Reduction In Depression Scores Research Articles

Evaluation of a male-specific psychotherapeutic program for major depressive disorder compared to cognitive behavioral therapy and waitlist: study protocol for a six-arm randomized clinical superiority trial examining depressed eugonadal and hypogonadal men receiving testosterone.

Treatment of major depressive disorder (MDD) in men is complicated by the endorsement of traditional masculinity ideologies (TMI) often leading to reluctance toward psychotherapy, therapy interfering processes, or premature termination. In addition, it has been shown that men with MDD have a significantly increased risk of being hypogonadal (e.g., total testosterone levels <12.1 nmoL/L). Therefore, it is recommended to examine depressed men with regard to their testosterone status and if hypogonadism is present to combine psychotherapy with testosterone treatment (TT). This project aims to evaluate a male-specific psychotherapeutic program (MSPP) for MDD in depressed eugonadal and hypogonadal men receiving testosterone in comparison to a standard cognitive behavioral therapy (CBT) for MDD and a Waitlist. The study presents a 2×3 factorial study design. In total, 144 men aged between 25 and 50 will be stratified by testosterone status (eugonadal/hypogonadal) and then randomized into one of the three conditions (MSPP, CBT, or Waitlist). Additionally, a healthy control group of 100 men will be recruited, which will undergo only baseline assessments. Both standardized psychotherapy programs will encompass 18 sessions delivered in a weekly manner. Aligned with the TT-related medical visits of the 72 hypogonadal men, all participants will be followed up with clinical assessments and bio sampling at weeks 0, 6, 15, 24, and 36. Compared to Waitlist control groups, treatment groups are expected to be more effective and efficacious (depression score reduction of ≥50%) at week 24 and at the follow-up at week 36. The MSPP is expected to show higher effectiveness and efficacy for depressive symptoms and higher acceptability (lower dropout rate) as compared to CBT. This study represents the first attempt to test a male-specific psychotherapy for MDD in a single-setting compared to standard CBT and a Waitlist control condition using randomized clinical trial methodology. In addition, the potential positive adjunct effect of psychotherapy to TT in reducing depressive burden and improving quality of life in hypogonadal depressed men represents a neglected research area and might introduce new hypogonadism screening procedures in depressed men and combined treatment approaches for depressed men suffering from hypogonadism. Limitations are the rigorous inclusion and exclusion criteria, which limit the generalizability of the study results to first episode treatment naïve depressed men. ClinicalTrials.gov, identifier NCT05435222.

Adding web-based support to exercise referral schemes improves symptoms of depression in people with elevated depressive symptoms: A secondary analysis of the e-coachER randomised controlled trial

BackgroundExercise referral schemes (ERS) reduce depression but the additional effect on mental health from web-based behavioural support is unknown. The e-coachER trial reported no effect of augmenting usual ERS with theory-driven web-based behavioural support on moderate to vigorous physical activity (MVPA) at 12 months for patients with chronic physical and mental health conditions. The present study reports the effects of the e-coachER intervention on depression, anxiety and MVPA only among participants with elevated depressive symptoms and investigates whether these were mediated by changes in MVPA and hypothesised cognitive and behavioural processes. MethodsOf the original 450 adults recruited into the e-coachER trial, 205 had at least mild depression, based on the Hospital Anxiety and Depression Scale (HADS), and were included in the present analysis. Data collected included the HADS, accelerometer measured and self-reported MVPA and survey process measures on physical activity action planning, self-monitoring and goal reviewing, and perceived importance, confidence, competence, autonomy and support. Linear mixed models were used to compare groups for change in depression and anxiety at 4 and 12 months using intention-to-treat complete case analysis, controlling for baseline. We also examined whether changes in physical activity and process variables at 4 months mediated changes in depression and anxiety at 12 months. ResultsOf the 205 participants, 138 (67%) provided follow-up data at four months and 126 (61%) at 12 months. For those that provided follow-up data, those randomised to e-coachER reported improved levels of depression (−1.36, 95% CI: −2.55 to −0.18) but not anxiety, or MVPA, compared with controls at four months. No differences were observed at 12 months for depression, anxiety or MVPA. Intervention effects on accelerometer-measured or self-reported MVPA did not mediate improvements in depression or anxiety. However, intervention effects on confidence, competence and self-monitoring at four months significantly mediated the reduction in depression scores at four months. Intervention effects on competence and self-monitoring at four months also significantly mediated improvements in anxiety scores at four months. InterpretationAdding web-based support to usual ERS leads to reductions in depression but not anxiety at four months. Changes in depression and anxiety were influenced by changing people's motivational regulations toward physical activity. The benefit of adding web-based support to usual ERS on mental health appears to be from increasing a sense of confidence, competence and self-monitoring rather than from increasing physical activity in people with elevated depression. ERS should focus more on strengthening motivational regulations than just doing more exercise. Trial registrationISRCTN15644451.

