Imaginal Retraining Reduces Cigarette Smoking: A Randomized Controlled Study

2020 ◽  
Vol 26 (6) ◽  
pp. 355-364
Author(s):  
Steffen Moritz ◽  
Anja S. Göritz ◽  
Moana Kraj ◽  
Josefine Gehlenborg ◽  
Birgit Hottenrott ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Smoking Behavior ◽  
Dose Effect ◽  
Treatment Programs ◽  
Current Evidence ◽  
Controlled Study ◽  
Control Group ◽  
Intention To Treat ◽  
Large Subgroup ◽  
Cigarette Dependence

<b><i>Objectives:</i></b> Smoking is a highly prevalent addictive behavior with severe and life-shortening health consequences. This is the first study to evaluate the efficacy of a newly developed imaginal variant of approach bias modification (ABM) (i.e., imaginal retraining) for the reduction of craving for tobacco and actual smoking behavior. <b><i>Methods:</i></b> We randomized 345 smokers to imaginal retraining (self-help manual) or a control group (either active control or wait-list control). Assessments were carried out online. The treatment interval was 6 weeks. Craving for tobacco represented the primary outcome. The study was registered as DRKS00016860. <b><i>Results:</i></b> Retention was 79.7% with no difference between groups. The intention-to-treat (ITT) analyses were significant for the primary outcome (Visual Analogue Scale on craving for tobacco) as well as subjective reduction of smoking (45.5 vs. 26.4%) in favor of imaginal retraining. In the treatment group, 47.6% performed the exercises at least once. This subgroup (per-protocol [PP] sample) showed a significant reduction in tobacco dependency as measured with the Cigarette Dependence Scale (short and long forms) and the Fagerström Test for Nicotine Dependence relative to controls. Number of daily cigarettes declined to a greater extent in imaginal retraining in the PP but not ITT analysis. A small dose-effect relationship emerged between craving and frequency of performance of the technique. <b><i>Conclusion:</i></b> When used regularly, imaginal retraining may reduce craving for tobacco and actual smoking behavior in a subgroup of smokers. In view of the large subgroup that did not read the manual or did not perform the exercises, alternative ways of conveying the imaginal retraining technique should be sought (e.g., demonstration via video clips). To conclude, imaginal retraining may represent a simple low-threshold technique to reduce smoking and assist current evidence-based treatment programs targeted at abstinence. It needs to be tested whether its mechanism of action deviates from standard ABM.

scholarly journals Effect of topiramate on eating behaviours in Prader-Willi syndrome: TOPRADER double-blind randomised placebo-controlled study

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Angèle Consoli ◽  
Sophie Çabal Berthoumieu ◽  
Marie Raffin ◽  
Denise Thuilleaux ◽  
Christine Poitou ◽  
...  
Keyword(s):  
Eating Disorders ◽  
Primary Outcome ◽  
Dose Effect ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Prader Willi Syndrome ◽  
Eating Behaviours ◽  
Behavioural Disorders ◽  
Double Blind ◽  
Effect Relationship

Abstract Prader–Willi Syndrome (PWS) is a rare genetic syndrome leading to severe behavioural disorders and mild cognitive impairment. The objective of this double-blind randomised placebo-controlled trial was to study the efficacy and tolerance of topiramate on behavioural disorders in patients with PWS. Participants (aged 12–45 years) had genetically confirmed PWS and severe irritability/impulsivity, eating disorders and/or obesity, and skin picking. Thirty-two participants received a placebo (PBO), and 30 participants received topiramate (TOP) (50–200 mg/day) for 8 weeks. The primary outcome was the rate of responders using the Clinical Global Impression-Improvement (CGI-I) scale. The secondary outcome measures included the Aberrant Behaviour Checklist, the Dykens Hyperphagia Questionnaire (DHK), the Self-Injurious Behaviour Scale (SIBS) and the body mass index (BMI). We found no significant difference in the primary outcome (the CGI-I): 9 (30%) patients were very much or much improved in the TOP group compared to 7 (22.6%) patients in the PBO group. However, the DHK behaviour and severity scores improved significantly more over time in patients treated with topiramate versus those receiving a placebo, with a significant dose–effect relationship. DHK scores were also significantly associated with genetic subtypes and hospitalisation status. The effects of topiramate on eating behaviours remained significant after adjusting for genetic subtype and hospitalisation. Topiramate had therefore a significant effect on eating disorders, with a dose–effect relationship. Given the burden of eating disorders in PWS, we believe that topiramate may become the first psychotropic option within the global care of obesity in individuals with PWS.

