Full-scale Randomized Clinical Trial Research Articles

A Randomized Controlled Pilot Trial of Primary Care Treatment Integrating Motivation and Exposure Treatment (PC-TIME) in Veterans With PTSD and Harmful Alcohol Use

Individuals with posttraumatic stress disorder (PTSD) often engage in harmful alcohol use. These co-occurring conditions are associated with negative health consequences and disability. PTSD and harmful drinking are typically experienced as closely related—thus treatments that target both simultaneously are preferred by patients. Many individuals with PTSD and harmful alcohol use receive primary care services but encounter treatment barriers in engaging in specialty mental health and substance use services. A pilot randomized controlled trial of a brief integrated treatment for PTSD and harmful drinking versus primary care treatment as usual (PC-TAU) took place in three U.S. Department of Veterans Affairs (VA) primary care clinics. The intervention (primary care treatment integrating motivation and exposure [PC-TIME]) combines motivational interviewing to reduce alcohol use and brief prolonged exposure for PTSD delivered over five brief sessions. Participants (N = 63) were veterans with PTSD and harmful drinking. Multilevel growth curve modeling examined changes in drinking (average number of drinks per drinking day and percentage of heavy drinking days) and self-reported PTSD severity at baseline, 8, 14, and 20 weeks. Participants reported high satisfaction with PC-TIME and 70% (n = 23) completed treatment. As hypothesized, a significantly steeper decrease in self-reported PTSD severity and heavy drinking was evident for participants randomized to PC-TIME compared with PC-TAU. Contrary to expectations, no significant posttreatment differences in PTSD diagnoses were observed. PC-TIME participants were less likely to exceed National Institute for Alcoholism and Alcohol Abuse (NIAAA) guidelines for harmful alcohol use posttreatment compared with PC-TAU participants. PC-TIME is a promising brief, primary care-based treatment for individuals with co-occurring PTSD and harmful alcohol use. A full-scale randomized clinical trial is needed to fully test its effectiveness.

Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery

The overprescription of opioids to surgical patients is recognized as an important factor contributing to the opioid crisis. However, the value of prescribing opioid analgesia (OA) vs opioid-free analgesia (OFA) after postoperative discharge remains uncertain. To investigate the feasibility of conducting a full-scale randomized clinical trial (RCT) to assess the comparative effectiveness of OA vs OFA after outpatient general surgery. This parallel, 2-group, assessor-blind, pragmatic pilot RCT was conducted from January 29 to September 3, 2020 (last follow-up on October 2, 2020). at 2 university-affiliated hospitals in Montreal, Quebec, Canada. Participants were adult patients (aged ≥18 years) undergoing outpatient abdominal (ie, cholecystectomy, appendectomy, or hernia repair) or breast (ie, partial or total mastectomy) general surgical procedures. Exclusion criteria were contraindications to drugs used in the trial, preoperative opioid use, conditions that could affect assessment of outcomes, and intraoperative or early complications requiring hospitalization. Patients were randomized 1:1 to receive OA (around-the-clock nonopioids and opioids for breakthrough pain) or OFA (around-the-clock nonopioids with increasing doses and/or addition of nonopioid medications for breakthrough pain) after postoperative discharge. Main outcomes were a priori RCT feasibility criteria (ie, rates of surgeon agreement, patient eligibility, patient consent, treatment adherence, loss to follow-up, and missing follow-up data). Secondary outcomes included pain intensity and interference, analgesic intake, 30-day unplanned health care use, and adverse events. Between-group comparison of outcomes followed the intention-to-treat principle. A total of 15 surgeons were approached; all (100%; 95% CI, 78%-100%) agreed to have patients recruited and adhered to the study procedures. Rates of patient eligibility and consent were 73% (95% CI, 66%-78%) and 57% (95% CI, 49%-65%), respectively. Seventy-six patients were randomized (39 [51%] to OA and 37 [49%] to OFA) and included in the intention-to-treat analysis (mean [SD] age, 55.5 [14.5] years; 50 [66%] female); 40 (53%) underwent abdominal surgery, and 36 (47%) underwent breast surgery. Seventy-five patients (99%; 95% CI, 93%-100%) adhered to the allocated treatment; 1 patient randomly assigned to OFA received an opioid prescription. Seventeen patients (44%) randomly assigned to OA consumed opioids after discharge. Seventy-three patients (96%; 95% CI, 89%-99%) completed the 30-day follow-up. The rate of missing questionnaires was 37 of 3724 (1%; 95% CI, 0.7%-1.4%). All the a priori RCT feasibility criteria were fulfilled. The findings of this pilot RCT support the feasibility of conducting a robust, full-scale RCT to inform evidence-based prescribing of analgesia after outpatient general surgery. ClinicalTrials.gov Identifier: NCT04254679.

