Significant Between-group Effects Research Articles

A 10-week implementation of the FIT FIRST FOR ALL school-based physical activity concept effectively improves cardiorespiratory fitness and body composition in 7-16-year-old schoolchildren.

The purpose of the present study was to investigate the impact of the FIT FIRST FOR ALL school-based physical activity program on health-related physical fitness in Faroese schoolchildren. The program aimed to add three weekly sessions of organized high-intensity physical activity to the standard weekly physical education sessions for all pupils across the entire school. A non-randomized controlled design was used to evaluate the effects of the program. Two schools participated, including one intervention school (INT; n =179) and one control school (CON; n =181), with pupils aged 7-16 years (grades 1-9). The FIT FIRST FOR ALL program consisted of three weekly 40-minute sessions of age-adjusted high-intensity physical activity over 10 weeks for the INT school, while the CON school continued their normal school program. Pre- and post-intervention assessments included cardiorespiratory fitness (Yo-Yo IR1C test), agility (Arrowhead Agility test), postural balance (Stork Stand), standing long jump performance, body composition, blood pressure, and resting heart rate. A significant time × group effect (p < 0.001) was observed for cardiorespiratory fitness, which increased by 31% [23;39] in INT (p < 0.001) and remained unaltered in CON (7% [-2;16], p = 0.13). In addition, a time × group effect (p < 0.001) was observed for agility, which improved by 2.1% [1.0;3.2] in INT (p < 0.001) and regressed by 3.3% [2.3;4.4] in CON (p < 0.001). No significant between-group effects were found for standing long jump and balance. A time × group effect (p < 0.001) was observed for changes in total muscle mass, which increased by 1.4 kg [1.2;1.5] in INT (p < 0.001) and by 0.4 kg [0.3;0.6] in CON (p < 0.05). Furthermore, a time × group effect (p < 0.001) was observed for total fat percentage, which decreased by -2.3% [-2.8;-1.9] in INT (p < 0.001) and remained unchanged in CON (-0.3% [-0.7;0.1], p = 0.16). No significant time × group effects were found for blood pressure and resting heart rate. The FIT FIRST FOR ALL program significantly improved cardiorespiratory fitness and agility, and it led to favorable changes in body composition in the intervention school. These findings suggest that the program is highly effective in enhancing physical fitness and health status across all investigated age groups when implemented at a school-wide level.

Impact of thoracic paravertebral block and sufentanil on outcomes and postoperative cognitive dysfunction in thoracoscopic lung cancer surgery

BACKGROUND Postoperative pain management and cognitive function preservation are crucial for patients undergoing thoracoscopic surgery for lung cancer (LC). This is achieved using either a thoracic paravertebral block (TPVB) or sufentanil (SUF)-based multimodal analgesia. However, the efficacy and impact of their combined use on postoperative pain and postoperative cognitive dysfunction (POCD) remain unclear. AIM To explore the analgesic effect and the influence on POCD of TPVB combined with SUF-based multimodal analgesia in patients undergoing thoracoscopic radical resection for LC to help optimize postoperative pain management and improve patient outcomes. METHODS This retrospective analysis included 107 patients undergoing thoracoscopic radical resection for LC at The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital between May 2021 and January 2023. Patients receiving SUF-based multimodal analgesia (n = 50) and patients receiving TPVB + SUF-based multimodal analgesia (n = 57) were assigned to the control group and TPVB group, respectively. We compared the Ramsay Sedation Scale and visual analog scale (VAS) scores at rest and with cough between the two groups at 2, 12, and 24 h after surgery. Serum levels of epinephrine (E), angio-tensin II (Ang II), norepinephrine (NE), superoxide dismutase (SOD), vascular endothelial growth factor (VEGF), transforming growth factor-β1 (TGF-β1), tumor necrosis factor-α (TNF-α), and S-100 calcium-binding protein β (S-100β) were measured before and 24 h after surgery. The Mini-Mental State Examination (MMSE) was administered 1 day before surgery and at 3 and 5 days after surgery, and the occurrence of POCD was monitored for 5 days after surgery. Adverse reactions were also recorded. RESULTS There were no significant time point, between-group, and interaction effects in Ramsay sedation scores between the two groups (P &gt; 0.05). Significantly, there were notable time point effects, between-group differences, and interaction effects observed in VAS scores both at rest and with cough (P &lt; 0.05). The VAS scores at rest and with cough at 12 and 24 h after surgery were lower than those at 2 h after surgery and gradually decreased as postoperative time increased (P &lt; 0.05). The TPVB group had lower VAS scores than the control group at 2, 12, and 24 h after surgery (P &lt; 0.05). The MMSE scores at postoperative days 1 and 3 were markedly higher in the TPVB group than in the control group (P &lt; 0.05). The incidence of POCD was significantly lower in the TPVB group than in the control group within 5 days after surgery (P &lt; 0.05). Both groups had elevated serum E, Ang II, and NE and decreased serum SOD levels at 24 h after surgery compared with the preoperative levels, with better indices in the TPVB group (P &lt; 0.05). Marked elevations in serum levels of VEGF, TGF-β1, TNF-α, and S-100β were observed in both groups at 24 h after surgery, with lower levels in the TPVB group than in the control group (P &lt; 0.05). CONCLUSION TPVB combined with SUF-based multimodal analgesia further relieves pain in patients undergoing thoracoscopic radical surgery for LC, enhances analgesic effects, reduces postoperative stress response, and inhibits postoperative increases in serum VEGF, TGF-β1, TNF-α, and S-100β levels. This scheme also reduced POCD and had a high safety profile.

