scholarly journals Development and evaluation of a WeChat-based life review programme for patients with cancer: protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e020239 ◽  
Author(s):  
Xiaoling Zhang ◽  
Huimin Xiao
Keyword(s):  
Meaning In Life ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Well Being ◽  
Life Review ◽  
Development Theory ◽  
Control Group ◽  
Patients With Cancer ◽  
Self Transcendence ◽  
Randomised Controlled

IntroductionPatients with cancer often suffer from considerable distress. Life review is a process of recalling, evaluating and integrating life experiences to alleviate a sense of despair and achieve self-integrity. Empirical data have supported the fact that life review is an effective psychological intervention, but it is not always accessible to patients with cancer. There is little evidence of internet-based life review programmes tailored to patients with cancer. This study aims to develop a WeChat-based life review programme and evaluate its effectiveness on the psycho-spiritual well-being of patients with cancer undergoing chemotherapy.Methods and analysisA single-centre randomised parallel group superiority design will be used. Patients with cancer will be randomised, to either a control group, or to an experimental group receiving a 6-week WeChat-based life review programme. The programme, which was mainly developed based on Erikson’s psycho-social development theory and Reed’s self-transcendence theory, provides synchronous and asynchronous communication modes for patients to review their life. The former is real-time communication, providing an e-life review interview guided by a facilitator online. The latter is not simultaneously dialogic and is used to interact with patients before and after a life review interview through Memory Prompts, Review Extraction, Mind Space and E-legacy products. The primary outcomes include anxiety, depression and self-transcendence, and the secondary outcomes are meaning in life and hope. These will be measured at baseline, and immediately, at 3 months, and at 6 months after the programme’s conclusion.Ethics and disseminationEthics approval has been obtained from the Biological and Medical Research Ethics Committee of the corresponding author’s university (IRB Ref No: 2016/00020). The trial results will be published in a peer-reviewed journal and presented at national and international conferences.Trial registration numberChiCTR-IOR-17011998.

scholarly journals Gamification as an entrepreneur well-being intervention: A study protocol for a single-blinded randomised controlled trial

2021 ◽  
Author(s):  
Waqar M. Naqvi
Keyword(s):  
Controlled Trial ◽  
Life Quality ◽  
Well Being ◽  
Likert Scale ◽  
Control Group ◽  
Group A ◽  
Measuring Scale ◽  
Group B ◽  
Randomised Controlled

Abstract Entrepreneurs usually work for long hours resulting in exhaustion, stress, and burnout. The prevalent symptoms of burnout are reduced levels of physical and mental energy, reduced job efficiency and diminished productivity. Therefore, it is important to improve the health of entrepreneurs. Gamification has a positive relationship with improvements in health and well-being as it influences positive experiences and satisfaction. This trial aims to study how 30-minutes of virtual reality game use via Kinect Azure and Oculus platforms 3-times per week, for 4 weeks, relates to differences in entrepreneur stress, burnout, subjective life quality, and downstream firm performance. We will recruit entrepreneurs over the age of 18 for the gamification analysis. Analysis of previous power using G*Power will determine the sample size. We will divide the participants into 3 groups, wherein Group A will undergo gamification on the Kinect platform, Group B will undergo the Oculus Quest intervention, and Group C will be the control group. We will conduct the study at two sites, one at the HuMen research. The outcome measures include a five-point Likert scale for measuring entrepreneurial stress, burnout-measuring scale (BMS) for burnout, five-point Likert scale for performance and SF-12 for Quality of life. Since current strains pave ways to future accomplishment, entrepreneurs' eudemonic well-being might particularly relate to forward-looking challenge stressors and burnouts. The results will provide an insight into how gamification could help entrepreneurs to deal with work stress and maintain high well-being.

