Shyness 3: Randomized Controlled Trial of Guided Versus Unguided Internet-Based CBT for Social Phobia

2008 ◽  
Vol 42 (12) ◽  
pp. 1030-1040 ◽  
Author(s):  
Nickolai Titov ◽  
Gavin Andrews ◽  
Isabella Choi ◽  
Genevieve Schwencke ◽  
Alison Mahoney

Objective: In two previous randomized controlled trials Titov et al. demonstrated significant benefit from an Internet- and email-based treatment programme for social phobia. The present study (Shyness 3) explores whether participants are able to complete this programme independently. Method: A total of 98 individuals with social phobia were randomly assigned to a clinician-assisted computerized cognitive behavioural treatment (CaCCBT) group, a self-guided computerized CBT (CCBT) group, or to a waitlist control group. CaCCBT group participants completed the usual Shyness programme consisting of six online lessons, cognitive behavioural homework assignments, email contact with a therapist, and participation in an online discussion forum. CCBT group participants accessed the same resources except for therapist emails. An intention-to-treat model was used for data analyses. Results: A total of 77% of CaCCBT and 33% of CCBT group participants completed all lessons. Significant differences were found after treatment between CaCCBT and control groups (mean between-groups effect size (ES) for the social phobia measures = 1.04), and between the CaCCBT and CCBT groups (mean between-groups ES for the social phobia measures = 0.66). No significant differences were found after treatment between the CCBT and control groups (mean between-groups ES for the social phobia measures = 0.38). CCBT participants, however, who completed the six lessons made good progress (mean within-group ES for the social phobia measures = 0.62). Quantitative and qualitative data indicate that both the CaCCBT and CCBT procedures were acceptable to participants. Conclusions: The reliability of this Internet-based treatment programme for social phobia has been confirmed. The therapist-guided condition was superior to the self-guided condition, but a subgroup of participants still benefited considerably from the latter. These data confirm that self-guided education or treatment programmes for common anxiety disorders can result in significant improvements.

2021 ◽  
pp. 026921552110411
Author(s):  
Hiromichi Takeda ◽  
Katsuhiko Takatori

Objective To assess the preliminary effects of a buddy-style intervention to improve exercise adherence. Design A parallel-group, open-label, pilot randomized controlled trial. Setting Adult day-care centers. Participants Sixty-five disabled older adults. Interventions All participants underwent a 12-week home exercise program, and the intervention group received a 5–10 min buddy-style intervention between older adults in the intervention group once weekly at an adult day-care center. Main measures Based on the exercise log calendar, the number of days of exercise was assessed for each of the three phases: 1–4 weeks, 5–8 weeks, and 9–12 weeks. Short physical performance battery was measured at baseline and after 12 weeks. Results Of the 590 screened older adults, 65 were recruited and 33 were assigned to the intervention group. One participant in each group withdrew before the program began, and four and five patients in the intervention and control groups, respectively, dropped out by the 12-week assessment. Analysis of covariance of the 28 and 26 patients in the intervention and control groups, respectively, for whom exercise log calendars could be retrieved, showed that the intervention group (24.4/28 days) exercised significantly more days than the control group (20.6/28 days) at 9–12 weeks ( P = 0.009). In the between-group effect of the intention-to-treat analysis of short physical performance battery, walking and standing test ( P = 0.790, P = 0.829) were not significantly different, and balance test ( P = 0.049) was significantly better in the control group. Conclusions There was a preliminary effect of the buddy-style intervention to improve exercise adherence.


2012 ◽  
Vol 27 (2) ◽  
pp. 133-141 ◽  
Author(s):  
Venkatesan Prem ◽  
Ramesh Chandra Sahoo ◽  
Prabha Adhikari

Objective: To compare two breathing exercises (Buteyko and pranayama) with a control group in patients with asthma. Design: Randomized controlled trial. Subjects: One hundred and twenty subjects were randomized to three groups through block randomization. Subjects with an Asthma Quality of Life Questionnaire score <5.5 participated in the study. Setting: Outpatient pulmonary medicine department. Interventions: Subjects in the Buteyko and pranayama groups were trained for 3–5 days and instructed to practise the exercises for 15 minutes twice daily, and for three months duration. The control group underwent routine pharmacological management during the study period. Outcome measures: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire and pulmonary function test. Results: The baseline characteristics were similar in all three groups. Post intervention, the Buteyko group showed better trends of improvement (mean (95% confidence interval), P-value) in total Asthma Quality of Life Questionnaire score than the pranayama (0.47 (–0.008–0.95), P = 0.056) and control groups (0.97 (0.48–1.46), P = 0.0001). In comparison between the pranayama and control groups, pranayama showed significant improvement (0.50 (0.01–0.98), P = 0.042) in total Asthma Quality of Life Questionnaire score. Conclusion: The Buteyko group showed better trends of improvement in quality of life and asthma control than the group performing the pranayama breathing exercise.


