scholarly journals Interventions for Softening Can Lead to Hardening of Opinions: Evidence from a Randomized Controlled Trial

2021 ◽  
Author(s):  
Andreas Spitz ◽  
Ahmad Abu-Akel ◽  
Robert West
Keyword(s):  
Randomized Controlled Trial ◽  
Strong Evidence ◽  
Controlled Trial ◽  
Emotional Responses ◽  
Randomized Controlled ◽  
Pre Treatment ◽  
Violated Expectations ◽  
The One ◽  
Pronounced Reduction ◽  
The Web

Motivated by the goal of designing interventions for softening polarized opinions on the Web, and building on results from psychology, we hypothesized that people would be moved more easily towards opposing opinions when the latter were voiced by a celebrity they like, rather than by a celebrity they dislike. We tested this hypothesis in a survey-based randomized controlled trial in which we exposed respondents to opinions that were randomly assigned to one of four spokespersons each: a disagreeing but liked celebrity, a disagreeing and disliked celebrity, a disagreeing expert, and an agreeing but disliked celebrity. After the treatment, we measured changes in the respondents' opinions, empathy towards the spokespersons, and use of affective language.Unlike hypothesized, no softening of opinions was observed regardless of the respondents' attitudes towards the celebrity. Instead, we found strong evidence of a hardening of pre-treatment opinions when a disagreeing opinion was attributed to an expert or when an agreeing opinion was attributed to a disliked celebrity. We also observed a pronounced reduction in empathy for disagreeing spokespersons, indicating a punitive response. The only celebrity for whom, on average, empathy remained unchanged was the one who agreed, even though they were disliked. Our results could be explained as a reaction to violated expectations towards experts and as a perceived breach of trust by liked celebrities. They confirm that naive strategies at mediation may not yield intended results, and how difficult it is to depolarize---and how easy it is to further polarize or provoke emotional responses.

Digital instruments for reporting of gastrointestinal symptoms in clinical trials: comparison of end-of-day diaries versus experience sampling method (Preprint)

2021 ◽  
Author(s):  
Abraham B. Beckers ◽  
Johanna T.W. Snijkers ◽  
Zsa Zsa R.M. Weerts ◽  
Lisa Vork ◽  
Tim Klaassen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Sampling Method ◽  
Sampling Methods ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Randomized Controlled ◽  
Pre Treatment ◽  
Irritable Bowel

BACKGROUND Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent compliance to a smartphone app used as symptom diary in a randomized clinical trial in irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time, provide useful information regarding possible symptom triggers and are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials. OBJECTIVE This study aimed to compare compliance rates of a smartphone-based end-of-day diary and ESM for symptom assessment in irritable bowel syndrome and functional dyspepsia (FD). METHODS Data from four studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+8 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+12 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Compliance rates were compared between these two symptom sampling methods. RESULTS Twenty-five patients with IBS and fifteen patients with FD were included. Overall compliance rates for the end-of-day diaries were significantly higher than for ESM (IBS: 92.7% versus 69.8%, FD: 90.1% versus 61.4%, respectively). CONCLUSIONS We here demonstrate excellent compliance rates for smartphone application-based end-of-day diaries as used in two separate clinical trials. Overall compliance rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuously during longer clinical trials.

Physicians’ Choice in Using Internet and Fax for Patient Recruitment and Follow-up in a Randomized Controlled Trial

2004 ◽  
Vol 43 (03) ◽  
pp. 268-272 ◽  
Author(s):  
S. Morita ◽  
T. Fukui ◽  
J. Sakamoto ◽  
M. Rahman
Keyword(s):  
Randomized Controlled Trial ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Data Entry ◽  
Regression Analyses ◽  
Multivariate Logistic Regression ◽  
Web Based ◽  
Randomized Controlled ◽  
The Web

Summary Objective: To examine the physicians’ preference between Web and fax-based remote data entry (RDE) system for an ongoing randomized controlled trial (RCT) in Japan. Methods: We conducted a survey among all the collaborating physicians (n = 512) of the CASE-J (Candesartan Antihypertensive Survival Evaluation in Japan) trial, who have been recruiting patients and sending follow-up data using the Web or a fax-based RDE system. The survey instrument assessed physicians’ choice between Web and fax-based RDE systems, their practice pattern, and attitudes towards these two modalities. Results: A total of 448 (87.5%) responses were received. The proportions of physicians who used Web, fax, and the combination of these two were 45.9%, 33.3% and 20.8%, respectively. Multivariate logistic regression analyses revealed that physicians 55 years or younger [odds ratio (OR) = 1.9, 95% confidence interval (CI) = 1.1-3.3] and regular users of computers (OR = 4.2, 95% CI = 2.1-8.2) were more likely to use the Web-based RDE system. Conclusions: This information would be useful in designing an RCT with a Web-based RDE system in Japan and abroad.