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 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.

scholarly journals Effectiveness of mental simulations on the early mobilization of patients after cesarean section: a randomized controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna Prokopowicz ◽  
Katarzyna Byrka
Keyword(s):  
Process Simulation ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Early Mobilization ◽  
Mental Simulation ◽  
Controlled Study ◽  
Control Group ◽  
Simulation Group ◽  
Randomised Controlled ◽  
Experimental Group

AbstractWe aimed to investigate whether psychological intervention (single mental simulation) among women after cesarean surgery (CC) can affect their willingness to verticalize, actual verticalization, and the duration of the first mobilization. In this prospective randomised, controlled study, 150 women after CC were divided into 3 groups: experimental group with process-simulation with elements of relaxation, experimental group with outcome-simulation with elements of relaxation and control group with elements of relaxation only. After a 5-h stay in the post-operative room, women listened to a recording with a stimulation. Pain and anxiety of verticalization were measured before and after listening to the recording and after verticalization. Almost 12% more patients verticalized in the process-simulation group than in the control group. Percentages of mobilized patients were: 39.4% the process-simulation group; 32.8% in the outcome-simulation group; 27.7% controls (p = 0.073). Mobilization was 5 min longer in the process-simulation group then in control (p < 0.01). Anxiety after the simulation was a significant covariate of the willingness to verticalize, actual verticalization and time spent in mobilization. We conclude that a single mental simulation can effectively motivate patients for their first verticalization after CC. Perceived anxiety before verticalization may affect the effectiveness of interventions, so we recommend to check it at the postoperative care.ClinicalTrials.gov Identifier: NCT04829266.

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 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.

scholarly journals PartnerCARE—a psycho-oncological online intervention for partners of patients with cancer: study protocol for a randomised controlled feasibility trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e035599
Author(s):  
Daniela Bodschwinna ◽  
Inga Lorenz ◽  
Natalie Bauereiss ◽  
Harald Gündel ◽  
Harald Baumeister ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Online Intervention ◽  
Feasibility Trial ◽  
Control Group ◽  
Negative Effects ◽  
Total N ◽  
Patients With Cancer ◽  
Randomised Controlled

IntroductionCancer burdens not only the patient but also the partner to a comparable extent. Partners of patients with cancer are highly involved in the caring process and therefore often experience distress and report a low quality of life. Interventions for supporting partners are scarce. Existing ones are rarely used by partners because they are often time-consuming per se and offer only limited flexibility with regard to schedule and location. The online intervention PartnerCARE has been developed on the basis of caregiver needs and consists of six consecutive sessions and four optional sessions, which are all guided by an e-coach. The study aims to evaluate feasibility and acceptance of the online intervention PartnerCARE and the related trial process. In addition, first insights of the putative efficacy of PartnerCARE should be gained.Methods and analysisA two-arm parallel-group randomised controlled trial will be conducted to compare the PartnerCARE online intervention with a waitlist control group. The study aims to recruit in total n=60 partners of patients with any type of cancer across different access paths (eg, university medical centres, support groups, social media). Congruent with feasibility study objectives, the primary outcome comprises recruitment process, study procedure, acceptance and satisfaction with the intervention (Client Satisfaction Questionnaire adapted to Internet-based interventions), possible negative effects (Inventory of Negative Effects in Psychotherapy) and dropout rates. Secondary outcomes include quality of life, distress, depression, anxiety, caregiver burden, fear of progression, social support, self-efficacy, coping and loneliness. Online measurements will be performed by self-assessment at three time points (baseline/pre-randomisation, 2 months and 4 months after randomisation). Data analyses will be based on intention-to-treat principle.Ethics and disseminationEthics approval has been granted by the Ethics Committee of the University of Ulm (No 390/18). Results from this study will be disseminated to relevant healthcare communities, in peer-reviewed journals and at scientific and clinical conferences.Trial registration numberDRKS00017019.

scholarly journals Protocol of a 12-month multifactorial eHealth programme targeting balance, dual-tasking and mood to prevent falls in older people: the StandingTall+ randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e051085
Author(s):  
Kimberley S van Schooten ◽  
Michele L Callisaya ◽  
Bridianne O'Dea ◽  
Thomas Lung ◽  
Kaarin Anstey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Older People ◽  
Fall Risk ◽  
Fear Of Falling ◽  
Controlled Trial ◽  
Intervention Strategy ◽  
Well Being ◽  
Cost Utility ◽  
Control Group ◽  
Randomised Controlled

