scholarly journals Developing and Testing the Effectiveness of a Novel Online Integrated Treatment for Problem Gambling and Tobacco Smoking: A Protocol for an Open Label Randomized Controlled Trial

2020 ◽  
Author(s):  
Elena Bilevicius ◽  
Alanna Single ◽  
Chris Baumgartner ◽  
Van Bui ◽  
Tyler Kempe ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Problem Gambling ◽  
Tobacco Smoking ◽  
Controlled Trial ◽  
Treatment Options ◽  
Integrated Treatment ◽  
Open Label ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Gambling Activities

Abstract Background: Gambling and tobacco smoking are highly comorbid among North American adults. However, there is a paucity of treatment options that are integrated (i.e., targeting both gambling and tobacco smoking simultaneously), accessible, and evidence based. Methods: The aim of this two-arm open label randomized controlled trial is to examine the effectiveness of an online, self-guided integrated treatment for problem gambling and tobacco smoking. A target sample of 214 participants will be recruited and be randomized into either an eight-week integrated or gambling-only control condition. Both conditions will consist of seven online modules following cognitive behavioral therapy and motivational interviewing principles. Our three primary outcomes are (1) number of days gambled, (2) money spent on gambling activities, and (3) time spent in gambling activities. Secondary outcomes include gambling disorder symptoms, cigarette use, and nicotine dependence symptoms. Assessments will be completed at baseline, at completion (i.e., eight-weeks from baseline), and follow-up (i.e., 24-weeks from baseline). Generalized linear mixed modelling will be used to evaluate our primary and secondary outcomes. We expect that participants receiving online integrated treatment will show larger reductions in gambling relative to those receiving a control gambling only intervention. We further hypothesize that reductions in smoking will mediate these group differences. Discussion: The rates of problem gambling and tobacco smoking are high in North America; yet, the treatment options for both are limited, with no integrated treatments available. If supported, our pilot study will be a cost-effective and accessible way to improve treatments for co-occurring problem gambling and tobacco use. Trial registration: Clinicaltrials.gov; ID NCT03614884. Registered August 3, 2019; https://clinicaltrials.gov/ct2/show/NCT03614884?term=keough&rank=1

scholarly journals Developing and testing the effectiveness of a novel online integrated treatment for problem gambling and tobacco smoking: a protocol for an open-label randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Elena Bilevicius ◽  
Alanna Single ◽  
Chris Baumgartner ◽  
Van Bui ◽  
Tyler Kempe ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Problem Gambling ◽  
Tobacco Smoking ◽  
Controlled Trial ◽  
Treatment Options ◽  
Integrated Treatment ◽  
Open Label ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Gambling Activities

Abstract Background Gambling and tobacco smoking are highly comorbid among North American adults. However, there is a paucity of treatment options that are integrated (i.e. targeting both gambling and tobacco smoking simultaneously), accessible, and evidence based. Methods The aim of this two-arm open-label randomized controlled trial is to examine the effectiveness of an online, self-guided integrated treatment for problem gambling and tobacco smoking. A target sample of 214 participants will be recruited and be randomized into either an 8-week integrated or gambling only control condition. Both conditions will consist of seven online modules following cognitive behavioural therapy and motivational interviewing principles. Our three primary outcomes are (1) the number of days gambled, (2) money spent on gambling activities, and (3) time spent in gambling activities. Secondary outcomes include gambling disorder symptoms, cigarette use, and nicotine dependence symptoms. Assessments will be completed at baseline, at completion (i.e. 8 weeks from baseline), and at follow-up (i.e. 24 weeks from baseline). Generalized linear mixed modelling will be used to evaluate our primary and secondary outcomes. We expect that participants receiving online integrated treatment will show larger reductions in gambling relative to those receiving a control gambling only intervention. We further hypothesize that reductions in smoking will mediate these group differences. Discussion The rates of problem gambling and tobacco smoking are high in North America; yet, the treatment options for both are limited, with no integrated treatments available. If supported, our pilot study will be a cost-effective and accessible way to improve treatments for co-occurring problem gambling and tobacco use. Trial registration ClinicalTrials.gov NCT03614884. Registered on August 3, 2019

scholarly journals Developing and Testing the Effectiveness of a Novel Online Integrated Treatment for Problem Gambling and Tobacco Smoking: A Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Elena Bilevicius ◽  
Alanna Single ◽  
Chris Baumgartner ◽  
Van Bui ◽  
Tyler Kempe ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Problem Gambling ◽  
Tobacco Smoking ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Treatment Options ◽  
Integrated Treatment ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Gambling Activities

