Wait-list Crossover Design Research Articles

Modifications in fMRI Representation of Mental Rotation Following a 6 Week Graded Motor Imagery Training in Chronic CRPS Patients

Complex regional pain syndrome (CRPS) is a neuropathic pain condition that is difficult to treat. For behavioral interventions, graded motor imagery (GMI) showed relevant effects, but underlying neural substrates in patient groups have not been investigated yet. A previous study investigating differences in the representation of a left/right hand judgment task demonstrated less recruitment of subcortical structures, such as the putamen, in CRPS patients than in healthy controls. In healthy volunteers, the putamen activity increased after a hand judgment task training. In order to test for longitudinal effects of GMI training, we investigated 20 CRPS patients in a wait-list crossover design with 3 evaluation time points. Patients underwent a 6 week GMI treatment and a 6 week waiting period in a randomized group assignment and treatment groups were evaluated by a blinded rater. When compared to healthy matched controls at baseline, CRPS patients showed less functional activation in areas processing visual input, left sensorimotor cortex, and right putamen. Only GMI treatment, but not the waiting period showed an effect on movement pain and hand judgment task performance. Regression analyses revealed positive associations of movement pain with left anterior insula activation at baseline. Right intraparietal sulcus activation change during GMI was associated with a gain in performance of the hand judgment task. The design used here is reliable for investigating the functional representation of the hand judgment task in an intervention study. PerspectiveTwenty chronic CRPS patients underwent a 6 week GMI intervention in a randomized wait-list crossover design. functional MRI was tested pre and post for the hand lateralization task which improved over GMI but not over WAITING. Performance gain was positively related to right parietal functional MRI activation.

Simulated laughter, perceived stress, and discourse in adults with aphasia

ABSTRACT Background Several studies have revealed an association between stress and language in nonclinical and aphasia groups. Laughter is considered to be an important contributor to physical and mental health including physiological and self-reported perceived stress. Simulated laughter programs, such as Laughter Yoga (LY), are a way to engage a person in the act of laughter without a humorous stimulus. The importance of laughter in aphasia therapy has been underexplored. Aims The current study investigated the effects of a simulated laughter program based in LY techniques on discourse measures and perceived stress for adults with aphasia. Qualitative feedback regarding the LY program was also collected from participants to assess their perception of the program. Additionally, the convergent validity of the Simple Aphasia Stress Scale (SASS) was explored. SASS measures were correlated with discourse measures in post hoc analyses to contribute to the growing literature examining the relation between perceived stress and language performance. Methods A waitlist crossover design was conducted across nine participants all with stroke and mild to moderate aphasia. All participants participated in a 3-day intervention period in which they engaged in a 20-minute simulated laughter program and a 3-day comparison condition in which they engaged in a 20-minute sitting session. Pre- and post- measures of self-reported perceived stress and discourse were taken on days 1 and 3 of each condition. Qualitative feedback on the simulated laughter program was also gathered. Outcomes & results No significant changes were noted in discourse measures or perceived stress in relation to the LY intervention. Responses regarding enjoyment of the simulated laughter program were primarily positive, however, some responses revealed an unfavorable opinion of the experience. The SASS demonstrated good convergent validity by significantly correlating with the Single-Item Stress Measurement (SISM) and Self-Assessment Manikin (SAM)-Arousal. Post-hoc analysis revealed associations between the SASS and certain measures of discourse dysfluency and productivity. Conclusions The simulated laughter program proved ineffective at differentially changing discourse dysfluency, productivity, or perceived stress in adults with aphasia when compared to a sitting condition. The SASS’ convergent validity is encouraging for its use as a measure of perceived stress by clinicians and researchers. Perceived stress correlated with certain discourse dysfluency and productivity measures adding to a growing body of literature in the area of stress and aphasia.

Feasibility of the Lee Silverman Voice Treatment-BIG Intervention in Stroke.

Lee Silverman Voice Treatment-BIG (LSVT BIG) has been used in Parkinson's disease and in two case studies with individuals post-stroke. The purpose of this study was to examine the feasibility, acceptability, and preliminary clinical effect of the LSVT BIG program for individuals post-stroke. This study was a waitlist crossover design. Outcomes were assessed at baseline, after 4 weeks, and after crossover. The primary outcomes were feasibility and acceptability; clinical outcomes were also assessed. We contacted 888 potential participants. Of the 35% of individuals who were interested in the study, most were ineligible to participate because they lacked transportation to the clinic. Five individuals were eligible and enrolled in the study. All completed 100% of in-clinic sessions. Four participants rated their occupational performance higher after the LSVT BIG intervention. It is feasible to deliver the LSVT BIG in the chronic stroke population. Individuals who complete the protocol demonstrate clinically relevant improvements.

An Affirmative Coping Skills Intervention to Improve the Mental and Sexual Health of Sexual and Gender Minority Youth (Project Youth AFFIRM): Protocol for an Implementation Study.