Abstract 52: Implementation of a Hospital-Based Peer Support Intervention Model for Cancer Patients: Results From a Pilot Study in Vietnam

Abstract Purpose: Provision of mental health psychosocial support can reduce psychological distress experienced by cancer patients, which can in turn improve their treatment adherence and outcomes. In this study, we present the results from the pilot trial of Stronger Together, a culturally adapted peer-to-peer support program, conducted in Vietnam. Methods: We recruited eligible women from four hospitals in Vietnam (K3 National Cancer Hospital, Hue Central Hospital Oncology Center, Can Tho Oncology Hospital, and Hung Vong Women’s Hospital Oncology Unit). Participants were newly diagnosed with breast or gynecologic cancers, and self-selected into either the control (usual care) or intervention arm (mentees who were matched up with trained peer mentors). Validated questionnaires were administered at baseline (0), 2-, 4-, and 6-months. We conducted a difference-in-difference (DID) analysis for the primary outcomes (assessed by the Depression, Anxiety, and Stress Scale [DASS-21]), comparing the difference in scores from baseline to 6 months and between intervention arms (mentees vs. usual care). Results: The analytic sample included n=186 participants (mentees: 91; usual care: 95), with the majority having breast cancer (85.5%), followed by cervical cancer (7.5%) and ovarian cancer (7.0%). There were no statistically significant differences between study arms in demographic and cancer characteristics (cancer type and stage). DID analyses showed that compared to usual care participants, mentees (those who received peer support) showed greater reductions in depression, anxiety, and stress scores between baseline and 6 months. Adjusting for age, education, marital status, and cancer stage, statistically significant reductions in stress scores (β=-1.47; 95%CI: [-2.9,-0.02]; p=0.047) were observed. Among breast cancer patients only, adjusted models showed significant reductions in depression scores (β=-1.80; 95%CI: [-3.0,-0.48]; p=0.007) and stress scores (β=-1.9; 95%CI: [-3.3,-0.37; p=0.015). Conclusion: The Stronger Together pilot study study shows that utilizing peer cancer survivors is a promising strategy to address the psychosocial needs of newly diagnosed cancer patients in low-resource settings. Future research should test this intervention model in larger samples or other similar populations and settings. Citation Format: PhuongThao Le, Carolyn Taylor, Rachel Monahan, Mai Do, Linh Nguyen, Minh Tri Phan, Cong Wang, Huong Tran, Ophira Ginsburg. Implementation of a Hospital-Based Peer Support Intervention Model for Cancer Patients: Results From a Pilot Study in Vietnam [abstract]. In: Proceedings of the 11th Annual Symposium on Global Cancer Research; Closing the Research-to-Implementation Gap; 2023 Apr 4-6. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(6_Suppl):Abstract nr 52.

Patterns of response to anti-CGRP monoclonal antibodies during first 6-months of treatment in resistant migraine patients: impact on outcome.

