Effects of a WeChat-based multimodal psychoeducational intervention on psychological well-being and quality of life in acute leukaemia patients in China: a randomised controlled trial

2021 ◽  
Author(s):  
Ying Wang ◽  
Lei Yang ◽  
Wenkui Xu ◽  
Chunfeng Wang ◽  
Jingyi Chen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Acute Leukaemia ◽  
Controlled Trial ◽  
Well Being ◽  
Psychoeducational Intervention ◽  
Psychological Well Being ◽  
Randomised Controlled

scholarly journals Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-being

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041573
Author(s):  
Eileen Bendig ◽  
Dominik Meißner ◽  
Benjamin Erb ◽  
Lena Weger ◽  
Ann-Marie Küchler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Emotion Regulation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Software Agents ◽  
Well Being ◽  
Psychological Well Being ◽  
Randomised Controlled

IntroductionOnly a minority of people living with mental health problems are getting professional help. As digitalisation moves on, the possibility of providing internet/mobile-based interventions (IMIs) arises. One type of IMIs are fully automated conversational software agents (chatbots). Software agents are computer programs that can hold conversations with a human by mimicking a human conversational style. Software agents could deliver low-threshold and cost-effective interventions aiming at promoting psychological well-being in a large number of individuals. The aim of this trial is to evaluate the clinical effectiveness and acceptance of the brief software agent-based IMI SISU in comparison with a waitlist control group.Methods and analysisWithin a two-group randomised controlled trial, a total of 120 adult participants living with low well-being (Well-being Scale/WHO-5) will be recruited in Germany, Austria and Switzerland. SISU is based on therapeutic writing and acceptance and commitment therapy-based principles. The brief intervention consists of three modules. Participants work through the intervention on 3 consecutive days. Assessment takes place before (t1), during (t2) and after (t3) the interaction with SISU, as well as 4 weeks after randomisation (t4). Primary outcome is psychological well-being (WHO-5). Secondary outcomes are emotional well-being (Flourishing Scale), psychological flexibility (Acceptance and Action Questionnaire-II), quality of life (Assessment of Quality of Life -8D), satisfaction with the intervention (Client Satisfaction Questionnaire-8) and side effects (Inventory for the assessment of negative effectsof psychotherapy). Examined mediators and moderators are sociodemographic variables, personality (Big Five Inventory-10), emotion regulation (Emotion Regulation Questionnaire), alexithymia (Toronto Alexithymia Scale-20), centrality of events (Centrality of Events Scale), treatment expectancies (Credibility Expectancy Questionnaire) and technology alliance (Inventory of Technology Alliance–Online Therapy). Data analysis will be based on intention-to-treat principles. SISU guides participants through a 3-day intervention.Ethics and disseminationThis trial has been approved by the ethics committee of the Ulm University (No. 448/18, 18.02.2019). Results will be submitted for publication in a peer-reviewed journal and presented at conferences.Trial registrationThe trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS): DRKS00016799 (date of registration: 25 April 2019). In case of important protocol modifications, trial registration will be updated. This is protocol version number 1.

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 Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024862 ◽  
Author(s):  
Adele Krusche ◽  
Katherine Bradbury ◽  
Teresa Corbett ◽  
Jane Barnett ◽  
Beth Stuart ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Well Being ◽  
Improve Quality ◽  
Randomised Controlled ◽  
Human Support

IntroductionLow quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management.Methods and analysisA randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support.Ethics and disseminationThe trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations.Trial registration numberISRCTN96374224; Pre-results.

scholarly journals Enriched Music-supported Therapy for chronic stroke patients: a study protocol of a randomised controlled trial

BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jennifer Grau-Sánchez ◽  
Emma Segura ◽  
David Sanchez-Pinsach ◽  
Preeti Raghavan ◽  
Thomas F. Münte ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Upper Limb ◽  
Controlled Trial ◽  
Well Being ◽  
Chronic Stroke ◽  
Stroke Patients ◽  
Home Based ◽  
Randomised Controlled

