Slow Cortical Potential Versus Live Z-score Neurofeedback in Children and Adolescents with ADHD: A Multi-arm Pragmatic Randomized Controlled Trial with Active and Passive Comparators

AbstractNeurofeedback (NF) as a treatment for Attention Deficit Hyperactivity Disorder (ADHD) has been evaluated in several trials, but the specificity and generalizability of effects remain unclear. This four-arm randomized controlled trial evaluated the efficacy of Slow Cortical Potential (SCP; standard NF protocol) and Live Z-score (LZS; non-standard NF protocol) delivered in high-frequency format (five sessions per week during five weeks), compared to Working-memory training (WMT; active comparator) and Treatment-as-usual (TAU; passive comparator). N = 202 children/adolescents aged 9 to 17 years with ADHD participated. The primary outcome measure was multi-report (self-, teacher-, and parent-report) ADHD core symptoms on the Conners-3, assessed at baseline, posttreatment, and 6-months follow-up. Data were analyzed using a linear mixed model. Between-group differences were scarce and did not show a distinct pattern. Superiority of LZS over TAU at endpoint were observed for teacher-rated measures only, while significant differences between SCP and TAU were restricted to posttreatment measurements. Contrary to our expectations, LZS outperformed SCP at endpoint for teacher-rated hyperactivity (-5.37; 95% CI: -10.14 to -0.60; p = .028; d = -.36) and overall ADHD symptoms (-2.20; -4.18 to -0.22; p = .030; d = -.41). There was no indication that either form of NF was superior to WMT. No severe adverse events were reported during the trial, whereas transient stress-related problems were quite frequent. Overall, the results from this pragmatic trial do not provide convincing support for broad implementation of NF in child and adolescent psychiatric services. Future research should try to clarify for whom and under what circumstances NF might be a viable treatment option.

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The effect of written information and counselling by an advanced practice nurse on resilience in women with vulvar neoplasia during six months after surgical treatment and the influence of social support, recurrence, and age: A secondary analysis of a multicenter randomized controlled trial, WOMAN-PRO-II

10.21203/rs.2.16848/v2 ◽

2020 ◽

Author(s):

Sabine Kofler ◽

Andrea Kobleder ◽

Stefan Ott ◽

Beate Senn

Keyword(s):

Randomized Controlled Trial ◽

Surgical Treatment ◽

Mixed Model ◽

Linear Mixed Model ◽

Practice Nurse ◽

Controlled Trial ◽

Advanced Practice ◽

Advanced Practice Nurse ◽

Randomized Controlled ◽

Written Information

Abstract Background: Women with vulvar neoplasia often complain about physical and psychological distress after surgical treatment. Lack of information and support can influence resilience. Whether an information-related intervention through an advanced practice nurse supports resilience and which other factors affect resilience in women with vulvar neoplasia has never been investigated. Methods: The aims of this study were (a) to analyse whether counselling based on the WOMAN-PRO II program causes a significant improvement in the resilience scores of women with vulvar neoplasia compared to written information and (b) to identify the potential predictors of resilience. A randomized controlled trial was conducted in women with vulvar neoplasia (n = 49) six months after surgical treatment in four Swiss hospitals and one Austrian hospital. Analyses of resilience and its predictors were performed using a linear mixed model. Results: Thirty-six women (intervention I, n = 8; intervention II, n = 28) completed the randomized controlled trial. In total, 13 women (26.5%) dropped out of the trial. The resilience score did not differ significantly between the two interventions three and six months after randomisation (p = 0.759). Age (b = .04, p = 0.001), social support (b = .28, p = 0.009), counselling time (b = .03, p = 0.018) and local recurrence (b = −.56, p = 0.009) were identified as significant predictors of resilience in the linear mixed model analyses. Conclusion: The results indicate that the WOMAN-PRO II program as single intervention does not cause a significant change in the resilience scores of women with vulvar neoplasia six months after surgery. Predictors that promote or minimise resilience have been identified and should be considered when developing resilience programs for women with vulvar neoplasia. A repetition of the study with a larger sample size is recommended.