The response pattern to monoclonal antibodies against calcitonin gene-related peptide (anti-CGRP MAbs) shown in migraine prevention clinical trials is not always reproducible at an individual-level. To describe patterns of start and consistency of the response to anti-CGRP MAbs during first six months of treatment and the association to baseline clinical characteristics METHODS: This is a prospective clinical cohort observational study. We included migraine patients treated with erenumab or galcanezumab evaluated at baseline and after three and six months (M3-M6) of treatment. The response was categorized according to reduction in monthly headache days (MHD): Sustained-response (SustainedR, ≥50% at M3 and M6); Short-Response (ShortR, M3≥50% and M6<50%), Later-Response (LaterR, M3<50% and M6≥50%); Limited-Response (LimitedR, 25-50% at M3 and M6) and No-Response (NoR, <25% at M3 and M6). Response patterns were compared at baseline and with outcome variables at M3 and M6. We included 357 patients with a headache frequency of 21.0(16.0, 28.0) MHD and 84.0% (300/357) were chronic migraine. The distribution according to response pattern was: 37.0% (110/297) Sustained-Response, 16.8% (50/297) Later-Response, 10.4% (31/297) Short-Response, 22.6% (67/297) Limited-Response and 13.1% showed No-Response (39/297). Sustained-R and Later-R groups showed statistically significant anxiety and depression score reduction at M3 and M6 compared to other groups. Initial response to anti-CGRP MAbs is not consistent in all patients. Persistence of anxiety and depression might be associated with lower response rates at month 6.

Profiles of Depression and Restoration in Nature-Based Group Therapy

This study focuses on a nature-based group treatment (Flow with Nature [FWN] treatment) for working-age adults diagnosed with clinical depression. We searched for different subgroups of depression and restoration levels to see who, in particular, benefits from FWN treatment. In total, 108 people participated in the study at various locations in Finland. The participants were 44.8 years old on average (range = 19–64), and most were female (81.5%). We used Latent Profile Analysis to identify different profiles of level and change in depression and restoration in the participants of FWN treatment to investigate who particularly benefits from it. We found three different profiles of depression level and observed a significant reduction of depression scores in the group with the lowest depression level. In addition, two different profiles of restoration were identified and depression symptoms were significantly alleviated in the group with higher restoration, whereas no such change was observed in the group with lower restoration. FWN can be especially beneficial as a low-threshold treatment for mild depression in addition to treatment-as-usual. Further, the results suggest that it is advisable to purposively support restoration by nature-based treatments for depression.

A Pilot Cross-Sectional Study on the Level of Depression and Physical Activity among Students in Poland and Portugal in the Second Year of the COVID-19 Pandemic

Objectives: The aim of the study was to make a preliminary assessment of depression rates and levels of physical activity and the association between physical activity and depression among Polish and Portuguese students in the second year of the COVID-19 pandemic. Methods: A web-based online survey was conducted among students in Poland and Portugal (398 respondents-229 from Poland and 169 from Portugal) aged between 17 and 26 in October 2022. The level of depression was assessed by the Beck Depression Inventory (BDI) in Polish and in Portuguese. The level of physical activity was measured by the International Physical Activity Questionnaire (IPAQ) in Polish and in Portuguese. Results: Overall, 20-35% of respondents suffered from moderate depression, with a lower proportion among men. There were no differences in the percentage distribution of depression classification between Polish and Portuguese students. A decrease in the severity of depression was observed with increasing physical activity. In both countries, walking more often had the strongest effect on reducing depression scores. Conclusions: The continued and alarming prevalence of depressive disorders among university students in the year after the pandemic began had a significant impact on this population-further research on the impact of physical activity on mental health in different populations should be conducted to adjust the optimal level of physical activity for alleviating negative psychiatric symptoms.

Factors associated with improvements in symptoms of anxiety and depression among gay, bisexual and other men who have sex with men (gbMSM) in Vancouver, Canada: A prospective cohort study

BackgroundDepression and anxiety are commonly experienced among gay, bisexual and other men-who-have-sex-with-men (gbMSM). We explored factors associated with improvements in mental health symptoms among gbMSM with abnormal depression and anxiety scores over a period of four years, in Vancouver, Canada. MethodsSexually active gbMSM ≥16 years of age were recruited using respondent-driven sampling from February 2012 to February 2015. Participants completed a computer-assisted questionnaire which included the Hospital Anxiety and Depression Scale (HADS), and psychometric scales to measure loneliness, self-esteem and social connectedness, every 6 months until July 2019. Generalized linear mixed models were used to assess factors associated with normal/borderline HADS scores (<11) following a previous abnormal score (≥11) for each of anxiety and depression subscales. ResultsWe recruited 694 participants, of whom 580 had at least one follow-up visit. Across all visits, 43.6 % of participants ever had abnormal anxiety scores and 16.2 % ever had abnormal depression scores. Among those with abnormal anxiety scores, 34.9 % of follow-up visits demonstrated reductions in anxiety scores. Among those with abnormal depression scores 51.0 % of follow-up visits demonstrated reductions in depression scores. Reductions in anxiety scores were associated with increased self-esteem, decreased loneliness and the number of gbMSM seen/spoken to in the previous month. Reductions in depression scores were associated with increased self-esteem, decreased loneliness and having a regular partner. ConclusionImprovements in mental health symptoms were frequently observed. Social connectedness was related with improved anxiety and depression symptoms. Interventions to improve social connectedness may help to improve mental health for gbMSM.

