Active Control Condition Research Articles

Preliminary Feasibility of a Novel Mind-Body Program to Prevent Persistent Concussion Symptoms Among Young Adults With Anxiety: Nonrandomized Open Pilot Study.

Concussions are common, particularly among young adults, and often are associated with persistent, debilitating, and hard-to-treat symptoms. Anxiety and concussion symptoms often amplify each other, and growing evidence indicates that anxiety plays a key role in symptoms persistence after concussion. Targeting anxiety early after concussion may be a promising means of helping prevent persistent concussion symptoms in this population. We developed the Toolkit for Optimal Recovery after Concussion (TOR-C), the first mind-body program tailored for young adults with a recent concussion and anxiety, aiming to prevent persistent concussion symptoms. This study aims to conduct an open pilot of TOR-C to test preliminary feasibility, signal of change in measures, and treatment perceptions. Five young adults (aged 18-24 years) attended 4 weekly one-on-one live video sessions with a clinician. Participants completed questionnaires measuring treatment targets (ie, pain catastrophizing, mindfulness, fear avoidance, limiting behaviors, and all-or-nothing behaviors) and outcomes (ie, postconcussive symptoms, physical function, anxiety, depression, and pain) at baseline, immediately following the intervention, and 3 months after intervention completion. At the conclusion of the program, participants attended a qualitative interview and provided feedback about the program to help optimize study content and procedures. Feasibility markers were excellent for credibility and expectancy (5/5, 100% of participants scored above the credibility and expectancy scale midpoint), client satisfaction (4/5, 80% of participants scored above the Client Satisfaction Questionnaire midpoint), therapist adherence (97% adherence), acceptability of treatment (5/5, 100% of participants attended 3 or more sessions), adherence to homework (87% home practice completion), and feasibility of assessments (no measures fully missing). The feasibility of recruitment was good (5/7, 71% of eligible participants agreed to participate). There were preliminary signals of improvements from pre-post comparisons in treatment targets (d=0.72-2.20) and outcomes (d=0.41-1.38), which were sustained after 3 months (d=0.38-2.74 and d=0.71-1.63 respectively). Exit interviews indicated overall positive perceptions of skills and highlighted barriers (eg, busyness) and facilitators (eg, accountability) to engagement. TOR-C shows preliminary feasibility, is associated with a signal of improvement in treatment targets and outcomes, and has the potential to support recovery from concussion. The quantitative findings along with the qualitative feedback obtained from the exit interviews will help optimize TOR-C in preparation for an upcoming randomized controlled trial of TOR-C versus an active control condition of health education for concussion recovery. RR2-10.2196/25746.

Mitigating the Stigma of Mental Illness: The Impact of Story-Telling in the Black Community

Racial/ethnic minorities, including the Black community, experience stigma as a significant barrier to mental health care, with fears of being devalued or discriminated against deterring individuals from seeking help. Racial stigma further exacerbates mental health issues and negatively influences perceptions of service utilization. To address this, our research team partnered with a national non-profit storytelling organization to develop and evaluate a virtual narrative storytelling intervention series that amplifies the voices and experiences of Black Americans living with mental illness and addiction. We randomly assigned 193 participants to either the intervention (n = 102) or an active control condition (n = 91) and used a pre–post survey design to assess the changes in the outcome variables. Contrary to our hypothesis, there were no race-based interactions; instead, the results show significant reductions in public stigma and perceived discrimination and increased positive attitudes toward seeking treatment universally among all the intervention participants. This study provided preliminary evidence that a virtual storytelling intervention is instrumental across varied demographic cohorts, transcending potential cultural barriers in the discourse and understanding of mental health to effectively mitigate stigma and improve attitudes toward mental health treatment.

