scholarly journals Let It Out (LIO) study: protocol for a mixed-methods study to optimise the design and assess the feasibility of an online emotional disclosure-based intervention in UK hospices

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e047135
Author(s):  
Daisy McInnerney ◽  
Bridget Candy ◽  
Patrick Stone ◽  
Nuriye Kupeli

IntroductionThe current COVID-19 pandemic has forced hospices to look for more ways to support people remotely, including psychological support. Emotional disclosure-based interventions hold potential as a way of providing support remotely. However, evidence of their efficacy in people with terminal illness is mixed. Reviews have highlighted this may be due to interventions not being tailored to the unique needs of this population. In response to this, we are developing Let It Out (LIO), an online, self-guided emotional disclosure-based intervention tailored for people living with terminal illness.AimsThe primary objective of the study is to optimise the design of the LIO intervention. Secondary objectives include assessing its acceptability and feasibility; exploring potential impact on well-being; identifying potential adverse effects; and informing choice of outcome measures for potential future evaluation.Methods and analysisA single arm, mixed-methods, multisite, longitudinal study. Up to 40 people living with a terminal illness under the care of hospices in England and Scotland will receive the online LIO intervention. LIO consists of 3, self-guided expression sessions over 2 weeks. The primary outcome measures are (1) a structured feedback form completed by participants after the final expression session; and (2) semi-structured interviews and focus groups with ≤15 patient participants, ≤30 hospice staff and ≤15 informal carers. These quantitative and qualitative data will be triangulated via process evaluation to inform optimisation of the intervention design. Secondary outcome measures include validated measures of physical and psychological health collected at baseline and after the final expression session (immediately, 1, 4 and 8 weeks after); and data on recruitment, retention and fidelity.Ethics and disseminationThe study is approved by the University College London Research Ethics Committee (reference: 15281/002). The findings will be shared through peer-reviewed scientific journals and conferences, and traditional, online and social media platforms.

2021 ◽  
Vol 9 ◽  
Author(s):  
Benjamin Kelly ◽  
Aidan Innes ◽  
Marc Holl ◽  
Laura Mould ◽  
Susan Powell ◽  
...  

Introduction: High levels of physical, cognitive, and psychosocial impairments are anticipated for those recovering from the COVID-19. In the UK, ~50% of survivors will require additional rehabilitation. Despite this, there is currently no evidence-based guideline available in England and Wales that addresses the identification, timing and nature of effective interventions to manage the morbidity associated following COVID-19. It is now timely to accelerate the development and evaluation of a rehabilitation service to support patients and healthcare services. Nuffield Health have responded by configuring a scalable rehabilitation pathway addressing the immediate requirements for those recovering from COVID-19 in the community.Methods and Analysis: This long-term evaluation will examine the effectiveness of a 12-week community rehabilitation programme for COVID-19 patients who have been discharged following in-patient treatment. Consisting of two distinct 6-week phases; Phase 1 is an entirely remote service, delivered via digital applications. Phase 2 sees the same patients transition into a gym-based setting for supervised group-based rehabilitation. Trained rehabilitation specialists will coach patients across areas such as goal setting, exercise prescription, symptom management and emotional well-being. Outcomes will be collected at 0, 6, and 12 weeks and at 6- and 12-months. Primary outcome measures will assess changes in health-related quality of life (HR-QOL) and COVID-19 symptoms using EuroQol Five Dimension Five Level Version (EQ-5D-5L) and Dyspnea-12, respectively. Secondary outcome measures of the Duke Activity Status Questionnaire (DASI), 30 s sit to stand test, General Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Patient Experience Questionnaire (PEQ) and Quality Adjusted Life Years (QALY) will allow for the evaluation of outcomes, mediators and moderators of outcome, and cost-effectiveness of treatment.Discussion: This evaluation will investigate the immediate and long-term impact, as well as the cost effectiveness of a blended rehabilitation programme for COVID-19 survivors. This evaluation will provide a founding contribution to the literature, evaluating one of the first programmes of this type in the UK. The evaluation has international relevance, with the potential to show how a new model of service provision can support health services in the wake of COVID-19.Trial Registration: Current Trials ISRCTN ISRCTN14707226Web: http://www.isrctn.com/ISRCTN14707226