Abstract Background Residual motor deficits of the upper limb in patients with chronic stroke are common and have a negative impact on autonomy, participation and quality of life. Music-Supported Therapy (MST) is an effective intervention to enhance motor and cognitive function, emotional well-being and quality of life in chronic stroke patients. We have adapted the original MST training protocol to a home-based intervention, which incorporates increased training intensity and variability, group sessions, and optimisation of learning to promote autonomy and motivation. Methods A randomised controlled trial will be conducted to test the effectiveness of this enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being and quality of life of chronic stroke patients when compared to a program of home-based exercises utilizing the Graded Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and randomly allocated to an eMST group (n = 30) or a control GRASP intervention group (n = 30). Patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. The primary outcome of the study is the functionality of the paretic upper limb measured with the Action Research Arm Test. Secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes. Discussion We hypothesize that patients treated with eMST will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based GRASP intervention. Trial registration The trial has been registered at ClinicalTrials.gov and identified as NCT04507542 on 8 August 2020.

scholarly journals Singing for people with aphasia (SPA): a protocol for a pilot randomised controlled trial of a group singing intervention to improve well-being

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e025167 ◽  
Author(s):  
Mark Tarrant ◽  
Mary Carter ◽  
Sarah Gerard Dean ◽  
Rod S Taylor ◽  
Fiona C Warren ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Public Involvement ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Well Being ◽  
Retention Rates ◽  
Short Version ◽  
Randomised Controlled

IntroductionThe singing for people with aphasia (SPA) intervention aims to improve quality of life and well-being for people with poststroke aphasia. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost effectiveness of SPA. The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design.Methods and analysisA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation. Forty-eight participants discharged from clinical speech and language therapy will be individually randomised 1:1 to SPA (10 group sessions plus a resource booklet) or control (resource booklet only). Outcome assessment at baseline, 3 and 6 months postrandomisation include: ICEpop CAPability measure for adults, Stroke and Aphasia Quality of Life, EQ-5D-5L, modified Reintegration into Normal Living Index, Communication Outcome After Stroke, Very Short Version of the Minnesota Aphasia Test, Service Receipt Inventory and Care Related Quality of Life. Feasibility, acceptability and process outcomes include recruitment and retention rates, with measurement burden and trial experiences being explored in qualitative interviews (15 participants, 2 music facilitators and 2 music champions). Analyses include: descriptive statistics, with 95% CIs where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis.Ethics and disseminationNHS National Research Ethics Service and the Health Research Authority confirmed approval in April 2017; recruitment commenced in June 2017. Outputs will include: pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised intervention manual for multicentre replication of SPA; presentations at conferences, public involvement events; internationally recognised peer reviewed journal publications, open access sources and media releases.Trial registration numberNCT03076736.

scholarly journals Yoga-based exercise to prevent falls in community-dwelling people aged 60 years and over: study protocol for the Successful AGEing (SAGE) yoga randomised controlled trial

2020 ◽  
Vol 6 (1) ◽  
pp. e000878
Author(s):  
Juliana S Oliveira ◽  
Catherine Sherrington ◽  
Stephen Lord ◽  
Romina Sesto ◽  
Sabrina Youkhana ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Exercise Programme ◽  
Community Dwelling ◽  
Successful Ageing ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionFalls significantly reduce independence and quality of life in older age. Balance-specific exercise prevents falls in people aged 60+ years. Yoga is growing in popularity and can provide a high challenge to balance; however, the effect of yoga on falls has not been evaluated. This trial aims to establish the effect on falls of a yoga exercise programme compared with a yoga relaxation programme in community-dwellers aged 60+ years.Method and AnalysisThis randomised controlled trial will involve 560 community-dwelling people aged 60+ years. Participants will be randomised to either: (1) the Successful AGEing (SAGE) yoga exercise programme or (2) a yoga relaxation programme. Primary outcome is rate of falls in the 12 months post randomisation. Secondary outcomes include mental well-being, physical activity, health-related quality of life, balance self-confidence, physical function, pain, goal attainment and sleep quality at 12 months after randomisation. The number of falls per person-year will be analysed using negative binomial regression models to estimate between-group difference in fall rates. Generalised linear models will assess the effect of group allocation on the continuously scored secondary outcomes, adjusting for baseline scores. An economic analysis will compare the cost-effectiveness and cost-utility of the two yoga programmes.Ethics and disseminationProtocol was approved by the Human Research Ethics Committee at The University of Sydney, Australia (approval 2019/604). Trial results will be disseminated via peer-reviewed articles, conference presentations, lay summaries.Trial registration numberThe protocol for this trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619001183178).

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