scholarly journals Internet-based self-help randomized trial for motor functional neurologic disorder (SHIFT)

Neurology ◽  
2020 ◽  
Vol 95 (13) ◽  
pp. e1883-e1896
Author(s):  
Jeannette M. Gelauff ◽  
Judith G.M. Rosmalen ◽  
Alan Carson ◽  
Joke M. Dijk ◽  
Martijn Ekkel ◽  
...  

ObjectiveTo determine whether self-rated health of patients with motor functional neurologic disorder (FND) can be improved by unguided Internet-based self-help and education.MethodsIn this nonblinded randomized controlled trial, patients were allocated 1:1 unbiased to an unguided education and self-help website in addition to usual care or usual care only. Patients over 17 years of age with a functional motor symptom that caused distress or disability were included. The primary outcome was self-rated health on the Clinical Global Improvement scale at 3 and 6 months. Secondary outcomes were severity of motor symptoms, other physical and psychiatric symptoms, physical functioning, quality of life, work and social adjustment, illness beliefs, and satisfaction with care.ResultsA total of 186 patients were randomized, with a follow-up rate of 87% at 6 months. There was no difference in improvement of self-rated health at 3 months (44% vs 40%, p = 0.899) or 6 months (42% vs 43%, p = 0.435). Secondary outcomes did not differ between groups, with a threshold of p < 0.01. Satisfaction was high, with 86% of patients recommending the website to other patients.ConclusionWe found no significant effect of the intervention added to usual care on self-rated health or secondary outcome measures, despite high patient satisfaction with the intervention. These results suggest that online education and nonguided self-help could be valuable additions to stepped care for motor FND, but are not effective treatments as interventions in their own right.Clinicaltrials.gov identifierNCT02589886.Classification of evidenceThis study provides Class III evidence that for patients with motor FND, online education and self-help intervention does not significantly improve self-rated health.

2018 ◽  
Vol 49 (6) ◽  
pp. 1005-1014 ◽  
Author(s):  
Heidi Frølund Pedersen ◽  
Johanne L. Agger ◽  
Lisbeth Frostholm ◽  
Jens S. Jensen ◽  
Eva Ørnbøl ◽  
...  

AbstractBackgroundPsychological treatment for functional somatic syndromes (FSS) has been found moderately effective. Information on how much treatment is needed to obtain improvement is sparse. We assessed the efficacy of a brief and extended version of group-based Acceptance and Commitment Therapy (ACT) v. enhanced care (EC) for patients with multiple FSS operationalised as Bodily Distress Syndrome multi-organ type.MethodsIn a randomised controlled three-armed trial, consecutively referred patients aged 20–50 with multiple FSS were randomly assigned to either (1) EC; (2) Brief ACT: EC plus 1-day workshop and one individual consultation; or (3) Extended ACT: EC plus nine 3-h group-based sessions. Primary outcome was patient-rated overall health improvement on the five-point clinical global improvement scale 14 months after randomisation. A proportional odds model was used for the analyses.ResultsA total of 180 patients were randomised; 60 to EC, 61 to Brief ACT, and 59 to Extended ACT. Improvement on the primary outcome after Extended ACT was significantly greater than after EC with an unadjusted OR of 2.9 [95% CI (1.4–6.2), p = 0.006]. No significant differences were found between Brief ACT and EC. Of the 18 secondary outcomes, the only significant difference found was for physical functioning in the comparison of Extended ACT with EC.ConclusionsPatients rated their overall health status as more improved after Extensive ACT than after EC; however, clinically relevant secondary outcome measures did not support this finding. Discrepancies between primary and secondary outcomes in this trial are discussed.


2011 ◽  
Vol 23 (6) ◽  
pp. 969-978 ◽  
Author(s):  
Els Dozeman ◽  
Digna J. F. van Schaik ◽  
Harm W. J. van Marwijk ◽  
Max L. Stek ◽  
Aartjan T. F. Beekman ◽  
...  

ABSTRACTBackground: Elderly people living in residential homes are at high risk for developing major depressive and anxiety disorders, and therefore deserve attention in terms of preventive interventions. We evaluated the feasibility and effectiveness of a guided self-help intervention for the prevention of depression and anxiety in these residents.Methods: We conducted a pragmatic randomized controlled trial in two parallel groups comparing the intervention with usual care in 14 residential homes in and surrounding the city of Amsterdam in the Netherlands. A total of 129 residents with a score of 8 or more on the Centre for Epidemiologic Studies Depression Scale (CES-D) screening instrument, who did not meet the full diagnostic criteria for disorders, and were not suffering from cognitive impairment were recruited between April 2007 and December 2008. Participants were randomized to a guided self-help intervention (n = 67) or to usual care (n = 62). The main outcome measures were improvement in the level of symptoms of depression and anxiety. The secondary outcome was improvement in participation in organized activities in the residential homes. The study is registered in de Dutch Cochrane Centre, under number ISRCTN27540731.Results: Only 21% of the participants (mean age 84.0 years (SD 6.7), 72.1% suffering from two or more chronic illnesses) completed the intervention. Although we found some large positive effect sizes on the CES-D, none of these effects was statistically significant.Conclusion: Although guided self-help may be promising in the prevention of depression and anxiety, it proved to be difficult to apply in this very old and vulnerable group of people living in residential homes.


