Contemporary clinical trials
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Contemp Clin Trials · Feb 2019
Randomized Controlled TrialOptimizing pain treatment interventions (OPTI): A pilot randomized controlled trial of collaborative care to improve chronic pain management and opioid safety-Rationale, methods, and lessons learned.
Veterans seeking care in VA medical facilities have high rates of chronic pain, which often co-occur with mental health and substance use disorders, including prescription opioid misuse. The overall goal of the Optimizing Pain Treatment Interventions (OPTI) study was to pilot a 12-week Collaborative Care intervention to improve opioid safety, chronic pain disability, and use of non-pharmacological pain management strategies in veterans in VA primary care. Between November 2014 and January 2017, 100 veteran patients with chronic pain and high-risk prescription opioid use (e.g., high-dose therapy, early refills, etc.) were enrolled and completed an initial one-hour study visit with a primary care provider (PCP) within 4 weeks of enrollment. ⋯ After the initial visit, patients randomized to Collaborative Care received one Motivational Interviewing (MI) session with a Care Manager followed by 3 Care Manager-delivered brief telephone MI sessions at 6, 8, and 12 weeks to reinforce Pain Care Plans; patients randomized to an Attention Control condition met with a Care Manager briefly, followed by 3 brief scripted telephone psychoeducation sessions at 6, 8, and 12 weeks. Masked evaluators assessed outcomes at baseline, end of intervention (12 weeks), and after eight weeks of no contact (20 weeks). We present study rationale, detailed methods, preliminary results and lessons learned.
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Contemp Clin Trials · Feb 2019
Randomized Controlled TrialEnhancing individual placement and support (IPS) - Supported employment: A Type 1 hybrid design randomized controlled trial to evaluate virtual reality job interview training among adults with severe mental illness.
Individual Placement and Support (IPS) is the evidence-based model of supported employment that increases employment rates in adults with severe mental illness (SMI). Although IPS is largely successful, over 80% of adults with SMI remain unemployed. An enhancement to high fidelity IPS could be an evidence-based job interview training component. ⋯ The results demonstrated that the intervention was efficacious at helping trainees improve their job interview skills and receive job offers within six months of completing VR-JIT compared to non-trainees. The overarching goal of this study is to evaluate the effectiveness of VR-JIT as an enhancement to IPS when delivered in a large community-based mental health service provider via a randomized controlled trial and initial process evaluation. Our aims are to: evaluate whether IPS services-as-usual in combination with VR-JIT, compared to IPS services-as-usual alone, enhances IPS outcomes for adults with SMI; evaluate mechanisms of employment outcomes and psychological distress; and conduct a multilevel, multidisciplinary, and mixed-method process evaluation of VR-JIT adoption and implementation to assess the acceptability, scalability, generalizability, and affordability of VR-JIT.
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Contemp Clin Trials · Feb 2019
Randomized Controlled TrialChat-based instant messaging support combined with brief smoking cessation interventions for Chinese community smokers in Hong Kong: Rationale and study protocol for a pragmatic, cluster-randomized controlled trial.
Novel approaches to engage community smokers in smoking cessation are needed as smokers typically lack motivation to quit or use evidence-based tobacco dependence treatment. Mobile instant messaging apps (e.g., WhatsApp, Facebook Messenger) are widely used but under-studied as a mobile health modality for delivering smoking cessation support. This paper presents the rationale and study design of a trial which aims to evaluate the effectiveness of a chat-based intervention using mobile instant messaging combined with brief interventions for community smokers. ⋯ This is the first trial examining the effectiveness of a chat-based cessation support programme combined with brief interventions in promoting abstinence. The intervention model can be adapted for other behavioural change treatments and more advanced digital smoking cessation intervention.
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Contemp Clin Trials · Feb 2019
Randomized Controlled TrialRationale and design of Smart Walk: A randomized controlled pilot trial of a smartphone-delivered physical activity and cardiometabolic risk reduction intervention for African American women.
African American (AA) women perform low levels of physical activity (PA) and are disproportionally burdened by cardiometabolic disease conditions when compared to White women and the U.S. population as a whole. These disparities emphasize the need for innovative and effective interventions to increase PA and reduce cardiometabolic disease risk among AA women. Recent evidence suggests that mobile health (mHealth) interventions have the potential to increase PA and reduce cardiometabolic disease risk factors. Few studies have examined the efficacy of mHealth PA interventions among racial/ethnic minorities, including AA women. This represents a missed opportunity given the reported success of technology-delivered PA interventions in predominately White populations and the high use of technology among AA women. ⋯ Smart Walk represents a culturally relevant, theory-based approach to promote PA and reduce cardiometabolic disease risk in AA women.
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Contemp Clin Trials · Jan 2019
Randomized Controlled TrialTelephone-delivered cognitive behavioral therapy for veterans with chronic pain following traumatic brain injury: Rationale and study protocol for a randomized controlled trial study.
Chronic pain is a highly prevalent and potentially disabling condition in Veterans who have had a traumatic brain injury (TBI) and access to non-pharmacological pain treatments such as cognitive behavioral therapy is limited and variable. The purpose of this randomized controlled trial (RCT) is to evaluate the efficacy of a telephone-delivered cognitive behavioral therapy (T-CBT) for pain in Veterans with a history of TBI. ⋯ In addition to evaluating the effects of the interventions on pain intensity (primary outcome), this study will determine their effects on pain interference, sleep, depression, and life satisfaction. We will also examine potential moderators of treatment outcomes such as cognition, PTSD, and alcohol and drug use. This non-pharmacologic one-on-one therapeutic intervention has the potential to reduce pain and pain-related dysfunction, improve access to care, and reduce barriers associated with geography, finances, and stigma, without the negative effects on physical and cognitive performance and potential for addiction as seen with some pharmacologic treatments for pain. This trial is registered at ClinicalTrials.gov, protocol NCT01768650.