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Cardiovascular Risk Comparison between Expanded Hemodialysis Using Theranova and Online Hemodiafiltration (CARTOON): A Multicenter Randomized Controlled Trial

Scientific Reports ◽

10.1038/s41598-021-90311-6 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Yeonhee Lee ◽

Myoung-jin Jang ◽

Junseok Jeon ◽

Jung Eun Lee ◽

Wooseong Huh ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Rank Test ◽

Cardiovascular Parameters ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Patient Reported ◽

Echocardiographic Parameters

AbstractExpanded hemodialysis (HDx) with medium cutoff (MCO) membranes, which remove middle-to-large molecules well, may be a good option to replace online hemodiafiltration (online-HDF). To provide more evidence, this randomized controlled trial compared several cardiovascular parameters between patients undergoing HDx and online-HDF. Eighty patients undergoing thrice-weekly hemodialysis were randomly assigned to receive either HDx with a Theranova membrane (n = 43) or online-HDF (n = 37). The primary endpoints were changes in brachial-ankle pulse wave velocity (baPWV), echocardiographic parameters, and coronary artery calcium (CAC) scores over 1 year, and the secondary endpoints included blood cardiovascular biomarkers, mortality, and patient-reported outcomes. A linear mixed model and log-rank test were used to estimate the group differences. 65 patients had completed the trial. The changes in baPWV and echocardiographic parameters did not differ between the two groups. The CAC scores remained stable in the online-HDF group, whereas an increasing trend was shown in the HDx group (P = 0.012). Other endpoints, including cardiovascular and all-cause mortalities, were similar between the two groups. The changes in cardiovascular parameters did not differ between HDx with an MCO membrane and online-HDF. However, attention may be needed in patients with high CAC scores or scores with an increasing tendency when online-HDF is replaced with HDx with an MCO membrane.

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Changing Stress Mindsets with a Novel Imagery Intervention: A Randomized Controlled Trial

10.31234/osf.io/z4qvh ◽

2019 ◽

Cited By ~ 1

Author(s):

Jacob J Keech ◽

Martin S Hagger ◽

Kyra Hamilton

Keyword(s):

Randomized Controlled Trial ◽

Academic Performance ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Future Research ◽

Ecological Stress ◽

Beneficial Effects ◽

Randomized Controlled

Objective: Changing individuals’ stress mindset has emerged as a technique that may be effective in aiding stress management, but there is limited data on the effects of this technique in managing stress in ‘real world’ contexts beyond a few days. This study aimed to (1) evaluate the efficacy of a novel imagery-based intervention in changing stress mindset; and, (2) evaluate the effect of the intervention on stress-related outcomes, compared to a control, after two weeks. Methods: The study adopted a pre-registered randomized controlled trial design. University students (N = 150) attended a research laboratory twice over two weeks, receiving the intervention or control condition stimuli in Session 1, and completing measures in both sessions. Academic performance data was collected from university records. Results: Mixed model ANOVAs revealed a large-sized difference in stress mindset among intervention group participants immediately following the intervention and at the follow-up relative to controls. There were also robust effects of the intervention on perceived distress, positive and negative affect, proactive behavior, and academic performance at the follow-up in individuals with high baseline perceived distress. Conclusions: Findings indicate that the intervention is a promising approach for changing individuals’ stress mindset and that changing stress mindset can have beneficial effects on coping with ecological stressors. Future research should use intensive longitudinal designs to examine momentary activation of stress mindset and responses to ecological stress.