IntroductionFalls have a multifactorial aetiology, which may limit the effectiveness of the common approach of exercise as the sole intervention strategy. Multifactorial interventions could be more effective in people at high risk of falling; however, the focus of such interventions has traditionally been quite narrow. This paper describes the design of a randomised controlled trial that will evaluate the effectiveness of an eHealth programme, which addresses cumulative effects of key fall-risk factors across the triad of physical, affective and cognitive functions on falls in older people.Methods and analysis518 older people aged 65 years and over with high fall risk, defined as having a history of falls in the past 6 months, self-reported fear of falling or being aged 80 years or over, will be recruited via local advertisements, newsletters and presentations, and randomised to an intervention or health education control group. The intervention comprises balance exercise, cognitive-motor exercise and cognitive–behavioural therapy, with their dosage based on participant’s baseline balance, executive function and mood. The primary outcome is the rate of falls in the 12 months after randomisation. Secondary outcomes at 6 and 12 months comprise programme adherence, healthcare use, physical activity, balance and mobility, cognitive function, psychological well-being, quality of life, health literacy and user experience and attitudes towards the programme. Data will be analysed following intention to treat to gauge real-world effectiveness. We will further determine complier averaged causal effects to correct for varying adherence and conduct economic analyses to gain insight into cost-effectiveness and cost–utility.Ethics and disseminationEthical approval was obtained from the University of New South Wales (UNSW) Human Research Ethics Committee in December 2017. Outcomes will be disseminated via peer-reviewed articles, conference presentations, community events and media releases.Trial registration numberACTRN12619000540112.

Efficacy of a Smartphone App Intervention for Reducing Caregiver Stress: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Matthew Fuller-Tyszkiewicz ◽  
Ben Richardson ◽  
Keriann Little ◽  
Samantha Teague ◽  
Linda Hartley-Clark ◽  
...  
Keyword(s):  
Active Control ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Self Esteem ◽  
Mobile App ◽  
Control Group ◽  
Self Monitoring

BACKGROUND Caregivers play a pivotal role in maintaining an economically viable health care system, yet they are characterized by low levels of psychological well-being and consistently report unmet needs for psychological support. Mobile app–based (mobile health [mHealth]) interventions present a novel approach to both reducing stress and improving well-being. OBJECTIVE This study aims to evaluate the effectiveness of a self-guided mobile app–based psychological intervention for people providing care to family or friends with a physical or mental disability. METHODS In a randomized, single-blind, controlled trial, 183 caregivers recruited through the web were randomly allocated to either an intervention (n=73) or active control (n=110) condition. The intervention app contained treatment modules combining daily self-monitoring with third-wave (mindfulness-based) cognitive-behavioral therapies, whereas the active control app contained only self-monitoring features. Both programs were completed over a 5-week period. It was hypothesized that intervention app exposure would be associated with decreases in depression, anxiety, and stress, and increases in well-being, self-esteem, optimism, primary and secondary control, and social support. Outcomes were assessed at baseline, postintervention, and 3-4 months postintervention. App quality was also assessed. RESULTS In total, 25% (18/73) of the intervention participants were lost to follow-up at 3 months, and 30.9% (34/110) of the participants from the wait-list control group dropped out before the postintervention survey. The intervention group experienced reductions in stress (<i>b</i>=−2.07; <i>P</i>=.04) and depressive symptoms (<i>b</i>=−1.36; <i>P</i>=.05) from baseline to postintervention. These changes were further enhanced from postintervention to follow-up, with the intervention group continuing to report lower levels of depression (<i>b</i>=−1.82; <i>P</i>=.03) and higher levels of emotional well-being (<i>b</i>=6.13; <i>P</i>&lt;.001), optimism (<i>b</i>=0.78; <i>P</i>=.007), self-esteem (<i>b</i>=−0.84; <i>P</i>=.005), support from family (<i>b</i>=2.15; <i>P</i>=.001), support from significant others (<i>b</i>=2.66; <i>P</i>&lt;.001), and subjective well-being (<i>b</i>=4.82; <i>P</i>&lt;.001). On average, participants completed 2.5 (SD 1.05) out of 5 treatment modules. The overall quality of the app was also rated highly, with a mean score of 3.94 out of a maximum score of 5 (SD 0.58). CONCLUSIONS This study demonstrates that mHealth psychological interventions are an effective treatment option for caregivers experiencing high levels of stress. Recommendations for improving mHealth interventions for caregivers include offering flexibility and customization in the treatment design. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12616000996460; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371170

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