CBT for post-traumatic stress disorder and depression in the context of pregnancy loss: a case study reflection

Abstract Women who experience pregnancy loss are at increased risk of psychological distress, including post-traumatic stress disorder (PTSD) and depression. Despite the substantial evidence base for trauma-focused cognitive behavioural therapy (CBT) for PTSD, there is limited research on this specific type of trauma, as well as a dearth of research exploring treatment for co-morbid PTSD and depression. This study used a single case experimental design to assess the efficacy of sequential CBT for treating PTSD and depression in a primary care setting in the United Kingdom. Results demonstrate a reduction in scores on the PCL-5 following trauma-focused CBT, but not a clinically significant reduction in depression scores. This write-up reflects on the effectiveness of sequential treatment and suggests alternative approaches. Future directions for research are also given. Dedication: The authors dedicate this paper to all parents who have experienced pregnancy or baby loss. Key learning aims (1) To gain an understanding of some of the challenges in delivering CBT for trauma related to pregnancy loss. (2) To reflect on treatment of co-morbid PTSD and depression through flexible use of evidence-based treatment, and consider alternative approaches to sequential treatment. (3) To consider the impact of grief in formulation and treatment.

Effect of antidepressants on psychological comorbidities, disease activity, and quality of life in inflammatory bowel disease: a systematic review and meta-analysis.

Patients with inflammatory bowel disease (IBD) are often accompanied by a more significant burden of depression or anxiety, and approximately one-third are prescribed antidepressants. However, previous studies on the efficacy of antidepressants in IBD have shown inconsistent results. To evaluate the effect of antidepressants on depression, anxiety, disease activity, and quality of life (QoL) in IBD patients. A systematic review and meta-analysis. We searched MEDLINE via Ovid, EMBASE via Ovid, the Cochrane Library, CINAHL, PsycINFO, Chinese CBM Database, China National Knowledge Infrastructure, VIP, and Wanfang Database from inception to 13th July 2022 without language restrictions. In all, 13 studies containing 884 individuals were included. Compared with the control group, antidepressants were superior in reducing depression scores [standardized mean difference (SMD) = -0.791; 95% confidence interval (CI): -1.009 to -0.572; p < 0.001], anxiety scores (SMD = -0.877; 95% CI: -1.203 to -0.552; p < 0.001), and disease activity scores (SMD = -0.323; 95% CI: -0.500 to -0.145; p < 0.001). Antidepressants had a positive effect in reaching clinical remission [risk ratio (RR) = 1.383; 95% CI: 1.176-1.626; p < 0.001]. Higher physical QoL (SMD = 0.578; 95% CI: 0.025-1.130; p = 0.040), social QoL (SMD = 0.626; 95% CI: 0.073-1.180; p = 0.027), and Inflammatory Bowel Disease Questionnaire (SMD = 1.111; 95% CI: 0.710-1.512; p < 0.001) were found in the experimental group. No significant differences were observed in clinical response (RR = 1.014; 95% CI: 0.847-1.214; p = 0.881), psychological QoL (SMD = 0.399; 95% CI: -0.147 to 0.944; p = 0.152), and environmental QoL (SMD = 0.211; 95% CI: -0.331 to 0.753; p = 0.446). Antidepressants are effective for ameliorating depression, anxiety, disease activity, and QoL in IBD patients. Due to most studies having a small sample size, further well-designed studies are required.

Therapeutic and Safety Outcomes of Intravenous Ketamine for Treatment-refractory Depression in a Veteran Population: A Case Series.