Feasibility and acceptability of somatocognitive therapy in the management of women with provoked localized vestibulodynia\u2014ProLoVe feasibility study

BackgroundProvoked vestibulodynia (PVD) is a prevalent chronic pain condition especially among young women. Pain is localized to the vulvar vestibule and is provoked by touch or pressure, such as penetrative intercourse. PVD can have profound consequences, adversely affecting a woman’s sexual life, relation to her partner, and her psychological health. There is an urgent need for well-designed randomized clinical trials (RCTs) to identify the most effective interventions for this neglected women’s health condition.AimsThe primary aim of this study is to assess the feasibility of undertaking a full-scale RCT of somatocognitive therapy (SCT), a multimodal physiotherapy intervention, for women with PVD. The secondary aim is to evaluate the implementation and acceptability of SCT and its potential treatment effectiveness in PVD. In the full-scale RCT, SCT will be compared to standard PVD treatment.MethodsA multimethod feasibility study with a single-arm before-after trial and qualitative interviews. Ten women with PVD, aged 18–33 were recruited from the Vulva Clinic at Oslo University Hospital. The intervention took place at Oslo Metropolitan University. Participants were assessed at baseline, post-treatment, and the 8-month follow-up with the tampon test and self-report questionnaires. The main feasibility outcomes were evaluation of recruitment rate, adherence to assessment tools, and follow-up rate. The participants’ experiences with the primary outcome and the intervention were explored with semi-structured interviews.ResultsTen out of 18 eligible patients were recruited over 11 weeks. None were lost to follow-up. Adherence to self-report questionnaires was excellent. Adherence to tampon tests and to the reporting of treatments was good, whereas adherence to the 14-day diary was poor. No adverse events were reported. The tampon test was suboptimal as a primary outcome. SCT was found to be an acceptable treatment, based on Global Perceived Effect scores and the participants’ experiences.ConclusionThe findings suggest that it is feasible to deliver a full-scale RCT of the SCT intervention for women with PVD. Some changes are suggested to optimize the protocol, such as increasing recruitment sites, change of primary outcome measures, and adding a booster session.Trial registrationClinicalTrials.govNCT04208204. Retrospectively registered on December 23, 2019.

A Comparison of Local Anesthetics for Intravenous Catheter Insertion in Hospitalized Pediatric Patients: A Randomized Clinical Pilot Trial.

Peripheral intravenous catheter (PIVC) insertion is one of the most painful procedures pediatric patients undergo during hospitalization. To date, local anesthetics delivered via cream, patch, and needle-free injection have not been rigorously evaluated together. This study aimed to investigate feasibility and potential efficacy of local anesthetics on pain intensity during PIVC insertion in an unblinded, single-center, randomized clinical pilot trial. Between March 2017 and February 2020, 88 hospitalized children aged 12 months to 18 years in an acute pediatric unit at an academic medical center were randomized to 1 of 3 local anesthetics: 1) lidocaine/prilocaine cream, 2) lidocaine/tetracaine patch, and 3) unbuffered lidocaine needle-free injection. Feasibility outcomes were recruitment and protocol adherence. Pain intensity was measured using the Face, Legs, Activity, Cry, Consolability (age <8 years) and Verbal Numeric Rating (VNRS) scales (age ≥8 years) before, during, and after procedure. Secondary outcomes included catheterization attempts, procedure time, and parent satisfaction. Recruitment rate was acceptable (2.7 patients per month). Protocol adherence was high (92%). Preliminary clinical findings showed no significant difference in pain intensity across treatments. Procedure time to successful insertion differed in the VNRS group, favoring unbuffered lidocaine needle-free injection. Conduct of a definitive, full-scale randomized clinical trial in the hospitalized pediatric population is feasible.

