Baseline Week Research Articles

Effectiveness of a Videoconference-Based Cognitive Behavioral Therapy Program for Patients with Schizophrenia: Pilot Randomized Controlled Trial.

Cognitive behavioral therapy for psychosis (CBTp) is not sufficiently widespread in clinical practice, although evidence has been presented. The purpose of this study was to explore whether one-on-one videoconference-based CBTp (vCBTp) is more effective than usual care (UC) alone for improving psychiatric symptoms in patients with schizophrenia attending outpatient clinics. In this exploratory randomized controlled trial, patients with schizophrenia and schizoaffective disorders who were still taking medication in an outpatient clinic were randomly assigned to either the vCBTp plus UC group (n=12) or the UC group (n=12). The vCBTp program was conducted once a week, with each session lasting for 50 minutes, for a total of 7 sessions conducted in real-time and in a one-on-one format remotely using a loaned tablet computer (iPad). The primary outcome was the Positive and Negative Syndrome Scale (PANSS) total score, which measures the difference in the mean change from baseline (week 0) to posttest (week 8). The study included 24 participants. There were no significant differences between the 2 groups at baseline. With regard to significant differences between the 2 groups in terms of the primary outcome, the mean change in the PANSS total score from baseline to week 8 in the vCBTp plus UC group was -9.5 (95% CI -12.09 to -6.91) and the mean change in the UC alone group was 6.9 (95% CI 1.54-12.30). The difference between the 2 groups was significant (P<.001). In addition, significant improvements were observed in the subscales of positive (P<.001) and negative (P=.004) symptoms and general psychopathology (P<.001). Significant differences were also observed in the secondary outcomes of the General Anxiety Disorder-7 (GAD-7; P=.04) and EQ-5D-5L (P=.005). There were no dropouts and no serious adverse events in this study. A total of 7 remote vCBTp sessions conducted in the vCBTp plus UC group could be safely administered to patients with schizophrenia. They were also observed to be effective for psychiatric symptoms, general anxiety, and quality of life. However, because of the observed worsening of scores in the UC group, caution is required in interpreting significant differences between the 2 groups. This approach is expected to improve accessibility to CBTp for outpatients with schizophrenia and social anxiety regarding transportation use and financial and physical burdens related to transportation, and to contribute to promoting CBTp acceptability by compensating for the shortage of implementers. University Hospital Medical Information Network Clinical Trials Registry UMIN000043396; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049544. RR2-10.1136/bmjopen-2022-069734.

Achieving Depth of Response in Skin Clearance and Itch Relief With Lebrikizumab is Associated With Minimal Impact of Atopic Dermatitis on Quality of Life

In Phase 3, monotherapy trials, ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967), Week 16-responders treated with lebrikizumab (LEB) every 2 weeks (Q2W) and every 4 weeks (Q4W) demonstrated extended maintenance of deep response in skin clearance and itch improvement. In this post hoc analysis of ADvocate1/-2, among LEB responders (defined by achieving Investigator’s Global Assessment [IGA] 0 or 1 with ≥2-point improvement or ≥75% improvement in the Eczema Area and Severity Index [EASI75], and not receiving rescue medication, including topicals, at Week 16), we evaluated quality of life (QOL) improvements for patients who achieved a deep response to LEB at Week 52, defined as: IGA score 0 (clear skin); ≥90% or 100% reduction in EASI (EASI90; EASI100); or Pruritus Numeric Rating Scale (PNRS; 0-10, none to worst itch imaginable) scores 0 or 1 (PNRS01) at Week 52. QOL was assessed by the Dermatology Life Quality Index (DLQI), scored 0–30, with higher scores indicating a worse effect of AD on QOL (scores ≤5: no/minimal effect; scores ≥11: very large/extremely-large effect). Descriptive analyses using as-observed data were reported at baseline (Week 0) and Week 52 for deep responders regardless of treatment arm (pooled) and by treatment arms separately. For patients with IGA0 at Week 52, mean (SD) DLQI scores decreased from 14.0 (7.5) at baseline to 1.8 (2.7) at Week 52 in the pooled dataset (Nx=73) and from 12.6 (7.9) to 1.6 (2.8) for LEBQ4W (Nx=32). For patients with EASI90 at Week 52, the scores decreased from 14.6 (7.3) to 2.6 (3.3) in the pooled dataset (Nx=151) and from 14.4 (7.5) to 2.4 (3.3) for LEBQ4W (Nx=67). For patients with EASI100 at Week 52, the scores decreased from 13.9 (7.4) to 1.9 (2.8) in the pooled dataset (Nx=68) and from 12.8 (8.2) to 1.6 (2.9) with LEBQ4W (Nx=29). For PNRS01, the scores decreased from 14.1 (6.8) to 1.4 (1.9) in the pooled dataset (Nx=80) and from 14.1 (7.5) to 1.3 (2.3) with LEBQ4W (Nx=36). Deep response in skin clearance and itch relief was achievable with LEB and was associated with substantial improvement in QOL to levels indicating minimal-to-no impact of AD on QOL.