2017 ◽  
Author(s):  
Denny Meyer ◽  
Madawa W Jayawardana ◽  
Samuel D Muir ◽  
David Yen-Teh Ho ◽  
Olivia Sackett

BACKGROUND Workplace programs designed to improve the health and psychological well-being of employees are becoming increasingly popular. However, there are mixed reports regarding the effectiveness of such programs and little analysis of what helps people to engage with such programs. OBJECTIVE This evaluation of a particularly broad, team-based, digital health and well-being program uses mixed methods to identify the elements of the program that reduce work stress and promote psychological well-being, sleep quality, and productivity of employees. METHODS Participation in the Virgin Pulse Global Challenge program during May to September 2016 was studied. Self-reported stress, sleep quality, productivity, and psychological well-being data were collected both pre- and postprogram. Participant experience data were collected through a third final survey. However, the response rates for the last 2 surveys were only 48% and 10%, respectively. A random forest was used to estimate the probability of the completion of the last 2 surveys based on the preprogram assessment data and the demographic data for the entire sample (N=178,350). The inverse of these estimated probabilities were used as weights in hierarchical linear models in an attempt to address any estimation bias caused by the low response rates. These linear models described changes in psychological well-being, stress, sleep, and productivity over the duration of the program in relation to gender and age, engagement with each of the modules, each of the program features, and participant descriptions of the Virgin Pulse Global Challenge. A 0.1% significance level was used due to the large sample size for the final survey (N=18,653). RESULTS The final analysis suggested that the program is more beneficial for older people, with 2.9% greater psychological well-being improvements observed on average in the case of women than men (P<.001). With one exception, all the program modules contributed significantly to the outcome measures with the following average improvements observed: psychological well-being, 4.1%-6.0%; quality of sleep, 3.2%-6.9%; work-related stress, 1.7%-6.8%; and productivity, 1.9%-4.2%. However, only 4 of the program features were found to have significant associations with the outcome measures with the following average improvements observed: psychological well-being, 3.7%-5.6%; quality of sleep, 3.4%-6.5%; work-related stress, 4.1%-6.4%; and productivity, 1.6%-3.2%. Finally, descriptions of the Virgin Pulse Global Challenge produced 5 text topics that were related to the outcome measures. Healthy lifestyle descriptions showed a positive association with outcomes, whereas physical activity and step count tracking descriptions showed a negative association with outcomes. CONCLUSIONS The complementary use of qualitative and quantitative survey data in a mixed-methods analysis provided rich information that will inform the development of this and other programs designed to improve employee health. However, the low response rates and the lack of a control group are limitations, despite the attempts to address these problems in the analysis.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Florian Scharpf ◽  
Anette Kirika ◽  
Faustine Bwire Masath ◽  
Getrude Mkinga ◽  
Joseph Ssenyonga ◽  
...  

Abstract Background Violence has severe and long-lasting negative consequences for children’s and adolescents’ well-being and psychosocial functioning, thereby also hampering communities’ and societies’ economic growth. Positive attitudes towards violence and the lack of access to alternative non-violent strategies are likely to contribute to the high levels of teachers’ ongoing use of violence against children in sub-Saharan African countries. Notwithstanding, there are currently very few school-level interventions to reduce violence by teachers that a) have been scientifically evaluated and b) that focus both on changing attitudes towards violence and on equipping teachers with non-violent discipline strategies. Thus, the present study tests the effectiveness of the preventative intervention Interaction Competencies with Children – for Teachers (ICC-T) in primary and secondary schools in Tanzania, Uganda, and Ghana. Methods The study is a multi-site cluster randomized controlled trial with schools (clusters) as level of randomization and three data assessment points: baseline assessment prior to the intervention, the first follow-up assessment 6 months after the intervention and the second follow-up assessment 18 months after the intervention. Multi-stage random sampling will be applied to select a total number of 72 schools (24 per country). Schools will be randomly allocated to the intervention and the control condition after baseline. At each school, 40 students (stratified by gender) in the third year of primary school or in the first year of secondary/junior high school and all teachers (expected average number: 20) will be recruited. Thus, the final sample will comprise 2880 students and at least 1440 teachers. Data will be collected using structured clinical interviews. Primary outcome measures are student- and teacher-reported physical and emotional violence by teachers in the past week. Secondary outcome measures include children’s emotional and behavioral problems, quality of life, cognitive functioning, academic performance, school attendance and social competence. Data will be analyzed using multilevel analyses. Discussion This study aims to provide further evidence for the effectiveness of ICC-T to reduce teacher violence and to improve children’s functioning (i.e., mental health, well-being, academic performance) across educational settings, societies and cultures. Trial registration The trial was registered at clinicaltrials.org under the ClinicalTrials.gov identifier NCT04948580 on July 2, 2021.


BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019472 ◽  
Author(s):  
Ailbhe Spillane ◽  
Karen Matvienko-Sikar ◽  
Celine Larkin ◽  
Paul Corcoran ◽  
Ella Arensman

ObjectivesResearch focussing on the impact of suicide bereavement on family members’ physical and psychological health is scarce. The aim of this study was to examine how family members have been physically and psychologically affected following suicide bereavement. A secondary objective of the study was to describe the needs of family members bereaved by suicide.DesignA mixed-methods study was conducted, using qualitative semistructured interviews and additional quantitative self-report measures of depression, anxiety and stress (DASS-21).SettingConsecutive suicide cases and next-of-kin were identified by examining coroner’s records in Cork City and County, Ireland from October 2014 to May 2016.ParticipantsEighteen family members bereaved by suicide took part in a qualitative interview. They were recruited from the Suicide Support and Information System: A Case-Control Study (SSIS-ACE), where family members bereaved by suicide (n=33) completed structured measures of their well-being.ResultsQualitative findings indicated three superordinate themes in relation to experiences following suicide bereavement: (1) co-occurrence of grief and health reactions; (2) disparity in supports after suicide and (3) reconstructing life after deceased’s suicide. Initial feelings of guilt, blame, shame and anger often manifested in enduring physical, psychological and psychosomatic difficulties. Support needs were diverse and were often related to the availability or absence of informal support by family or friends. Quantitative results indicated that the proportion of respondents above the DASS-21 cut-offs respectively were 24% for depression, 18% for anxiety and 27% for stress.ConclusionsHealthcare professionals’ awareness of the adverse physical and psychosomatic health difficulties experienced by family members bereaved by suicide is essential. Proactively facilitating support for this group could help to reduce the negative health sequelae. The effects of suicide bereavement are wide-ranging, including high levels of stress, depression, anxiety and physical health difficulties.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
C. Le Gall-Ianotto ◽  
R. Verdet ◽  
E. Nowak ◽  
L. Le Roux ◽  
A. Gasse ◽  
...  

Abstract Background Aquagenic pruritus (AP), an intense sensation of scratching induced after water contact, is the most troublesome aspect of BCR-ABL1-negative myeloproliferative neoplasms (MPNs). Mostly described in polycythemia vera (PV, ~ 40%), it is also present in essential thrombocythemia (ET) and primary myelofibrosis (PMF) (10%). Even if this symptom can decrease or disappear under cytoreductive treatments, 30% of treated MPN patients still persist with a real impact on the quality of life (QoL). Because its pathophysiology is poorly understood, efficient symptomatic treatments of AP are missing. The neuropeptide substance P (SP) plays a crucial role in the induction of pruritus. Several studies showed the efficacy of aprepitant, an antagonist of SP receptor (NK-1R), in the treatment of chronic pruritus but never evaluated in AP. The objectives of APHYPAP are twofold: a clinical aim with the evaluation of the efficacy of two drugs in the treatment of a persistent AP for MPN patients and a biological aim to find clues to elucidate AP pathophysiology. Methods/design A multicentric, double-blind, double-placebo, randomized study will include 80 patients with MPN (PV or ET or PMF) treated since at least 6 months for their hemopathy but suffering from a persistent AP (VAS intensity ≥6/10). Patients will be randomized between aprepitant (80 mg daily) + placebo to match to hydroxyzine OR hydroxyzine (25 mg daily) + placebo to match to aprepitant for 14 days. At D0, baseline information will be collected and drugs dispense. Outcome measures will be assessed at D15, D30, D45, and D60. The primary study endpoint will be the reduction of pruritus intensity below (or equal) at 3/10 on VAS at D15. Secondary outcome measures will include the number of patients with a reduction or cessation of AP at D15 or D60; evaluation of QoL and AP characteristics at D0, D15, D30, D45, and D60 with MPN-SAF and AP questionnaires, respectively; modification of plasmatic concentrations of cytokines and neuropeptides at D0, D15, D30, and D60; and modification of epidermal innervation density and pruriceptor expression at D0 and D15. Discussion The APHYPAP trial will examine the efficacy of aprepitant vs hydroxyzine (reference treatment for AP) to treat persistent AP in MPN patients. The primary objective is to demonstrate the superiority of aprepitant vs hydroxyzine to treat persistent AP of MPN patients. The treatment received will be considered efficient if the AP intensity will be reduced at 3/10 or below on VAS after 14 days of treatment. The results of this study may provide a new treatment option for this troublesome symptom and also give us more insights in the pathophysiology understanding of AP. Trial registration APHYPAP. NCT03808805, first posted: January 18, 2019; last update posted: June 10, 2021. EudraCT 2018-090426-66


BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030669
Author(s):  
Jessica Herkes ◽  
Louise A Ellis ◽  
Kate Churruca ◽  
Jeffrey Braithwaite

ObjectivesOrganisational and workplace cultures are fundamental determinants of health systems performance; through better understanding of the dimensions of culture there is the potential to influence them, and subsequently improve safety and quality of care, as well as the experiences of both patients and staff. One promising conceptual framework for studying culture in healthcare is person-environment (P-E) fit. Comprising person-organisational (P-O) and person-group (P-G) components, P-E fit is defined as the extent to which individuals are compatible with their work environment. The aim of this study was to examine the associations of P-O and P-G fit with staff outcomes in mental healthcare.Setting and participantsParticipants (n=213) were staff and volunteers at 31 primary mental health facilities across six states of Australia.Primary and secondary outcome measuresStaff outcomes, comprising burnout (depersonalisation and emotional exhaustion), job satisfaction and work stress.DesignA multidimensional survey tool was used to measure P-O and P-G fit, and staff outcomes. Multiple regression analyses were used to test the associations between fit and outcome measures.ResultsThe regression analyses indicated that, based on a Bonferroni adjusted alpha value of α=00417, P-O fit accounted for 36.6% of the variability in satisfaction (F=8.951, p≤0.001); 27.7% in emotional exhaustion (F=6.766, p≤0.001); 32.8% in depersonalisation (F=8.646, p≤0.001); and 23.5% in work stress (F=5.439, p≤0.001). The P-G fit results were less conclusive, with P-G fit accounting for 15.8% of the variability in satisfaction (F=4.184, p≤0.001); 10.0% in emotional exhaustion (F=2.488, p=0.014); 28.6% in depersonalisation (F=8.945, p≤0.001); and 10.4% in work stress (F=2.590, p=0.032). There was no statistically significant increase in the variability accounted for when the interaction term of P-O and P-G fit was added to the regression.ConclusionsThe findings highlight that staff’s perception of their workplace and organisational culture can have implications for staff well-being.


BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e048126
Author(s):  
Sarah-Maria Thumbeck ◽  
Philipp Schmid ◽  
Sophie Chesneau ◽  
Frank Domahs