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Nudging customers towards healthier food and beverage purchases in a real-life online supermarket: a multi-arm randomized controlled trial

BMC Medicine ◽

10.1186/s12916-021-02205-z ◽

2022 ◽

Vol 20 (1) ◽

Author(s):

Josine M. Stuber ◽

Jeroen Lakerveld ◽

Loes W. Kievitsbosch ◽

Joreintje D. Mackenbach ◽

Joline W. J. Beulens

Keyword(s):

Randomized Controlled Trial ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Intervention Strategy ◽

Real Life ◽

Healthy Food ◽

Lower Percentage ◽

Randomized Controlled ◽

Deprived Areas

Abstract Background Nudging is increasingly used to promote healthy food choices in supermarkets. Ordering groceries online is gaining in popularity and nudging seems efficacious there as well, but is never comprehensively tested in real-life. We evaluated the real-life effectiveness of nudging in an online supermarket on healthy food purchases. Methods We conducted a multi-arm, parallel-group, individually randomized controlled trial in an online supermarket. During 1 month, all customers were randomized to (1) control condition, (2) information nudges, (3) position nudges, and (4) information and position nudges combined. Allocation was concealed and customers were not blinded, but unaware of the intervention. Mean differences between the control condition and the intervention arms in the total percentage of healthy purchases were assessed with a linear mixed model. We tested for effect modification by area-level deprivation. Results Based on sales data from 11,775 shoppers, no overall significant effects were detected. Yet, effects were modified by area-level deprivation (pArm 2 < 0.001). Among shoppers from deprived areas, those allocated to information nudges purchased a 2.4% (95%CI 0.8, 4.0) higher percentage of healthy products compared to controls. No significant differences were observed for position (− 1.3%; 95%CI − 2.8, 0.3) and combined nudges (− 0.1%; 95%CI − 1.7, 1.5). Shoppers from non-deprived areas exposed to information nudges (− 1.6%; 95%CI − 3.2, − 0.1) and the combined nudges (− 2.1%; 95%CI − 3.6, − 0.6), but not position nudges (− 0.9%; 95%CI − 2.4, 0.7), purchased a lower percentage of healthy products. Conclusion Information nudges in an online supermarket can increase healthy product purchases, but only for those living in deprived areas. The adverse effects found on purchasing behaviors for those from non-deprived areas call for further research. Further research should also focus on real-life effects of online healthy food nudging as part of a broader nutrition intervention strategy, and on the equitability of the online nudging intervention within populations. Trial registration Retrospectively registered in the ISRCTN registry at May 21, 2021 (ISRCTN10491616).

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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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A Randomized Controlled Trial Evaluating Integrative Psychotherapeutic Group Treatment Compared to Self-Help Groups in Functional Vertigo/Dizziness

Journal of Clinical Medicine ◽

10.3390/jcm10102215 ◽

2021 ◽

Vol 10 (10) ◽

pp. 2215

Author(s):

Karina Limburg ◽

Katharina Radziej ◽

Heribert Sattel ◽

Peter Henningsen ◽

Marianne Dieterich ◽

...

Keyword(s):

Group Treatment ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Clinical Psychologist ◽

Control Group ◽

Attrition Rates ◽

Randomized Controlled ◽

Self Help ◽

Self Help Groups

We tested the efficacy of an integrative psychotherapeutic group treatment (IPGT) in reducing vertigo/dizziness-related impairment along with depression, anxiety, and somatization by conducting a randomized controlled superiority trial comparing IPGT to self-help groups moderated by a clinical psychologist (SHG). Adult patients with functional vertigo and dizziness symptoms were randomly allocated to either the IPGT or SHG as active control group. Outcomes were assessed at baseline (t0), after treatment lasting 16 weeks (t1), and 12 months after treatment (t2). A total of 81 patients were assigned to IPGT and 78 patients were assigned to SHG. Vertigo-related impairment was reduced in both conditions (IPGT: t0–t1: d = 1.10, t0–t2: d = 1.06; SHG: t0–t1: d = 0.86, t0–t2: d = 1.29), showing the efficiency of both IPGT and SHG. Clinically relevant improvements were also obtained for depression in both groups. Linear mixed model analyses revealed no differences between groups for all outcomes (effect of group for the primary outcome: b = −1.15, SE = 2.13, t = −0.54, p = 0.59). Attrition rates were higher in SHG (52.6%) than in IPGT (28.4%). Both conditions improved primary and secondary outcomes while IPGT was better accepted by patients than SHG. Trial registration: ClinicalTrials.gov, Identifier: NCT02320851.