The feasibility and acceptability of a web-based physical activity for the heart (PATH) intervention designed to reduce the risk of heart disease among inactive African Americans: Protocol for a pilot randomized controlled trial

BackgroundMany studies have used the internet to promote physical activity (PA) in several settings, including the home environment, but few have been tailored for African Americans (AAs). To address this research gap, we conducted focus groups with AAs to inform the development of a web-based intervention, Physical Activity for The Heart (PATH), that leverages openly accessible platforms, such as YouTube, to promote PA in any setting. PurposeTo describe the rationale and design of a pilot randomized clinical trial (RCT), that examines the feasibility and acceptability of the PATH intervention among 30 AA adults aged 40‐–70 years without history of cardiovascular disease. MethodsA 12-week, single-site, wait-listed RCT with subjects randomized 1:1 to either: 1) treatment group - participants receive the PATH intervention, including the online portal and twice a month phone calls from a PA coach, or 2) attention control group - participants receive a self-help PA handout and twice a month general health newsletter. All participants self-monitor step count using actigraphy. The primary outcomes of this 12-week, pilot RCT are recruitment, retention, and adherence to self-monitoring (Actigraph wear time) and the intervention protocol (PATH utilization). The secondary outcomes include changes in PA (step count, moderate-to-vigorous PA, exercise self-efficacy), and cardiometabolic risk (HbA1C, HDL, LDL, total cholesterol, type 2 diabetes risk score, percent body fat, weight, and waist circumference) from baseline to 12 weeks. ConclusionsThis study will provide PATH intervention feasibility and acceptability data among inactive AA adults and will inform a future, full-scale RCT testing efficacy.

Evaluation of a Web-Based Self-Management Program for Patients With Cardiovascular Disease: Explorative Randomized Controlled Trial.

BackgroundWeb-based self-management programs have the potential to support patients with cardiovascular disease (CVD) in their self-management (eg, by focusing on behavior change and improving physical activity). The intervention mapping framework was used to develop a web-based program called Vascular View. The Vascular View program contained 6 modules (coping with CVD, setting boundaries, lifestyle, healthy nutrition, being physically active, interaction with health professionals) aiming to increase self-management behavior by tailoring to the perceived problems and (support) needs of patients after CVD.ObjectiveThe aim was to test the effectiveness of Vascular View before embarking on a full-scale randomized clinical trial (RCT) by evaluating the potential effectiveness and effect sizes of the Vascular View program and identifying outcome measures most likely to capture the potential benefits.MethodsAn explorative RCT was performed. Both control and intervention groups received care as usual and, in addition, the intervention group received 12 months of access to a web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included general patient-reported outcome measurements: Illness Perception Questionnaire (IPQ), Rand-36, Patient Activation Measure, and patient self-efficacy. Module-specific patient-reported outcome measurements were Beliefs about Medicines Questionnaire, International Physical Activity Questionnaire, Dutch Healthy Diet Index, Fagerström Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test, and Perceived Efficacy in Patient-Physician Interaction. Linear mixed models for repeated measures using intention-to-treat and per-protocol analysis were applied to study differences between the patients in the intervention and control groups. Floor and ceiling effects were explored to give insight into the outcome measures most likely to capture the potential benefits.ResultsA total of 105 patients in the control group and 103 patients in the intervention group participated in the study. A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND). Floor and ceiling effects were seen in the IPQ, Rand-36, and the self-efficacy questionnaire.ConclusionsNo conclusion for the efficacy of the Vascular View program or selection of outcome measurements can be taken yet. A process evaluation will be conducted to gain thorough insight into the working elements of the program, patient needs in eHealth, and the use of the program by patients. This can determine for whom web-based self-management programs will work and help to adapt the program.Trial RegistrationDutch Trial Register NTR5412; https://www.trialregister.nl/trial/5303International Registered Report Identifier (IRRID)RR2-10.2196/resprot.6352

Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study

BackgroundPlantar heel pain (PHP) is present in a wide range of individuals and creates significant burden to quality of life and participation in physical activity. The high recurrence rates and persistence of PHP suggests current management options may not address all potentially modifiable factors associated with the condition. Reports of intrinsic foot muscle (IFM) atrophy in individuals with PHP, together with biomechanical evidence of their important contribution to optimal foot function, suggests that an intervention focused on IFM training may be beneficial in managing PHP. We will test the feasibility of a prospective, assessor-blinded, parallel-group, randomised clinical trial that compares foot exercise plus education to brief advice in individuals with PHP.MethodsTwenty participants with PHP will be randomly allocated to one of two groups for a 12-week intervention period: (i) foot exercise plus education, or (ii) brief advice. The foot exercise plus education group will attend eight sessions with a physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs. The brief advice group will attend one session with a physiotherapist and receive brief information about self-management strategies and reassurance. Outcome measures will be obtained at baseline and the primary end-point of 12 weeks. Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention. Secondary outcomes will explore treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance.DiscussionTo reduce the burden of PHP on individuals and society, there is a need to establish effective treatments that are feasible and accepted by patients and health professionals. This trial will be the first to evaluate the feasibility of conducting a full-scale RCT, as well as the credibility, acceptability, and treatment effects, of education and foot exercise for PHP. The findings of this study will inform the development of a full-scale RCT.Trial registrationThe trial protocol was prospectively registered with the Australia and New Zealand Clinical Trial Registry (ACTRN12619000987167) on 11th July 2019.

The application of Strategy-based Training to Enhance Memory (STEM) in multiple sclerosis: A pilot RCT

ABSTRACT New learning and memory (NLM) impairments are common in multiple sclerosis (MS), negatively impacting daily life. Few studies seek to remediate these deficits to improve everyday functioning. Self-generation, spaced learning and retrieval practice have been shown to improve NLM in healthy persons and have been incorporated into an 8-session treatment protocol, Strategy-based Training to Enhance Memory (STEM). STEM teaches participants about each of the techniques, how to apply them in daily life and provides practice. Participants are taught to restructure a memory-demanding situation to optimize self-generation, spaced learning and retrieval practice. This pilot double-blind, placebo-controlled, randomized clinical trial (RCT) tested the efficacy of STEM in 20 learning-impaired participants with clinically definite MS (9 treatment, 11 control). Significant treatment effects were noted on self-report measures of daily functioning (primary outcome). Objective neuropsychological testing approached significance, showing a medium-large effect on verbal NLM. Results suggest that STEM may improve everyday functioning in individuals with MS. A full-scale RCT is warranted to validate findings in a larger sample so that findings may be generalized to the broader MS community.

Motor control exercise and patient education program for low resource rural community dwelling adults with chronic low back pain: a pilot randomized clinical trial.

This pilot randomized clinical trial assessed the feasibility of implementing motor control exercise (MCE) and patient education (PE) program for the management of chronic low back pain (CLBP) in a low resource rural Nigerian community. Thirty patients with CLBP were recruited and randomly assigned to MCE, PE, or MCE plus PE groups. The MCE program was provided twice a week while the PE program was provided once a week all for 6 weeks. Feasibility was assessed through recruitment rate, treatment compliance, retention/dropout rate, report of adverse events, perceived helpfulness, overall satisfaction, and clinical outcome of pain (numeric pain rating scale) and functional disability (Oswestry Disability Index). Many patients were willing to participate in the study and the recruitment rate was 77%. Treatment compliance in all the three groups were >65% for supervised treatment sessions and <50% for prescribed home program. Retention rate was high and greater overall satisfaction with the interventions was reported. Compared with the baseline, all the three groups improved significantly in pain and disability (P<0.05) after 6 weeks. Pairwise comparison revealed that the MCE plus PE group was superior to the PE group for pain and to the MCE for disability (P<0.05), with large effect size. It was concluded that the designed interventions are promising and conducting a full-scale randomized clinical trial in the future is feasible to confirm the effectiveness of the interventions for the management CLBP in rural Nigeria. (Trial registration: ClinicalTrials.gov, NCT03398174)

An evaluation of a common elements treatment approach for youth in Somali refugee camps.

This paper reports on: (1) an evaluation of a common elements treatment approach (CETA) developed for comorbid presentations of depression, anxiety, traumatic stress, and/or externalizing symptoms among children in three Somali refugee camps on the Ethiopian/Somali border, and (2) an evaluation of implementation factors from the perspective of staff, lay providers, and families who engaged in the intervention. This project was conducted in three refugee camps and utilized locally validated mental health instruments for internalizing, externalizing, and posttraumatic stress (PTS) symptoms. Participants were recruited from either a validity study or from referrals from social workers within International Rescue Committee Programs. Lay providers delivered CETA to youth (CETA-Youth) and families, and symptoms were re-assessed post-treatment. Providers and families responded to a semi-structured interview to assess implementation factors. Children who participated in the CETA-Youth open trial reported significant decreases in symptoms of internalizing (d=1.37), externalizing (d=0.85), and posttraumatic stress (d=1.71), and improvements in well-being (d=0.75). Caregivers also reported significant decreases in child symptoms. Qualitative results were positive toward the acceptability and appropriateness of treatment, and its feasibility. This project is the first to examine a common elements approach (CETA: defined as flexible delivery of elements, order, and dosing) with children and caregivers in a low-resource setting with delivery by lay providers. CETA-Youth may offer an effective treatment that is easier to implement and scale-up versus multiple focal interventions. A fullscale randomized clinical trial is warranted.