scholarly journals One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Chandra Y Osborn ◽  
Ashley Hirsch ◽  
Lindsay E Sears ◽  
Mark Heyman ◽  
Jennifer Raymond ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Type 1 Diabetes ◽  
Controlled Trial ◽  
Mobile App ◽  
Analysis Of Covariance ◽  
Activity Tracker ◽  
Randomized Controlled ◽  
Hemoglobin A ◽  
The One

BACKGROUND In 2017, mobile app support for managing diabetes was available to 64% of the global population of adults with diabetes. One Drop’s digital therapeutics solution includes an evidence-based mobile app with global reach, a Bluetooth-connected glucometer, and in-app coaching from Certified Diabetes Educators. Among people with type 1 diabetes and an estimated hemoglobin A<sub>1c</sub> level≥7.5%, using One Drop for 3 months has been associated with an improved estimated hemoglobin A<sub>1c</sub> level of 22.2 mg/dL (–0.80%). However, the added value of integrated activity trackers is unknown. OBJECTIVE We conducted a pragmatic, remotely administered randomized controlled trial to evaluate One Drop with a new-to-market activity tracker against One Drop only on the 3-month hemoglobin A<sub>1c</sub> level of adults with type 1 diabetes. METHODS Social media advertisements and online newsletters were used to recruit adults (≥18 years old) diagnosed (≥1 year) with T1D, naïve to One Drop’s full solution and the activity tracker, with a laboratory hemoglobin A<sub>1c</sub> level≥7%. Participants (N=99) were randomized to receive One Drop and the activity tracker or One Drop only at the start of the study. The One Drop only group received the activity tracker at the end of the study. Multiple imputation, performed separately by group, was used to correct for missing data. Analysis of covariance models, controlling for baseline hemoglobin A<sub>1c</sub>, were used to evaluate 3-month hemoglobin A<sub>1c</sub> differences in intent-to-treat (ITT) and per protocol (PP) analyses. RESULTS The enrolled sample (N=95) had a mean age of 41 (SD 11) years, was 73% female, 88% White, diagnosed for a mean of 20 (SD 11) years, and had a mean hemoglobin A<sub>1c</sub> level of 8.4% (SD 1.2%); 11% of the participants did not complete follow up. Analysis of covariance assumptions were met for the ITT and PP models. In ITT analysis, participants in the One Drop and activity tracker condition had a significantly lower 3-month hemoglobin A<sub>1c</sub> level (mean 7.9%, SD 0.60%, 95% CI 7.8-8.2) than that of the participants in the One Drop only condition (mean 8.4%, SD 0.62%, 95% CI 8.2-8.5). In PP analysis, participants in the One Drop and activity tracker condition also had a significantly lower 3-month hemoglobin A<sub>1c</sub> level (mean 7.9%, SD 0.59%, 95% CI 7.7-8.1) than that of participants in the One Drop only condition (mean 8.2%, SD 0.58%, 95% CI 8.0-8.4). CONCLUSIONS Participants exposed to One Drop and the activity tracker for the 3-month study period had a significantly lower 3-month hemoglobin A<sub>1c</sub> level compared to that of participants exposed to One Drop only during the same timeframe. One Drop and a tracker may work better together than alone in helping people with type 1 diabetes. CLINICALTRIAL ClinicalTrials.gov NCT03459573; https://clinicaltrials.gov/ct2/show/NCT03459573.

scholarly journals Polysomnographic Predictors of Treatment Response to Cognitive Behavioral Therapy for Insomnia in Participants With Co-morbid Insomnia and Sleep Apnea: Secondary Analysis of a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Alexander Sweetman ◽  
Bastien Lechat ◽  
Peter G. Catcheside ◽  
Simon Smith ◽  
Nick A. Antic ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Apnea ◽  
Cognitive Behavioral Therapy ◽  
Sleep Disturbance ◽  
Treatment Response ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Pre Treatment

