: 5-year outcomes of a randomised controlled trial for hospital-treated self-poisoning

2013 ◽  
Vol 202 (5) ◽  
pp. 372-380 ◽  
Author(s):  
Gregory L. Carter ◽  
Kerrie Clover ◽  
Ian M. Whyte ◽  
Andrew H. Dawson ◽  
Catherine D'Este
Keyword(s):  
Randomised Controlled Trial ◽  
Psychiatric Hospital ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Treatment As Usual ◽  
Psychiatric Admissions ◽  
Bed Days ◽  
Randomised Controlled ◽  
Event Rates

BackgroundRepetition of hospital-treated self-poisoning and admission to psychiatric hospital are both common in individuals who self-poison.AimsTo evaluate efficacy of postcard intervention after 5 years.MethodA randomised controlled trial of individuals who have self-poisoned: postcard intervention (eight in 12 months) plus treatment as usualv.treatment as usual. Our primary outcomes were self-poisoning admissions and psychiatric admissions (proportions and event rates).ResultsThere was no difference between groups for any repeat-episode self-poisoning admission (intervention group: 24.9%, 95% CI 20.6-29.5; control group: 27.2%, 95% CI 22.8-31.8) but there was a significant reduction in event rates (incidence risk ratio (IRR)=0.54, 95% CI 0.37-0.81), saving 306 bed days. There was no difference for any psychiatric admission (intervention group: 38.1%, 95% CI 33.1-43.2; control group: 35.5%, 95% CI 30.8-40.5) but there was a significant reduction in event rates (IRR=0.66, 95% CI 0.47-0.91), saving 2565 bed days.ConclusionsA postcard intervention halved self-poisoning events and reduced psychiatric admissions by a third after 5 years. Substantial savings occurred in general hospital and psychiatric hospital bed days.

scholarly journals Community-based doula support for migrant women during labour and birth: study protocol for a randomised controlled trial in Stockholm, Sweden (NCT03461640)

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e031290
Author(s):  
Erica Schytt ◽  
Anna Wahlberg ◽  
Amani Eltayb ◽  
Rhonda Small ◽  
Nataliia Tsekhmestruk ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Well Being ◽  
Ethical Review ◽  
Control Group ◽  
Migrant Women ◽  
Intrapartum Care ◽  
Community Based ◽  
Randomised Controlled

IntroductionMigrant women consistently rate their care during labour and birth more negatively than non-migrant women, due to communication difficulties, lack of familiarity with how care is provided, and discrimination and prejudicial staff attitudes. They also report being left alone, feeling fearful, unsafe and unsupported, and have poorer birth outcomes than non-migrant women. Community-based doulas (CBDs) are bilingual women from migrant communities who are trained in childbirth and labour support, and who facilitate communication between woman-partner-staff during childbirth. This study protocol describes the design, rationale and methods of a randomised controlled trial that aims to evaluate the effectiveness of CBD support for improving the intrapartum care experiences and postnatal well-being of migrant women giving birth in Sweden.Methods and analysisA randomised controlled trial. From six antenatal care clinics in Stockholm, Sweden, we aim to recruit 200 pregnant Somali, Arabic, Polish, Russian and Tigrinya-speaking women who cannot communicate fluently in Swedish, are 18 years or older and with no contraindications for vaginal birth. In addition to standard labour support, women are randomised to CBD support (n=100) or no such support during labour (n=100). Trained CBDs meet with women once or twice before the birth, provide emotional, physical and communication support to women throughout labour and birth in hospital, and then meet with women once or twice after the birth. Women’s ratings of the intrapartum care experiences and postnatal well-being are assessed at 6–8 weeks after the birth using selected questions from the Migrant Friendly Maternity Care Questionnaire and by the Edinburgh Postnatal Depression Scale. The intervention group will be compared with the control group using intention-to-treat analyses. ORs and 95% CIs will be estimated and adjustments made if key participant characteristics differ between trial arms.Ethics and disseminationThe study was approved by the Regional Ethical Review Board in Stockholm (approval number: 2018/12 - 31/2).Trial registration numberNCT03461640; Pre-results.

