scholarly journals Reducing arthritis fatigue impact: two-year randomised controlled trial of cognitive behavioural approaches by rheumatology teams (RAFT)

2019 ◽  
Vol 78 (4) ◽  
pp. 465-472 ◽  
Author(s):  
Sarah Hewlett ◽  
Celia Almeida ◽  
Nicholas Ambler ◽  
Peter S Blair ◽  
Ernest H Choy ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Cognitive Behavioural ◽  
Numerical Rating ◽  
Randomised Controlled ◽  
Group Programme

ObjectivesTo see if a group course delivered by rheumatology teams using cognitive-behavioural approaches, plus usual care, reduced RA fatigue impact more than usual care alone.MethodsMulticentre, 2-year randomised controlled trial in RA adults (fatigue severity>6/10, no recent major medication changes). RAFT (Reducing Arthritis Fatigue: clinical Teams using CB approaches) comprises seven sessions, codelivered by pairs of trained rheumatology occupational therapists/nurses. Usual care was Arthritis Research UK fatigue booklet. Primary 26-week outcome fatigue impact (Bristol RA Fatigue Effect Numerical Rating Scale, BRAF-NRS 0–10). Intention-to-treat regression analysis adjusted for baseline scores and centre.Results308/333 randomised patients completed 26 week data (156/175 RAFT, 152/158 Control). Mean baseline variables were similar. At 26 weeks, the adjusted difference between arms for fatigue impact change favoured RAFT (BRAF-NRS Effect −0.59, 95% CI –1.11 to -0.06), BRAF Multidimensional Questionnaire (MDQ) Total −3.42 (95% CI –6.44 to -0.39), Living with Fatigue −1.19 (95% CI –2.17 to -0.21), Emotional Fatigue −0.91 (95% CI –1.58 to -0.23); RA Self-Efficacy (RASE, +3.05, 95% CI 0.43 to 5.66) (14 secondary outcomes unchanged). Effects persisted at 2 years: BRAF-NRS Effect −0.49 (95% CI −0.83 to -0.14), BRAF MDQ Total −2.98 (95% CI −5.39 to -0.57), Living with Fatigue −0.93 (95% CI −1.75 to -0.10), Emotional Fatigue −0.90 (95% CI −1.44, to -0.37); BRAF-NRS Coping +0.42 (95% CI 0.08 to 0.77) (relevance of fatigue impact improvement uncertain). RAFT satisfaction: 89% scored > 8/10 vs 54% controls rating usual care booklet (p<0.0001).ConclusionMultiple RA fatigue impacts can be improved for 2 years by rheumatology teams delivering a group programme using cognitive behavioural approaches.Trial registration numberISRCTN52709998.

Long-term effects on income and sickness benefits after work-focused cognitive-behavioural therapy and individual job support: a pragmatic, multicentre, randomised controlled trial

2018 ◽  
Vol 75 (10) ◽  
pp. 703-708 ◽  
Author(s):  
Simon Øverland ◽  
Astrid Louise Grasdal ◽  
Silje Endresen Reme
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioural Therapy ◽  
Work Participation ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundThere is moderate quality evidence that integrating work-directed interventions and components from psychological therapies reduces sickness absence in the medium term. We aimed to extend this evidence by examining objectively ascertained income and work participation status up to 4 years after an intervention to improve outcomes among people who struggle with work from common mental disorder.MethodsThe intervention combined components from cognitive behavioural therapy with principles from supported employment, and compared its efficacy with usual care. Outcomes were derived from registry data with no attrition, in a pragmatic multisite randomised controlled trial (N=1193).ResultsThe intervention group had higher income, higher work participation and more months without receiving benefits over the 10-month to 46-month long-term follow-up period after end of treatment, but differences were not statistically significant. For the group on long-term benefits at inclusion, effect sizes were larger and statistically significant.ConclusionThere were no statistically significant differences between the two groups in the primary outcome in the total population. In a secondary analysis for the subgroup most at risk of permanent work exclusion, long-term outcomes were favourable in the intervention group compared with usual care. The results support integrated work and health services for people on the severe end of work participation challenges.Trial registration numberNCT01146730.

scholarly journals Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Rating Scale ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Mild Dementia ◽  
Link Type ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. Trial registration ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

scholarly journals Intramuscular versus oral diclofenac for acute pain in adults with acute musculoskeletal injuries presenting to the ED setting: a prospective, double-blind, double-dummy, randomised controlled trial

2019 ◽  
pp. emermed-2018-208214
Author(s):  
Isma Qureshi ◽  
Sameer A Pathan ◽  
Raheel Sharfeen Qureshi ◽  
Stephen H Thomas
Keyword(s):  
Randomised Controlled Trial ◽  
Pain Score ◽  
Drug Administration ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Musculoskeletal Injuries ◽  
Number Needed To Treat ◽  
Randomised Controlled