2017 ◽  
Vol 45 (5) ◽  
pp. 448-466 ◽  
Author(s):  
Sheila Ali ◽  
Kimberley Goldsmith ◽  
Mary Burgess ◽  
Trudie Chalder

Background: Previous research suggests that minimal interventions such as self-help guidance can improve outcomes in patients with fatigue or chronic fatigue syndrome (CFS). Aims: The aim of the current study was to investigate whether self-help guidance could improve physical functioning, social adjustment and fatigue in a group of patients with CFS who were awaiting CBT at a clinic in secondary care. Method: Patients completed questionnaires at their initial assessment (baseline), immediately before beginning CBT (pre-treatment), and after their last session of CBT (end of treatment). The primary outcome was physical functioning, and the secondary outcomes were social adjustment and fatigue. Multi-level linear models were used to assess change over time after adjustment for gender and age. Results: Multi-level models revealed that from baseline to pre-treatment, patients showed statistically significant improvements in physical functioning, but there were no statistically significant improvements in fatigue or social adjustment. However, all the primary and secondary outcomes showed statistically significant changes after CBT. Conclusions: The findings of this study indicate that self-help guidance may be beneficial for patients with CFS who are awaiting CBT treatment or those who are unable to access specialist treatment in their local area.


Author(s):  
Angel M. Dzhambov ◽  
Peter Lercher ◽  
Drozdstoy Stoyanov ◽  
Nadezhda Petrova ◽  
Stoyan Novakov ◽  
...  

Background: Online education became mandatory for many students during the Coronavirus disease 2019 (COVID-19) pandemic and blurred the distinction between settings where processes of stress and restoration used to take place. The lockdown also likely changed perceptions of the indoor acoustic environment (i.e., soundscape) and raised its importance. In the present study, we seek to understand how indoor soundscape related to university students’ self-rated health in Bulgaria around the time that the country was under a state of emergency declaration caused by the COVID-19 pandemic. Methods: Between 17 May and 10 June 2020, we conducted a cross-sectional online survey among 323 students (median age 21 years; 31% male) from two universities in the city of Plovdiv, Bulgaria. Self-rated health (SRH) was measured with a single-item. Participants were asked how frequently they heard different types of sounds while at home and how pleasant they considered each of those sounds to be. Restorative quality of the home (the “being away” dimension of the Perceived Restorativeness Scale) was measured with a single-item. A priori confounders and effect modifiers included sociodemographics, house-related characteristics, general sensitivity to environmental influences, and mental health. Our analysis strategy involved sequential exploratory factor analysis (EFA), multivariate linear and ordinal regressions, effect modification tests, and structural equation modeling (SEM). Results: EFA supported grouping perceived sounds into three distinct factors—mechanical, human, and nature sounds. Regression analyses revealed that greater exposure to mechanical sounds was consistently associated with worse SRH, whereas no significant associations were found for human and nature sounds. In SEM, exposure to mechanical sounds related to lower restorative quality of the home, and then to poorer SRH, whereas nature sounds correlated with higher restorative quality, and in turn with better SRH. Conclusions: These findings suggest a role of positive indoor soundscape and restorative quality for promoting self-rated health in times of social distancing.


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.


2021 ◽  
pp. 145507252110078
Author(s):  
Thi-Thuy-Dung Nguyen ◽  
Eleonor Säfsten ◽  
Filip Andersson ◽  
Maria Rosaria Galanti

Aim: This two-arm parallel randomised controlled trial explored the effectiveness of a brief counselling model compared with the usual multi-session counselling at an alcohol telephone helpline. Methods: A total of 320 callers who contacted the Swedish Alcohol Helpline (SAH) because of hazardous or harmful alcohol use were randomised to either brief structured intervention (self-help booklet plus one proactive call) or usual care (multi-session telephone counselling). The primary outcome was a downward shift in risk level at 12-month follow-up compared with baseline, based on self-reports. Sustained risk level reduction throughout the whole follow-up was also assessed as secondary outcome. Results: Both interventions were significantly associated with a shift to a lower level of risky alcohol use (75% among participants in the brief structured intervention, and 70% in the usual care group) after 12 months. There was no difference between the two interventions in the proportions changing alcohol use or sustaining risk level reduction. Conclusion: In the context of telephone helplines, minimal and extended interventions appear to be equally effective in promoting long-term change in alcohol use.