scholarly journals Effect of Ketorolac on the Prevention of Postoperative Catheter-Related Bladder Discomfort in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy: A Randomized, Double-Blinded, Placebo-Controlled Study

2019 ◽  
Vol 8 (6) ◽  
pp. 759
Author(s):  
Jun-Young Park ◽  
Jun Hyuk Hong ◽  
Jihion Yu ◽  
Doo-Hwan Kim ◽  
Gi-Ho Koh ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Radical Prostatectomy ◽  
Primary Outcome ◽  
Laparoscopic Radical Prostatectomy ◽  
Controlled Study ◽  
Control Group ◽  
Robot Assisted ◽  
Pain Scores ◽  
Patient Satisfaction Scores ◽  
Double Blinded

Urinary catheterization can cause catheter-related bladder discomfort (CRBD). Ketorolac is widely used for pain control. Therefore, we evaluated the effect of ketorolac on the prevention of CRBD in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). All patients were randomly allocated to the ketorolac group or the control group. The primary outcome was CRBD above a moderate grade at 0 h postoperatively. CRBD above a moderate grade at 1, 2, and 6 h was also assessed. Postoperative pain, opioid requirement, ketorolac-related complications, patient satisfaction, and hospitalization duration were also assessed. The incidence of CRBD above a moderate grade at 0 h postoperatively was significantly lower in the ketorolac group (21.5% vs. 50.8%, p = 0.001) as were those at 1, 2, and 6 h. Pain scores at 0 and 1 h and opioid requirement over 24 h were significantly lower in the ketorolac group, while patient satisfaction scores were significantly higher in the ketorolac group. Ketorolac-related complications and hospitalization duration were not significantly different between the two groups. This study shows ketorolac can reduce postoperative CRBD above a moderate grade and increase patient satisfaction in patients undergoing RALP, suggesting it is a useful option to prevent postoperative CRBD.

scholarly journals Telephone-Based Reeducation of Drug Administration for Helicobacterpylori Eradication: A Multicenter Randomized Controlled Study

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Yan Zhao ◽  
Mudan Ren ◽  
Xin Wang ◽  
Guifang Lu ◽  
Xinlan Lu ◽  
...  
Keyword(s):  
Eradication Rate ◽  
Symptom Relief ◽  
Intervention Group ◽  
Eradication Therapy ◽  
Incidence Rates ◽  
Controlled Study ◽  
Control Group ◽  
Intention To Treat ◽  
Event Rates

Poor adherence to treatment instructions may play an important role in the failure of Helicobacter pylori eradication. The aim of this study was to evaluate the effects of telephone-based reeducation on 14-day quadruple H. pylori eradication therapy. In total, 162 patients were randomly assigned (1 : 1) to either the intervention group (patients received telephone-based reeducation on the 4th, 7th, and 10th days of the course) or the control group (patients received instructions only at the time of getting the prescriptions). All patients received a 14-day quadruple H. pylori eradication therapy. The primary outcome was the H. pylori eradication rate. The secondary outcomes included the symptom relief rates and the incidence rates of adverse events. Seventy-five patients in the reeducation group and 74 patients in the control group completed the follow-up. The H. pylori eradication rate in the reeducation group was statistically higher than that in the control group (intention-to-treat: 72.8% vs. 50.6%, P=0.006; per-protocol: 78.7% vs. 55.4%, P=0.003). However, the symptom relief rates and the adverse event rates in these two groups were not significantly different. Overall, the results from this study suggest that telephone-based reeducation can be potentially applied to improve the H. pylori eradication rate in clinical practice, without significantly increasing the adverse effects.

scholarly journals Retraining automatic action tendencies for smoking using mobile phone-based approach-avoidance bias training: Study protocol for a randomized controlled study