EFFECTS OF THERAPEUTIC TAPING ON CLINICAL SYMPTOMS OF STUDENTS WITH PRIMARY DYSMENORRHEA.

Primary Dysmenorrhea (PD) is a prevalent gynaecological condition affecting young females, characterized by cyclic, cramping pelvic pain with no organic pathology. It can significantly impact their Quality of life (QOL) and academic performance. The study aimed to determine the effect of therapeutic taping on clinical symptoms, QOL and academic performance of students with PD. It was a single-blind, parallel design, Randomized controlled trial SETTING: Study conducted from May to September 2023 in Girls Hostel, Islamabad, Pakistan. Women aged 18-25 years with PD and pain severity of VAS ≥4 were recruited. Those with other health conditions and having an allergy to Kinesio taping (KT) were excluded from the study. A total of 66 women have completed the study. They were randomly assigned to three groups: experimental (KT), sham tape (ST), and control group (CG). KT tape was applied to the suprapubic and sacral regions using the ligament technique in the KT group and without stretch in the ST group. Assessments were taken at baseline, 8th and 12th weeks. The study tools were the visual analogue scale (VAS), menstrual symptoms questionnaire (MSQ), Health-related quality of life (SF-36) and Academic Performance Questionnaire (APQ). Data analysis was done using SPSS-25. The participants' mean age (years) was (KT: 22.04±2.13, Sham: 22.35±3.11 and CT: 23±2.52). Between-group analysis shows a statistically significant difference in VAS (p<0.05) and MSQ (p<0.01) after the 12th week of intervention, whereas the APQ score was statistically significant (p <0.01) on the 8th and 12th week. Similarly, the SF-36 score was significant for both physical (p<0.001) and mental (p<0.05) component summary between the intervention groups. Kinesio Taping is an effective intervention option for pain reduction, menstrual symptom relief, and improved academic performance for individuals with PD.

Impact of Time-Restricted Eating and High-Intensity Exercise on Nutrient Intake in Women with Overweight/Obesity: Secondary Analysis of a Randomized Controlled Trial.

Inadequate micronutrient intakes are common in individuals with overweight/obesityand can exacerbate cardiovascular and metabolic disease risk. Diet and exercise are primary strategies for managing overweight and may influence nutrient intakes. In this secondary analysis of dietary data collected in a randomized controlled trial (RCT, ClinicalTrials.gov (NCT04019860), 15 June 2019) of time-restricted eating (TRE), high-intensity interval training (HIIT), a combination (TREHIIT), or a control group (CON), we investigated intervention effects on energy and nutrient intakes in women with overweight/obesity. We randomized 131 women (body mass index (BMI) ≥ 27 kg/m2) to 7 weeks of TRE (≤10-h daily eating window with ad libitum energy intake), HIIT (3 sessions/week, performed at ≥90% maximal heart rate), TREHIIT, or CON. Participants recorded all energy intake in an online food diary during a baseline week (week 0) and at the end of the study (week 6 and week 7). We investigated between-group differences in changes in mean energy, macronutrient, and micronutrient intakes. TRE had reduced intakes of potassium, magnesium, and phosphorus compared with CON (p < 0.01). TREHIIT had non-significant reduced intakes of potassium, thiamine, magnesium, copper, and phosphorus (0.01< p < 0.05). HIIT alone did not negatively impact micronutrient intakes. TRE and TREHIIT induced suboptimal intakes for a greater number of micronutrients compared with HIIT and CON. A ≤10-h TRE window might increase the risk of micronutrient inadequacy in women with overweight/obesity. Future research is needed to investigate the effects of integrating nutritional guidelines with TRE interventions to mitigate the risk of micronutrient inadequacy in individuals with overweight/obesity.

Asparagopsis taxiformis supplementation to mitigate enteric methane emissions in dairy cows - effects on performance and metabolism.