Major depressive disorder is a serious, recurrent, and disabling psychiatric illness. Despite many proven treatments with multiple medications or therapies, approximately 30% of patients fail to achieve remission and are considered to have treatment-refractory depression (TRD). Recently, there has been a growing interest in the use of intravenous (IV) ketamine for the treatment of TRD. There is limited yet increasing evidence to support the use of ketamine, a glutamate receptor antagonist, in the management of depression; however, the lack of data regarding the safety and tolerability of therapy has limited its clinical use. By analyzing a cohort of veterans with TRD and comorbid psychiatric conditions treated with IV ketamine infusions for a 24-month study period, we aim to provide critical information about ketamine's clinical effectiveness and safety. Based on a retrospective chart review, we identified eight veterans with TRD receiving treatment with repeated-dose IV ketamine from 2018 to 2020. The magnitude of clinical response was based on the Beck Depression Inventory self-report scale and the Patient Health Questionnaire-9, both measured at the initial patient consultation and before the beginning of each ketamine infusion treatment. Safety analysis included changes to pre- and post-ketamine infusion on vital signs, effects on alertness and sedation, and potential psychosis-like effects. For all outcomes, we estimated a linear mixed-effects model that allowed heterogeneous residual variances for each veteran. The effect of continuous predictor variables was estimated using restricted cubic splines with knot points specified at the 5th, 35th, 65th, and 95th percentiles. All the analyses were conducted using SAS v.9.4, with P < .05 indicating the statistical significance. This study had institutional review board approval: 1220. During the study period, the median number of ketamine infusions was 15 across a median of 164 days of treatment follow-up with a median time between ketamine infusions of 4 days. For both Beck Depression Inventory and Patient Health Questionnaire-9 scores, there was a statistically significant reduction across infusions (both P < .001), but the strongest reduction occurred before day 40. The change was statistically significant for decreased heart rate (P = .019) but not for systolic blood pressure (P = .612), diastolic blood pressure (P = .942), respiratory rate (P = .822), oxygen saturation (P = .070), and temperature (P = .943). Side effects were reported in six patients (75%); however, the only side effect reported was excessive sedation or dizziness immediately after infusion. In this study, repeated-dose IV ketamine infusions over a 24-month study period resulted in a significant reduction in depression scores in a group of veterans with TRD. The rapid onset of significant response, absence of psychosis-like effects or dissociative symptoms despite psychiatric comorbidities, and minimal effects on vital signs support the clinical efficacy and safety of this exciting new treatment option for patients with TRD. Limitations include a 2-year study period, lack of information on long-term effects, and the retrospective nature of the study. Prospective studies of longer duration are needed to assess the long-term efficacy and safety of IV ketamine for TRD.

Neurophysiological impact of theta burst stimulation followed by cognitive exercise in treatment of youth depression

• Changes in cortical reactivity following bilateral DLPFC TBS combined with cognitive exercise treatment were assessed in youth with depression. • Cortical reactivity was modulated at cortical sites both local and distal to the site of TBS application. • Modulation of cortical reactivity at different sites was associated with improvement in both depression and rumination scores. • TBS combined with cognitive exercise may exert its therapeutic effect by modulating the neurophysiology of sites both local and distal to the stimulation sites. Targeting the dorsolateral prefrontal cortex (DLPFC) with repeated sessions of theta-burst stimulation (TBS) is a promising treatment for youth depression. However, it remains unclear whether TBS selectively acts upon inhibitory and/or excitatory measures. Such insight could aid with the development of biomarker driven approaches to delivering TBS in depressed youth. Transcranial magnetic stimulation combined with electroencephalography (TMS-EEG) was used to assess the neurophysiological impact of a 4-week bilateral DLPFC-targeted TBS trial followed by a cognitive exercise for the treatment of depression in youth. In 26 youth with depression (aged 16 – 24 years old), TMS-evoked potentials (TEPs) were assessed at baseline and after treatment completion from the bilateral DLPFC and intraparietal lobules (IPL). Following treatment, there were significant changes in TEPs both local and distal to the stimulated treatment sites. The amplitude of the left DLPFC N100 response was significantly reduced. Also, there was a significant association between changes in the right DLPFC N45 response and reduction in depressive and rumination scores. Additionally, the amplitude of the right IPL N100 response was reduced. Moreover, the modulation of the right IPL N100 response was significantly associated with a reduction in depressive scores. The primary limitation was the lack of a sham treatment arm. Bilateral DLPFC TBS may exert its therapeutic impact by modulating the neurophysiology of regions and networks both local and distal to the treatment site. Collectively, our findings offer novel insight into the potential therapeutic mechanisms of TBS for the treatment of youth depression.