2019 ◽  
Author(s):  
Alla Machulska ◽  
Tanja Joan Eiler ◽  
Armin Grünewald ◽  
Rainer Brück ◽  
Katharina Jahn ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Mobile Phone ◽  
Smoking Behavior ◽  
Smoking Cessation Intervention ◽  
Controlled Study ◽  
Future Research ◽  
Control Group ◽  
Waitlist Control ◽  
Quit Smoking ◽  
Cessation Intervention

Abstract Background: Automatic tendencies to approach drug-related cues have been linked to the development and maintainance of harmful drug taking behavior. Recent studies have demonstrated that these automatic approach tendencies can be targeted directly by means of Cognitive Bias Modification (CBM) approaches. Moreover, changing those approach tendencies may enhance treatment outcomes. However, training and therapy effects tend to be rather small and adherence to the training might be impaired by time-consuming multiple lab-training sessions. Here, we present a protocol for a randomized waitlist-control design to improve CBM training efficiency and facilitate access to the training by providing mobile phone-based training sessions at home to current smokers motivated to quit smoking. Methods/Design: Participants (n = 100) are current smokers who smoke at least 6 cigarettes per day for at least 6 months and are willing to quit smoking. All participants attend a brief smoking cessation intervention (TAU) and are randomly assigned either to a training or a waitlist-control group. Participants in the training condition are given access to a training app aimed at retraining automatic approach biases for smoking cues. Participants are instructed to perform the app-training outside the laboratory context on a daily basis for 14 consecutive days. Approach, attentional and association biases, biochemical outcomes, and self-reported smoking behavior will be measured at baseline, directly after training, and at a 4-week follow-up. After completition of the study, smokers in the waitlist-control condition will receive access to the training app. Discussion: This RCT is the first to test the effectiveness of an app-based CBM intervention as an adjunct to a brief smoking cessation intervention in smokers motivated to quit smoking. The results of this study can inform future research in the optimisation and advancement of CBM treatment for addiction. Trial Registration: Registered with Current Controlled Trials: study ID ISRCTN15690771. Registered on 20 November 2018; http://www.isrctn.com/ISRCTN15690771

Closed-Wound Negative Pressure Therapy Dressing After Loop Ostomy Closure.

2021 ◽  
Author(s):  
P. Curchod ◽  
D. Clerc ◽  
J.Jurt ◽  
M. Hubner ◽  
D. Hahnloser ◽  
...  
Keyword(s):  
Negative Pressure ◽  
Primary Outcome ◽  
Negative Pressure Wound Therapy ◽  
Enhanced Recovery ◽  
Surgical Site Infections ◽  
Controlled Study ◽  
Control Group ◽  
Study Group ◽  
Pressure Therapy ◽  
Absorbable Sutures

Abstract Purpose: Closed-wound negative pressure wound therapy (NPWT) dressings were recently introduced with the purpose to reduce incisional surgical site infections (iSSI) in high-risk wounds.The aim of this study was to compare iSSI rates in patients after ostomy closure with and without additional application of a closed-wound NPWT dressing.Methods: Single-center retrospective analysis of consecutive patients undergoing ileo- or colostomy closure over an 8-year period (January 2013 - January 2021). Intradermal absorbable sutures were used in all patients. Since November 2018, all patients (study group) received a NPWT device for a maximum of 5 days postoperatively (PICO® Smith and Nephew).Primary outcome was iSSI rate within 30 days of surgery. Data was retrieved from the institutional enhanced recovery after surgery (ERAS) database, with standardized complication assessment by trained abstractors.Results: In total, 85 patients (25%) in the study group were comparable with 252 (75%) patients in the control group regarding demographics (age, gender, body mass index, ASA score), ostomy type and anastomotic technique (all p>0.05). Median time to NPWT removal was 4 (IQR 3-5) days. Incisional SSI were observed in 4 patients (4.7%) in the study group and in 27 patients (10.7%) in the control group (p=0.097).Conclusion: These preliminary results suggest a potential benefit of systematic application of the NPWT device after loop ostomy closure. A randomized controlled study is needed to confirm these findings.

scholarly journals Monsel´s solution for first degree perineal bleeding tears treatment: a randomized controlled clinical trial