ObjectiveThe current study aimed to ascertain differences in early postmedication pain reduction in participants presenting with acute musculoskeletal injuries (MSI) to the ED receiving intramuscular (IM) versus per oral (PO) diclofenac.MethodsThis was a prospective, double-blinded, randomised controlled trial conducted between January and June 2018 at the ED of Hamad General Hospital in Doha, Qatar. Adults (18–65 years of age) presenting to the ED within 24 hours of an acute MSI, who had a triage pain score measured using numerical rating scale of at least five or above were enrolled in this trial. Participants randomised to either IM (75 mg) with oral placebo, or oral (100 mg) diclofenac group with IM placebo using a computer-generated randomised concealed list in blocks of six and eight. The primary objective was to compare the proportion of IM versus PO participants attaining a 50% reduction in pain score at 30 min from t0.Results300 participants were enrolled (150 in the IM diclofenac group and 150 in the PO diclofenac group) in the trial. The primary outcome was achieved in 99.3 (95% CI 96.3 to 100) in the IM group and 86.7 (95% CI 80.2 to 91.7) in PO group. There was an absolute risk difference of 12.7%. This corresponds to a number needed to treat of 8 cases (95% CI 6 to 14) receiving IM rather than the PO diclofenac in order to achieve one additional case of 50% pain reduction within 30 min of drug administration. There were no adverse events experienced in any treatment groups.ConclusionIM diclofenac injection provides rapid analgesia over PO administration of diclofenac. However, given the preparation needed for an IM injection, oral administration may be preferable when and if clinical circumstances allow a choice in non-steroidal anti-inflammatory drug administration route.

scholarly journals Cost-effectiveness of therapist-delivered online cognitive–behavioural therapy for depression: randomised controlled trial

2010 ◽  
Vol 197 (4) ◽  
pp. 297-304 ◽  
Author(s):  
Sandra Hollinghurst ◽  
Tim J. Peters ◽  
Surinder Kaur ◽  
Nicola Wiles ◽  
Glyn Lewisand ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Qaly Gain ◽  
Cognitive Behavioural ◽  
Life Years ◽  
Randomised Controlled

BackgroundTherapist-delivered online cognitive–behavioural therapy (CBT) has been found to be effective for depression in primary care.AimsTo determine the cost-effectiveness of online CBT compared with usual care.MethodEconomic evaluation at 8 months alongside a randomised controlled trial. Cost to the National Health Service (NHS), personal costs, and the value of lost productivity, each compared with outcomes based on the Beck Depression Inventory and quality-adjusted life-years (QALYs). Incremental analysis indicated the NHS cost per QALY gain.ResultsOnline CBT was more expensive than usual care, although the outcomes for the CBT group were better. Cost per QALY gain based on complete case data was £17 173, and £10 083 when missing data were imputed.ConclusionsOnline CBT delivered by a therapist in real time is likely to be cost-effective compared with usual care if society is willing to pay at least £20 000 per QALY; it could be a useful alternative to face-to-face CBT.

scholarly journals Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e027864
Author(s):  
Chunmei Zhao ◽  
Yitong Jia ◽  
Zipu Jia ◽  
Xiong Xiao ◽  
Fang Luo
Keyword(s):  
Postoperative Pain ◽  
Study Protocol ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Local Anaesthetics ◽  
Intracranial Surgery ◽  
Intention To Treat ◽  
Incisional Pain ◽  
Randomised Controlled

IntroductionPre-emptive scalp infiltration with local anaesthetics is the simplest and most effective method to prevent postoperative incisional pain. However, local infiltration of an anaesthetic only provides relatively short-term pain relief. Methylprednisolone (MP) treatment, administered as an adjuvant at the wound site, has been shown to provide satisfactory pain management after lumbar laminectomy. However, there is no evidence regarding the efficacy of MP infiltration for the relief of postoperative pain after craniotomy. Currently, postoperative pain after craniotomy in children is undertreated. Therefore, we aim to investigate whether pre-emptive scalp infiltration with ropivacaine (RP) plus MP is superior to RP alone to improve postoperative pain after craniotomy in children.Methods and analysisThe RP/MP versus RP trial is a prospective, single-centre, randomised, parallel-group study of 100 children aged 8–18 years undergoing intracranial surgery. Participants will be randomly allocated to receive pre-emptive scalp infiltration with either RP plus MP or RP alone. The primary outcome will be the cumulative fentanyl dose administered by patient-controlled intravenous analgesia within 24 hours postoperatively. The secondary outcomes will include postoperative Numerical Rating Scale scores, pain control satisfaction scores, length of stay and adverse events. Data will be analysed by the intention-to-treat principle.Ethical approval and disseminationThe study protocol has been approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (Approval Number: KY 2018-066-02). The results will be disseminated in international academic meetings and published in peer-reviewed journals.Trial registration numberNCT03636165; Pre-results.

scholarly journals Acupuncture for Cancer Related Pain: Protocol for a Pragmatic Randomised Wait-List Controlled Trial