A randomized controlled trial of an online single session intervention for body image in individuals with recurrent binge eating.

Theoretical models highlight body image disturbances as central to the maintenance of eating disorders, with empirical evidence finding negative body image to be a robust predictor of treatment nonresponse, relapse and symptom persistence. Accessible, scalable, and inexpensive interventions that can effectively target negative body image across the eating disorders are needed. We developed an online single session intervention (SSI) for negative body image and evaluated its acceptability and efficacy in a randomized controlled trial in individuals with recurrent binge eating. Participants with recurrent binge eating were randomly assigned to the SSI (n = 99) or a waitlist (n = 101). Assessments were conducted at baseline, 4 week follow-up, and 8 week follow-up. 81% of participants accessed the SSI, demonstrating reasonable uptake. However, issues with attrition were apparent; a 32% study dropout rate was observed at posttest, while a 58% dropout rate was observed at follow-up. 87% of participants who completed satisfaction measures would recommend the SSI. SSI participants experienced greater improvements in negative body image at both 4 (d = -0.65) and 8 week (d = -0.74) follow-up. Significant between-group effects were also observed on most other secondary symptom measures, though no differences were found for motivations and help-seeking beliefs and intentions. Body image-focused self-guided SSIs for recurrent binge are largely accepted by those who are retained in the trial, but are associated with significant attrition. Although SSIs are not intended to replace standard treatment, they may help with short-term symptom management and could play an important role in eating disorder care. Single session interventions (SSI) are a potentially accessible, scalable, and cost-effective way to deliver evidence-based treatment content to people with eating disorders. This study shows that an online (SSI) designed to target body image among people with recurrent binge eating is accepted and produced short-term symptom relief.

Long-acting exenatide does not prevent cognitive decline in mild cognitive impairment: a proof-of-concept clinical trial

PurposeAccording to preclinical evidence, GLP-1 receptor may be an actionable target in neurodegenerative disorders, including Alzheimer’s disease (AD). Previous clinical trials of GLP-1 receptor agonists were conducted in patients with early AD, yielding mixed results. The aim was to assess in a proof-of-concept study whether slow-release exenatide, a long-acting GLP-1 agonist, can benefit the cognitive performance of people with mild cognitive impairment (MCI).MethodsThirty-two (16 females) patients were randomized to either slow-release exenatide (n = 17; 2 mg s.c. once a week) or no treatment (n = 15) for 32 weeks. The primary endpoint was the change in ADAS-Cog11 cognitive test score at 32 weeks vs baseline. Secondary endpoints herein reported included additional cognitive tests and plasma readouts of GLP-1 receptor engagement. Statistical analysis was conducted by intention to treat.ResultsNo significant between-group effects of exenatide on ADAS-Cog11 score (p = 0.17) were detected. A gender interaction with treatment was observed (p = 0.04), due to worsening of the ADAS-Cog11 score in women randomized to exenatide (p = 0.018), after correction for age, scholar level, dysglycemia, and ADAS-Cog score baseline value. Fasting plasma glucose (p = 0.02) and body weight (p = 0.03) decreased in patients randomized to exenatide.ConclusionIn patients with MCI, a 32-week trial with slow-release exenatide had no beneficial effect on cognitive performance.Trial registration numberNCT03881371, registered on 21 July, 2016.

When Inequity Leads to Boredom: An Experimental Study With University Students.

While theoretical connections between social inequity and boredom have been established, empirical evidence is lacking. Inequity aversion is important in this relationship. If individuals believe that the amount of work invested in pursuing an outcome has been unfairly devalued in relation to the investment of others, they may feel that their investment is greater than the outcome's worth. This experimental study explores whether devaluation of one's investment in a task, in relation to another individual's investment required to obtain equal rewards, is experienced as boredom. Undergraduate and graduate students (N = 31) were randomly assigned to one of three conditions and performed a monotonous task in the presence of a confederate, for equal reward. Exposure time to the confederate varied. It was expected that participants who spent more time on the task than the confederate would report more boredom and a negatively distorted time experience. Significant between-group effects were found for Tedium (F(2, 28) = 3.55, p = .04) and Temporal Estimation (F(2, 28) = 5.37, p = .01). Participants who spent more time on the task felt more bored (Mdiff = -1.05, p = .05) and rated time as progressing slower (Mdiff = -1.26, p = .03). There were no significant differences between the other conditions. A parsimonious interpretation is that the perceived inequity in resource investment costs associated with different lengths of social exposure during the boredom-inducing task increased the salience of investment loss, which was experienced as boredom and resulted in a distorted time experience.