A network meta-analysis of 12,116 individuals from randomized controlled trials in the treatment of depression after acute coronary syndrome.

Post-acute coronary syndrome (ACS) depression is a common but not well understood complication experienced by ACS patients. Research on the effectiveness of various therapies remains limited. Hence, we sought to conduct a network meta-analysis to assess the efficacy of different interventions for post-ACS depression in improving patient outcomes. Three electronic databases were searched for randomised controlled trials describing different depression treatment modalities in post-ACS patients. Each article was screened based on inclusion criteria and relevant data were extracted. A bivariate analysis and a network meta-analysis was performed using risk ratios (RR) and standardized mean differences (SMD) for binary and continuous outcomes, respectively. A total of 30 articles were included in our analysis. Compared to standard care, psychosocial therapy was associated with the greatest reduction in depression scores (SMD:-1.21, 95% CI: -1.81 to -0.61, p<0.001), followed by cognitive behavioural therapy (CBT) (SMD: -0.75, 95% CI: -0.99 to -0.52, p<0.001), antidepressants (SMD: -0.73, 95% CI: -1.14 to -0.31, p<0.001), and lastly, combination therapy (SMD: -0.15, 95% CI: -0.28 to -0.03, p = 0.016). No treatment modalities was found to be more effective in reducing depression scores when compared to one another. Additional analysis showed that these treatment modalities did not have significant impact on the overall mortality, cardiac mortality and recurrent myocardial infarction. This network meta-analysis found that the treatment effect of the various psychological modalities on depression severity were similar. Future trials on psychological interventions assessing clinical outcomes and improvement in adherence to ACS-specific interventions are needed.

Ecological Sustainability and Households’ Wellbeing: Linking Households’ Non-Traditional Fuel Choices with Reduced Depression in Rural China

A sustainable and pleasant environment is deemed to offer various positive externalities such as scenic, visual and behavioral archetypes and patterns exhibiting in various forms. Such a scenario can significantly relieve households from many psychological and personal complications such as depression. Depression has aroused great concerns in recent years due to its personal and social burdens and unforeseeable damage. Many studies have explored the effects of air pollution caused by traditional fuel consumption on depression. However, limited evidence is available on how household non-traditional fuel choices affect depression. Based on a nationally representative dataset collected from China Family Panel Studies (CFPS) in 2012, this paper employs an endogenous switching regression (ESR) model and an endogenous switching probit (ESP) model to address the endogenous issue and to estimate the treatment effects of non-traditional fuel choices on depression in rural China. The empirical results show that non-traditional fuel users have significantly lower Epidemiologic Studies Depression Scale (CES-D) scores, indicating non-traditional fuel users face a lower risk of depression. Compared to solid fuels, employing non-traditional fuels will lead to a 3.659 reduction in depression score or decrease the probability of depression by 8.2%. In addition, the results of the mechanism analysis show that household non-traditional fuel choices affect depression by reducing the probability of physical discomfort and chronic disease. This study provides new insight into understanding the impact of air pollution in the house on depression and how to avoid the risk of depression in rural China effectively.