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Long-Term Effects on Loneliness of a Computer-Tailored Intervention for Older Adults With Chronic Diseases: A Randomized Controlled Trial

Journal of Aging and Health ◽

10.1177/08982643211015027 ◽

2021 ◽

pp. 089826432110150

Author(s):

Janet M. Boekhout ◽

Esmee Volders ◽

Catherine A. W. Bolman ◽

Renate H. M. de Groot ◽

Lilian Lechner

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Chronic Diseases ◽

Controlled Trial ◽

Social Activity ◽

Time Frame ◽

Future Research ◽

Long Term Effects ◽

Randomized Controlled ◽

Social Loneliness

Objectives: This study explores the effects of the Active Plus intervention aiming to decrease loneliness among older adults (>65 years) with chronic diseases. Methods: A randomized controlled trial (RCT) was performed (N = 585; age: M = 74.5 years, SD = 6.4), assessing loneliness at baseline, 6 months and 12 months. Outcome measures in the multilevel linear regression analyses were total, social and emotional loneliness. Results: At 12 months, significant decreases in total ( B = −.37, p = .01) and social loneliness ( B = −.24, p = .02) were found. Age was a significant moderator for total and social loneliness; however, the intervention was effective only for participants aged 80 years and older. Discussion: The Active Plus intervention showed a significant decrease in total and social loneliness and was especially beneficial for the vulnerable age group of 80 years and older. A more comprehensive tool for measuring social activity and mobility impairments, and using a longer time frame to detect loneliness changes, may form interesting future research.

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Efficacy of Adjuvant Application of Platelet-Rich Plasma After Needle Aspiration of Calcific Deposits for the Treatment of Rotator Cuff Calcific Tendinitis: A Double-Blinded, Randomized Controlled Trial With 2-Year Follow-up

The American Journal of Sports Medicine ◽

10.1177/0363546520987579 ◽

2021 ◽

Vol 49 (4) ◽

pp. 873-882

Author(s):

Bart W. Oudelaar ◽

Rianne Huis In ‘t Veld ◽

Edwin M. Ooms ◽

Relinde Schepers-Bok ◽

Rob G.H.H. Nelissen ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Rotator Cuff ◽

Mixed Model ◽

Platelet Rich Plasma ◽

Controlled Trial ◽

Needle Aspiration ◽

Randomized Controlled ◽

Clinical Scores ◽

Calcific Deposits

Background: Needle aspiration of calcific deposits (NACD) is a frequently used treatment for rotator cuff calcific tendinitis (RCCT). However, a substantial number of patients experience recurrent or persisting shoulder symptoms after NACD. Purpose: To compare the effects of adjuvant application of platelet-rich plasma (PRP) after NACD (NACP+PRP) with those of conventional NACD with corticosteroids (NACD+corticosteroids) on pain, shoulder function, and quality of life (QoL). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In a single-center, double-blinded, randomized controlled trial, 80 adults with symptomatic RCCT were randomly allocated to receive NACD+corticosteroids or NACD+PRP. Pain, shoulder function, and QoL were assessed at baseline; 6 weeks; and 3, 6, 12, and 24 months after treatment using a numeric rating scale for pain (NRS); the Constant-Murley score (CMS); the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH); the Oxford Shoulder Score (OSS); and the EuroQol 5-dimension scale (EQ-5D). Additionally, resorption of calcific deposits and the integrity of rotator cuff tendons were assessed by using standard radiographs and ultrasound examination, respectively. The results were analyzed using noninferiority analysis for NRS scores and a mixed model for repeated measures. Results: Eighty patients were included (48 female; mean age, 49 ± 6 years; 41 patients in the NACD+PRP group). Both groups showed improvement of clinical scores at the 2-year follow-up ( P < .001 for all clinical scores). NACD+PRP was found to be noninferior to NACD+corticosteroids with regard to the mean decrease of NRS scores (4.34 vs 3.56; P = .003). Mixed-model analysis showed a significant difference in favor of NACD+PRP (CMS, P < .001; DASH, P = .002; OSS, P = .010; EQ-5D, P < .001). However, clinically relevant differences in favor of NACD+PRP were only seen at the 6-month follow-up for NRS and CMS scores, whereas at the 6-week follow-up a clinically relevant difference in favor of NACD+corticosteroids was found for all clinical scores except for the NRS. Full resorption of calcific deposits was present in 84% of the NACD+PRP group compared with 66% in the NACD+corticosteroids group ( P = .081). In the NACD+PRP group, 10 (24%) patients required a second NACD procedure compared with 19 (49%) patients in the NACD+corticosteroids group ( P = .036). Six complications, of which 5 were frozen shoulders, occurred in the NACD+PRP group compared with 1 complication in the NACD+corticosteroids group ( P = .11). Conclusion: NACD+PRP resulted in worse clinical scores at the 6-week follow-up but better clinical scores at the 6-month follow-up compared with NACD+corticosteroids. At the 1- and 2-year follow-ups, the results were comparable between groups. Furthermore, PRP seemed to reduce the need for additional treatments but was associated with more complications. In conclusion, NACD+corticosteroids had a favorable early effect on pain and function combined with low comorbidity. Thus, it remains the treatment of choice for patients with RCCT. Registration: NCT02173743 (ClinicalTrials.gov identifier).