scholarly journals Virtual reality for relatives of ICU patients to improve psychological sequelae: study protocol for a multicentre, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e049704
Author(s):  
Johan H Vlake ◽  
Jasper van Bommel ◽  
Evert-Jan Wils ◽  
Tim Korevaar ◽  
Merel E Hellemons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Virtual Reality ◽  
Intensive Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Icu Patients ◽  
Randomised Controlled

IntroductionIntensive care unit (ICU) admission of a relative might lead to psychological distress and complicated grief (post-intensive care syndrome–family; PICS-F). Evidence suggests that increased distress during ICU stay increases risk of PICS-F, resulting in difficulty returning to their normal lives after the ICU experience. Effective interventions to improve PICS-F are currently lacking. In the present trial, we hypothesised that information provision using ICU-specific Virtual Reality for Family members/relatives (ICU-VR-F) may improve understanding of the ICU and subsequently improve psychological well-being and quality of life in relatives of patients admitted to the ICU.Methods and analysisThis multicentre, clustered randomised controlled trial will be conducted from January to December 2021 in the mixed medical-surgical ICUs of four hospitals in Rotterdam, the Netherlands. We aim to include adult relatives of 160 ICU patients with an expected ICU length of stay over 72 hours. Participants will be randomised clustered per patient in a 1:1 ratio to either the intervention or control group. Participants allocated to the intervention group will receive ICU-VR-F, an information video that can be watched in VR, while the control group will receive usual care. Initiation of ICU-VR-F will be during their hospital visit unless participants cannot visit the hospital due to COVID-19 regulations, then VR can be watched digitally at home. The primary objective is to study the effect of ICU-VR-F on psychological well-being and quality of life up to 6 months after the patients’ ICU discharge. The secondary outcome is the degree of understanding of ICU treatment and ICU modalities.Ethics and disseminationThe Medical Ethics Committee of the Erasmus Medical Centre, Rotterdam, the Netherlands, approved the study and local approval was obtained from each participating centre (NL73670.078.20). Our findings will be disseminated by presentation of the results at (inter)national conferences and publication in scientific, peer-reviewed journals.Trial registration numberNetherlands Trial Register (TrialRegister.nl, NL9220).

scholarly journals Acupuncture for cancer pain: protocol for a pilot pragmatic randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e025564
Author(s):  
Yihan He ◽  
Brian H May ◽  
Anthony Lin Zhang ◽  
Xinfeng Guo ◽  
Yihong Liu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cancer Pain ◽  
Clinical Guidelines ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Control Group ◽  
Clinical Effects ◽  
Phone Calls ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

IntroductionAlthough acupuncture has been recommended for alleviating cancer pain by clinical guidelines, the level of the supporting evidence needs to be improved. A pragmatic randomised controlled trial (pRCT) in a hospital setting would provide real-world assessments of the overall clinical effects of acupuncture. This pilot trial aims to explore the feasibility and provide data for sample size calculations for a pRCT evaluating the effectiveness of acupuncture as an adjunctive therapy to routine medical care for cancer pain.Methods and analysisThirty patients with cancer admitted to the oncology department with moderate or severe pain will be recruited. Participants will be randomised at a ratio of 1:1 to the adjunctive acupuncture group or a control group which receives routine pain management without acupuncture. The standardised section of the acupuncture protocol will be developed based on the results of reviews of the literature, recommendations in clinical guidelines and interviews with clinical experts. The acupuncturist will be allowed to tailor the protocol according to the individual situation of each participant. Primary outcomes relevant to the feasibility of conducting a fully powered trial include: numbers and proportions of participants recruited, screened, consented and randomised; numbers and reasons for withdrawals and dropouts; numbers and types of adverse events; feasibility of implementing the trial procedures; evaluation of the comprehensiveness and ease-of-use of the case report form. Secondary outcomes are clinical measurements of the effectiveness of the treatment that are intended for use in the full-scale trial. Analysis of feasibility will be descriptive and pain intensity measures will be analysed using mixed-effects regression.Ethics and disseminationEthics approval was obtained from the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no: Z2017-184-01) and RMIT University Human Research Ethics Committee (reference no: 21361). Results will be disseminated in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration numberChiCTR1800017023