Short-Term Stability and Night-to-Night Variability of Sleep Parameters in Nightmares Comorbid with Chronic Insomnia Disorder Across Multiple Nights of Polysomnography.

The purpose of this study was to examine the degree of short-term stability of polysomnographic (PSG) measured sleep parameters and the overall differences between individuals with comorbid nightmares and insomnia compared to those with chronic insomnia disorder alone or good sleeping controls across four nights in the sleep lab. A total of 142 good sleeping controls, 126 chronic insomnia alone and 24 comorbid insomnia/nightmare participants underwent 4 consecutive nights of 8-hour PSG recordings. Outcomes included sleep continuity, architecture, and REM-related parameters across nights 1 through 4. Intraclass correlation coefficients with mixed-effect variances and repeated-measure analysis of covariance were used, respectively, to determine short-term stability as well as between-subjects and time-by-group interaction effects. Wake after sleep onset and stage 1 showed "poor stability" in the comorbid insomnia/nightmare group compared to "moderate stability" in the good sleeping controls and chronic insomnia alone group. Significant between-group effects (all ps<0.05) showed that the comorbid insomnia/nightmare group took longer to fall asleep and had a greater first-night-effect in stage 1 compared to good sleeping controls and chronic insomnia alone group; in addition, the comorbid insomnia/nightmare and insomnia alone groups slept shorter, yet had fewer awakenings and REM periods, compared to the good sleeping controls. Nightmares are associated with abnormal sleep above and beyond REM disruption, as sleep continuity was the primary aspect in which poor stability and group differences emerged. The greater inability to fall asleep and instability of sleep fragmentation in those with comorbid insomnia/nightmares compared to chronic insomnia alone may be attributed to the impact of pre-sleep anticipatory anxiety and nightmare-related distress itself.

Neurological music therapy for poststroke depression, activity of daily living and cognitive function: A pilot randomized controlled study

ABSTRACT Introduction Music therapy (MT) has been adapted to post-stroke rehabilitation for years and there were several theories of treatment methods. Our music therapist utilized neurological MT to design a treatment program for stroke survivors. We aimed to compare the effects of a low-dose neurological MT with no MT on outcomes measuring depression, activity of daily living and cognitive function amongst stroke survivors. Method A single masked, randomized controlled study was designed and patients with subacute stroke were recruited. The patients were assigned to a MT group or a conventional therapy (CT) group. Both groups received CT including physical therapy and occupational therapy. Patients with aphasia also received speech therapy. The MT group underwent an additional hour of neurological MT per week for a total duration of 4 weeks. Our MT method comprised therapeutic singing, therapeutic instrument music playing, melodic intonation therapy, and rhythmic speech cueing. The primary outcome measure was the Beck Depression Inventory-II (BDI-II). Secondary outcomes were the Mini-Mental State Examination (MMSE), modified Rankin Scale (MRS) and Barthel Index (BI). Result Eighty-two patients were recruited. No significant differences were found at baseline. There was significant post-treatment effect among both groups for the BI (p < 0.001, Mdiff = 13.96, 95%CI = (11.64,16.29)), MMSE (p < 0.001, Mdiff = 1.04, 95%CI = (0.51,1.57)) and MRS (p < 0.001, Mdiff = −0.45, 95%CI = (−0.57,−0.34)). Additionally, a significant difference was observed between the groups for the MRS (p = 0.033, Mdiff = −0.24, 95%CI = (−0.03,0.52)). No significant between-group effect was found regarding the BI and MMSE. Discussion This study highlights the added value of MT in improving MRS, while requiring relatively less therapeutic time.

Quality and Reliability Analysis of YouTube as a Source of Patient Information on de Quervain's Tenosynovitis

Abstract Purpose This study seeks to evaluate the quality and reliability of information regarding de Quervain's tenosynovitis on YouTube. Methods A search on the YouTube was performed using the keywords de Quervain's tenosynovitis, and the first 50 videos were evaluated. Video characteristics including views, content type, and video upload source were recorded. Video reliability was assessed using the Journal of the American Medical Association (JAMA) benchmark criteria. Video quality was assessed using the Global Quality Score (GQS) and a novel de Quervain's Tenosynovitis-Specific Score (DQT-SS). Results The total number of views for all videos evaluated was 5,508,498 (mean, 110,169.96 ± 155,667.07). Video reliability and quality metrics were low, with a mean JAMA score of 2.17 ± 0.82 out of 4, a mean GQS of 2.49 ± 1.28 out of 5, and a mean DQT-SS of 4.53 ± 2.35 out of 11. Significant between-group effects were found for the video source and DQT-SS (p = 0.027), as well as between content type and JAMA score (p = 0.027), GQS (p = 0.003), and DQT-SS (p = 0.003). Positive independent predictors of DQT-SS included video duration in seconds (β = 0.391) and disease-specific information content type (β = 0.648). Conclusion Videos on YouTube regarding de Quervain's tenosynovitis were frequently viewed; however, the information present was of low quality and reliability. Physician-uploaded videos had the highest mean JAMA scores, GQS, and DQT-SS, but had the second-lowest mean number of views of video sources. Patients should receive proper in-office education and be directed toward reputable resources for their orthopaedic conditions.