Methane emissions from ruminant digestion contribute significantly to global anthropogenic greenhouse gas emissions. Members of the phylum Rhodophyta (red algae), particularly Asparagopsis sp., have shown promising results in reducing methane emissions in ruminants, due to their high content of halogenated methane analog compounds. However, knowledge is lacking regarding the effects of red algae on animal performance and metabolism. This study investigated the effects of dairy cow diet supplementation with Asparagopsis taxiformis on enteric methane performance, metabolism of bromine and iodine, and health status of the cows. Thirty lactating Nordic Red dairy cows fed a total mixed ration, were blocked according to parity and days in milk, and randomly assigned to one of 3 diets: a control diet with no Asparagopsis taxiformis (CON), a diet with 0.15% Asparagopsis taxiformis on an organic matter (OM) basis (L-AT), and a diet with 0.3% Asparagopsis taxiformis on an OM basis (H-AT). The cows were fed the experimental diets continuously for 13 weeks, beginning with a baseline week (wk 0), which served as covariate by week where all cows received the basal diet. Individual feed intake and milk yield were recorded automatically throughout the experiment. Milk composition was determined by collecting milk samples during each milking session on 2 consecutive days every experimental week. While enteric methane and hydrogen levels were measured continuously by the GreenFeed system. Feces grab samples were collected as spot samples from a subset of 6 cows per treatment after milking during sampling wk 0, 2, 4, 8, and 12. Urine spot samples were collected from the same subset of cows during the same weeks as fecal samples. One urine sample was taken per day on 2 consecutive days, and the samples were analyzed for wk 12. Rumen fluid was collected after morning milking using a stomach tube in wk 0, 2, 4, and 12. We observed a 30% reduction in methane production in the H-AT group, with a concomitant increase in hydrogen production by 383%. However, the interaction between treatment and week showed that the AT effect on methane reduction began to diminish by wk 9 of the experiment. In the L-AT group, methane was reduced by 7.6% and hydrogen production was increased by 70%. However, dry matter intake (DMI) was 7% lower and energy-corrected milk (ECM) yield was 2% lower in the H-AT group compared with the other 2 groups. Total concentration of volatile fatty acids in rumen fluid was lower in the H-AT group compared with CON, with a reduction in acetate concentration and an increase in propionate, butyrate and valerate in the H-AT group. Bromine concentration was 5-fold higher and iodine concentration was 9-fold higher in milk from the H-AT group compared with CON. Bromine concentration in feces and urine samples from H-AT cows was approximately 4-fold and 9-fold higher, respectively, than in samples from CON cows. Metabolic profiling revealed a reduction in cholesterol levels and a decrease in the ferric-reducing ability of plasma in the H-AT treatment group compared with the CON group, as well as an increase in plasma magnesium concentration in the H-AT group. In conclusion, using 0.3% Asparagopsis taxiformis as an additive in dairy cow feed rations can mitigate enteric methane emissions, but this reduction was observed only during the first 8 weeks of the experiment, with no effect on methane emissions from wk 9 to 12. Additionally, it may have negative effects on DMI and ECM yield. Further long-term studies on red algae as methane inhibitor is needed to examine its sustained inhibitory effects over time and its impact on various metabolic processes. The effects appear to decline after wk 8 and influence several metabolic mechanisms.

The effects of a sleep intervention in the early COVID-19 pandemic on insomnia and depressive symptoms: Results of a randomized controlled pilot study.

The COVID-19 Pandemic increased the prevalence and severity of insomnia and depression symptoms. The effects of an insomnia intervention on future insomnia and depression symptoms delivered during an ongoing stressor, which may have precipitated the insomnia symptoms, is unknown. We conducted a two-arm randomized controlled pilot study to evaluate whether an insomnia intervention would improve the trajectory of insomnia and depression symptoms in the context of a global pandemic. Forty-nine individuals with clinically significant insomnia symptoms that emerged after the start of the COVID-19 Pandemic were randomized to one of two groups: one group received four sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) over five weeks via telehealth, and the other was assigned to a 28-week waitlist control group. Participants completed assessments of insomnia and depressive symptom severity at baseline (week 0) and at weeks 1-6, 12, and 28. Linear mixed-effects models were used to evaluate treatment efficacy. The MacArthur model was used to test whether improvement in insomnia symptoms mediated subsequent improvement in mood. The CBT-I group showed improved trajectories of insomnia (b=-1.03, p<0.005, 95% CI [-1.53, -0.53]) and depressive symptoms (b=-0.47, p=0.007, [-0.80, -0.13]) across the 28 weeks compared to the control group. The rate of improvement of insomnia symptoms during treatment mediated the subsequent improvement in depressive symptom severity following treatment (b=2.10, p=0.024, [0.30, 3.90]). Although the sample size was small, these results underscore the potential CBT-I in the context of an ongoing stressor to not only alleviate insomnia symptoms, but also improve depressive symptoms.

Effects of Face and Body Acupuncture on Glabellar Frown Lines in Women Aged 30-59: a Study Protocol for a Double-Arm Randomized Waitlist-Controlled Trial.

As average life expectancy increases, the role of beauty in quality of life (QOL) becomes more important. Invasive rejuvenation methods, such as cosmetic surgery and botulinum toxin injections, do not address the underlying causes of facial aging, are expensive, and carry inherent risks. Acupuncture, as a holistic alternative, may offer a safer method for facial rejuvenation by addressing the overall health of the body. This study will evaluate the efficacy and safety of facial and body acupuncture in reducing frown lines in women aged 30-59 in Mashhad, Iran. A total of 72 participants will be randomly allocated to intervention and control groups. The intervention group will receive 12 sessions of face and body acupuncture over six weeks, while the control group will receive no treatment. The primary outcome will be the Global Aesthetic Improvement Scale (GAIS) assessed using standardized photographs. Secondary outcomes include the Subject Satisfaction Scale (SSS) and the QOL scores. Outcomes will be measured at three time points: baseline (week 0), posttreatment (week 7), and follow-up (week 12). The results of this trial will provide robust evidence regarding the efficacy and safety of acupuncture in reducing frown lines.