Scopolamine fails to demonstrate efficacy in depression treatment

Scopolamine fails to demonstrate efficacy in depression treatment

Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression

BackgroundPsilocybin is being studied for use in treatment-resistant depression.MethodsIn this phase 2 double-blind trial, we randomly assigned adults with treatment-resistant depression to receive a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support. The primary end point was the change from baseline to week 3 in the total score on the Montgomery–Åsberg Depression Rating Scale (MADRS; range, 0 to 60, with higher scores indicating more severe depression). Secondary end points included response at week 3 (≥50% decrease from baseline in the MADRS total score), remission at week 3 (MADRS total score ≤10), and sustained response at 12 weeks (meeting response criteria at week 3 and all subsequent visits).ResultsA total of 79 participants were in the 25-mg group, 75 in the 10-mg group, and 79 in the 1-mg group. The mean MADRS total score at baseline was 32 or 33 in each group. Least-squares mean changes from baseline to week 3 in the score were −12.0 for 25 mg, −7.9 for 10 mg, and −5.4 for 1 mg; the difference between the 25-mg group and 1-mg group was −6.6 (95% confidence interval [CI], −10.2 to −2.9; P<0.001) and between the 10-mg group and 1-mg group was −2.5 (95% CI, −6.2 to 1.2; P=0.18). In the 25-mg group, the incidences of response and remission at 3 weeks, but not sustained response at 12 weeks, were generally supportive of the primary results. Adverse events occurred in 179 of 233 participants (77%) and included headache, nausea, and dizziness. Suicidal ideation or behavior or self-injury occurred in all dose groups.ConclusionsIn this phase 2 trial involving participants with treatment-resistant depression, psilocybin at a single dose of 25 mg, but not 10 mg, reduced depression scores significantly more than a 1-mg dose over a period of 3 weeks but was associated with adverse effects. Larger and longer trials, including comparison with existing treatments, are required to determine the efficacy and safety of psilocybin for this disorder. (Funded by COMPASS Pathfinder; EudraCT number, 2017-003288-36; ClinicalTrials.gov number, NCT03775200.)

Complementary Approaches for Military Women with Chronic Pelvic Pain: A Randomized Trial.

Introduction: Active duty (AD) women suffer with chronic pelvic pain (CPP) while providers tackle diagnoses and treatments to keep them functional without contributing to the opioid epidemic. The purpose of this randomized trial was to determine the effectiveness of noninvasive, self-explanatory mindfulness-based stress reduction (MBSR) or self-paced healthy lifestyle (HL) interventions on CPP in AD women. Methods: A 6-week, interventional prospective study with AD women aged 21-55 years at Mountain Home (MTHM), Idaho, was conducted. Women were randomly assigned to MBSR (N = 21) or HL (N = 20) interventions. The primary outcome was pain perception. The secondary outcomes were depression and circulating cytokine levels. Results: Women in the MBSR group exhibited reduced pain interference (p < 0.01) and depression (p < 0.05) alongside decreased interleukin (IL)-4 (p < 0.05), IL-6 (p < 0.05), eotaxin (p < 0.05), monocyte chemoattractant protein-1 (p = 0.06), and interleukin-1 receptor antagonist (IL-1ra) (p < 0.01) and increased vascular endothelial growth factor (p < 0.05). Women in the HL group did not have changes in pain; however, they did exhibit reduced depression (p < 0.05) alongside decreased granulocyte-macrophage colony-stimulating factor (p < 0.05) and increased tumor necrosis factor alpha (p < 0.05), stromal cell-derived factor-1 (p < 0.01), and IL-1ra (p < 0.01). Conclusions: AD women receiving MBSR or HL had reduced depression scores and altered circulating cytokine levels; however, only those receiving MBSR had reduced pain perception. Findings support MBSR as an effective and viable behavioral treatment for AD women suffering from CPP and provide premise for larger randomized controlled studies. Clinical Trial Registration: MOCHI-An RCT of mindfulness as a treatment for CPP in AD Women NCT04104542 (September 26, 2019).

Evaluation of DNA methylation in BDNF, SLC6A4, NR3C1 and FKBP5 before and after treatment with selective serotonin-reuptake inhibitor in major depressive disorder.

Aim: To identify the DNA methylation status of related genes in major depressive disorder following selective serotonin-reuptake inhibitor treatment. Materials & methods: 45 patients with major depressive disorder and 45 healthy volunteers were considered experimental and control groups,respectively. High-resolution melting real-time PCR was implemented to evaluate DNA methylation. Results: After 100days of selective serotonin-reuptake inhibitor treatment, methylation of promoter CpG sites of BDNF, NR3C1, FKBP5 and SLC6A4 was significantly reduced. Compared with before treatment, patients' Hamilton Depression Rating Scale scores were significantly reduced after selective serotonin-reuptake inhibitor treatment (p≤0.0001). Conclusion: Based on the proven effect of antidepressants on DNA methylation and gene expression, these medications can improve the treatment process and reduce depression scores after treatment.

Autonomic variability, depression and the disability paradox in spinal cord injury.