Patient-Reported Postoperative Neuropsychological Deterioration After Heart Valve Replacement and Coronary Artery Bypass Grafting

BackgroundPostoperative cognitive decline (POCD) after cardiosurgical interventions are well described through objective psychometric tests. However, a patient’s subjective perception is essential to clinical assessment and quality of life. This study systematically evaluated patient-reported POCD between subjects undergoing coronary artery bypass grafting and heart valve replacement. MethodsThis study was a multicentre, prospective questionnaire survey conducted at the cardiac surgery departments at the Kerckhoff Clinic in Bad Nauheim and the University Hospital in Giessen, Germany. We included patients undergoing elective coronary artery bypass grafting (CABG), aortic valve replacement (AVR), mitral valve replacement or reconstruction (MVR), and combined surgery (CABG + valve replacement [VR]) with extracorporeal circulation. The Hospital Anxiety and Depression Scale, the Cognitive Failures Questionnaire (CFQ) for Self-assessment (CFQ-S), and the external assessment (CFQ-foreign [F]) were completed preoperatively, as well as at 3 and 12 months postoperatively. ResultsA total of 491 patients were available for analyses (CABG = 182, AVR = 134, MVR = 93, CABG + VR = 82). POCD and postoperative depression increase (PODI) were observed for each surgical procedure. (At the 3-month follow-up: CFQ-S [CABG = 7.1%, AVR = 3.7%, MVR = 9.7%, CABG + VR = 9.8%]; CFQ-F [CABG = 9.9%, AVR = 9.7%, MVR = 9.7%, CABG + VR = 15.9%]; PODI [CABG = 7.7%, AVR = 9.7%, MVR = 6.5%, CABG + VR = 8.5%]. At the 12-month follow-up: CFQ-S [CABG = 6.6%, AVR = 7.5%, MVR = 15.1%, CABG + VR = 7.3%]; CFQ-F [CABG = 7.1%, AVR = 14.9%, MVR = 10.8%, CABG + VR = 9.8%]; PODI [CABG = 10.4%, AVR = 11.2%, MVR = 6.5%, CABG + VR = 4.9%]). No significant between-group effects were observed for the CFQ-S, CFQ-F, or the Hospital Anxiety and Depression Scale. ConclusionsFor clinicians, paying attention to patients' self-reported experiences of reduced cognitive function and symptoms of depression following cardiac surgery is important. Such reporting is an indication that interventions such as cognitive training or psychotherapy should be considered.

Physical Exercise and Serum BDNF Levels: Accounting for the Val66Met Polymorphism in Older Adults.

Brain-derived neurotrophic factor (BDNF) expression, which can be measured in blood serum, has been found to increase with aerobic exercise. The link between BDNF level, physical exercise, and genetic status (Val66Met polymorphism) has not been well researched in older adults. To investigate the possible link between BDNF expression, acute aerobic exercise, and the Val66Met polymorphism in older adults. Twenty-three healthy older adults participated in one session of acute aerobic exercise. Their serum BDNF levels were measured both at baseline and post exercise. Saliva samples were collected to identify each individual's genetic status. At baseline, the individuals' mean serum BDNF level was 16.03 ng/mL (Val66Val = 15.89 ng/mL; Val66Met = 16.34 ng/mL); post exercise, the individuals' mean serum BDNF level was 16.81 ng/mL (Val66Val = 16.14 ng/mL; Val66Met = 18.34 ng/mL). One session of acute aerobic exercise significantly increased the individuals' mean serum BDNF level. Males had higher BDNF levels than females. There was a significant interaction between gender and BDNF expression post exercise and a significant between-group effect of gender. The Val66Met carriers had a more positive response to the acute aerobic exercise compared with the Val66Val carriers, although without a significant difference between the two groups.

Differences in the topographical distribution of sleep spindles among adult epilepsy with cognitive impairment.