A randomized controlled clinical trial of a Wim Hof Method intervention in women with high depressive symptoms

ObjectiveStress is a driver of depression, and people with depression often struggle to cope with stress and anxiety. This study directly compares the mental health effects of a Wim Hof Method intervention to an active control condition (slow breathing) in women with high stress and high depressive symptoms. MethodsWe randomized 84 healthy midlife women with high stress and high depressive symptoms to either: 1) the hormetic stress condition based on the Wim Hof Method (WHM) involving a breathing technique designed to induce intermittent hypoxia and cold showers (n = 41) or 2) an active comparison condition involving slow-paced breathing and warm showers (n = 43). We provided participants with daily audio instructions (15 min) for three weeks during the COVID-19 pandemic (2020–2021). Our primary outcomes were depressive symptoms, anxiety symptoms, and perceived stress collected at pre-intervention, post-intervention, and 3 months later. We also assessed daily stress rumination and affect with daily diary during the intervention, and participants completed a laboratory stressor, the Trier Social Stress Test, before and after the intervention, and provided samples for salivary cortisol reactivity. ResultsParticipants in the active control condition perceived the intervention to be more credible and expected greater mental wellbeing benefits compared to those in the Wim Hof Method condition. Differential attrition was observed with six participants (7 %) dropping out -- all from WHM condition. Among the participants who completed the intervention, both groups improved on mental health outcomes immediately after the intervention with a 24 % reduction in depressive symptoms, a 27 % reduction in anxiety symptoms, and 20 % reduction in perceived stress. Improvements were maintained at the 3-month follow-up with 46 % of the sample reporting mild or no depressive symptoms. Participants in the WHM condition had significant reductions in rumination after daily stressful events compared to those in the active control group. Both conditions had reduced daily negative affect across the intervention and lower peak cortisol reactivity to the lab stressor post-intervention. ConclusionsCounter to the preregistered predictions, and despite participants’ differing expectations, the interventions led to equivalent reductions in depressive symptoms, anxiety symptoms, and perceived stress, which were sustained at three months. They also produced comparable reductions in cortisol reactivity and daily negative affect. However, the WHM condition was associated with greater reduction in reported rumination after daily stressful events than the active control, a finding that needs replication with larger and more diverse samples.

Engagement, Acceptability, and Effectiveness of the Self-Care and Coach-Supported Versions of the Vira Digital Behavior Change Platform Among Young Adults at Risk for Depression and Obesity: Pilot Randomized Controlled Trial.

Adolescence and early adulthood are pivotal stages for the onset of mental health disorders and the development of health behaviors. Digital behavioral activation interventions, with or without coaching support, hold promise for addressing risk factors for both mental and physical health problems by offering scalable approaches to expand access to evidence-based mental health support. This 2-arm pilot randomized controlled trial evaluated 2 versions of a digital behavioral health product, Vira (Ksana Health Inc), for their feasibility, acceptability, and preliminary effectiveness in improving mental health in young adults with depressive symptoms and obesity risk factors. A total of 73 participants recruited throughout the United States were randomly assigned to use Vira either as a self-guided product (Vira Self-Care) or with support from a health coach (Vira+Coaching) for 12 weeks. The Vira smartphone app used passive sensing of behavioral data related to mental health and obesity risk factors (ie, activity, sleep, mobility, and language patterns) and offered users personalized insights into patterns of behavior associated with their daily mood. Participants completed self-reported outcome measures at baseline and follow-up (12 weeks). All study procedures were completed via digital communications. Both versions of Vira showed strong user engagement, acceptability, and evidence of effectiveness in improving mental health and stress. However, users receiving coaching exhibited more sustained engagement with the platform and reported greater reductions in depression (Cohen d=0.45, 95% CI 0.10-0.82) and anxiety (Cohen d=0.50, 95% CI 0.13-0.86) compared to self-care users. Both interventions also resulted in reduced stress (Vira+Coaching: Cohen d=-1.05, 95% CI -1.57 to --0.50; Vira Self-Care: Cohen d=-0.78, 95% CI -1.33 to -0.23) and were perceived as useful and easy to use. Coached users also reported reductions in sleep-related impairment (Cohen d=-0.51, 95% CI -1.00 to -0.01). Moreover, participants increased their motivation for and confidence in making behavioral changes, with greater improvements in confidence among coached users. An app-based intervention using passive mobile sensing to track behavior and deliver personalized insights into behavior-mood associations demonstrated feasibility, acceptability, and preliminary effectiveness for reducing depressive symptoms and other mental health problems in young adults. Future directions include (1) optimizing the interventions, (2) conducting a fully powered trial that includes an active control condition, and (3) testing mediators and moderators of outcome effects. ClinicalTrials.gov NCT05638516; https://clinicaltrials.gov/study/NCT05638516.

