Mindfulness-Based Stress Reduction Specifically Improves Social Anhedonia among Adults with Chronic Stress

This randomized controlled trial examined the effects of mindfulness on anhedonic symptoms in a sample of adults reporting high levels of chronic stress. Meditation-naïve adults (N=68, Mage=32, 62% female) were randomized to either an 8-week MBSR intervention group (N=35), or to a waitlist control group (N=33). We hypothesized that changes in mindfulness would mediate the relationship between condition and changes in anhedonic symptoms. Additionally, the present study aimed to determine if other theoretically-linked mechanisms (i.e., stress, negative affect(NA), depression) were involved in producing changes in anhedonic symptoms. Results provided evidence for full mediation of the effect of MBSR on social anhedonia through its essential mechanism of ΔMindfulness. These results highlight specificity of anhedonic symptoms targeted by MBSR, with social anhedonia symptoms being modified by changes in mindfulness whereas other anhedonic domains were not. Additionally, although associative relationships were present for stress, depression, NA, and anhedonic symptoms, no mediational relationships emerged.

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Implementation and Effects of an Information Technology-Based Intervention to Support Speech and Language Therapy Among Stroke Patients with Aphasia: Protocol for a Virtual Randomized Controlled Trial (Preprint)

10.2196/preprints.30621 ◽

2021 ◽

Author(s):

Esther Kim ◽

Laura Laird ◽

Carlee Wilson ◽

Till Bieg ◽

Phillip Mildner ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Lexical Retrieval ◽

Evidence Based ◽

Waitlist Control ◽

Treatment Assessment ◽

Randomized Controlled ◽

Waitlist Control Group

BACKGROUND Mobile application-based therapies are increasingly being employed by speech-language pathologists in the rehabilitation of people with aphasia (PwA) as an adjunct or in lieu of traditional in-person therapy approaches. These apps can increase the intensity of treatment, and have been shown to result in meaningful outcomes across several domains OBJECTIVE VoiceAdapt is a mobile therapy app designed with user and stakeholder feedback within a user-centered design framework. VoiceAdapt uses two evidence-based lexical retrieval treatments to engage PwA to improve their naming abilities through interaction with the app. The purpose of the randomized controlled trial (RCT) proposed here is to examine the feasibility and clinical efficacy of training with VoiceAdapt on the language and communication outcomes of people with aphasia. METHODS A multicenter RCT is being conducted at two locations within Canada. A total of 80 people with aphasia will be recruited to participate in a two-arm, waitlist-controlled, crossover group RCT. After baseline assessment, participants will be randomized into an intervention group or a waitlist control group. Intervention group participants will engage in five weeks of training with the app, followed by post-treatment assessment and follow-up assessment after an additional five weeks. Those in the waitlist control group will have five weeks of no training, followed by a pre-treatment assessment, training for five weeks and post-treatment assessment. All aspects of the trial are being conducted remotely given the COVID-19 pandemic. RESULTS Recruitment of participants started in September 2020 and the study is expected to be completed by March 2022. Publication of results is expected within six months of study completion. CONCLUSIONS Results of the RCT will provide data to inform evidence-based practice on the use of technology-based solutions to treat aphasia. If positive results are obtained from this RCT, the VoiceAdapt app can be recommended as an efficacious means of improving lexical retrieval and communicative functioning in PwA within an easily accessible, cost-effective manner. Moreover, the implementation of this RCT through remote assessment and delivery can inform the profession on telerehabilitation practices and monitoring app-based home therapy programs. CLINICALTRIAL ClinicalTrials.gov NCT04108364; https://clinicaltrials.gov/ct2/show/NCT04108364

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The Effects of the Dietary Approaches to Stop Hypertension (DASH) Diet on Metabolic Syndrome in Hospitalized Schizophrenic Patients: A Randomized Controlled Trial

Nutrients ◽

10.3390/nu11122950 ◽

2019 ◽

Vol 11 (12) ◽

pp. 2950 ◽

Cited By ~ 1

Author(s):

Tamara Sorić ◽

Mladen Mavar ◽

Ivana Rumbak

Keyword(s):

Metabolic Syndrome ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Dash Diet ◽