Acute and one-year outcome of a randomised controlled trial of brief cognitive therapy for major depressive disorder in primary care

1997 ◽  
Vol 171 (2) ◽  
pp. 131-134 ◽  
Author(s):  
Christine Scott ◽  
Mary Jane Tacchi ◽  
Roger Jones ◽  
Jan Scott
Keyword(s):  
Primary Care ◽  
Major Depressive Disorder ◽  
Randomised Controlled Trial ◽  
Depressive Disorder ◽  
Cognitive Therapy ◽  
Controlled Trial ◽  
Control Group ◽  
Major Depressive ◽  
Treatment As Usual ◽  
Randomised Controlled

BackgroundThe consensus statement on the treatment of depression (Paykel & Priest, 1992) advocates the use of cognitive therapy techniques as an adjunct to medication.MethodThis paper describes a randomised controlled trial of brief cognitive therapy (BCT) plus ‘treatment as usual’ versus treatment as usual in the management of 48 patients with major depressive disorder presenting in primary care.ResultsAt the end of the acute phase, significantly more subjects (P < 0.05) met recovery criteria in the intervention group (n=15) compared with the control group (n=8). When initial neuroticism scores were controlled for, reductions in Beck Depression Inventory and Hamilton Rating Scale for Depression scores favoured the BCT group throughout the 12 months of follow-up.ConclusionsBCT may be beneficial, but given the time constraints, therapists need to be more rather than less skilled in cognitive therapy. This, plus methodological limitations, leads us to advise caution before applying this approach more widely in primary care.

scholarly journals Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e022514 ◽  
Author(s):  
Stanley Kam Chung Chan ◽  
Dexing Zhang ◽  
Susan M Bögels ◽  
Christian Shaunlyn Chan ◽  
Kelly Yee Ching Lai ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Parenting Styles ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Brain Regions ◽  
Control Group ◽  
Children With Adhd ◽  
Informed Consent Form ◽  
Randomised Controlled

IntroductionMindfulness is one of the potential alternative interventions for children with attention-deficit hyperactivity disorder (ADHD). Some evidence suggests that mindfulness is related to changes in brain regions associated with ADHD. The potential benefits of mindfulness on children with ADHD, as well as the feasibility of this intervention approach, are warranted through prior local and foreign studies. This study aims to evaluate the effect of mindfulness-based group intervention for children with ADHD and their respective parents through a robust research design.Methods and analysisThis study will adopt a randomised controlled trial design including 140 children aged 8–12 years with ADHD together with one of their parents (n=140). These families will be randomised into intervention group (n=70) who will be offered the MYmind programme delivered by trained healthcare professionals, and an active control group (n=70) who will be offered the CBT programme. The intervention includes 8 weekly 90 min group sessions for children with ADHD (aged 8–12 years) and their respective parents. The primary and secondary outcomes will include children’s attention, ADHD-related symptoms, behaviours, executive function and mindfulness levels measured by validated objective measures and parent’s reported instruments. Parents’ parental stress, parenting styles, ADHD related symptoms, well-being, rumination level and mindfulness levels will also be measured. Analysis is by intention to treat. The effects of intervention will be evaluated by comparing outcomes between the two arms, as well as comparing outcomes within subject through comparing measurements at baseline (T0), immediately after the 8 week intervention (T1) and at 3 (T2) and 6 (T3) months postintervention.Ethics and disseminationEthics approval has been granted by the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC). Participants will be required to sign informed consent form from both parents and children. Findings will be reported in conferences and peer-reviewed publications in accordance with recommendations of Consolidated Standards of Reporting Trials.Trial registration numberChiCTR1800014741; Pre-results.

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