Is the Unified Protocol for Children Effective for the Transdiagnostic Treatment of Children’s Emotional Disorders? A Randomized Controlled Trial

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) aims to reduce internalizing symptoms in children by addressing fundamental mechanisms that underlie emotional disorders through a combination of cognitive, emotional, and behavioral strategies. This study, the largest randomized controlled trial (RCT) to date of UP-C efficacy and the first one conducted outside the U.S., assesses the efficacy of UP-C compared to an active control group. A total of 153 children (6–13 years old; 58.8% girls) with at least one emotional disorder as a primary diagnosis and their parents (88.2% mothers) were randomly assigned to either the UP-C condition (n = 77) or an active control condition (n = 76; receiving a psychoeducational intervention, the ABC of Emotions). Participants completed self-report questionnaires at pretreatment, midtreatment, posttreatment, and at the 3-month follow-up, assessing children’s internalizing symptoms and their interference with the child and family functioning. Clinicians assessed the severity of the child’s symptoms and monitored clinical improvement throughout the study. Descriptive statistics, comparative tests and Linear Mixed Models were used. Results showed greater satisfaction, lower dropout rates, and better adherence in the UP-C condition, with a reduced need for additional interventions posttreatment compared to the control group. The UP-C demonstrated significantly greater efficacy in reducing internalizing symptoms, with a large effect size, including anxiety and depression, as well as in reducing the interference and severity of child symptoms and in improving clinical gains compared to the control group. These findings provide strong support for UP-C as a feasible, acceptable, and effective treatment for childhood emotional disorders, reinforcing its status as an evidence-based treatment.

Effects of a Brief Safe Drinking Intervention on Depressive and Anxiety Symptomatology: Examining Potential Side Effects of Deviance Regulation Theory Interventions.

College students are at a heightened risk of experiencing depression and anxiety symptomatology and engaging in maladaptive alcohol use. Understanding how alcohol interventions impact emotional functioning is essential. One such intervention uses Deviance Regulation Theory (DRT), which posits that behavior can be modified using targeted messaging as a function of perceived norms. DRT has been shown to be effective at increasing responsible drinking behaviors and decreasing alcohol-related consequences. However, it is unclear if this intervention influences emotional functioning. The current examines the impact of a DRT intervention on emotional functioning. Participants (n = 147) were recruited from a large Southeastern university. The study included a screening phase, intervention, and six-week follow-up. Participants were randomly assigned to one of three conditions: a positive message condition about people who drink responsibly, a negative message condition about people who do not drink responsibly, and an active control condition. During the study, all participants reported on depression/anxiety symptoms, alcohol use, responsible drinking, and alcohol-related consequences. Mixed-effects regression was used to analyze the data. Results suggest an overall reduction of depressive and anxiety symptomatology in the intervention conditions but not in the control condition. In the positive condition, there was a decrease in depressive and anxiety symptomatology. The messaging was not moderated by normative beliefs. The negative condition also led to decreases in depression and anxiety symptomatology over time. In addition, perceived norms moderated the negative message in the first week after the intervention, an effect consistent with DRT. Prior research indicates this intervention is efficacious for the reduction of adverse alcohol outcomes; these data show that the intervention may also have positive effects on downstream mental health outcomes.

The Effects of Static Stretching 2-Hours Prior to a Traditional Warm-Up on Performance.