Habit substitution toward more active commuting

AbstractCommuting to work is often a highly habitual behavior that people perform automatically over a long period of time. Substituting an inactive with a more active commuting habit might thus support long‐term behavior change. This study investigated habit substitution processes in commuting behavior and related psychological determinants. We report primary analyses of an online planning intervention study conducted in Germany with a one‐arm pre‐post design over 14 weeks including multiple‐a‐day workday assessments across a baseline week followed by five post‐intervention measurement weeks. Forty‐two participants (60% female, Mage = 32.3 years) reported daily automaticity, experienced reward and regret, and weekly plan enactment for new and old commuting behaviors. Multilevel models were fit. In this one‐arm study, automaticity of the old commuting behavior declined linearly, whereas the increase in automaticity of the new commuting behavior was more pronounced in earlier than later study weeks. Within‐person plan enactment and experienced reward were positively linked with automaticity of the new commuting behavior. Between‐person plan enactment was negatively linked with automaticity of the old commuting behavior. Weekly plan enactment and outcome experiences were associated with increases of new habits and decay of old habits in this study. Results warrant replication using an experimental design.

Effects of a 12-week Baduanjin regimen on biomechanical properties of axial muscle fascia in ankylosing spondylitis

Background: This study aims to evaluate the effects of a 12-week Baduanjin regimen on the biomechanical properties of axial muscle fascia in patients with ankylosing spondylitis (AS) through a randomized controlled trial, and to explore the underlying mechanisms of Baduanjin in AS treatment. Methods: Thirty patients with AS were randomly assigned to either the Baduanjin intervention group or the nonintervention group, with 15 patients in each group. The intervention group underwent a 12-week Baduanjin fitness program, while the nonintervention group continued their usual lifestyle and medication. Biomechanical parameters of muscle fascia, including muscle stiffness (N/m), muscle tension (frequency, Hz), and muscle elasticity (logarithmic decrement of oscillation amplitude), were measured at specified spinal locations using the MyotonPRO® soft tissue tester at baseline (week 0) and after 12 weeks (week 12). Results: The Baduanjin group exhibited significant improvements in muscle fascia stiffness, tension, and elasticity in the lumbar and cervical spine compared to the nonintervention group, with notable differences in lumbar stiffness and tension (P &lt; .05). Postintervention, lumbar stiffness and tension were significantly reduced, and elasticity increased in the Baduanjin group, indicating beneficial effects on the biomechanical properties of axial muscle fascia in AS patients. No significant changes were observed in the nonintervention group. The Baduanjin group reported only mild muscle pain initially, which resolved with appropriate management, with no serious adverse effects noted. Conclusion: The findings suggest that Baduanjin significantly enhances the biomechanical properties of axial muscle fascia in AS patients. By improving these properties, Baduanjin may reduce mechanical stress, alleviate micro-damage and inflammation at attachment points, regulate downstream signaling pathways, and potentially limit new bone formation. This study provides scientific support for the use of Baduanjin in managing AS and offers a foundation for future research.

Impact of drug-resistant tuberculosis on socio-economic status, quality of life and psychological well-being of patients in Bucharest, Romania: a prospective cohort study

BackgroundTuberculosis (TB) remains a global health challenge, with 1.3 million deaths in 2022. Ten countries in the European Union (EU) and European Economic Area (EEA) accounted for 88.3% of TB cases, of which 23.8% were from Romania. Evidence shows that mental health issues, decreased quality of life and negative socio-economic impact are common among TB patients; however, there is limited evidence available in Romania. The main aim of this study is to longitudinally assess the quality of life, mental health, and socio-economic status of patients with drug-resistant TB (DR TB) in Romania.MethodsA prospective cohort study was conducted at the Marius Nasta Institute of Pneumology in Bucharest, Romania, enrolling 50 participants with DR TB. Demographic data, clinical examinations, laboratory test and medical history were recorded at study start. At baseline (week two), month 10, and month 20 we also administered the Short-Form-36 and Kessler Psychological Distress Scale to assess health-related quality of life and mental health status, and socio-economic questionnaires to 46 participants.ResultsOf the 46 participants with median age of 48.9 years, 71.7% were males. Majority of the participants were employed at the baseline but due to the rigorous treatment and hospitalization had to take sick leave, thereby affecting the individual and household income. 26.1% and 39.3% of participants reported psychological distress at baseline and at the end of month 20, respectively. The quality-of-life scores improved during treatment: PCS with a mean of 67.0 (SD-33.9) at baseline, 63.3 (SD-31.9) at month 10 and 70.3 (SD-30.3) at month 20, and MCS with 62.8 (SD-30.6), 67.8 (SD-29) and 70.8 (SD-27.3), accordingly, but differences were not significant.ConclusionsWe examined the socio-economic impact, quality of life, and psychological distress among patients affected by DR TB in Romania. The results of this study suggest that social and psychological support will ensure a better standard of living during and following TB treatment.