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Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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A Randomized Clinical Trial of Snus Examining the Effect of Complete Versus Partial Cigarette Substitution on Smoking-Related Behaviors, and Biomarkers of Exposure

Nicotine & Tobacco Research ◽

10.1093/ntr/ntz055 ◽

2019 ◽

Vol 22 (4) ◽

pp. 473-481 ◽

Cited By ~ 1

Author(s):

Ellen Meier ◽

Bruce R Lindgren ◽

Amanda Anderson ◽

Sarah A Reisinger ◽

Kaila J Norton ◽

...

Keyword(s):

New York ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Partial Substitution ◽

Randomized Controlled ◽

Biomarkers Of Exposure ◽

Wilcoxon Rank Sum Test ◽

Volatile Organic ◽

Subsequent Exposure

Abstract Introduction This 8-week multisite, randomized controlled trial of snus examined the differential effects of instructions on (1) snus use, (2) smoking and smoking-related measures, and (3) exposure to tobacco-related constituents. Method US adult daily cigarette smokers (n = 150; 43.3% female; Medianage = 43.5) were recruited from Minneapolis, Minnesota; Columbus and Coshocton, Ohio; and Buffalo, New York. Following a 1-week sampling phase of snus, participants who used at least 7 pouches were randomized to either (1) partial substitution (PS; “use snus as you like with your cigarettes”), (2) complete substitution (CS; “avoid cigarettes”), or (3) usual brand cigarettes (UB). Analyses included between-group analyses (eg, PS vs. CS) using Wilcoxon rank sum test of cigarettes per day and snus pouches per day, and a linear mixed model (biomarkers). Results Compared to the PS and UB groups, smokers assigned to CS reported greater reductions in cigarettes per day (ps < .001), using more snus pouches per day (p = .02), and more smoke-free days (CS median = 14.5, PS and UB medians = 0, p < .001). In addition, results demonstrated reductions in carbon monoxide (p < .001), total nicotine equivalents (p = .02), and four out of five measured volatile organic compounds (ps < .01) over time among the CS group. Exposure to N′-nitrosonornicotine increased by trial end only among the PS group (p < .04). Phenanthrene tetraol increased among all groups by trial end (p = .02) with no difference between groups. Conclusions Instructions to completely switch from cigarettes to snus resulted in the greatest reduction in cigarettes and exposure to harmful constituents. Implications Directly instructing smokers to switch completely to snus, rather than using ad libitum (with no instructions to avoid cigarettes), is necessary for reductions in smoking and subsequent exposure to harmful constituents.

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