Cognitive comorbidities are common in epilepsy; however, symptomatic treatment is currently the only available effective therapy. Sleep, cognition, and epilepsy are closely associated. Therefore, many studies on epilepsy and cognition have focused on sleep structures, such as sleep spindles, which are considered windows to understanding the sleeping brain. This study aimed to investigate the relationship between sleep spindles and the severity of cognitive impairment in adult epilepsy. Fifty-seven adults with epilepsy underwent overnight sleep electroencephalogram recordings and cognitive testing. Slow (9-12 Hz) and fast (12-15 Hz) spindle characteristics during N2 sleep were calculated using a convolutional neural network-based sleep staging system and automatic spindle detection algorithm. Repeated-measures analysis of variance was used to analyze differences in fast and slow spindle densities among subgroups of patients based on cognitive impairment severity. A significant between-group effect was observed for both slow and fast spindle densities. Multiple comparisons showed that slow and fast spindle densities of the severe cognitive impairment subgroup were lower than those of the noncognitive impairment subgroup (P < 0.05). Simple-effect analysis revealed differences in slow spindle density distributed among the EEG channels Fp1, Fp2, F3, C3, P4, O1, O2, F8, T4, T5, T6, Fz, and Cz (P < 0.05). Differences in fast spindle density were distributed among the channels Fp1, Fp2, F3, C3, O1, O2, F7, F8, T4, T5, T6, and Fz (P < 0.05). Significant differences in topographical distribution of fast and slow spindle densities were observed at the scalp level among patients with different cognitive statuses. Compared with patients with no cognitive impairment, those with severe cognitive impairment had lower slow and fast spindle densities over multiple scalp regions during N2 sleep. This study provides a reference for objective assessment of cognitive dysfunction in epilepsy patients.

Evaluation of brewers’ spent grain on cardiovascular disease risk factors in adults: Lessons learned from a pilot study

The beer industry generates large amounts of leftover barley called brewers’ spent grain (BSG). Fiber-rich grains like barley are associated with ameliorating cardiovascular disease (CVD) risk factors. This randomized pilot study investigated the influence of daily BSG consumption for 8 weeks on lipid profiles, inflammation, and metabolic functions in healthy adults. Subjects (n = 37, 26 ± 4 y; BMI 23 ± 3 kg/m2) received muffins containing 8.3 g BSG or 0 g BSG daily for 8 weeks. Body composition, blood pressure, and fasting blood were collected at baseline and week 8. Gastrointestinal symptoms and Bristol stool scale ratings remained stable throughout the study in both groups. Dietary fiber intake increased in the BSG group (5 g/day; 26%; p = 0.003); however, there were no significant between-group effects on blood lipids, glucose, insulin sensitivity, C-reactive protein, body composition, or blood pressure. Consuming 8.3 g BSG for 8 weeks is well tolerated and improves dietary fiber intake but does not significantly impact CVD risk factors in this sample of healthy adults. Subject health status, sample size, and BSG flour substitution rate may support the lack of effect in the current study. Larger controlled trials are needed to understand the potential of BSG as a value-added ingredient and its impact on human health.

The effect of immersion on sense of presence and affect when experiencing an educational scenario in virtual reality: A randomized controlled study

In this paper, the objective was to investigate these outcomes in two VR conditions, immersive and desktop in a randomized controlled trial with a parallel design. The sample consisted of 134 university students (70 women, mean age 23 years, SD=2.99). These were randomized using a covariate-adaptive randomization procedure based on stratification by gender into two interventions; play out a VR scenario in either desktop (control group) or immersive VR (intervention group). The setting was a university lab. There was a significant within subject effect for positive affect and a significant between-group effect for the immersive compared to desktop VR groups. Positive affect was reduced after interacting with the VR scenario in both the immersive and desktop versions, however, positive affect was overall higher in the immersive, compared to the desktop version. The results show higher scores for sense of presence (d=0.90, p<0.001) and positive affect pre- and post-scenario in the immersive VR condition (d=0.42, p=0.017 and d=0.54, p=0.002) compared to the desktop condition. Immersive VR may be beneficial in higher education as it promotes high levels of sense of presence as well as positive emotions. When it comes to changing the immediate emotions of the students, type of VR does not seem to matter. The project was funded by the Norwegian Directorate for Higher Education and Skills.