Whereas prolonged static stretching (SS: >60-seconds per muscle) can increase range of motion (ROM) for up to 2-hours, it can also decrease maximal voluntary isometric contraction (MVIC) forces, countermovement (CMJ) and drop jump (DJ) heights, and muscle activation immediately after the stretching exercise. When an appropriate SS duration (<60-seconds per muscle) is incorporated into a dynamic warm-up, performance decrements are often trivial. However, there is a lack of studies that observed the effects of extensive SS (180-seconds) 2-hours prior to a dynamic warm-up. The objective was to investigate ROM and performance effects of prolonged SS, 2-hours prior to a traditional warm-up. This study investigated 9 female and 8 male healthy recreationally active, young adult participants on the effects of prolonged SS (180-seconds per muscle) of the quadriceps and hamstrings, 2-hours before a traditional warm-up compared to an active control condition on hip flexion ROM, knee extension and flexion MVIC forces, CMJ, DJ, and quadriceps and hamstrings electromyography (EMG). There were no significant changes in knee flexion/extension MVIC forces, EMG, CMJ, or DJ height. However, there was significant, small magnitude (p = 0.002) greater post-warm-up left hip flexion ROM (115.4° ± 17.2) than pre-SS (108.9° ± 17.13, Effect size [ES]: 0.28) and control post-warm-up (p = 0.05, ES: 0.31, 109.5° ± 20.55). Similarly, right hip flexion ROM (117.2° ± 16.5) also demonstrated significant small magnitude (p = 0.003) greater than the pre-SS (112.4° ± 18.4, ES: 0.22) and control post-warm-up (p = 0.046, ES: 0.33, 110.8° ± 20.5). Additionally, significant, large magnitude greater hip flexion ROM was observed with the women vs. men (ES: 1.29 - 1.34). Significant hip flexion ROM increases were not accompanied by significant changes in knee flexion/extension MVIC forces, EMG, or jump heights, suggesting that extensive SS can positively impact ROM without performance deficits when followed by a traditional warm-up, 2-hours after SS.

Efficacy of a cognitive training based on inhibitory spillover and attribute conditioning: No weight and food intake reductions in adults with overweight and obesity

BackgroundOvereating and obesity have been linked to deficient self-control and recent evidence suggests that the inhibitory spillover effect (ISE) may be an effective means to improve self-control. Specifically, it was shown that the ISE increases self-control by transfer of self-control capacity from one domain to another unrelated domain. Against this backdrop, our aim was to reduce hedonic food intake and body weight in non-dieting participants with overweight and obesity by transferring inhibitory control abilities from a food-unrelated domain to the food domain by means of an attribute conditioning procedure in a novel cognitive training (vs. a placebo training) comprising 8-sessions delivered over four weeks. MethodIn total, 93 adults with overweight and obesity were included in a two-arm randomized controlled trial and assigned to the computerized cognitive training or a placebo training (active control condition). Food intake in a bogus taste test and body weight were assessed prior to and after the training. Weight was additionally assessed at 3-months follow-up. ResultsThere was no improvement in food intake and weight reduction. DiscussionThe cognitive training based on the ISE and attribute conditioning (ISAC) is not yet ready for application. Future studies need to identify the factors critical for a successful implementation of conditioning procedures aiming to associate food stimuli with self-control in overweight and obesity.

Improvement in Math Ability and Cognitive Processing in Children with Low Attention: An Intervention Based on PASS Theory.

This study investigates the effects of math training on math and cognitive performance among 8-9 year-old students with low attention. Fifty-six students with low attention were randomly assigned to a training group (n = 24) and a passive control group (n = 32). They completed math problem-solving, calculation fluency and PASS cognitive processing tests both before and after training. The children in the training group received 3 days of training per week for a total of 21 days using the math modules of The Children's Mathematics and Cognition Training Manual in Chinese. The results showed that the training group's math problem-solving performance improved significantly. Moreover, the cognitive performance on the CAS-2 in the planning and simultaneous processing tests for the training group was enhanced. The implications of these findings are discussed with consideration of the interpretability being constrained by the fact that no active control condition was applied.