2021 ◽  
Vol 17 (6) ◽  
pp. 445-453
Author(s):  
Angelina Vascimini, PharmD ◽  
Kevin Duane, PharmD ◽  
Stacey Curtis, PharmD

Objective: The opioid epidemic is frequently discussed including the staggering numbers involved with coprescribing opioids and benzodiazepines associated with death. Community pharmacists, with the help of a system intervention, have a unique opportunity to help reduce the coprescribing of benzodiazepines and opioids and reduce the associated risk of death.Design: A single center retrospective chart review was conducted after a system intervention was placed, as a quality improvement project, from November 2019 to May 2020.Setting: Independent community pharmacy.Patients/participants: Data included demographics, dosing of each medication pre- and post-intervention, and naloxone status.Main outcome(s) measures: The primary outcome evaluated was reduction in dose/discontinuation of these prescriptions. The secondary outcome evaluated was the number of naloxone prescriptions ordered per protocol and picked up.Results: The primary outcome did not show statistical difference; however, the secondary outcomes showed statistical significance.Conclusion: In conclusion, community pharmacists, with the help of evolving technologies, can reduce harm associated with the coprescribing of benzodiazepines and opioids.


BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e019845 ◽  
Author(s):  
Katherine Chaplin ◽  
Peter Bower ◽  
Mei-See Man ◽  
Sara T Brookes ◽  
Daisy Gaunt ◽  
...  

ObjectivesRecent evidence has highlighted the high prevalence and impact of multimorbidity, but the evidence base for improving management is limited. We have tested a new complex intervention for multimorbidity (the 3D model). The paper describes the baseline characteristics of practices and patients in order to establish the external validity of trial participants. It also explores current ‘usual primary care’ for multimorbidity, against which the 3D intervention was tested.DesignAnalysis of baseline data from patients in a cluster-randomised controlled trial and additional data from practice staff.SettingPrimary care in the UK.ParticipantsPatients with multimorbidity (n=5253) and 154 practice staff.Primary and secondary outcome measuresUsing surveys and routinely available data, we compared the characteristics of participating and non-participating practices and participating and non-participating eligible patients.Baseline questionnaire data from patient participants was used to examine participant illness burden, treatment burden and perceptions of receiving patient-centred care. We obtained data about usual care preintervention from practice staff using questionnaires and a structured pro forma.ResultsParticipating practices were slightly larger, in less deprived areas, and with slightly higher scores for patient satisfaction compared with non-participating practices. Patients with dementia or learning difficulties were likely to be excluded by their general practitioners, but comparison of participants with non-participants identified only minor differences in characteristics, suggesting that the sample was otherwise representative. Patients reported substantial illness burden, and an important minority reported high treatment burden. Although patients reported relatively high levels of satisfaction with care, many reported not having received potentially important components of care.ConclusionThis trial achieved good levels of external validity. Although patients were generally satisfied with primary care services, there was significant room for improvement in important aspects of care for multimorbidity that are targeted by the 3D intervention.Trial registration numberISRCTN06180958; Post-results.


BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e028526 ◽  
Author(s):  
Esther Hobson ◽  
Wendy Baird ◽  
Mike Bradburn ◽  
Cindy Cooper ◽  
Susan Mawson ◽  
...  

ObjectivesTo evaluate the processes involved in using a novel digitally enabled healthcare system (telehealth in motor neuron disease (TiM)) in people living with motor neuron disease (MND) and their informal carers. We examined TiM implementation, potential mechanisms of impact and contextual factors that might influence TiM implementation or impact.DesignAn 18-month, single-centre process evaluation within a randomised, pilot and feasibility study.InterventionTiM plus usual care versus usual care alone.SettingA specialist UK MND care centre.Participants40 patients with MND and 37 primary informal carers.Primary and secondary outcome measuresPatient, carer and staff outcomes and experiences using semistructured interviews. Descriptive data on implementation and use of TiM.ResultsThe TiM was acceptable and accessible to patients, carers and staff. Intervention uptake and adherence were good: 14 (70%) patients completed a TiM session at least fortnightly. Barriers to TiM use (such as technology experience and disability) were overcome with well-designed technology and face-to-face training. Reported potential benefits of TiM included improved communication and care coordination, reassurance, identification of complications and the potential for TiM to be an alternative or addition to clinic. Benefits depended on patients’ current level of needs or disability. The main challenges were the large number of alerts that were generated by TiM, how the clinicians responded to these alerts and the mismatch between patient/carer expectations and nurses actions. This could be improved by better communication systems and adjusting the alerts algorithm.ConclusionTiM has the potential to facilitate access to specialist care, but further iterative developments to the intervention and process evaluations of the TiM in different services are required.Trial identifier numberISRCTN26675465.


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