Coronectomy of lower third molars with and without guided bony regeneration: a pilot study

This pilot study for a split-mouth, randomised, clinical trial compared the incidence of postoperative complications, root migration, and adjacent second molar periodontal attachment after coronectomy of the lower third molars with or without guided bony regeneration. Six patients (three men and three women, mean (range) age 27 (21-44) years), each with bilateral lower third molars in close proximity to the inferior alveolar nerve, were recruited. One third molar of each patient was randomised to be treated by coronectomy with guided bony regeneration, and the other side coronectomy alone. All subjects were reviewed for 12 months. No neurosensory deficit was noted in either group. We found no significant differences between the two groups in postoperative morbidity. Mean (SD) root migration after coronectomy with guided bony regeneration at postoperative 2 weeks, 3 months, 6 months, and 12 months were 0.14 (0.34), 0.56 (0.68), 0.63 (0.83), and 0.63 (0.83) mm, respectively. These were significantly less than the results in the control group from postoperative 3 months onwards (3 months p=0.01, 6 months p=0.004, and 12 months p=0.003). There was a trend towards reduced periodontal depth at the adjacent second molar in the study group compared with that in the control group, but not significantly so. These results show that coronectomy of lower third molars with guided bony regeneration has low morbidity and seems to reduce root migration. A full-scale randomised clinical trial will show the effect on root migration and periodontal attachment of the adjacent second molar.

Clinical Therapeutic Effects of Aspirin in Combination with Fufang Danshen Diwan, a Traditional Chinese Medicine Formula, on Coronary Heart Disease: A Systematic Review and Meta-Analysis

Background/Aims: Coronary heart disease is characterized by vascular stenosis or occlusion resulting in myocardial ischemia, hypoxia and necrosis. In China, the combination of aspirin and Fufang Danshen Diwan (FDD), a traditional Chinese medicine formula, has been suggested in the treatment of coronary heart disease. There have been several studies comparing the effectiveness of aspirin alone and in combination with FDD to treat coronary artery disease; however, it remains unclear whether combined aspirin therapy is superior. This study was thus designed to clarify this issue through a systematic review and meta-analysis. Methods: Databases including PubMed, EMBASE, China National Knowledge Infrastructure (CNKI) database, Wanfang Data and VIP Information were searched. Papers were reviewed systematically by two researchers and analyzed using Cochrane software Revman 5.1. Results: Fourteen randomized controlled trials enrolling 1367 subjects were included. Meta-analyses revealed that aspirin in combination with FDD was significantly more effective at alleviating angina pectoris and improving electrocardiogram (ECG) results relative to aspirin therapy alone, reflected by the summary effects for the clinical markedly effective (OR = 2.45; 95% CI 1.95-3.08) and the total effective (OR = 3.92; 95% CI 2.87-5.36) rates. In addition, combined aspirin and FDD was significantly more efficacious than aspirin monotherapy at improving blood lipid levels, as indicated by the following outcomes: 1) reduction of TC level (SMD −1.12; 95% CI −1.49 to −0.76); 2) reduction of TG level (SMD −0.94; 95% CI −1.15 to -0.74); 3) reduction of LDL level (SMD -0.68; 95% CI -0.88 to -0.48); and 4) improvement of HDL level (SMD 0.52; 95% CI 0.04 to 0.99 ). No serious adverse events were reported in any of the included trials. Conclusion: The present meta-analysis demonstrated that aspirin in combination with FDD was more effective than aspirin alone for treating coronary heart disease. More full-scale randomized clinical trials with reliable designs are recommended to further evaluate the clinical benefits and long-term effectiveness of FDD for the treatment of coronary heart disease.

Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial.