Auditory confounds can drive online effects of transcranial ultrasonic stimulation in humans.

Transcranial ultrasonic stimulation (TUS) is rapidly emerging as a promising non-invasive neuromodulation technique. TUS is already well-established in animal models, providing foundations to now optimize neuromodulatory efficacy for human applications. Across multiple studies, one promising protocol, pulsed at 1000 Hz, has consistently resulted in motor cortical inhibition in humans (Fomenko et al., 2020). At the same time, a parallel research line has highlighted the potentially confounding influence of peripheral auditory stimulation arising from TUS pulsing at audible frequencies. In this study, we disentangle direct neuromodulatory and indirect auditory contributions to motor inhibitory effects of TUS. To this end, we include tightly matched control conditions across four experiments, one preregistered, conducted independently at three institutions. We employed a combined transcranial ultrasonic and magnetic stimulation paradigm, where TMS-elicited motor-evoked potentials (MEPs) served as an index of corticospinal excitability. First, we replicated motor inhibitory effects of TUS but showed through both tight controls and manipulation of stimulation intensity, duration, and auditory masking conditions that this inhibition was driven by peripheral auditory stimulation, not direct neuromodulation. Furthermore, we consider neuromodulation beyond driving overall excitation/inhibition and show preliminary evidence of how TUS might interact with ongoing neural dynamics instead. Primarily, this study highlights the substantial shortcomings in accounting for the auditory confound in prior TUS-TMS work where only a flip-over sham and no active control was used. The field must critically reevaluate previous findings given the demonstrated impact of peripheral confounds. Furthermore, rigorous experimental design via (in)active control conditions is required to make substantiated claims in future TUS studies. Only when direct effects are disentangled from those driven by peripheral confounds can TUS fully realize its potential for research and clinical applications.

Auditory confounds can drive online effects of transcranial ultrasonic stimulation in humans

Transcranial ultrasonic stimulation (TUS) is rapidly emerging as a promising non-invasive neuromodulation technique. TUS is already well-established in animal models, providing foundations to now optimize neuromodulatory efficacy for human applications. Across multiple studies, one promising protocol, pulsed at 1000 Hz, has consistently resulted in motor cortical inhibition in humans (Fomenko et al., 2020). At the same time, a parallel research line has highlighted the potentially confounding influence of peripheral auditory stimulation arising from TUS pulsing at audible frequencies. In this study, we disentangle direct neuromodulatory and indirect auditory contributions to motor inhibitory effects of TUS. To this end, we include tightly matched control conditions across four experiments, one preregistered, conducted independently at three institutions. We employed a combined transcranial ultrasonic and magnetic stimulation paradigm, where TMS-elicited motor-evoked potentials (MEPs) served as an index of corticospinal excitability. First, we replicated motor inhibitory effects of TUS but showed through both tight controls and manipulation of stimulation intensity, duration, and auditory masking conditions that this inhibition was driven by peripheral auditory stimulation, not direct neuromodulation. Furthermore, we consider neuromodulation beyond driving overall excitation/inhibition and show preliminary evidence of how TUS might interact with ongoing neural dynamics instead. Primarily, this study highlights the substantial shortcomings in accounting for the auditory confound in prior TUS-TMS work where only a flip-over sham and no active control was used. The field must critically reevaluate previous findings given the demonstrated impact of peripheral confounds. Furthermore, rigorous experimental design via (in)active control conditions is required to make substantiated claims in future TUS studies. Only when direct effects are disentangled from those driven by peripheral confounds can TUS fully realize its potential for research and clinical applications.