2020 ◽  
Vol 11 (1) ◽  
Author(s):  
Casale Roberto Antonio ◽  
Varela Silvana
Keyword(s):  
Clinical Trial ◽  
Vaginal Delivery ◽  
Primary Outcome ◽  
Intervention Group ◽  
Active Bleeding ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Wound Infections ◽  
Suture Materials ◽  
Intention To Treat

Introduction: During vaginal delivery, tears can occur in different areas of the lower genital tract. The policy of "restrictive episiotomy" increases anterior perineal trauma, mainly paraurethral tears. The topical application of Monsel´s solution in first degree perineal bleeding tears may benefit patients because of less use of anesthetics, sutures and procedure time. Objective: To determine if the Monsel´s solution stops active bleeding in first degree tears compared to traditional suture. Materials and methods: Randomized clinical trial, carried out at Hospital Nacional "Prof. Alejandro Posadas" from January 2011 to December 2013. 330 patients with recent postpartum vaginal delivery were admitted with a diagnosis of first degree bleeding tears. They were randomized to receive the application of Monsel´s solution, until stopping bleeding (intervention group) or traditional suture (control group). The primary outcome was the stoppage of active bleeding. Secondary outcomes were: patient discomfort with the procedure, practicality of the procedure, alterations in the scarring of the tear and wound infections. Crude and adjusted ORs and 95% CI were calculated. Analysis was done by intention to treat. The study was approved by the Bioethics Committee of the Hospital. Results: Monsel´s solution was effective for the stoppage of active bleeding in 86.7% of first degree bleeding tears. Out of 150 patients randomized to the intervention group, 130 met the primary outcome, ORc 0.04 (95% CI 0.01-0.27)/ORa 0.05 (95% CI 0.01-0.34) Monsel´s solution was safe, because it did not interfere with the scarring process It also offered a protective aspect on wound infections. The procedure was practical and simple for the intervening professionals and, despite being an irritant for the mucous; it was well tolerated by the patients. Conclusion: The Monsel´s solution appears effective, practical and safe for treatment of first degree bleeding tears.

scholarly journals Once-Weekly Whole-Body Electromyostimulation Increases Strength, Stability and Body Composition in Amateur Golfers. A Randomized Controlled Study

2021 ◽  
Vol 18 (11) ◽  
pp. 5628
Author(s):  
Carina Zink-Rückel ◽  
Matthias Kohl ◽  
Sebastian Willert ◽  
Simon von Stengel ◽  
Wolfgang Kemmler
Keyword(s):  
Body Composition ◽  
Body Fat ◽  
Low Frequency ◽  
Fat Content ◽  
Whole Body ◽  
Controlled Study ◽  
Control Group ◽  
Intention To Treat ◽  
Habitual Activity ◽  
Body Fat Content

Whole-body electromyostimulation (WB-EMS), an innovative training technology, is considered as a joint-friendly, highly customizable and particularly time-effective option for improving muscle strength and stability, body composition and pain relief. The aim of the present study was to determine the effect of 16 weeks of once-weekly WB-EMS on maximum isometric trunk (MITS), leg extensor strength (MILES), lean body mass (LBM) and body-fat content. A cohort of 54 male amateur golfers, 18 to 70 years old and largely representative for healthy adults, were randomly assigned to a WB-EMS (n = 27) or a control group (CG: n = 27). Bipolar low-frequency WB-EMS combined with low-intensity movements was conducted once per week for 20 min at the participants’ locations, while the CG maintained their habitual activity. The intention to treat analysis with multiple imputation was applied. After 16 weeks of once-weekly WB-EMS application with an attendance rate close to 100%, we observed significant WB-EMS effects on MITS (p < 0.001), MILES (p = 0.001), LBM (p = 0.034), but not body-fat content (p = 0.080) and low-back pain (LBP: p ≥ 0.078). In summary, the commercial setting of once-weekly WB-EMS application is effective to enhance stability, maximum strength, body composition and, to a lower extent, LBP in amateur golfers widely representative for a healthy male cohort.

scholarly journals Procalcitonin-Guided Antibiotics after Surgery for Peritonitis: A Randomized Controlled Study