BackgroundAtopic eczema or atopic dermatitis is a chronic inflammatory skin disease. Current conventional medical treatment for moderate and severe atopic eczema is not satisfactory. There is promising evidence derived from randomised clinical trials to support the clinical use of Chinese herbal medicine in the management of atopic eczema. However, the available evidence is compromised by the high risk of bias associated with most of the included trials. Therefore, well-designed and adequately powered randomised clinical trials are needed. The primary aim of this trial is to evaluate the efficacy and safety of oral ingestion of an oral Chinese herbal formula (Pei Tu Qing Xin granules; PTQX) in children aged between 6 and 16 years with moderate to severe atopic eczema.Methods/DesignWe have designed a randomised, double-blind, placebo-controlled, two-arm, parallel clinical trial with 12 weeks of treatment and a 4-week follow-up period. A pilot study with 30 participants will be conducted at the RMIT University in Australia to determine the feasibility of the full-scale randomised clinical trial (N = 124). Eczema Area and Severity Index score will be the primary outcome. Secondary outcome measures include change in symptoms using the Patient-Oriented Eczema Measure, the Children’s Dermatology Life Quality Index and the use of concomitant medicines. Safety parameters include report of adverse events and pathology tests during the trial period.DiscussionKey elements for conducting a high-quality randomised clinical trial have been addressed in this protocol. Findings from the proposed trial will provide critical evidence regarding Chinese herbal medicine treatment for atopic eczema.Trial registrationAustralian New Zealand Clinical Trials Registry Identifier: ACTRN12614001172695. Date of Registration: 7 November 2014.

Methodology of the Stroke Self-Management Rehabilitation Trial: An International, Multisite Pilot Trial

Stroke is a major cause of long-term adult disability with many survivors living in the community relying on family members for on-going support. However, reports of inadequate understanding of rehabilitation techniques are common. A self-management DVD-based observational learning tool may help improve functional outcomes for survivors of stroke and reduce caregivers' burden. This article describes the methodology of the stroke self-management rehabilitation trial. The overall aim of this pilot trial is to assess the feasibility and preliminary efficacy of a DVD-based intervention for improving functional outcomes of survivors of stroke 2 months postrandomization to inform the design of a full-scale randomized clinical trial. Recruitment of a minimum of 20 survivors of stroke and their informal caregivers (where available) in each of the participating centers will occur across multiple international sites. After baseline assessments, participants will be randomly assigned to an intervention or standard care group. The intervention comprises a structured DVD observation and practice schedule over 8 weeks. All participants will complete follow-up assessments. The outcome measures will include a global shift in the Rankin Scale scores and dichotomized scores, changes in quality of life, general health, depression, and caregiver burden at 2 months postrandomization. A qualitative analysis of the effects of the intervention will also be undertaken. The results of the pilot study will provide knowledge of whether observational learning techniques delivered via DVD can effectively improve recovery after stroke and reduce caregiver burden.

Treatment of complicated grief in elderly persons: a randomized clinical trial.

Complicated grief (CG) is a debilitating condition, most prevalent in elderly persons. However, to our knowledge, no full-scale randomized clinical trial has studied CG in this population. To determine whether complicated grief treatment (CGT) produces greater improvement in CG and depressive symptoms than grief-focused interpersonal psychotherapy (IPT). Randomized clinical trial enrolling 151 individuals 50 years or older (mean [SD] age, 66.1 [8.9] years) scoring at least 30 on the Inventory of Complicated Grief (ICG). Participants were recruited from the New York metropolitan area from August 20, 2008, through January 7, 2013, and randomized to receive CGT or IPT. The main outcome was assessed at 20 weeks after baseline, with interim measures collected at 8, 12, and 16 weeks after baseline. Sixteen sessions of CGT (n = 74) or IPT (n = 77) delivered approximately weekly. Rate of treatment response, defined as a rating from an independent evaluator of much or very much improved on the Improvement subscale of the Clinical Global Impression Scale. Both treatments produced improvement in CG symptoms. Response rate for CGT (52 individuals [70.5%]) was more than twice that for IPT (24 [32.0%]) (relative risk, 2.20 [95% CI, 1.51-3.22]; P < .001), with the number needed to treat at 2.56. Secondary analyses of CG severity and CG symptom and impairment questionnaire measures confirmed that CGT conferred a significantly greater change in illness severity (22 individuals [35.2%] in the CGT group vs 41 [64.1%] in the IPT group were still at least moderately ill [P = .001]), rate of CG symptom reduction (1.05 ICG points per week for CGT vs 0.75 points per week for IPT [t633 = 3.85; P < .001]), and the rate of improvement in CG impairment (0.63 work and Social Adjustment Scale points per week with CGT and 0.39 points per week with IPT [t503 = 2.87; P = .004]). Results were not moderated by participant age. Complicated grief treatment produced clinically and statistically significantly greater response rates for CG symptoms than a proven efficacious treatment for depression (IPT). Results strongly support the need for physicians and other health care providers to distinguish CG from depression. Given the growing elderly population, the high prevalence of bereavement in aging individuals, and the marked physical and psychological impact of CG, clinicians need to know how to treat CG in older adults. clinicaltrials.gov Identifier: NCT01244295.