2011 ◽  
Vol 3 (3) ◽  
pp. 157-159
Author(s):  
Sudha A Raddi ◽  
TT Sheeba ◽  
MB Ballad

ABSTRACT Objectives The objectives of the study are to: (i) Assess the perineal muscle strength of postnatal mothers after vaginal delivery in the experimental and control groups before and after the intervention. (ii) Evaluate the effectiveness of Kegel's exercise on perineal laxity in the experimental group compared to control group. Methods This single blinded randomized controlled trial at a 1000 bedded tertiary care teaching hospital in India, enrolled 290 postnatal mothers between 20 and 40 years who had vaginal delivery with < 2 on modified Oxford grading scale as measured by per vaginal digital examination. The subjects were randomized into experimental and control groups. The experimental group received instructions to perform Kegel's exercises along with routine postnatal care while the control group received advice on routine postnatal care. Two follow-up assessments were done at 6 and 10 weeks. The primary outcome measure was increase in Oxford grading score. Results Major findings of the study were: The mean perineal muscle strength assessment scores noted before the intervention and during first and second postintervention assessments were 1.5 ± 0.52, 3.58 ± 0.51 and 4.28 ± 0.57 respectively for the experimental group and 1.56 ± 0.55, 2.41 ± 0.52 and 3 ± 0.51 respectively for the control group. Comparison of these scores between the groups by unpaired t-test yielded p-value of < 0.0001 suggesting high significant difference in favor of the experimental group. However, no additional benefit was observed after Kegel's exercise in the mothers who had episiotomy during vaginal delivery. Conclusion The Kegel's exercise is effective to reduce perineal laxity and hence should be included as a part of routine postnatal care.


2021 ◽  
Author(s):  
David Scheim ◽  
Jennifer A. Hibberd ◽  
Juan Chamie-Quintero

A randomized controlled trial for treatment of mild cases of COVID-19 conducted in Cali, Colombia reported no statistically significant differences in outcomes for its ivermectin (IVM) and placebo arms. A striking anomaly, however, was that certain adverse events (AEs) that are distinctive for the study’s high-dose IVM use occurred at nearly identical rates in its IVM and placebo arms. The backdrop for these indicators of IVM use in study controls was widespread sales of IVM for COVID-19 in the Cali area during the study period, with 1.6 IVM doses sold over the counter for each case of COVID-19. The study compounded these risks of contamination of the control arm with critical errors in blinding and segregation of IVM v. placebo doses. A labeling error substituted IVM for placebo doses of 38 patients. Also, 5% dextrose solution was used for several weeks as a placebo, easily distinguishable from bitter tasting IVM. Given widespread availability and sales of IVM in Cali, lapses in segregation and blinding of IVM and control doses, and IVM-characteristic AEs in controls, the integrity of the study’s control arm was violated. Some useful information can nevertheless be salvaged from outcomes of this study’s IVM treatment arm, which had 0 deaths and generally mild symptoms, with AEs typical for high-dose IVM (replicated in the control group) that were generally mild and transient.


2020 ◽  
Vol 7 (3) ◽  
pp. 191818 ◽  
Author(s):  
Anisa Rowhani-Farid ◽  
Adrian Aldcroft ◽  
Adrian G. Barnett

Sharing data and code are important components of reproducible research. Data sharing in research is widely discussed in the literature; however, there are no well-established evidence-based incentives that reward data sharing, nor randomized studies that demonstrate the effectiveness of data sharing policies at increasing data sharing. A simple incentive, such as an Open Data Badge, might provide the change needed to increase data sharing in health and medical research. This study was a parallel group randomized controlled trial (protocol registration: doi:10.17605/OSF.IO/PXWZQ ) with two groups, control and intervention, with 80 research articles published in BMJ Open per group, with a total of 160 research articles. The intervention group received an email offer for an Open Data Badge if they shared their data along with their final publication and the control group received an email with no offer of a badge if they shared their data with their final publication. The primary outcome was the data sharing rate. Badges did not noticeably motivate researchers who published in BMJ Open to share their data; the odds of awarding badges were nearly equal in the intervention and control groups (odds ratio = 0.9, 95% CI [0.1, 9.0]). Data sharing rates were low in both groups, with just two datasets shared in each of the intervention and control groups. The global movement towards open science has made significant gains with the development of numerous data sharing policies and tools. What remains to be established is an effective incentive that motivates researchers to take up such tools to share their data.