0141 Short-Term Stability of Sleep Parameters in Comorbid Nightmares and Chronic Insomnia Disorder

Abstract Introduction Nightmares are highly comorbid with insomnia and have been associated, yet not consistently, with distinct polysomnographic (PSG) disturbances, such as reduced total sleep time (TST), sleep efficiency and slow wave sleep as well as increased nocturnal awakenings and wake after sleep onset (WASO) or abnormal REM sleep. However, most prior studies have relied on a single night of PSG and the degree of stability of sleep parameters or overall differences between individuals with nightmares comorbid with insomnia disorder (NCI), individuals with chronic insomnia disorder (CID) and otherwise good sleeping controls (GSC), remain unknown. Therefore, the aim of this study was to determine if there were significant differences amongst these aforementioned groups in the way their sleep changes across time while being studied in the lab. Methods A total of 142 GSC, 126 CID and 24 NCI participants underwent 8-hour PSG recordings for 4 consecutive nights. Outcomes included sleep continuity, architecture, and REM-related parameters across nights 1 through 4. Intraclass correlation coefficients (ICC) with mixed-effect variances and repeated-measure analysis of variance (ANOVA) were used to determine short-term stability as well as between-subjects and time-by-group interaction effects, respectively. Results ICC were similar across groups on all outcomes (ICCs&amp;gt;0.6) except that the NCI group did not display stability for WASO, stage 1 sleep, REM latency or REM interval. There were no significant time-by-group interaction effects on PSG parameters (ps&amp;gt;0.05). There were significant between-group effects for SOL, number of awakenings, WASO, TST, REM latency, and number of REM episodes (all ps&amp;lt; 0.05), where the NCI group showed significantly longer SOL (58.10±11.08), shorter TST (6.64 hours±1.02), and less REM episodes (3.81±0.76). Conclusion This study suggests greater night-to-night variability and overall disturbance in nighttime sleep continuity and REM sleep in individuals with NCI. These disturbances may be attributed to the occurrence of nightmares, causing wakefulness out of REM sleep, as well as a greater level of hyperarousal as evidenced by the greater SOL and reduced TST, relative to the other groups. These data also suggest the utility of objective sleep measures in nightmare research and clinical practice alike. Support (if any) National Institutes of Health (UL1TR000127)

The effectiveness of an additive informal social network intervention for forensic psychiatric outpatients: results of a randomized controlled trial.

A supportive social network is associated with better mental health and wellbeing, and less criminal behavior. Therefore, this study examined the effectiveness of an additive informal social network intervention to treatment as usual (TAU) among forensic psychiatric outpatients. An randomized controlled trial (RCT) was conducted in forensic psychiatric care, allocating eligible outpatients (N = 102) to TAU with an additive informal social network intervention or TAU alone. Participants receiving the additive intervention were matched to a trained community volunteer over 12 months. TAU consisted of forensic care (e.g., cognitive behavioral therapy and/or forensic flexible assertive community treatment). Follow-up assessments were conducted at 3, 6, 9, 12, and 18 months after baseline. The primary outcome was the between-group effect on mental wellbeing at 12 months. Between-group effects on secondary outcomes (e.g., general psychiatric functioning, hospitalization, criminal behavior) were explored. Intention-to-treat analyses showed non-significant between-group effects on mental wellbeing on average over time and at 12 months. However, significant between-group effects were found on hospitalization duration and criminal behavior. Specifically, TAU participants were hospitalized 2.1 times more days within 12 months and 4.1 more days within 18 months than participants in the additive intervention. Furthermore, TAU participants reported 2.9 times more criminal behaviors on average over time. There were no significant effects on other outcomes. Exploratory analyses revealed that sex, comorbidity, and substance use disorders moderated effects. This is the first RCT examining the effectiveness of an additive informal social network intervention in forensic psychiatric outpatients. Although no improvements were found on mental wellbeing, the additive intervention was effective in reducing hospitalization and criminal behavior. The findings suggest that forensic outpatient treatment can be optimized by collaborating with informal care initiatives aimed at improving social networks within the community. Future research is warranted to determine which specific patients might benefit from the intervention and if effects can be improved by extending the intervention duration and enhancing patient compliance.Clinical Trial Registration: [https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7163], identifier [NTR7163].

Effect of an Individually Tailored and Home-Based Intervention in the Chronic Phase of Traumatic Brain Injury