A prospective study in the treatment of androgenic alopecia using combination of procapil, capixyl, redensyl

Background: Androgenic alopecia is characterized by its diffuse loss and the miniaturization of the hair. The study aimed to assess the safety and efficacy of procapil, redensyl, capixyl, bicapil, and anagain in topical hair growth serum in androgenic alopecia. Methods: A prospective study was conducted on 110 healthy subjects aged 18-60 with androgenic alopecia in the Department of Dermatology, Tundla, Etmadhpur. Each subject applied 1 ml of serum on a dry scalp and was followed up on the 4th, 8th, 12th, and 16th week. Mean, median, and standard deviation were calculated. A repeated measure of the ANOVA test followed by post-hoc pairwise comparison using the Bonferroni test was applied. JAMOVI® (Sydney, Australia) software, was used for the statistical analysis. Results: Seventy subjects completed the four follow-ups. Post hoc pair-wise comparison showed that each pair differed significantly, and an increased mean score was observed between the initial and follow-up assessments for the mean Anagen:Telogen (A:T) ratio and mean hair diameter [76.84 μm vs 77.77μm, 76.84μm vs 80.03 μm, 76.84 μm vs 82.33 μm; p&lt;0.05]. A significant difference was found in hair density between baseline and 16th week [76.84 vs 84.60; p=0.002]. No adverse effects were observed. Conclusion: This study's results suggest that after 120 days of treatment with hair serum, it is safe and effective, improving the A:T ratio, hair density, and hair thickness and hence reducing hair fall.

P79 Long-term psoriasis management: the role of NB-UVB phototherapy and topical Cal/BD foam

Abstract Many psoriasis patients struggle to achieve long-term disease control despite numerous treatment options. Recent research suggests that some biological treatments may lead to sustained, drug-free disease control by targeting underlying immunological factors, though the exact mechanisms remain unclear. This emphasizes the need to identify treatments that contribute to longer-lasting remission. As topical treatments are essential in psoriasis management, it is crucial to determine their role alongside more advanced therapies and how they can be combined for long-term remission. This study aimed to evaluate the efficacy of full-body narrowband UVB (NB-UVB) phototherapy combined with placebo and calcipotriene/betamethasone dipropionate (Cal/BD) foam in 12 patients with plaque psoriasis. Using an open-phase, non-randomized, single-group split-body design (ClinicalTrials.gov: #NCT05185258; Danish Regional Research Ethics Committee: #78623), each patient had two plaques designated for once-daily application of Cal/BD and placebo foam at baseline. After 4 weeks, applications were reduced to twice weekly until end of treatment (EOT). During the first 8 weeks, patients received NB-UVB sessions three times weekly. Study visits were conducted at baseline (week 0), week 8, week 13, and EOT (week 18) and included clinical evaluations using the Investigator Global Assessment (IGA), Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI), and Target Plaque Severity Score (TPSS). At weeks 8 and 13, IGA and DLQI were significantly reduced compared with baseline, indicating improved disease control and quality of life. However, scores returned to baseline levels at EOT, highlighting the short-term efficacy of NB-UVB. PASI and TPSS were significantly reduced at all visits compared with baseline. Notably, PASI and TPSS for placebo-treated plaques increased from week 8 to EOT, whereas TPSS for Cal/BD treated plaques demonstrated a sustained reduction. Moreover, Cal/BD-treated plaques exhibited significantly lower TPSS than placebo at EOT (p = 0.0429), demonstrating Cal/BD’s longer-lasting effect. To compare TPSS with overall psoriasis severity, unweighted average PASI values across body regions were used, providing a standardized total severity score predominantly reflecting non-topical-treated areas. Cal/BD and placebo-treated plaques showed significantly lower severity than the total severity at weeks 8 and 13. Interestingly, at EOT, only Cal/BD maintained significantly lower severity. In conclusion, combining Cal/BD with NB-UVB effectively reduced disease activity, improved patient outcomes, and enhanced quality of life. Cal/BD demonstrated superior efficacy compared with placebo, underscoring its potential for long-term management. Although NB-UVB can be burdensome due to frequent clinic visits and short-term efficacy, combining it with Cal/BD helps maintain therapeutic effects with a more patient-convenient regimen.

Saving Legs & Lives: the efficacy of a community-based cardiovascular rehabilitation programme versus usual care on exercise capacity and quality of life in patients who have undergone lower limb revascularisation for peripheral arterial disease—protocol for a single-centre randomised-controlled trial

IntroductionPeripheral artery disease (PAD) is an atherosclerotic condition characterised by stenosis or occlusion of the arteries in the lower limbs. Patients with PAD commonly report intermittent claudication (leg pain/discomfort) during...

Effectiveness of acupuncture treatment in post-stroke depression and anxiety disorders: a prospective, randomized, controlled, single-blind study.