2017 ◽  
Vol 46 (2) ◽  
pp. 388-395 ◽  
Author(s):  
Zoe Y.S. Chan ◽  
Janet H. Zhang ◽  
Ivan P.H. Au ◽  
Winko W. An ◽  
Gary L.K. Shum ◽  
...  

Background: The increasing popularity of distance running has been accompanied by an increase in running-related injuries, such that up to 85% of novice runners incur an injury in a given year. Previous studies have used a gait retraining program to successfully lower impact loading, which has been associated with many running ailments. However, softer footfalls may not necessarily prevent running injury. Purpose: To examine vertical loading rates before and after a gait retraining program and assess the effectiveness of the program in reducing the occurrence of running-related injury across a 12-month observation period. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 320 novice runners from the local running club completed this study. All the participants underwent a baseline running biomechanics evaluation on an instrumented treadmill with their usual running shoes at 8 and 12 km/h. Participants were then randomly assigned to either the gait retraining group or the control group. In the gait retraining group (n = 166), participants received 2 weeks of gait retraining with real-time visual feedback. In the control group (n = 154), participants received treadmill running exercise but without visual feedback on their performance. The training time was identical between the 2 groups. Participants’ running mechanics were reassessed after the training, and their 12-month posttraining injury profiles were tracked by use of an online surveillance platform. Results: A significant reduction was found in the vertical loading rates at both testing speeds in the gait retraining group ( P < .001, Cohen’s d > 0.99), whereas the loading rates were either similar or slightly increased in the control group after training ( P = .001 to 0.461, Cohen’s d = 0.03 to −0.14). At 12-month follow-up, the occurrence of running-related musculoskeletal injury was 16% and 38% in the gait retraining and control groups, respectively. The hazard ratio between gait retraining and control groups was 0.38 (95% CI, 0.25-0.59), indicating a 62% lower injury risk in gait-retrained runners compared with controls. Conclusion: A 2-week gait retraining program is effective in lowering impact loading in novice runners. More important, the occurrence of injury is 62% lower after 2 weeks of running gait modification. Registration: HKUCTR-1996 (University of Hong Kong Clinical Trials Registry).


2021 ◽  
Author(s):  
Huib Van de Kop ◽  
Huub Toussaint ◽  
Mirka Janssen ◽  
Vincent Busch ◽  
Arnoud Verhoeff

BACKGROUND A consistent finding in the literature is the decline in physical activity during adolescence, resulting in activity levels below the recommended guidelines. Therefore, promotion of physical activity is recommended specifically for prevocational students. OBJECTIVE This protocol paper describes the background and design of a physical activity promotion intervention study in which prevocational students are invited to participate in the design and implementation of an intervention mix. The intervention is expected to prevent a decline in physical activity in the target group. METHODS The effectiveness of the intervention was evaluated in a two-group cluster randomized controlled trial with assessments at baseline and 2-year follow-up. A simple randomization was applied, allocating 11 schools to the intervention group and 11 schools to the control group, which followed the regular school curriculum. The research population consisted of 3003 prevocational students, aged 13-15 years. The primary outcome measures were self-reported physical activity levels (screen time, active commuting, and physical activity). As a secondary outcome, direct assessment of physical fitness (leg strength, arm strength, hip flexibility, hand speed, abdominal muscle strength, BMI, and body composition) was included. An intervention-control group comparison was presented for the baseline results. The 2-year interventions began by mapping the assets of the prevocational adolescents of each intervention school using motivational interviewing in the structured interview matrix and the photovoice method. In addition, during focus group sessions, students, school employees, and researchers cocreated and implemented an intervention plan that optimally met the students’ assets and opportunities in the school context. The degree of student participation was evaluated through interviews and questionnaires. RESULTS Data collection of the SALVO (stimulating an active lifestyle in prevocational students) study began in October 2015 and was completed in December 2017. Data analyses will be completed in 2021. Baseline comparisons between the intervention and control groups were not significant for age (<i>P</i>=.12), screen time behavior (<i>P</i>=.53), nonschool active commuting (<i>P</i>=.26), total time spent on sports activities (<i>P</i>=.32), total physical activities (<i>P</i>=.11), hip flexibility (<i>P</i>=.22), maximum handgrip (<i>P</i>=.47), BMI (<i>P</i>=.44), and sum of skinfolds (<i>P</i>=.29). Significant differences between the intervention and control groups were found in ethnicity, gender, active commuting to school (<i>P</i>=.03), standing broad jump (<i>P</i>=.02), bent arm hang (<i>P</i>=.01), 10× 5-m sprint (<i>P</i>=.01), plate tapping (<i>P</i>=.01), sit-ups (<i>P</i>=.01), and 20-m shuttle run (<i>P</i>=.01). CONCLUSIONS The SALVO study assesses the effects of a participatory intervention on physical activity and fitness levels in prevocational students. The results of this study may lead to a new understanding of the effectiveness of school-based physical activity interventions when students are invited to participate and cocreate an intervention. This process would provide structured health promotion for future public health. CLINICALTRIAL ISRCTN Registry ISRCTN35992636; http://www.isrctn.com/ISRCTN35992636 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/28273