Traumatic brain injury (TBI) can cause long-lasting and heterogeneous difficulties that require an individually tailored approach to rehabilitation. However, high-quality studies of treatment options in the chronic phase of TBI are lacking. To evaluate the effect of a home-based, individualized, and goal-oriented rehabilitation intervention in the chronic phase of TBI. This study was an intention-to-treat parallel-group assessor-blinded randomized clinical trial with 1:1 randomization to an intervention or control group. Participants included adults in southeastern Norway who had sustained a TBI more than 2 years earlier, lived at home, and had ongoing TBI-related difficulties. A population-based sample of 555 individuals were invited, and 120 were included. Participants were assessed at baseline, 4 months, and 12 months after inclusion. Specialized rehabilitation therapists provided the intervention in patients' homes or via video conference and telephone. Data collection was conducted between June 5, 2018, and December 14, 2021. The intervention group received an 8-session individually tailored and goal-oriented rehabilitation program over 4 months. The control group received usual care in their municipality. Preestablished primary outcomes were disease-specific health-related quality of life (HRQOL; measured by the Quality of Life After Brain Injury [QOLIBRI] overall scale) and social participation (measured by the Participation Assessment With Recombined Tools-Objective [PART-O] social subscale). Preestablished secondary outcomes included generic HRQOL (measured by the EuroQol 5-dimension 5-level [EQ-5D-5L] questionnaire), difficulty with TBI-related problem management (target outcomes; mean severity calculated across 3 main self-identified problem areas that were individually measured using a 4-point Likert scale), TBI symptoms (measured by the Rivermead Post Concussion Symptoms Questionnaire [RPQ]), psychological distress (depression and anxiety; measured by the Patient Health Questionnaire 9-item scale and the Generalized Anxiety Disorder 7-item scale [GAD-7], respectively), and functional competency (measured by the Patient Competency Rating Scale). Among 120 participants in the chronic phase of TBI, the median (IQR) age was 47.5 (31.0-55.8) years, and the median (IQR) time since injury was 4 (3-6) years; 85 (70.8%) were male. A total of 60 participants were randomized to the intervention group, and 60 were randomized to the control group. Between baseline and 12 months, no significant between-group effects were found for the primary outcomes of disease-specific HRQOL (QOLIBRI overall scale score: 2.82; 97.5% CI, -3.23 to 8.88; P = .30) or social participation (PART-O social subscale score: 0.12; 97.5% CI, -0.14 to 0.38; P = .29). At 12 months, the intervention group (n = 57) had significantly higher generic HRQOL (EQ-5D-5L score: 0.05; 95% CI, 0.002-0.10; P = .04) and fewer symptoms of TBI (RPQ total score: -3.54; 95% CI, -6.94 to -0.14; P = .04) and anxiety (GAD-7 score: -1.39; 95% CI, -2.60 to -0.19; P = .02) compared with the control group (n = 55). At 4 months only, the intervention group (n = 59) had significantly less difficulty managing TBI-related problems (target outcomes mean severity score: -0.46, 95% CI, -0.76 to -0.15; P = .003) compared with the control group (n = 59). No adverse events were reported. In this study, no significant results were observed for the primary outcomes of disease-specific HRQOL or social participation. However, the intervention group reported improvements in secondary outcomes (generic HRQOL and symptoms of TBI and anxiety) that were maintained at 12-month follow-up. These findings suggest that rehabilitation interventions could help patients even in the chronic phase of TBI. ClinicalTrials.gov Identifier: NCT03545594.

The PTSD Family Coach App in Veteran Family Members: Pilot Randomized Controlled Trial.

Posttraumatic stress disorder (PTSD) among US military veterans can adversely impact their concerned significant others (CSOs; eg, family members and romantic partners). Mobile apps can be tailored to support CSO mental health through psychoeducation, coping skills, and stress monitoring. This study assessed the feasibility, acceptability, and potential efficacy of PTSD Family Coach 1.0, a free, publicly available app that includes psychoeducation, stress management tools, self-assessments, and features for connecting to alternative supports, compared with a psychoeducation-only version of the app for cohabitating CSOs of veterans with PTSD. A total of 200 participants with an average age of 39 (SD 8.44) years, primarily female (193/200, 97%), and White (160/200, 80%) were randomized to self-guided use of either PTSD Family Coach 1.0 (n=104) or a psychoeducation-only app (n=96) for 4 weeks. Caregiver burden, stress, depression, anxiety, beliefs about treatment, CSO self-efficacy, and relationship functioning assessed using measures of dyadic adjustment, social constraints, and communication danger signs were administered via a web survey at baseline and after treatment. User satisfaction and app helpfulness were assessed after treatment. Data were analyzed using linear mixed methods. Overall, 50.5% (101/200) of randomized participants used their allocated app. Participants found PTSD Family Coach 1.0 somewhat satisfying (mean 4.88, SD 1.11) and moderately helpful (mean 2.99, SD 0.97) to use. Linear mixed effects models revealed no significant differences in outcomes by condition for caregiver burden (P=.45; Cohen d=0.1, 95% CI -0.2 to 0.4), stress (P=.64; Cohen d=0.1, 95% CI -0.4 to 0.6), depression (P=.93; Cohen d= 0.0, 95% CI -0.3 to 0.3), anxiety (P=.55; Cohen d=-0.1, 95% CI -0.4 to 0.2), beliefs about treatment (P=.71; Cohen d=0.1, 95% CI -0.2 to 0.3), partner self-efficacy (P=.59; Cohen d=-0.1, 95% CI -0.4 to 0.2), dyadic adjustment (P=.08; Cohen d=-0.2, 95% CI -0.5 to 0.0), social constraints (P=.05; Cohen d=0.3, 95% CI 0.0-0.6), or communication danger signs (P=.90; Cohen d=-0.0, 95% CI -0.3 to 0.3). Post hoc analyses collapsing across conditions revealed a significant between-group effect on stress for app users versus nonusers (β=-3.62; t281=-2.27; P=.02). Approximately half of the randomized participants never used their allocated app, and participants in the PTSD Family Coach 1.0 condition only opened the app approximately 4 times over 4 weeks, suggesting limitations to this app version's feasibility. PTSD Family Coach 1.0 users reported moderately favorable impressions of the app, suggesting preliminary acceptability. Regarding efficacy, no significant difference was found between PTSD Family Coach 1.0 users and psychoeducation app users across any outcome of interest. Post hoc analyses suggested that app use regardless of treatment condition was associated with reduced stress. Further research that improves app feasibility and establishes efficacy in targeting the domains most relevant to CSOs is warranted. ClinicalTrials.gov NCT02486705; https://clinicaltrials.gov/ct2/show/NCT02486705.