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Juliette C. Slieker ◽  
Steve Aellen ◽  
Philippe Eggimann ◽  
Valentine Guarnero ◽  
Markus Schäfer ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Respiratory Infections ◽  
Group Versus ◽  
Perforated Appendicitis ◽  
Length Of Hospital Stay ◽  
Infectious Complications ◽  
Gastrointestinal Perforation ◽  
Controlled Study ◽  
Control Group ◽  
Study Group

Background. Serum procalcitonin (PCT) is a useful biomarker to tailor the duration of antibiotics in respiratory infections. The objective of this study was to determine whether PCT levels could tailor postoperative antibiotic therapy in patients operated for peritonitis. Method. Patients with peritonitis were randomized postoperatively. The control group received antibiotics for a defined duration according to institutional guidelines. In the study group, antibiotics were stopped based on serum PCT levels. Patients were stratified into three categories: (1) gastrointestinal perforation, (2) perforated appendicitis, and (3) postoperative complication. Primary outcome was duration of antibiotics. Results. We included 162 patients: 83 and 79 patients in the control group and study group, respectively. In the subgroup of patients with peritonitis due to gastrointestinal perforation, we found 7 days of antibiotics in the PCT group versus 10 days in the control group (p value 0.065). There was no difference in infectious complications, mortality, median length of hospital stay, and necessity to restart antibiotics. Conclusion. No significant differences were found in duration of antibiotics when applying PCT guidance. However, in the subgroup of primary perforation of the gastrointestinal tract, there was a difference in duration of antibiotics in favor of the PCT group without obtaining significance, as the study was not powered for subgroup analysis. Further studies including only this subgroup should be performed.

scholarly journals Nalmefene in the treatment of pathological gambling: multicentre, double-blind, placebo-controlled study

2010 ◽  
Vol 197 (4) ◽  
pp. 330-331 ◽  
Author(s):  
Jon E. Grant ◽  
Brian L. Odlaug ◽  
Marc N. Potenza ◽  
Eric Hollander ◽  
Suck Won Kim
Keyword(s):  
Pathological Gambling ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Symptom Control ◽  
Primary Outcome Measure ◽  
Controlled Study ◽  
Double Blind ◽  
Intention To Treat ◽  
Secondary Outcomes ◽  
Post Hoc

SummaryPathological gambling is a disabling disorder experienced by about 1% of adults. We randomised 233 participants (41.6% women) 1:1:1 to nalmefene (20 or 40 mg) or placebo. In analyses performed using an intention-to-treat (ITT) population, nalmefene failed to show statistically significant differences from placebo on primary and secondary outcomes. Post hoc analyses of only participants who received a full titration of the medication for at least 1 week demonstrated that nalmefene 40 mg/day resulted in significantly greater reductions on the primary outcome measure. These findings suggest that medication dosing may be an important consideration in achieving symptom control.

scholarly journals Treadmill training as an augmentation treatment for Alzheimer?s disease: a pilot randomized controlled study

2014 ◽  
Vol 72 (3) ◽  
pp. 190-196 ◽  
Author(s):  
Cynthia Arcoverde ◽  
Andrea Deslandes ◽  
Helena Moraes ◽  
Cloyra Almeida ◽  
Narahyana Bom de Araujo ◽  
...  
Keyword(s):  
Functional Capacity ◽  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Exercise Group ◽  
Moderate Intensity ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Dependent Variables ◽  
And Control

Objective To assess the effect of aerobic exercise on the cognition and functional capacity in Alzheimer’s disease (AD) patients. Method Elderly (n=20) with mild dementia (NINCDS-ADRDA/CDR1) were randomly assigned to an exercise group (EG) on a treadmill (30 minutes, twice a week and moderate intensity of 60% VO2max) and control group (GC) 10 patients. The primary outcome measure was the cognitive function using Cambridge Cognitive Examination (CAMCOG). Specifics instruments were also applied to evaluate executive function, memory, attention and concentration, cognitive flexibility, inhibitory control and functional capacity. Results After 16 weeks, the EG showed improvement in cognition CAMCOG whereas the CG declined. Compared to the CG, the EG presented significant improvement on the functional capacity. The analysis of the effect size has shown a favorable response to the physical exercise in all dependent variables. Conclusion Walking on treadmill may be recommended as an augmentation treatment for patients with AD.

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