2020 ◽  
Vol 28 (6) ◽  
pp. 828-835
Author(s):  
Ya-Chen Liu ◽  
Wen-Wen Yang ◽  
I-Yao Fang ◽  
Hope Li-Ling Pan ◽  
Wei-Han Chen ◽  
...  

Outdoor fitness equipment (OFE) is installed in parks to promote health, particularly among seniors. However, no quantitative study has investigated its effectiveness. Therefore, this study aimed to examine the effectiveness of 12 weeks of OFE training on functional fitness in seniors. Forty-two active seniors were recruited and randomly assigned into OFE and control groups. The OFE group underwent 12 weeks of training using popular OFE for cardiorespiratory function, flexibility, and strength, whereas participants in the control group were asked to maintain their previous lifestyles. The senior fitness test was assessed before and after the 12-week period. Unexpectedly, the results showed no significant improvement within or between the groups after the 12-week training in all parameters (p > .05). In conclusion, the 12-week OFE training failed to enhance functional fitness among active seniors. Potential reasons for the limited training effects might be lack of resistance components and diversity of the OFE design and installation.


2015 ◽  
Vol 2015 ◽  
pp. 1-14 ◽  
Author(s):  
Heidi Ruotsalainen ◽  
Helvi Kyngäs ◽  
Tuija Tammelin ◽  
Hanna Heikkinen ◽  
Maria Kääriäinen

Background. The aim was to evaluate the effects of a 12-week, Facebook-delivered lifestyle counselling intervention, with or without physical activity self-monitoring, on physical activity and body mass index (BMI) in overweight and obese 13–16-year-old adolescents.Methods. Three-arm randomized controlled trial. Participants (n=46) were randomly assigned to intervention and control groups: one group received Facebook-delivered lifestyle counselling and monitoring of their physical activity (Fb + Act,n=15), whereas a second experimental group received the same Facebook-delivered lifestyle counselling without self-monitoring (Fb,n=16) and a third group served as the control group (n=15). Objective and self-reported physical activity assessment were used. Nonparametric statistical tests were used.Results. There were no significant intervention effects in terms of changes in physical activity levels or BMI from baseline to the 12-week postintervention measurements between the intervention and control groups. The Fb + Act group had lower sedentary time on weekdays compared to the control group during postintervention measurements (p=0.021), but there was no interaction between time and group.Conclusions. Interventions were not effective at increasing physical activity in overweight and obese adolescents. Before implementing such interventions, more evaluations on their effectiveness are needed. This trial is registered with ClinicalTrials.gov identifierNCT02295761(2014-11-17).


2020 ◽  
Vol 110 ◽  
pp. 205-209
Author(s):  
Donna K. Ginther ◽  
Janet M. Currie ◽  
Francine D. Blau ◽  
Rachel T. A. Croson

Women continue to be underrepresented in academic ranks in the economics profession. The Committee on the Status of Women in the Economics Profession of the American Economic Association established the CeMENT mentoring workshop to support women in research careers. The program was designed as a randomized controlled trial. This study evaluates differences between the treatment and control groups in career outcomes. Results indicate that relative to women in the control group, treated women are more likely to stay in academia and more likely to have received tenure in an institution ranked in the top 30 or 50 in economics in the world.


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