IntroductionAt least 68% of persons with aphasia (PWA) experience reading difficulties. Even though strategy-based interventions are a promising treatment approach for text level reading comprehension deficits in PWA, empirical evidence for their efficacy remains rare. The primary objective of this study is the analysis of the efficacy of a strategy-based intervention on text-level reading comprehension and on reading activities in PWA.Methods and analysisIn a repeated measures trial, 24 PWA will first participate in a waiting period and then in a strategy-based intervention (14 face-to-face-sessions, 60 min each). We will apply two combinations of strategies to treat either the microstructure or the macrostructure, respectively. Participants will be randomly allocated to two parallel groups that will receive these combinations in interchanged sequences. Assessments will be implemented before and after each period as well as 3 and 6 months after the intervention. The primary outcome measure is text-level reading comprehension measured with a German version of the Test de Compréhension de Textes (TCT-D) and represented by the score TCT-D Total . A non-blinded and a blinded rater will evaluate the primary outcome measure. Secondary outcome measures will address specific reading functions, reading activities and cognitive functions. The sample size was determined with an a priori power analysis. For statistical analysis, we will use contrast analyses within repeated measures analysis of variance models. We expect significant improvements in primary and secondary outcome measures during the intervention as compared with changes during the waiting period.Ethics and disseminationThis study was approved by the ethics committee of Deutscher Bundesverband für akademische Sprachtherapie und Logopädie (20–10074-KA-MunmErw+Ko). Results and relevant data will be disseminated in peer-reviewed journals, at conferences and on the Open Science Framework.Trial registration numberDRKS00021411 (see Supplementary Table 1).


2015 ◽  
Vol 2 (1) ◽  
pp. 1-36 ◽  
Author(s):  
Daniel Freeman ◽  
Graham Dunn ◽  
Helen Startup ◽  
David Kingdon

BackgroundPersecutory delusions are a key experience in psychosis, at the severe end of a paranoia continuum in the population. Treatments require significant improvement. Our approach is to translate recent advances in understanding delusions into efficacious treatment. In our research we have found worry to be an important factor in the occurrence of persecutory delusions. Worry brings implausible ideas to mind, keeps them there and makes the experience distressing. Reducing worry should lead to reductions in persecutory delusions.ObjectiveThe objective was to test the clinical efficacy of a brief cognitive–behavioural intervention for worry for patients with persistent persecutory delusions and determine how the treatment might reduce delusions. Embedded within the trial were theoretical studies to improve the understanding of worry in psychosis.DesignParticipants were randomised either to the psychological intervention added to standard care or to standard care. Assessments, carried out by an assessor blind to allocation, were carried out at 0 weeks, 8 weeks (post treatment) and 24 weeks.SettingPatients were recruited from mental health secondary services: Oxford Health NHS Foundation Trust and Southern Health NHS Foundation Trust.ParticipantsA total of 150 patients with persistent persecutory delusions in the context of non-affective psychosis took part.InterventionThe six-session manualised cognitive–behavioural therapy (CBT) intervention aimed to reduce time worrying and did not dispute the content of delusions.Main outcome measuresThe main outcomes measures were of worry (Penn State Worry Questionnaire; PSWQ) and persecutory delusions (Psychotic Symptom Rating Scales; PSYRATS). Secondary outcome measures were paranoia, overall psychiatric symptoms, psychological well-being, rumination and a patient-chosen outcome.ResultsIn total, 95% of the patients provided primary outcome follow-up data. For the primary outcomes, in an intention-to-treat analysis, when compared with treatment as usual, the therapy led to highly significant reductions in both worry [PSWQ: 6.35, 95% confidence interval (CI) 3.30 to 9.40;p < 0.001] and the persecutory delusions (PSYRATS: 2.08, 95% CI 0.64 to 3.51;p = 0.005). The intervention also led to significant improvements in all of the secondary outcomes. All gains were maintained. A planned mediation analysis indicated that change in worry explained 66% of the change in the delusions. We also found that patients without intervention report a passive relationship with worry, feeling unable to do anything about it; worry brings on depersonalisation experiences; and the patient group has very low levels of psychological well-being.ConclusionsThis was the first large randomised controlled trial specifically focused on the treatment of persecutory delusions. Long-standing delusions were significantly reduced by a brief CBT intervention targeted at worry. The intervention also improved well-being and overall levels of psychiatric problems. An evaluation of the intervention in routine clinical setting is now indicated. We envisage developing the intervention booklets for online and app delivery so that the intervention, with health professional support, has the possibility for greater self-management.Trial registrationCurrent Controlled Trials ISRCTN23197625.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership.


BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e029555 ◽  
Author(s):  
Andy Hau Yan Ho ◽  
Stephanie Hilary Xinyi Ma ◽  
Moon-Ho Ringo Ho ◽  
Joyce Shu Min Pang ◽  
Emily Ortega ◽  
...  