O-219 Developing And Evaluating An On Line Parent Information And Support Application To Facilitate Home-based Care By Parents Of Long-term Conditions: A Feasibility Rct

Background/aims We developed a novel, long-term condition-specific Interactive Health Communication Application, the on- line parent information and support (OPIS) to promote parents’ home-based management ability. We aimed to assess feasibility of a future full-scale randomised clinical trial (RCT) of OPIS in terms of recruitment, retention and data collection procedures; and investigate trends in change on outcomes in a small-scale preliminary RCT in parents. Methods Parents were randomly assigned to: usual support (control) or usual support plus OPIS access for 20 weeks (intervention). Both groups completed study measures at study entry (T1) and exit (T2). We assessed feasibility between groups. Results 55 parents of 39 children enrolled in the RCT;19/26 (73%) of intervention parents and 22/29 (76%) of control parents completed T2 data collection. The overall retention rate was 41/55 (75%). Data collection was judged to be feasible. All intervention parents showed evidence of having accessed OPIS, indicating complete uptake. The intent-to-treat analysis showed greater improvement in self-efficacy to manage their child’s condition for intervention parents when compared to control group parents (3.21 v 1.09, 95% CI -1.27 to 5.51, Cohen’s d =.41). Conclusion A full-scale RCT of OPIS is feasible. OPIS has the potential to beneficially affect self-reported outcomes including parents’ competence to provide home-based clinical care-givin. ll-scale RCT that is sufficiently powered to detect the effects of OPIS on outcomes is indicated. Our design and methodology could potentially be transferred to the management of other conditions. Acknowledgements Families and professionals who participated and the National Institute of Health Research for funding support.

Nutrition and physical activity influence on breast cancer incidence and outcome

Introduction and aimsTo provide a current perspective on nutrition and physical activity influence on breast cancer. Methods and resultsA comprehensive literature review was conducted and selective presentation of findings follows. While some observational studies have associated higher dietary fat intake with higher breast cancer incidence, two full-scale randomized, clinical trials of dietary fat intake reduction programs were negative. However, a lifestyle intervention targeting fat intake reduction in the Women's Intervention Nutrition Study (WINS), resulted in weight loss and also reduced breast cancer recurrences in women with early stage disease. Observational studies evaluating specific nutrient intakes and dietary supplements have provided mixed results. Several observational studies find women with early stage breast cancer with lower 25-hydroxyvitamin D levels at higher recurrence risk, a finding requiring cautious interpretation. The lifestyle factor most strongly and consistently associated with both breast cancer incidence and breast cancer recurrence risk is physical activity. A meta-analyses of observational studies supports the concept that moderate recreational physical activity (about 3–4 h walking per week) may reduce breast cancer incidence and that women with early stage breast cancer who increased or maintain their physical activity may have lower recurrence risk as well. Feasibility of achieving increased physical activity and weight loss in women with early-stage breast cancer has been established. Two full-scale randomized clinical trials are evaluating weight loss/maintenance and increased physical activity in relation to recurrence risk in women with early-stage, resected breast cancer. Discussion/conclusionsDietary intake may influence breast cancer but influence is difficult to separate from influence of body weight. A consistent body of observational study evidence suggests higher physical activity has favorable influence on breast cancer incidence and outcome. While awaiting definitive evidence from ongoing randomized trials, breast cancer patients can reasonably be counseled to avoid weight gain and reduce body weight if overweight or obese and increase or maintain a moderate level of physical activity.