Abstract Background: Gambling and tobacco smoking are highly comorbid among North American adults. However, there is a paucity of treatment options that are integrated (i.e., targeting both gambling and tobacco smoking simultaneously), accessible, and evidence based.Methods: The aim of this two-arm randomized controlled trial is to examine the effectiveness of an online, self-guided integrated treatment for problem gambling and tobacco smoking. A target sample of 214 participants will be recruited and be randomized into either an eight-week integrated or gambling-only control condition. Both conditions will consist of seven online modules following cognitive behavioral therapy and motivational interviewing principles. Our three primary outcomes are (1) number of days gambled, (2) money spent on gambling activities, and (3) time spent in gambling activities. Secondary outcomes include gambling disorder symptoms, cigarette use, and nicotine dependence symptoms. Assessments will be completed at baseline, at completion (i.e., eight-weeks from baseline), and follow-up (i.e., 24-weeks from baseline). Generalized linear mixed modelling will be used to evaluate our primary and secondary outcomes. We expect that participants receiving online integrated treatment will show larger reductions in gambling relative to those receiving a control gambling only intervention. We further hypothesize that reductions in smoking will mediate these group differences.Discussion: The rates of problem gambling and tobacco smoking are high in North America; yet, the treatment options for both are limited, with no integrated treatments available. If supported, our intervention will be a cost-effective and accessible way to improve treatments for co-occurring problem gambling and tobacco use.Trial registration: Clinicaltrials.gov; ID NCT03614884. Registered August 3, 2019;

scholarly journals Nasotracheal vs. Orotracheal Intubation and Post-extubation Airway Obstruction in Critically Ill Children: An Open-Label Randomized Controlled Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Vijay Kumar ◽  
Suresh Kumar Angurana ◽  
Arun Kumar Baranwal ◽  
Karthi Nallasamy
Keyword(s):  
Randomized Controlled Trial ◽  
Airway Obstruction ◽  
Critically Ill ◽  
Controlled Trial ◽  
Orotracheal Intubation ◽  
Critically Ill Children ◽  
Open Label ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Tube Malposition

Background: The data on long-term nasotracheal intubation among mechanically ventilated critically ill children is limited. The purpose of this study was to compare the rate of post-extubation airway obstruction (PEAO) with nasotracheal and orotracheal intubation.Methods: This open-label randomized controlled trial was conducted in PICU of a tertiary care and teaching hospital in North India from January-December 2020 involving intubated children aged 3 months−12 years. After written informed consent, children were randomized into nasotracheal and orotracheal intubation groups. Post-extubation, modified Westley's croup score (mWCS) was used at 10-timepoints (0-min, 30 min, 1, 2, 3, 6, 12, 24, 36, and 48-h after extubation) to monitor for PEAO. The primary outcome was the rate of PEAO; and secondary outcomes were time taken for intubation, number of intubation attempts, complications during intubation, unplanned extubation, repeated intubations, tube malposition/displacement, endotracheal tube blockade, ventilator associated pneumonia, skin trauma, extubation failure/re-intubation, duration of PICU stay, and mortality.Results: Seventy children were randomized into nasotracheal (n = 30) and orotracheal (n = 40) groups. Both the groups were similar in baseline characteristics. The rate of PEAO was similar between nasotracheal and orotracheal groups (10 vs. 20%, p = 0.14). The maximum mWCS and mWCS at 10-timepoints were similar in two groups. The time taken for intubation was significantly longer (85 vs. 48 s, p < 0.001) in nasotracheal group, whereas other secondary outcomes were similar in two groups.Conclusion: The rate of PEAO was not different between nasotracheal and orotracheal groups.Clinical Trial Registration:http://ctri.nic.in, Identifier: CTRI/2020/01/022988.

scholarly journals Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aaron Gazendam ◽  
◽  
Seper Ekhtiari ◽  
Nolan S. Horner ◽  
Nicole Simunovic ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Control ◽  
Shoulder Arthroscopy ◽  
Controlled Trial ◽  
Arthroscopic Surgery ◽  
Standard Of Care ◽  
Opioid Prescription ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Arthroscopic Knee

Abstract Background Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. Methods This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons’ pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. Discussion The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. Trial registration The NO PAin trial has been prospectively registered with clinicaltrials.gov (NCT04566250).

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

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.

scholarly journals Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rui Luo ◽  
Fangfang Zheng ◽  
Haobo Zhang ◽  
Weiquan Zhu ◽  
Penghui He ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Natural Orifice ◽  
Specimen Extraction ◽  
Natural Orifice Specimen Extraction ◽  
Robotic Assisted ◽  
Randomized Controlled ◽  
Robotic Assisted Surgery ◽  
Secondary Outcomes

Abstract Background Natural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are conducting this randomized controlled trial to assess whether robotic NOSES is non-inferior to traditional robotic-assisted surgery for patients with colorectal cancer in terms of primary and secondary outcomes. Method/design Accordingly, a prospective, open-label, randomized controlled, parallel-group, multicenter, and non-inferiority trial will be conducted to discuss the safety and efficacy of robotic natural orifice extraction surgery compared to traditional robotic-assisted surgery. Here, 550 estimated participants will be enrolled to have 80% power to detect differences with a one-sided significance level of 0.025 in consideration of the non-inferiority margin of 10%. The primary outcome is the incidence of surgical complications, which will be classified using the Clavien-Dindo system. Discussion This trial is expected to reveal whether robotic NOSES is non-inferior to traditional robotic-assisted surgery, which is of great significance in regard to the development of robotic NOSES for patients with colorectal cancer in the minimally invasive era. Furthermore, robotic NOSES is expected to exhibit superiority to traditional robotic-assisted surgery in terms of both primary and secondary outcomes. Trial registration ClinicalTrials.govNCT04230772. Registered on January 15, 2020.

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