Modifying outcome expectancies and behavioral reinforcers to induce quit attempts among young adult smokers

Research has shown that outcome expectancies predict smoking behavior, and expectancy challenge interventions can reduce smoking. This study tested the hypothesis that supplementing expectancy challenge with a behavioral activation intervention promoting increased exposure to alternative reinforcers would help increase motivation to quit and induce actual quit attempts within the following month among young adult smokers. Smokers, aged 18–35 (N = 159, of whom 93 provided one-month follow-up data) and not required to be interested in quitting at the point of enrollment, were randomized to (a) the combined cognitive-behavioral intervention, (b) a cognitive-only expectancy challenge, or (c) a neutral reading (control) task. There were no significant between-group effects on motivation, but the conditions differed significantly in likelihood of leading to a quit attempt. Post hoc comparisons showed the combined condition participants (52 % of completers) to be significantly more likely than control group participants (25 %) to make a quit attempt, with the cognitive-only group (43 %) intermediate and not significantly different from the other conditions. These data provide preliminary evidence of utility for the brief cognitive-behavioral intervention in promoting smoking cessation attempts; more research is needed to test various possible explanations of how and for whom the intervention is effective, as well as whether it would significantly exceed expectancy challenge alone in larger samples.

The Influence of Kinesiology Tape on Breathing Mechanics in College-Aged Individuals–A Randomized Trial

Purpose: Kinesiology Tape (KT) has been used to improve mobility and muscle activation. Limited research has studied its effect on respiratory function. The purpose of this study was to investigate the influence of KT on chest wall excursion (CWE) and magnitude of respiratory muscle activation. Methods: Ninety subjects were randomly assigned to receive KT, sham tape, or no tape around the lower thoracic region. Measures, including CWE, maximal inspiratory pressure (MIP), and surface electromyography (sEMG) of intercostal and scalene muscles, were taken during a maximal inspiratory effort before (T-B) and after (T-1) tape application. Subjects continued to wear the tape and returned 48 hours later for another set of measurements (T-2). Repeated measures Analysis of Variance and post-hoc paired t-tests were used to determine the influence of tape. Results: No significant differences were identified for sEMG amplitude or CWE. Maximal inspiratory pressure scores showed no significant between-group effect; however, a significant within-group effect was found. Post-hoc analyses revealed significant differences between T-B and T-2 and T-1 and T-2 for all groups. Conclusion: Kinesiology Tape application did not show increased muscle activation, CWE, or MIP compared with sham and control scenarios. A significant training effect for MIP was identified. Future research should investigate KT effects in other age groups or with the presence of pulmonary pathology.

A randomized controlled trial of an mHealth application with nursing interaction to promote quality of life among community-dwelling older adults.

Using mHealth apps alone at home without the support of healthcare experts could mean that older adults might not fully utilize the functions of the apps, recognize their benefits, and sustain their use. Incorporating an integrated health-social partnership model to support the app usage when further help is needed by the older adults might maximize the apps' benefits in the long term. This study aimed to examine the benefits of adding nursing interaction supported by a health-social partnership model in the use of mHealth, and the sustained beneficial effects on psychological outcomes, including quality of life, self-efficacy, and depression, among older adults after the completion of the program. A three-arm, randomized controlled trial design was adopted. Community-dwelling older adults with chronic pain, hypertension, or diabetes, were randomly assigned to either the mHealth, mHealth with interactivity, or control group. Subjects in both the mHealth and the mHealth with interactivity groups received the mHealth application. In addition, the mHealth with interactivity group received support from a nurse case manager, who was supported by a health-social partnership team. mHealth apps and services from a nurse case manager were not provided to the control group. The primary outcome measure was quality of life, and secondary outcomes were self-efficacy and depression. Data were collected at pre-intervention (T1), post-intervention (T2), and at 3 months post-intervention to measure the sustained effect of the program. There were 74 mHealth+I, 71 mHealth, and 76 control group subjects enrolled in the program. No statistically significant between-group, within-group, and interaction effects between group and time in both physical component summary (PCS) and mental component summary (MCS) scores were found among the three groups. The mHealth group showed an improvement in PCS and depression scores from T1 to T2, sustained at T3; while the mHealth+I group demonstrated improved self-efficacy from T1 to T2, with a decrease at T3. Adding nurse-directed telephone calls may be of little to no benefit at all in the long term. Future studies may consider a longer intervention period to build and sustain quality of life and self-efficacy levels among community-dwelling older adults. www.ClinicalTrials.gov, identifier: NCT03878212.