ObjectiveTo assess the frequency and intensity of arts engagement inclusive of active and passive engagements in arts, culture and heritage activities among Singaporean adults aged 50 and above, and examine the relationships between participatory art and holistic well-being.DesignCross-sectional stratified household survey.SettingAll residential areas across Singapore’s Central, East, North, North-East and West Regions.Participants1067 community-dwelling, Singaporean older adults between the ages of 50 and 95 years were recruited.Primary and secondary outcome measuresRespondents completed a self-reported questionnaire, consisting of standardised ad hoc items assessing the frequencies and durations of active and passive participatory arts engagement, as well as validated psychometric assessments on psychosociospiritual health including the primary outcome measure on quality of life, and the secondary outcome measures on physical, psychological, emotional, spiritual, and social well-being. sociodemographic information, as well as frequency and intensity of physical activity were also collected.ResultsPassive engagement (60%) and active engagement (17%) in the arts were associated with better holistic wellness and social support. Specifically, findings from the propensity score matching and independent t-test analyses revealed that adults aged 50 and above who passively engaged in arts and culture-related events experienced higher quality of life (t(728)=3.35, p=0.0008, d=0.25), perceived health (t(728)=2.21, p=0.0277, d=0.16) and sense of belonging (t(728)=2.17, p=0.03, d=0.16), as compared with those who did not. Moreover, those who actively engaged in participatory arts experienced greater quality of life (t(442)=3.68, p=0.0003, d=0.36), self-rated health (t(442)=2.59, p=0.0099, d=0.25), spiritual well-being (t(442)=3.75, p=0.0002, d=0.37), meaning in life (t(442)=5.03, p<0.0001, d=0.50) and sense of peace (t(442)=3.72, p=0.0002, d=0.36), as compared with those who did not actively engaged in the arts.ConclusionThis study provided robust evidence to support a significant causal relationship between arts engagements and holistic well-being. Recommendations for art-based public health and elderly care research, practice and policy are discussed.


2019 ◽  
Author(s):  
Taaike Debeuf ◽  
Sandra Verbeken ◽  
Elisa Boelens ◽  
Brenda Volkaert ◽  
Eva Van Malderen ◽  
...  

Abstract Background: The prevalence rates of childhood obesity are growing. The current multidisciplinary treatments for (childhood) obesity are working, but only in short term and rather moderate. Therefore, research needs to search for underlying mechanisms that can improve the existing multidisciplinary treatments. A possible underlying mechanism can be ‘emotion regulation’. Therefore, the current RCT-study aims to test the effectiveness of adding an emotion regulation training to care as usual (multidisciplinary obesity treatment) in young inpatients (10-14) involved in an obesity treatment program compared to care as usual alone. The research model for this RCT-study states that when high levels of stress are regulated in a maladaptive way, this can contribute to the development of obesity. Method: The current study will recruit 140 youngsters (10-14 years) that are involved in an inpatient multidisciplinary obesity treatment (MOT) program. After giving consent to participate in the study, youngsters will be randomly assigned, during consecutive waves, to one of two conditions: care as usual (receiving MOT) or intervention (receiving MOT and on top an emotion regulation training). The training itself consists of 12 weekly sessions, followed by a booster session after three and five months. The participants will be tested pre, post and at 6 months’ follow-up. We hypothesize that, compared to the control condition, youngsters in the intervention condition will (1) use more adaptive emotion regulation strategies and (2) report less emotional eating, both primary outcome measures. Moreover, on the level of secondary outcome measures, we hypothesize that youngsters in the intervention condition, compared with the control condition, will (3) report a better sleep quality, (4) undergo an improved weight-loss and weight-loss maintenance and (5) experience a better long-term (6-months) psychological well-being. Discussion: This study will add to both the scientific and clinical literature on the role of emotion regulation in the development and maintenance of different psychopathologies, as emotion regulation is a transdiagnostic factor. Trial Registration: The RCT-study protocol is registered at ISRCTN Registry, with study ID ‘ISRCTN 83822934’. Registered at 13 December 2017; http://www.isrctn.com/ISRCTN83822934


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