Longitudinal. With an increased risk of depression in spinal cord injury, the study longitudinally examines depression to understand how post-injury autonomic regulation and coping might be related to somatic and cognitive manifestations of depression after 3 years. Indian Spinal Injuries Center. Twenty-eight spinal cord injury participants completed the follow-up assessment of the Patient Health Questionnaire 3 years post-injury. The participants were grouped based on post-injury autonomic regulation (high and low HRV) and the somatic and cognitive manifestation of depression reflected in a depression ratio. Wilcoxson signed-rank test tested the post-injury (T1) and 3 year follow-up (T2) depression scores. Depression score reduced after 3 years of injury (p ≤ 0.05). Only the high HRV group showed a higher depression ratio (somatic/ cognitive) atfollow-up (T2) (p ≤ 0.05). No difference was observed in post-injury coping between high and low HRV groups. The reduced depression score at follow-up (T2) aligns with the 'disability paradox' and mightindicate cognitive adaptation, specifically for those who showed autonomic adaptability in the form of post-injury high autonomic variability.

Physical and Psychological Outcomes of Patients Undergoing Traditional Cardiac Rehabilitation and Intensive Cardiac Rehabilitation.

Both traditional cardiac rehabilitation (TCR) and intensive cardiac rehabilitation (ICR) have proven benefits for patients with cardiovascular disease. The aim of this study was to compare ICR versus TCR on cardiac rehabilitation (CR) outcomes in patients with cardiovascular disease. In a retrospective cohort study of 970 patients (n = 251, ICR; n = 719, TCR) who were referred for CR between January 2018 and December 2019, 693 (71.4%) patients completed it. The TCR sessions were 90 min (60-min exercise) three times/wk for 12 wk, while ICR sessions were 4 hr (60-min exercise) two times/wk for 9 wk. Primary endpoints were change in cardiorespiratory fitness (CRF) (by difference in exercise prescription metabolic equivalents [METs] between the last session and the average of the second and third sessions), anxiety (Generalized Anxiety Disorder-7) scores, percent depression (Patient Health Questionnaire-9 or Center for Epidemiologic Studies Depression Scale) scores, and health status (36-item Short Form Health Survey physical and mental composite scores). Linear regression adjusted for imbalanced baseline characteristics (age, race, and diagnosis of angina). Of the 693 patients who completed CR (ICR = 204/251 [81%] vs TCR = 489/719 [68%], P < .01), mean age was 66 yr and 31% were female. Patients in TCR had a higher improvement in CRF (CR session METs: ICR +1.5 ± 1.2 vs TCR +1.9 ± 1.5, P < .01) but no difference in health status scores. Conversely, patients in ICR had more reduction in anxiety scores (-2 ± 4 vs -1 ± 3, P < .01) and percent reduction in depression scores (-8.3 ± 13.7% vs -5.0 ± 11.7%, P < .01) than patients in TCR. Patients in TCR had higher improvement in CRF while patients in ICR had higher improvement in anxiety and depression scores.

Effects of Diastolic Blood Pressure on Brain Structures and Cognitive Functions in Middle and Old Ages: Longitudinal Analyses.

Hypertension is a pervasive public health concern due to strong associations with cardiovascular diseases and stroke. Alternatively, the associations between hypertension and the risk of Alzheimer’s disease are complex and recent large sample studies reported positive associations. In this paper, we examine the associations between diastolic blood pressure (BP) and subsequent changes in brain structure and cognitive function over several years by multiple regression analyses (with adjustment for a wide range of potential confounding variables) among a large cohort from the UK Biobank. Higher baseline diastolic BP was associated with a slightly smaller relative increase (relative improvements) in reaction time and a slightly greater reduction in depression scores. Higher baseline diastolic BP was also associated with a greater total gray matter volume (GMV) retention, while aging alone was associated with GMV reduction. White matter microstructural analyses revealed that a greater diastolic BP was associated with reduced longitudinal mean and regional fractional anisotropy, greater increases in mean and regional mean diffusivity, radial diffusivity, and axial diffusivity, a greater decline in mean intracellular volume fraction, and greater increases in mean and regional isotropic volume fraction. These white matter microstructural changes were consistent with those seen in the aging process. Additional analyses revealed a greater cheese intake level at baseline, which is associated with a subsequent decline in diastolic BP and a relative subsequent increase in depressive tendency together with a relative increase in fluid intelligence and visuospatial memory performance. These results are congruent with the view that a higher BP in the aging brain has a complex role.