Randomized Controlled ◽

Parallel Group ◽

Schizophrenic Patients ◽

The Relationship

The relationship between the Dietary Approaches to Stop Hypertension (DASH) diet and metabolic syndrome (MetS) in people with schizophrenia is unknown and remains to be investigated. Therefore, we have conducted a three-month parallel-group randomized controlled trial. Sixty-seven hospitalized schizophrenic patients with MetS [n = 33 in the intervention group (IG) and n = 34 in the control group (CG)] completed the intervention. The IG followed the DASH diet with the caloric restriction of approximately 1673.6 kJ/day (400 kcal/day) when compared to the standard hospital diet followed by the CG. Simultaneously, both groups participated in a nutrition counseling program. Anthropometric and biochemical parameters and blood pressure were measured at the baseline and after three months, while nutrient intakes during the intervention were assessed using three non-consecutive 24-hour dietary recalls. The analyses were carried out based on the per-protocol approach. At three months, the MetS prevalence significantly decreased in both the IG and the CG (75.8%, p = 0.002, and 67.7%, p = 0.0003, respectively; odds ratio = 0.9; 95% confidence interval = 0.43–1.87). No significant differences in the prevalence of MetS and its features were found between the groups.

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Effects of the Satir Model on Mental Health: A Randomized Controlled Trial

Research on Social Work Practice ◽

10.1177/1049731518819829 ◽

2018 ◽

Vol 29 (7) ◽

pp. 775-785 ◽

Cited By ~ 1

Author(s):

Way Kwok-Wai Lau ◽

Pamela Pui-Yu Leung ◽

Catherine Lai-Ping Chung

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Mental Health Problems ◽

Controlled Trial ◽

Intervention Group ◽

Health Problems ◽

Control Group ◽

Mediation Analyses ◽

Randomized Controlled ◽

The Relationship

Objective: This randomized controlled trial examined the effect of an intensive experiential workshop based on the Satir growth model (SGM) that aims at cultivating self-transformation. Method: Ninety-six adult participants were randomly assigned to the intervention group (52 participants) or the wait-list control group. The role of self-transformation, measured by the Perceived Self-Transformation Scale, in the relationship between affects and mental health problems was examined using mediation analyses. Results: After the workshop, the intervention group demonstrated higher levels of self-transformation (η2 = .308, p < .001), as well as significant improvement ( p < .001) in positive (η2 = .557) and negative (η2 = .293) affects, self-esteem (η2 = .538), spirituality (η2 = .473), and mental health problems (η2 = .386). Importantly, increased self-transformation after the workshop partially mediated the relationship between reduced negative affect and mental health problems in the intervention group (indirect effect: β = 0.163, 95% confidence interval [0.035, 0.343]). Conclusion: Findings of this study suggest that the SGM-based intervention can be effective in ameliorating mental health problems.

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

2019 ◽

Vol 10 (2) ◽

pp. 70

Author(s):

Samah Nasser Abd El-Aziz El-Shora ◽

Amina Mohamed Rashad El-Nemer

Keyword(s):

Randomized Controlled Trial ◽

Cesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Cost Effective ◽

Control Group ◽

Induced Hypotension ◽

Randomized Controlled ◽

Significant Difference ◽

Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18063097 ◽

2021 ◽

Vol 18 (6) ◽

pp. 3097

Author(s):

Dorien Vanden Bossche ◽

Susan Lagaert ◽

Sara Willems ◽

Peter Decat

Keyword(s):

Randomized Controlled Trial ◽

Community Health ◽

Health Workers ◽

Psychosocial Support ◽

Controlled Trial ◽

Intervention Group ◽

Psychosocial Health ◽

Control Group ◽

Randomized Controlled ◽

The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06045-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Keivan Ranjbar ◽

Mohsen Moghadami ◽

Alireza Mirahmadizadeh ◽

Mohammad Javad Fallahi ◽

Vahid Khaloo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Clinical Status ◽

Intervention Group ◽

Length Of Hospital Stay ◽

Ordinal Scale ◽

Control Group ◽

Randomized Controlled ◽

Group Data ◽

Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

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Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

BMC Public Health ◽

10.1186/s12889-021-10627-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mariko Nishikawa ◽

Masaaki Yamanaka ◽

Akira Shibanuma ◽

Junko Kiriya ◽

Masamine Jimba

Keyword(s):

Health Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Safety Information ◽

Intervention Group ◽

Health And Safety ◽

Trial Registration ◽

Control Group ◽

Internet Portal ◽

Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

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Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

Health Informatics Journal ◽

10.1177/1460458221996409 ◽

2021 ◽

Vol 27 (1) ◽

pp. 146045822199640

Author(s):

Faranak Kazemi Majd ◽

Vahideh Zarea Gavgani ◽

Ali Golmohammadi ◽

Ali Jafari-Khounigh

Keyword(s):

Randomized Controlled Trial ◽

Hospital Readmission ◽

Medical Information ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Long Term Follow Up ◽

Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

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