Clinical Perspective: Influence of Modifiable Lifestyle Factors, Body Weight, Physical Activity, and Alcohol on Breast Cancer Outcome

Observational studies associate obesity and physical inactivity with adverse breast cancer outcome. Whether weight loss/maintenance or increase in physical activity after diagnosis can improve breast cancer outcome is not established. While alcohol use increases breast cancer risk, the role of alcohol in altering breast cancer outcome is not established. Only two full-scale randomized clinical trials have evaluated lifestyle change in early-stage, resected breast cancer and they provide mixed results. Despite strong preclinical evidence and identified potential mediating factors, only one full-scale lifestyle intervention trial is currently ongoing, SUCCESS-C, which will evaluate a program of weight reduction and increased physical activity in an adjuvant setting. On the basisi of current evidence, weight loss/maintenance and physical activity increase/maintenance can reasonably be recommended for breast cancer patients with early-stage disease. However, the strength of the recommendation awaits definitive randomized clinical trial evidence.

Meta-analysis of the clinical effectiveness of traditional Chinese medicine formula Chaihu-Shugan-San in depression

Aim of studyDepression is a psychiatric disorder. Chaihu-Shugan-San (CSS) is a traditional Chinese medicine formula suggested in the treatment of depression, but its effectiveness and safety are not well defined. This meta-analysis aimed to assess the effectiveness and safety of CSS in depression therapy. Materials and methodsThe databases including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, CNKI database, Wanfang Data and VIP Information were searched. Papers were reviewed systematically by two researchers and were analyzed using Cochrane software Revman 5.0. ResultsTen randomized controlled trials comparing 835 subjects were included. Of these studies, seven studies used fluoxetine (20mg, once a day), two used paroxetine (20mg, once a day) and one used doxepin (25mg, two times a day) as the antidepressant drugs. Meta-analyses revealed that CSS in combination with antidepressant drugs treatment significantly improved depressive symptoms (WMD=−3.56; 95% CI −5.09 to −2.03) and significantly increased effective rate (OR=3.31; 95% CI 1.80–6.10) and recovery rate (OR=2.32; 95% CI 1.61–3.34) compared with antidepressant drugs therapy. In addition, the efficacy of CSS as monotherapy was significantly better than antidepressants in improving depressive symptoms (WMD=−3.09; 95% CI −5.13 to −1.06) and in creasing effective rate (OR=2.61; 95% CI 1.23–5.53). CSS was comparable to antidepressants in increasing recovery rate (OR=1.83; 95% CI 0.84–3.98). No serious adverse events were reported in any of the included trials. ConclusionThe present work supported that CSS was effective and safe in treating depressed patients. More full-scale randomized clinical trials with reliable designs are recommended to further evaluate the clinical benefit and long-term effectiveness of CSS for the treatment of depression.

Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial

BackgroundBack-related leg pain (BRLP) is a common variation of low back pain (LBP), with lifetime prevalence estimates as high as 40%. Often disabling, BRLP accounts for greater work loss, recurrences, and higher costs than uncomplicated LBP and more often leads to surgery with a lifetime incidence of 10% for those with severe BRLP, compared to 1-2% for those with LBP.In the US, half of those with back-related conditions seek CAM treatments, the most common of which is chiropractic care. While there is preliminary evidence suggesting chiropractic spinal manipulative therapy is beneficial for patients with BRLP, there is insufficient evidence currently available to assess the effectiveness of this care.Methods/DesignThis study is a two-site, prospective, parallel group, observer-blinded randomized clinical trial (RCT). A total of 192 study patients will be recruited from the Twin Cities, MN (n = 122) and Quad Cities area in Iowa and Illinois (n = 70) to the research clinics at WHCCS and PCCR, respectively.It compares two interventions: chiropractic spinal manipulative therapy (SMT) plus home exercise program (HEP) to HEP alone (minimal intervention comparison) for patients with subacute or chronic back-related leg pain.DiscussionBack-related leg pain (BRLP) is a costly and often disabling variation of the ubiquitous back pain conditions. As health care costs continue to climb, the search for effective treatments with few side-effects is critical. While SMT is the most commonly sought CAM treatment for LBP sufferers, there is only a small, albeit promising, body of research to support its use for patients with BRLP.This study seeks to fill a critical gap in the LBP literature by performing the first full scale RCT assessing chiropractic SMT for patients with sub-acute or chronic BRLP using important patient-oriented and objective biomechanical outcome measures.Trial RegistrationClinicalTrials.gov NCT00494065