A Randomized Controlled Trial of a Behavioral Activation Intervention to Increase Engagement with Life and Well-Being in Older Adults

Introduction: Engagement with life is central to aging well. There is currently a lack of flexible programs for promoting engagement that tailor to the unique interests, capacities, and life circumstances of individuals. We designed and evaluated a new program for promoting engagement with later life based on principles of behavioral activation. Methods: A total of 135 adults aged 65 years and older who scored at or below the median on the Life Engagement Test were randomly assigned to either a 6-week behavioral activation program (n = 69) or a 6-week well-being program based on brief positive psychology interventions (the active control; n = 66). Participants completed assessments at baseline, 1-week follow-up, and 3-month follow-up. The primary outcome was engagement with life, and secondary outcome measures included social network characteristics, measures of mental health, well-being, and psychological and self-regulatory resources. Results: Participants in both conditions showed improvements in engagement with life post-intervention that were sustained at 3 months. Post-intervention improvements in both conditions were observed across most secondary outcomes; however, for several outcomes, participants with more limited functional and cognitive resources benefitted from participation in the positive psychology (active control) condition, but not the treatment condition. Conclusion: Similar levels of improvement in engagement with life and well-being were evident for participants who completed a behavioral activation-focused intervention, compared with participants who completed a positive psychology-focused intervention. The positive psychology approach may confer greater benefits for emotional well-being among those with poorer functional and cognitive abilities.

Analyses of prediction, moderation, and mediation of a transdiagnostic, indicated preventive intervention (PROCARE-I) for adolescents at high risk of emotional problems

ABSTRACT Background Emotional disorders, such as anxiety and depression, are highly prevalent among adolescents, emphasizing the critical importance of developing effective preventive interventions and advancing the understanding of mechanisms inherent in these interventions. Objective To conduct secondary prediction/moderation analyses of sociodemogrphic and clinical variables regarding outcomes of a transdiagnostic, indicated preventive intervention for high-risk adolescents (PROCARE-I) and an active control condition (ACC) based on psychoeducation. Additionally, mediation analyses examined the role of resilience in improved PROCARE-I outcomes. Method Sixty-four emotionally high-risk adolescents (53% female and 47% male), aged 12 to 18 years (M = 13.69; SD = 1.56), were randomized into the PROCARE-I condition (n = 36) and the ACC (n = 28). Results There was a nonspecific prediction effect, indicating that a combination of anxious and depressive symptoms is associated with higher self-reported emotional risk following the interventions. No treatment moderation effect was found. Regarding mediation analyses, receiving a transdiagnostic preventive intervention, as opposed to an intervention based solely on psychoeducation, increased resilience levels. This rise in resilience mediated the reduction in emotional risk levels, emotional symptomatology, as well as the improvement in the quality of life reported by adolescents. Conclusions Enhancement of resilience could play a fundamental role in achieving positive outcomes following a transdiagnostic preventive intervention for emotionally high-risk adolescents.

Mental Health Interventions in Middle Schools: A 10-Year Review of Research.

Schools can play an important role in addressing growing concerns about adolescent mental health. Mental health of high school students has predominantly been the focus in literature with less emphasis on younger adolescents. This review identified articles published in the last decade that described evaluations of middle school-based mental health interventions and randomized participants to an intervention or control condition. Fourteen interventions met the inclusion criteria. About two-thirds of interventions were based on mindfulness or cognitive behavioral therapy. Many trials utilized racially diverse, low-income samples. All interventions were delivered to groups, and three contained a parent component. Five trials increased rigor by using an active control condition. Almost two-thirds of the interventions were effective (p < .10) in reducing at least one depression, anxiety, affect, or internalizing symptom outcome compared to a control group. This article provides information about intervention characteristics, efficacy, theoretical framework, and acceptability/feasibility.

Mindfulness-Oriented Recovery Enhancement: Implementing an evidence-based intervention for chronic pain, opioid use, and opioid addiction in clinical settings.