Our aim was to examine the effectiveness of acupuncture in post-stroke depression/anxiety disorders and to determine whether it reduces the need for anxiolytic and sedative drug use. This study included 54 stroke patients with depression and/or anxiety disorder. Patients were randomly assigned to the acupuncture treatment group (n = 27) or the control group (n = 27). A conventional rehabilitation program was applied to all patients and acupuncture was performed twice a week for 4 weeks. Patients were evaluated blindly by a psychiatrist at baseline (week 0), week 4 and week 8, using the Hamilton depression rating scale (HAM-D) and Hamilton anxiety rating scale (HAM-A), and drug doses were adjusted when necessary. The HAM-D and HAM-A scores at week 4 were pre-specified as the two primary outcome measures. Within each group, there was a significant decrease in the mean scores of HAM-D and HAM-A at weeks 4 and 8. No between-group differences in HAM-A or HAM-D scores were seen at 4 weeks but there was a significant decrease in HAM-D scores in favor of the acupuncture group at week 8 (p < 0.025). At week 4, the number of cases whose selective serotonin reuptake inhibitor (SSRI) dose was increased was found to be significantly higher in the control group. While the study was negative with respect to its primary outcomes, the findings with respect to certain secondary outcomes suggests further research is warranted to determine if acupuncture treatment is an effective/safe treatment to alleviate post-stroke depression/anxiety. NCT04283591 (ClinicalTrials.gov).

Ultrasonographic Evaluation of Vascular Response to Mechanical Compression during Induced Gingival Inflammation

The aim of this study was to evaluate the gingival vascular response to mechanical compression during inflammation using ultrasonography. Four female and 4 male Sinclair mini pigs 18 mo of age were included in the study. Pathogenic bacteria–impregnated silk ligatures were placed around the third premolars (PM3), fourth premolars (PM4), and first molars (M1). Ligatures were placed per quadrant at 2-wk intervals in random order. Ultrasonographic study was performed at 2-wk intervals following baseline until the 10th week. Brightness mode (B-mode) images and color flow cine loops were captured at 2 different conditions: 1 with only coupling gel between the ultrasound transducer and the mucosal surface and 1 with the transducer compressing the mucosal surface. The compression was visually adjusted until minimal to no blood flow was detected in color-flow mode. Compression was facilitated using a solid gel pad attached to the transducer. Strain values were obtained from B-mode images of the gel pad and plotted versus study weeks. The t test comparisons were obtained to the baseline (week 0). Data from female and male pigs were plotted and analyzed separately for comparison. Gel pad strain increased with peak around week 4 and gradually decreased in both sexes. In male pigs, the increase in strain was statistically significant in weeks 2, 4, and 6 of all teeth regions and week 8 of PM4 and M1 regions. In female pigs, the increase in strain was significant in only week 4 of PM4. Higher strain required for stoppage of blood flow implies increased gingival blood flow with inflammation, which corresponds with previous studies. Considerably smaller changes in gel pad strain were noted from female pigs, indicating a smaller increase in gingival blood flow compared with males. This study demonstrated a possible application of intraoral ultrasonography for assessment of gingival inflammation.

Abstract 4120229: Shift in body mass index category and associated cardiometabolic risk factors: a post hoc analysis from the SURMOUNT-4 trial

Background: In SURMOUNT-4, participants with obesity demonstrated a mean weight reduction of 21% during the 36-week lead-in with the maximum tolerated dose (MTD) of tirzepatide (TZP). During the 52-week double-blind period, participants who switched to placebo (PBO) experienced a 14% weight regain, while those who continued TZP achieved an additional 6% weight reduction. This post hoc analysis assessed whether participants who shifted to a lower BMI category had improved cardiometabolic factors. Methods: Shift in BMI category (&lt;25 kg/m 2 , 25 to &lt;30 kg/m 2 , 30 to &lt;35 kg/m 2 , 35 to &lt;40 kg/m 2 , and ≥40 kg/m 2 ) from baseline (week 0) during the lead-in period (week 36) and at the primary endpoint (week 88) and from week 36 to week 88 was assessed in participants from SURMOUNT-4 randomized to TZP MTD (N=332) or PBO (N=329). BMI shifts were grouped into “improved” (shift to ≥1 lower category) or “not improved” (stable/attenuated [no change/shift to a higher category]). Changes from baseline in waist circumference, fasting insulin, fasting glucose, HbA1c, vitals and lipid profile were assessed. Results: From weeks 0 to 36, 296 (89%) participants improved in BMI category with TZP, and none had attenuated (Table). From weeks 36 to 88, 130 (39%) participants improved in BMI category with TZP, while the majority (99%) randomized to PBO did not. Overall, from weeks 0 to 88, 304 (92%) vs 189 (57%) participants improved in BMI category with TZP vs PBO, respectively, where the improvements observed in the PBO group originated from the 36-week lead-in period. In general, participants who improved in BMI category at week 88 were noted to have greater improvements in cardiometabolic parameters with TZP vs PBO, including decreases from baseline in waist circumference, fasting insulin, fasting glucose, HbA1c, blood pressure, triglycerides, and cholesterol (total, non-HDL-c, LDL-c, and VLDL-c). Conclusions: In this post hoc analysis of SURMOUNT-4, the majority of TZP-treated participants shifted to lower “improved” BMI categories. Shift to an improved BMI category was accompanied by improved cardiometabolic risk factors, suggesting that TZP treatment may lower further cardiovascular outcomes. Relevant outcomes trials are ongoing.