2020 ◽  
Vol 19 ◽  
pp. 153473542097657
Author(s):  
Qi Zhao ◽  
Suyang Zheng ◽  
Geoff P. Delaney ◽  
Eugene Moylan ◽  
Meera R. Agar ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Post Treatment ◽  
Local Health ◽  
Wait List ◽  
Clinical Trial Registry ◽  
Numerical Rating ◽  
Randomised Controlled

Background: Acupuncture has been proved effective for cancer related pain (CRP) in China, America and some other countries. However, there is relative lack of evidence to support the use of acupuncture for CRP in Australia. Objectives: To assess the effectiveness and safety of acupuncture for management of CRP in a real-world setting and to understand cancer patients’ experience of undergoing acupuncture for CRP. Methods: A pragmatic randomised controlled trial will be conducted in South Western Sydney Local Health District (SWSLHD) in NSW, Australia. Adults with cancer related pain (n = 106) will be randomised in a 1:1 ratio to receive the acupuncture intervention up front versus after a wait list period of 4 weeks. Pain level (by Numerical Rating Scale), analgesic use, auricular acupressure frequency and adverse events will be assessed at baseline, mid-treatment and post-treatment. Expectancy on trial outcome (by Credibility and Expectancy questionnaire) will be assessed at baseline. The perspective of the participants (by an interview) will be recorded after the last intervention. Expected outcomes: We hypothesise that acupuncture will relieve cancer related pain at mid-treatment and post-treatment. We also hypothesise that few adverse events will be provoked by acupuncture. Trial registration: Australia New-Zealand Clinical Trial Registry (ACTRN12620000325909).

London-East Anglia randomised controlled trial of cognitive-behavioural therapy for psychosis

1998 ◽  
Vol 173 (1) ◽  
pp. 61-68 ◽  
Author(s):  
Elizabeth Kuipers ◽  
David Fowler ◽  
Phiuppa Garety ◽  
Daniel Chisholm ◽  
Daniel Freeman ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Control Group ◽  
Service Utilisation ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundA randomised controlled trial of cognitive — behavioural therapy (CBT) for people with medication-resistant psychosis showed improvements in overall symptomatology after nine months of treatment; good outcome was strongly predicted by a measure of cognitive flexibility concerning delusions. The present paper presents a follow-up evaluation 18 months after baseline.MethodForty-seven (78% of original n=60) participants were available for follow-up at 18 months, and were reassessed on all the original outcome measures (see Part I). An economic evaluation was also completed.ResultsThose in the CBT treatment group showed a significant and continuing improvement in Brief Psychiatric Rating Scale scores, whereas the control group did not change from baseline. Delusional distress and the frequency of hallucinations were also significantly reduced in the CBT group. The costs of CB Tappear to have been offset by reductions in service utilisation and associated costs during follow-up.ConclusionsImprovement in overall symptoms was maintained in the CBT group 18 months after baseline and nine months after intensive therapy was completed. CBT may be a specific and cost-effective intervention in medication-resistant psychosis.

scholarly journals Portable light therapy in the treatment of unipolar non-seasonal major depressive disorder: study protocol for the LUMIDEP randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e049331
Author(s):  
Eve Cosker ◽  
Marie Moulard ◽  
Samuel Schmitt ◽  
Karine Angioi-Duprez ◽  
Cédric Baumann ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Randomised Controlled Trial ◽  
Depressive Disorder ◽  
Sleep Quality ◽  
Usual Care ◽  
Rating Scale ◽  
Controlled Trial ◽  
Light Therapy ◽  
Major Depressive ◽  
Randomised Controlled

IntroductionMajor depressive disorder (MDD) affects more than 264 million people worldwide and is associated with an impaired quality of life as well as a higher risk of mortality. Current routine treatments demonstrate limited effectiveness. Light therapy (LT) on its own or in combination with antidepressant treatments could be an effective treatment, but the use of conventional LT devices use is restrictive. Portable LT devices allow patients to continue with their day-to-day activities and therefore encourage better treatment compliance. They have not been evaluated in MDD.Methods and analysisThe study is a single-centre, double-blind, randomised controlled trial assessing the efficacy of LT delivered via a portable device in addition to usual care (medical care and drug treatment) for inpatients and outpatients with unipolar non-seasonal MDD. Over the course of 8 weeks, patients use the device daily for 30 min at medium intensity as soon as possible after waking up and preferably between 07:00 and 09:00. All patients continue their usual care with their referring physician. N=50 patients with MDD are included. The primary outcome measure is depressive symptom severity assessed using the Montgomery-Åsberg Depression Rating Scale between baseline and the eighth week. Secondary outcome measures are sleep quality assessed using the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale and anxiety level assessed on the Hamilton Anxiety Rating Scale, between baseline and week 8. Further parameters relating to cognitive function are measured at baseline and after the intervention. An ancillary study aims to evaluate the impact of MDD on the retina and to follow its progression. Main limitations include risk of discontinuation or non-adherence and bias in patient selection.Ethics and disseminationThe study protocol was approved by Ile de France X’s Ethics Committee (protocol number 34–2018). Findings will be published in peer-reviewed journals.Trial registration numberNCT03685942.

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