The opioid crisis emerged in part due to the overprescribing of opioid analgesics for chronic pain. Although not the only source of the current epidemic of opioid use disorder (OUD), the prescription of opioids for chronic pain remains one vector for the development of opioid misuse and OUD. However, opioid tapering is not appropriate for all patients, and some patients may need to remain on opioid therapy for the long term. To reduce the risk of opioid-related harm among people with chronic pain and to treat incipient or entrenched addictive behaviours, new interventions are needed. This review discusses the clinical outcomes, biobehavioural mechanisms and implementation considerations for a novel, evidence-based intervention for chronic pain, opioid use and OUD called Mindfulness-Oriented Recovery Enhancement (MORE). MORE unites complementary aspects of mindfulness training, cognitive behavioural therapy and principles from positive psychology to simultaneously address addictive behaviour, emotion dysregulation and chronic pain by targeting brain reward and stress systems. MORE has been tested in 13 completed randomized clinical trials, including over 1300 patients, and has demonstrated efficacy against a range of active control conditions for reducing opioid dosing, opioid misuse, illicit drug use, depression, post-traumatic stress symptoms and chronic pain. Opportunities for implementing MORE include facilitating opioid tapering and promoting safe opioid use in primary care and specialty pain clinics, decreasing opioid misuse and enhancing medication-assisted treatment for OUD. Given evidence of MORE's efficacy, it is now time to consider disseminating this evidence-based treatment in the United States, the United Kingdom and worldwide.

Remotely-delivered exercise training program for improving physical and cognitive functions among older adults with multiple sclerosis: Protocol for an NIH stage-I randomized controlled trial

BackgroundOlder adults with multiple sclerosis (MS) present with low physical activity participation, cognitive and ambulatory dysfunctions, and compromised quality of life (QOL). ObjectiveWe propose a NIH Stage-I, randomized controlled trial (RCT) that examines the feasibility and efficacy of a 16-week theory-based, remotely-delivered, exercise training program for improving cognitive and physical functions in older adults with MS who have moderate mobility disability without severe cognitive impairment. MethodsThis Stage-I study utilizes a parallel-group RCT design. Participants (N = 50; age ≥ 50 years) will be randomly assigned into exercise training (combined aerobic and resistance exercise) or active control (flexibility and stretching) conditions. The conditions will be undertaken within a participant's home/community over a 16-week period, and monitored remotely and supported by Zoom-based chats guided by social cognitive theory (SCT) via a behavioral coach. Participants will receive training manuals and equipment, one-on-one behavioral coaching, action-planning calendars, self-monitoring logs, and SCT-based newsletters. The primary outcomes include feasibility (e.g., recruitment and retention rates), exercise behavior and physical activity; other outcomes include physical function (lower-extremity function, mobility, walking), cognition (processing speed, learning and memory, executive function), MS symptoms, QOL, and vascular function. We will collect outcome data at baseline (Week 0), post-intervention (Week 16), and follow-up (Week-32). Data analysis will follow intent-to-treat principles using linear mixed-effects models. DiscussionThis Stage-I trial adopts an innovative approach for exercise training via telerehabilitation and is convenient and accessible for older adults with MS. If successful, the study will provide foundations for future research using remotely-delivered exercise intervention for managing the consequences of aging with MS.Trial Registration Number:NCT05930821

Unleashing creative potential: Evaluating the impact of a cognitive-based creativity training program in the classroom

While the evidence supporting cognitive-based creativity training as a means of enhancing creative thinking is increasing, its long-term effects and who can benefit from the training remain unclear. To address this gap, we developed a cognitive-based creativity training program for school-aged children and assessed its efficacy through pre-, post-, and follow-up tests, comparing the performance of two groups matched for working memory in the pre-test. One group (n = 33) underwent the training program, whereas the other group (n = 27) participated in the active control condition. The results showed that the training group exhibited significantly better creative thinking performance than the control group in the post-test. This difference was sustained over six months, and the improvement in creative thinking was independent of any changes in working memory, as determined using a subsample. In addition, individuals with lower levels of creative thinking performance before training gained more from training than those with higher levels.