Virtual Coach-Guided Online Acceptance and Commitment Therapy for Chronic Pain: Pilot Feasibility Randomized Controlled Trial.

Veterans are disproportionately affected by chronic pain, with high rates of pain diagnoses (47%-56%) and a 40% higher rate of prevalence of severe pain than nonveterans. This is often accompanied by negative functional outcomes and higher mortality. Combined with research suggesting medical treatments for chronic pain are often insufficient, there is an urgent need for nonmedical pain self-management programs. An interactive online platform to deliver an efficacious treatment for chronic pain such as acceptance and commitment therapy (ACT) could be a valuable option to assist veterans with pain care at home. This study aims to evaluate the virtual coach-guided Veteran ACT for Chronic Pain (VACT-CP) online program compared to a waitlist and treatment as usual (WL+TAU) control group through a small pilot feasibility randomized controlled trial. The primary aim was to evaluate the feasibility and acceptability of VACT-CP and study procedures, such as ease of recruitment, treatment receptivity, attrition and retention, sustained participation, system usability, and assessment of trial procedures. Secondary aims explored differences in the VACT-CP and WL+TAU groups on pre- and posttest (week 7) outcome measures for pain, mental health, functioning, and ACT processes. Veterans with chronic pain were recruited and randomized to either the VACT-CP (n=20) or the WL+TAU (n=22) group in a parallel group trial design. Self-report surveys were administered to participants at baseline (week 0), at the intervention midpoint (week 3), immediately after the intervention (week 7), and at the 1-month follow-up (week 11). We used Wilcoxon signed rank tests with the intention-to-treat sample to describe changes in secondary outcomes from pre- to postintervention within each group. Study procedures showed good feasibility related to recruitment, enrollment, randomization, and study completion rates. Participants reported that VACT-CP was easy to use (System Usability Scale: mean 79.6, SD 12.8; median 82.5, IQR 70-87.5); they completed an average of 5 of the 7 total VACT-CP modules with high postintervention satisfaction rates. Qualitative feedback suggested a positive response to program usability, content tailoring, veteran centeredness, and perceived impact on pain management. Although the pilot feasibility trial was not powered to detect differences in clinical outcomes and significant findings should be interpreted with caution, the VACT-CP group experienced significant increases in chronic pain acceptance (P<.001) and decreases in depressive symptoms (P=.03). VACT-CP showed encouraging evidence of feasibility, usability, and acceptance, while also providing promising initial results in improving a key process in ACT for chronic pain-chronic pain acceptance-after online program use. A full-scale efficacy trial is needed to assess changes in clinical outcomes. ClinicalTrials.gov NCT03655132; http://clinicaltrials.gov/ct2/show/NCT03655132. RR2-10.2196/45887.

Effectiveness of telerehabilitation-based mckenzie method versus manual therapy in low-back pain management: a randomised controlled trial

Abstract Background Studies comparing the effectiveness of telerehabilitation and spinal manual therapy (SMT) for chronic non-specific low-back pain (NSLBP) are limited. This study aimed to compare the efficacy of the telerehabilitation-based McKenzie therapy (TBMT) and SMT among patients with NSLBP. Methods Forty-nine consenting patients randomised into either TBMT (n = 28) or SMT (n = 21) group completed the study. TBMT is a mobile phone-based telerehabilitation involving the ‘McKenzie extension protocol’. SMT is a grade II (10 oscillations) posterior-anterior central vertebral pressure on the offending spinous process. Both interventions were applied thrice weekly for eight weeks, and outcomes were assessed on Pain Intensity (PI), Activity Limitation (AL), Participation Restriction (PR), and Health-related Quality of Life (HRQoL) in the fourth and eighth weeks. Results Within-group comparison across baseline, 4th and 8th week indicate that SMT had a significant effect on PI (F = 132.804, p = 0.001), AL (F = 75.984, p = 0.001), PR (F = 99.428, p = 0.001) and for all the scales of SF-12 except for mental health domain (p &gt; 0.05). Similarly, TBMT had a significant effect on PI (F = 243.631; p = 0.001), AL (F = 85.930; p = 0.001), PR (F = 48.425; p = 0.001), and for all the scales except also for mental health domain (p &gt; 0.05). However, there were no significant differences (p &gt; 0.05) in the treatment effects between SMT and TBMT, except for the ‘health perception’ (p = 0.045) scale at week four and the ‘mental health’ scale (p = 0.023) at week eight. Conclusion Telerehabilitation-based McKenzie method and SMT are effective in chronic NSLBP, with TBMT leading to significantly higher long-term health perception improvement. Trial Registration Pan African Clinical Trial Registry (PACTR202010667228786), Registered 27 October 2020-Retrospectively registered.