BackgroundSexual and gender minority youth (SGMY, aged 14-29 years) face increased risks to their well-being, including rejection by family, exclusion from society, depression, substance use, elevated suicidality, and harassment, when compared with their cisgender, heterosexual peers. These perils and a lack of targeted programs for SGMY exacerbate their risk for HIV and other sexually transmitted infections. Cognitive behavioral therapy (CBT) interventions support clients by generating alternative ways of interpreting their problems and beliefs about themselves. CBT, tailored to the experiences of SGMY, may help SGMY improve their mood and coping skills by teaching them how to identify, challenge, and change maladaptive thoughts, beliefs, and behaviors. Based on the promising results of a pilot study, a CBT-informed group intervention, AFFIRM, is being tested in a pragmatic trial to assess its implementation potential.ObjectiveThe aim of this study is to scale-up implementation and delivery of AFFIRM, an 8-session manualized group coping skills intervention focused on reducing sexual risk behaviors and psychosocial distress among SGMY. Our secondary aim is to decrease sexual risk taking, poor mental health, and internalized homophobia and to increase levels of sexual self-efficacy and proactive coping among SGMY.MethodsSGMY are recruited via flyers at community agencies and organizations, as well as through Web-based advertising. Potential participants are assessed for suitability for the group intervention via Web-based screening and are allocated in a 2:1 fashion to the AFFIRM intervention or a wait-listed control in a stepped wedge wait-list crossover design. The intervention groups are hosted by collaborating community agency sites (CCASs; eg, community health centers and family health teams) across Ontario, Canada. Participants are assessed at prewait (if applicable), preintervention, postintervention, 6-month follow-up, and 12-month follow-up for sexual health self-efficacy and capacity, mental health indicators, internalized homophobia, stress appraisal, proactive and active coping, and hope. Web-based data collection occurs either independently or at CCASs using tablets. Participants in crisis are assessed using an established distress protocol.ResultsData collection is ongoing; the target sample is 300 participants. It is anticipated that data analyses will use effect size estimates, paired sample t tests, and repeated measures linear mixed modeling in SPSS to test for differences pre- and postintervention. Descriptive analyses will summarize data and profile all variables, including internal consistency estimates. Distributional assumptions and univariate and multivariate normality of variables will be assessed.ConclusionsAFFIRM is a potentially scalable intervention. Many existing community programs provide safe spaces for SGMY but do not provide skills-based training to deal with the increasingly complex lives of youth. This pragmatic trial could make a significant contribution to the field of intervention research by simultaneously moving AFFIRM into practice and evaluating its impact.International Registered Report Identifier (IRRID)DERR1-10.2196/13462

Testing the effectiveness of group-based memory rehabilitation in chronic stroke patients

Memory complaints are common after stroke, yet there have been very few studies of the outcome of memory rehabilitation in these patients. The present study evaluated the effectiveness of a new manualised, group-based memory training programme. Forty outpatients with a single-stroke history and ongoing memory complaints were enrolled. The six-week course involved education and strategy training and was evaluated using a wait-list crossover design, with three assessments conducted 12 weeks apart. Outcome measures included: tests of anterograde memory (Rey Auditory Verbal Learning Test: RAVLT; Complex Figure Test) and prospective memory (Royal Prince Alfred Prospective Memory Test); the Comprehensive Assessment of Prospective Memory (CAPM) questionnaire and self-report of number of strategies used. Significant training-related gains were found on RAVLT learning and delayed recall and on CAPM informant report. Lower baseline scores predicted greater gains for several outcome measures. Patients with higher IQ or level of education showed more gains in number of strategies used. Shorter time since onset was related to gains in prospective memory, but no other stroke-related variables influenced outcome. Our study provides evidence that a relatively brief, group-based training intervention can improve memory functioning in chronic stroke patients and clarified some of the baseline factors that influence outcome.

Effective group-based memory training for patients with epilepsy

Patients with epilepsy experience memory problems, but there have been few attempts to provide and evaluate the effectiveness of memory training. We designed a 6-week, group-based, psychoeducation and strategy course that was evaluated using a waitlist crossover design, with three assessments conducted 12weeks apart. Thirty-one patients with a history of seizures participated. Significant gains were found on tests of anterograde (Rey Auditory Verbal Learning Test) and appointment memory. In addition, patients reported using more strategies and experiencing fewer prospective memory difficulties in daily life. Memory was more likely to improve in participants who were younger, less educated, and less depressed. Moreover, lower baseline memory, but better attention corresponded to better outcome. Of the clinical variables related to epilepsy, only number of anticonvulsant medications was found to be associated with outcome. Our study provides evidence that a relatively short intervention can improve memory functioning in patients with epilepsy.

Symptomatic autoregulatory failure in acute ischemic stroke

<h3>Background:</h3> Although randomized controlled trials are often a gold standard for determining intervention effects, in the area of practice-based research (PBR), there are many situations in which individual randomization is not possible. Alternative approaches to evaluating interventions have received increased attention, particularly those that can retain elements of randomization such that they can be considered “controlled” trials. <h3>Methods:</h3> Methodological design elements and practical implementation considerations for two quasi-experimental design approaches that have considerable promise in PBR settings – the stepped-wedge design, and a variant of this design, a wait-list cross-over design, are presented along with a case study from a recent PBR intervention for patients with diabetes. <h3>Results:</h3> PBR-relevant design features include: creation of a cohort over time that collects control data but allows all participants (clusters or patients) to receive the intervention; staggered introduction of clusters; multiple data collection points; and one-way cross-over into the intervention arm. Practical considerations include: randomization versus stratification, training run in phases; and extended time period for overall study completion. <h3>Conclusion:</h3> Several design features of practice based research studies can be adapted to local circumstances yet retain elements to improve methodological rigor. Studies that utilize these methods, such as the stepped-wedge design and the wait-list cross-over design, can increase the evidence base for controlled studies conducted within the complex environment of PBR.