scholarly journals Does befriending by trained lay workers improve psychological well-being and quality of life for carers of people with dementia, and at what cost? A randomised controlled trial

2008 ◽  
Vol 12 (4) ◽  
Author(s):  
G Charlesworth ◽  
L Shepstone ◽  
E Wilson ◽  
M Thalanany ◽  
M Mugford ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Psychological Well Being ◽  
People With Dementia ◽  
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 Pilot Randomised Evaluation of Singing in Dementia (PRESIDE): protocol for a two-arm, parallel-group randomised controlled feasibility study with waiting-list control

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Becky Dowson ◽  
Justine Schneider ◽  
Boliang Guo ◽  
Philip M. Bath ◽  
Orii McDermott ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Waiting List ◽  
Community Group ◽  
People With Dementia ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Person With Dementia

Abstract Background As the number of people living with dementia grows, so does the need to provide them with adequate psychosocial support. Many people with dementia live at home with family carers, who also require social and emotional support to cope with their role. Community group singing has received attention for its potential to support people with dementia and their carers. It is postulated that singing can improve cognitive function, strengthen the bonds between care partners and help to establish social support networks. However, there is a lack of rigorous evidence of singing’s benefits for this population. This study aims to test the feasibility of a randomised controlled trial of community singing in dementia, to pave the way for a larger, conclusive study. Methods The PRESIDE study is designed as a two-arm, parallel-group randomised trial with a waiting list control. Dyads consisting of a person with dementia (n = 80) and their carer (n = 80) will be recruited. Each dyad will be randomised either to attend 10 weeks of community group singing sessions straight away or to wait for 3 months before attending the sessions. The singing sessions will be led by experienced professional musicians and will last about 90 min, including time for socialising. The primary outcome of this study is the attainment of feasibility criteria around recruitment, retention and the acceptability of the waiting list control. Secondary outcomes include the quality of life, mood, cognition, and musical engagement of the person with dementia, and quality of life, mood, and experiences/challenges of the carer. These data will be collected during home visits at baseline, and 3 and 6 months post-baseline. Discussion Despite growing public interest in the positive effects of singing, and encouraging findings from qualitative and non-randomised quantitative studies, there is a lack of rigorous evidence. This is the first randomised controlled trial of community group singing for people with dementia in Europe, to our knowledge. If the results favour a full trial, conclusively demonstrating the effectiveness of group singing could positively affect the opportunities available to community-dwelling people with dementia and their carers. Trial registration Unique identification number in ISRCTN registry: ISRCTN10201482. Date registered: 12 May 2020

scholarly journals Pilot Randomised Evaluation of Singing in Dementia (PRESIDE): protocol for a two-arm, parallel group randomised controlled feasibility study with waiting-list control

2020 ◽  
Author(s):  
Becky Dowson ◽  
Justine Schneider ◽  
Boliang Guo ◽  
Philip M Bath ◽  
Orii McDermott ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Waiting List ◽  
Community Group ◽  
People With Dementia ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Person With Dementia

Abstract BackgroundAs the number of people living with dementia grows, so does the need to provide them with adequate psychosocial support. Many people with dementia live at home with family carers, who also require social and emotional support to cope with their role. Community group singing has received attention for its potential to support people with dementia and their carers. It is postulated that singing can improve cognitive function, strengthen the bonds between care partners, and help to establish social support networks. However, there is a lack of rigorous evidence of singing’s benefits for this population. This study aims to test the feasibility of a randomised controlled trial of community singing in dementia, to pave the way for a larger, conclusive study.MethodsThe PRESIDE study is designed as a two-arm, parallel group randomised trial with a waiting list control. Dyads consisting of a person with dementia (n=80) and their carer (n=80) will be recruited. Each dyad will be randomised either to attend 10 weeks of community group singing sessions straight away, or to wait for three months before attending the sessions. The singing sessions will be led by experienced professional musicians and will last about 90 minutes, including time for socialising. The primary outcome of this study is the attainment of feasibility criteria around recruitment, retention and the acceptability of the waiting list control. Secondary outcomes include the quality of life, mood, cognition, and musical engagement of the person with dementia, and quality of life, mood, and experiences/challenges of the carer. These data will be collected during home visits at baseline, and three and six months post-baseline. DiscussionDespite growing public interest in the positive effects of singing, and encouraging findings from qualitative and non-randomised quantitative studies, there is a lack of rigorous evidence. This is the first randomised controlled trial of community group singing for people with dementia in Europe, to our knowledge. If the results favour a full trial, conclusively demonstrating the effectiveness of group singing could positively affect the opportunities available to community-dwelling people with dementia and their carers.Trial RegistrationUnique identification number in ISRCTN registry: ISRCTN10201482 https://www.isrctn.com/ISRCTN10201482. Date registered: 12/05/2020

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.

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