Medication development for AUD: A systematic review of clinical trial methodology

Refining clinical trial methodology has become increasingly important as study design is shown to influence treatment efficacy. To maximize the efficiency of randomized clinical trials (RCTs), researchers aim to establish standardized practices. The goal of this systematic review is to describe methodological practices of clinical trials for alcohol use disorder (AUD) over the past 40 years. To achieve this goal, a PubMed search was conducted in April 2023 for RCTs on AUD medications published between July 2018 through April 2023. Resulting studies were combined with a previous search from 1985 through 2018. Inclusion criteria for the RCT studies were: (1) a randomized controlled trial, (2) double or single blinded, (3) placebo or active control condition, (4) alcohol use as the primary endpoint, (5) 4 or more weeks of treatment, and (6) 12 or more weeks of follow-up. In total, methodological data from 139 RCTs representing 19 medications and spanning the past four decades were summarized. Results indicated that the most common medications tested were naltrexone (k = 42), acamprosate (k = 24), and baclofen (k = 11). On average, participants were 74% male and consumed 226 drinks per month pre-randomization. The median length of treatment was 12 weeks (IQR = 12–16; min = 4 max = 52) and the median follow-up duration was 12.5 weeks (IQR: 12–26; min = 7 max = 104). There were two broad domains of outcomes (i.e., abstinence and heavy drinking), with most studies featuring outcomes from both domains (k = 87; 63%). Reporting practices were summarized by decade, revealing an increased enrollment of females, better reporting of race and ethnicity data, and less studies requiring pre-trial abstinence. This review summarizes the current state of the literature on randomized clinical trials for AUD including effect sizes for individual studies and summaries of key methodological features across this representative set of clinical trials.

Effect of Psychotherapy on Intolerance of Uncertainty: A Systematic Review and Meta-Analysis.

Intolerance of uncertainty (IU) is the tendency to react negatively on affective, cognitive and behavioural levels to uncertain situations and to harbour negative beliefs about the implications of uncertainty. IU has been linked to psychopathology and shown to impact treatment outcomes. This study systematically reviewed the literature and performed a meta-analysis of the effects of psychotherapy on IU. A total of 22 studies (1491 participants) were identified in online searches and included in the meta-analyses. Analyses were performed on studies with passive and active control conditions. The pooled effect on IU from studies with passive control was large (g = -0.94 [95% CI -1.25 to -0.62]) but with significant heterogeneity. Pooled effects on IU from studies with active controls were not significant. Moderator analysis showed that among studies with a passive control condition, studies that recruited participants from clinical care facilities produced smaller effect sizes. Among studies with an active control condition, study quality significantly moderated the results, with higher quality leading to a larger effect size. These results indicate that changes in IU may be difficult to reliably achieve in psychotherapy and leave many questions about the effect of psychotherapy on IU unanswered, such as what active components produced the observed changes in studies with passive control.

Centering and flourishing: an online intervention study assessing the effects of a Christian contemplative practice on stress-reduction and human flourishing

Despite widespread engagement in contemplative religious practices, comparatively little research has been conducted on their potential effects on well-being. Furthermore, few studies have focused on how an explicitly religious framing may impact the outcomes of such practices. In this online randomized controlled trial (N = 702), we tested the well-being effects of a contemplative prayer practice called Centering Prayer on self-identifying Christians. We compared 1) presenting the practice with an explicitly religious framing (experimental condition), 2) presenting the practice without an explicitly religious framing (active control), and 3) presenting simple instructions to reflect on the day, without any instructions regarding a meditation-like practice (passive control). After randomization into one of these three conditions, participants were asked to complete their assigned practice daily for 28 days. We hypothesized that the religious framing version of the practice would increase well-being over the active and passive control conditions. Well-being was assessed at three follow-up time points: one day, one week, and one month after the practice period. We found no group differences between the conditions on our primary outcome measure of well-being at one-week post-intervention. Each group increased in well-being from baseline to follow-up. We found significant group differences on acute measures of spiritual experience, the Mystical Experience Questionnaire (MEQ-30) and Daily Spiritual Experience Questionnaire (DSES). These results suggest that a religious framing may not enhance well-being effects but may alter spiritual outcomes related to contemplative practices.