scholarly journals Therapeutic Effects of Ba-Duan-Jin versus Pregabalin for Fibromyalgia Treatment: Protocol for a Randomized Controlled Trial

Author(s):  
Yang Yang ◽  
Yan-ting Li ◽  
Yu-ruo Sun ◽  
Jing Wang ◽  
Yang Li ◽  
...  
2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.


2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Martha G Welch ◽  
◽  
Myron A Hofer ◽  
Susan A Brunelli ◽  
Raymond I Stark ◽  
...  

2012 ◽  
Vol 32 (1) ◽  
pp. 25-30 ◽  
Author(s):  
Sze-ling CHAN ◽  
Ka-hang OR ◽  
Wai-zhu SUN ◽  
Kwan-yee NG ◽  
See-kit LO ◽  
...  

Crisis ◽  
2010 ◽  
Vol 31 (2) ◽  
pp. 62-68 ◽  
Author(s):  
Carly J. Gibbons ◽  
Shannon Wiltsey Stirman ◽  
Gregory K. Brown ◽  
Aaron T. Beck

Background: High attrition rates in longitudinal research can limit study generalizability, threaten internal validity, and decrease statistical power. Research has demonstrated that there can be significant differences between participants who complete a research study and those who drop out prematurely, and that treatment outcomes may be dependent on retention in a treatment protocol. Aims: The current paper describes the challenges encountered when implementing a randomized controlled trial of cognitive therapy for the prevention of suicide attempts and the solutions developed to overcome these problems. Methods: Problems unique to suicide attempters are discussed, and strategies successfully implemented to boost retention rates are provided. Results: The methods implemented appeared to increase retention rates in the randomized controlled trial. Conclusions: Many steps can be taken to work with this difficult population, and researchers are encouraged to be as involved and flexible with participants as possible.


2019 ◽  
Author(s):  
Judith Schlaeger ◽  
Hui Yan Cai ◽  
Alana D. Steffen ◽  
Veronica Angulo ◽  
Adhir R. Shroff ◽  
...  

BACKGROUND Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for analgesic effects is the downregulation of M1 macrophages, Interleukin-1β, Interleukin-6, Interleukin-18, and tumor necrosis factor alpha (TNF-α). OBJECTIVE The purpose of this study is to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in healthcare systems and other salient variables. METHODS We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized Traditional Chinese Medicine (TCM) point prescription. The attention control group will view non-pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. Primary outcomes are anginal pain and quality of life. RESULTS Results will be available upon completion of the randomized controlled trial and the analysis of the data. CONCLUSIONS We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a pro-inflammatory state and/or hyperalgesia caused by multiple neural and immune processes not always relieved with medication. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT02914834


Author(s):  
Andoni Carrasco-Uribarren ◽  
Jacobo Rodríguez-Sanz ◽  
Carlos López-de-Celis ◽  
Pablo Fanlo-Mazas ◽  
Sara Cabanillas-Barea

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Martha G Welch ◽  
◽  
Myron A Hofer ◽  
Susan A Brunelli ◽  
Raymond I Stark ◽  
...  

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