Using fruit and vegetable intakes to illustrate the impacts of personalised nutrition feedback: Results from the MyPlanetDiet RCT

Previous research has shown personalised nutrition feedback is more effective than generic onesize-fits-all nutrition advice(1). Using fruit and vegetable intakes from the MyPlanetDiet randomized controlled trial, this analysis will determine if different severity of personalised nutrition feedback delivers greater dietary change.Participants were recruited from the general public and randomised to receive personalised feedback based on a more sustainable diet (intervention) or Healthy Eating Guidelines (control). Intervention participants received feedback on total fruit, total vegetables, dark green vegetables, and/or red/orange vegetables. Control participants received feedback on total fruit and vegetables, total vegetables, citrus fruits, and/or fruit juice. Participants completed dietary assessments (3x 24-hour recalls) at baseline (Week 0) and endpoint (Week 12) using Foodbook24, a validated online dietary assessment tool(2). Mean food group intakes and Healthy Eating Index scores were calculated. Personalised feedback messaging was assessed to measure the severity of fruit and vegetable feedback, ranging from zero messages (least severe) to four messages (most severe). Data are presented as mean ± standard error. Data were analysed via two-way mixed analysis of covariance and univariate general linear models using IMB SPSS Statistics (Version 29).Participants (n = 292) were 56% female and 42.3 ± 0.7 years old. Mean fruit and vegetable intake at baseline was 325.4 ± 183.3g. Almost all participants (97%) received feedback for at least one component of fruit and vegetable intake. Control participants were more likely to receive feedback on fruit (p&lt;0.001) while intervention participants were more likely to receive vegetable feedback (p&lt;0.001). There was a significant time*group interaction for fruit intake (p = 0.005) with larger increases in the control (+102.3g) than the intervention group (+38.6g). The intervention group had higher vegetable intakes (200.6 ± 7.9g) compared to control (164.2 ± 7.5g) at endpoint (p&lt;0.001). Those receiving more severe fruit and vegetable feedback had significantly lower intakes of fruit and vegetables at baseline (p&lt;0.001) but not endpoint (p = 0.80). There was a significant time*group interaction for fruit and vegetable intake (p&lt;0.001) between severity groups. Those with least severe feedback decreased fruit and vegetable intake (-57.4g) while those in the most severe group increased intakes by 162.2g. However, mean fruit and vegetable intake in the least severe group was still higher (472.9 ± 31.8g) at endpoint than in the most severe group (397.2 ± 23.6g). There was a significant time (p&lt;0.001) and time*group interaction (p = 0.039) in HEI scores with the smallest increase in the least severe group (+3.7) and the largest increase in the most severe feedback group (+9.6).More personalised nutrition feedback was associated with greater behaviour change when using fruit and vegetable intake as an example. Differences in messaging between control and intervention groups led to corresponding differences in dietary change. Different severity of personalised nutrition feedback resulted in participants having comparable fruit and vegetable intakes at endpoint.

Resting-State Electroencephalogram Complexity Is Associated With Oral Ketamine Treatment Response: A Bayesian Analysis of Lempel-Ziv Complexity and Multiscale Entropy.

Subanesthetic doses of ketamine are a promising novel treatment for suicidality; however, the evidence for predictive biomarkers is sparse. Recently, measures of complexity, including Lempel-Ziv complexity (LZC) and multiscale entropy (MSE), have been implicated in ketamine's therapeutic action. We evaluated electroencephalogram (EEG)-derived LZC and MSE differences between responders and nonresponders to oral ketamine treatment. A total of 31 participants received six single, weekly (titrated) doses of oral racemic ketamine (0.5-3mg/kg) and underwent EEG scans at baseline (Week 0), post-treatment (Week 6), and follow-up (Week 10). Resting-state (eyes closed and open) recordings were processed in EEGLAB, and complexity metrics were extracted using the Neurokit2 package. Participants were designated responders or nonresponders by clinical response (Beck Suicide Scale [BSS] score reduction of ≥50% from baseline to the respective timepoint or score ≤6) and then compared in terms of complexity across resting-state conditions and time. Employing a Bayesian mixed effects model, we found strong evidence that LZC was higher in the eyes-open compared to eyes-closed condition, as were MSE scales 1-3. At a global level, responders displayed elevated eyes-open baseline complexity compared to nonresponders, with these values decreasing from baseline to post-treatment (Week 6) in responders only. Exploratory analyses revealed that the elevated baseline eyes-open LZC in responders was spatially localized to the left frontal lobe (F1, AF3, FC1, and F3). EEG-complexity metrics may be sensitive biomarkers for evaluating and predicting oral ketamine treatment response, with the left prefrontal cortex bein a possible treatment response region.