ObjectiveCo-morbid insomnia and sleep apnea (COMISA) is a common and debilitating condition that is more difficult to treat compared to insomnia or sleep apnea-alone. Emerging evidence suggests that cognitive behavioral therapy for insomnia (CBTi) is effective in patients with COMISA, however, those with more severe sleep apnea and evidence of greater objective sleep disturbance may be less responsive to CBTi. Polysomnographic sleep study data has been used to predict treatment response to CBTi in patients with insomnia-alone, but not in patients with COMISA. We used randomized controlled trial data to investigate polysomnographic predictors of insomnia improvement following CBTi, versus control in participants with COMISA.MethodsOne hundred and forty five participants with insomnia (ICSD-3) and sleep apnea [apnea-hypopnea index (AHI) ≥ 15] were randomized to CBTi (n = 72) or no-treatment control (n = 73). Mixed models were used to investigate the effect of pre-treatment AHI, sleep duration, and other traditional (AASM sleep macrostructure), and novel [quantitative electroencephalography (qEEG)] polysomnographic predictors of between-group changes in Insomnia Severity Index (ISI) scores from pre-treatment to post-treatment.ResultsCompared to control, CBTi was associated with greater ISI improvement among participants with; higher AHI (interaction p = 0.011), less wake after sleep onset (interaction p = 0.045), and less N3 sleep (interaction p = 0.005). No quantitative electroencephalographic, or other traditional polysomnographic variables predicted between-group ISI change (all p &gt; 0.09).DiscussionAmong participants with COMISA, higher OSA severity predicted a greater treatment-response to CBTi, versus control. People with COMISA should be treated with CBTi, which is effective even in the presence of severe OSA and objective sleep disturbance.

scholarly journals Go Play Outside! A web-based and in-person risk reframing intervention to influence mothers’ tolerance for, and parenting practices associated with, children’s outdoor risky play: Results of a randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Mariana Brussoni ◽  
Christina S Han ◽  
Yingyi Lin ◽  
John Jacob ◽  
Ian Pike ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Social Cognitive Theory ◽  
Social Cognitive ◽  
Cognitive Theory ◽  
Controlled Trial ◽  
Post Intervention ◽  
Web Based ◽  
Randomized Controlled ◽  
Risky Play ◽  
The Web

BACKGROUND Outdoor risky play, such as climbing, racing and independent exploration, is an important part of childhood and is associated with various positive physical, mental and developmental outcomes for children. Parental attitudes and fears, particularly mothers’, are a major deterrent to children’s opportunities for outdoor risky play. OBJECTIVE To evaluate the efficacy of two versions of an intervention to reframe mothers’ perceptions of risk and change parenting behaviours: web-based intervention or an in-person workshop, compared to the control condition. METHODS The Go Play Outside! randomized controlled trial was conducted in Canada in 2017 to 2018. Participants were recruited through social media, snowball sampling, and community notices. Mothers of children aged 6-12 years were self-assessed through eligibility questions, and those eligible and consented to participate in the study were randomized into a fully automated web-based intervention, the in-person workshop or the control condition. The intervention was underpinned by social cognitive theory, incorporating behaviour change techniques. Participants progressed through a series of self-reflection exercises and developed a goal for change. Control participants received the Position Statement on Active Outdoor Play. The primary outcome was increase in tolerance of risky play and the secondary outcome was goal attainment. Data were collected online via REDCap at baseline, 1-week and 3-months post-intervention. Randomization was conducted using sealedenvelope.com. Allocations were concealed to researchers at assignment and data analysis. We conducted mediation analyses to examine whether the intervention influenced elements of social cognitive theory, as hypothesized. RESULTS A total of 451 mothers were randomized and completed baseline socio-demographic assessments: 150 in the web-based intervention, 153 in the in-person workshop, and 148 in the control condition; of which a total of 351 mothers completed the intervention. At 1-week post-intervention, 121, 85, and 135 mothers completed assessments for each condition, respectively, and at 3-months post-intervention, 105, 84 and 123 completed the assessments, respectively. Compared to mothers in the control condition, mothers in the web-based intervention had significantly higher tolerance of risky play at 1-week, and 3-months post-intervention; and mothers in the in-person workshop had significantly higher tolerance of risky play at 1-week post-intervention. No other significant outcomes were found. None of the potential mediators were found to significantly mediate the outcomes. CONCLUSIONS The trial demonstrates that the web-based intervention was effective in increasing mothers’ tolerance for risk in play. CLINICALTRIAL ClinicalTrials.gov, NCT03374683. Retrospectively registered on December 15, 2017. INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-018-2552-4

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