Improvement In Depressive Symptoms Research Articles

The Effectiveness of Patient Education on Laparoscopic Surgery Postoperative Outcomes to Determine Whether Direct Coaching Is the Best Approach: Systematic Review of Randomized Controlled Trials.

As of 2022, patient adherence to postoperative guidelines can reduce the risk of complications by up to 52.4% following laparoscopic abdominal surgery. With the availability of various preoperative education interventions (POEIs), understanding which POEI results in improvement in patient outcomes across the procedures is imperative. This study aims to determine which POEI could be the most effective on patient outcomes by systematically reviewing all the POEIs reported in the literature. In total, 4753 articles investigating various POEIs (eg, videos, presentations, mobile apps, and one-on-one education or coaching) were collected from the PubMed, Embase, and Scopus databases. Inclusion criteria were adult patients undergoing abdominal laparoscopic surgery, randomized controlled trials, and studies that provided postoperative outcomes. Exclusion criteria included studies not published in English and with no outcomes reported. Title and abstract and full-text articles with POEI randomized controlled studies were screened based on the above criteria through a blinded, dual review using Covidence (Veritas Health Innovation). Study quality was assessed through the Cochrane Risk of Bias tool. The included articles were analyzed for educational content, intervention timing, intervention type, and postoperative outcomes appropriate for a particular surgery. Only 17 studies matched our criteria, with 1831 patients undergoing laparoscopic cholecystectomy, bariatric surgery (gastric bypass and gastric sleeve), and colectomy. In total, 15 studies reported a statistically significant improvement in at least 1 patient postoperative outcome. None of these studies were found to have an overall high risk of bias according to Cochrane standards. In total, 41% (7/17) of the included studies using direct individual education improved outcomes in almost all surgery types, while educational videos had the greatest statistically significant impact for anxiety, nausea, and pain postoperatively (P<.01). Direct group education demonstrated significant improvement in weight, BMI, exercise, and depressive symptoms in 33% (2/6) of the laparoscopic gastric bypass studies. Direct education (individual or group based) positively impacts postoperative laparoscopic surgery outcomes. PROSPERO CRD42023438698; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=438698.

The Relative Effectiveness of Bilateral and Unilateral Electrode Placement in Electroconvulsive Therapy (ECT) in Patients With Major Depressive Disorder: A Retrospective Cohort Study.

Background This study is focused on the comparative efficacy of bilateral and unilateral electroconvulsive therapy (ECT) on depressive symptoms in patients at the Perth Clinic for the period from 2016 to 2021. Methods This was a retrospective cohort study of 485 patients who received ECT treatment. The expected improvements in depressive symptoms were evaluated by the Depression Anxiety Stress Scale(DASS)assessment tool filled out by the patients on admission and discharge from the hospital. Only the depression score of the DASS scale was utilised for this research. Results The results suggested that both electrode placements resulted in a significant improvement in depressive symptoms. The positive response rates for the bilateral and unilateral electrode placements were 78.3% and 71.6%, respectively. There was no difference between males and females in the average DASS score at discharge for bilateral and unilateral electrode placements. Conclusions This study confirmed that the results obtained at the Perth Clinic are similar to the existing international research results on the same topic. Bifrontal and unilateral ECT electrode placements are equally efficacious in improving depressive symptoms in patients suffering from major depressive disorder (MDD).

Kappa opioid receptor in nucleus accumbens regulates depressive-like behaviors following prolonged morphine withdrawal in mice

Prolonged withdrawal from opioids leads to negative emotions. Kappa opioid receptor (KOR) plays an important role in opioid addiction and affective disorders. However, the underlying mechanism of KOR in withdrawal-related depression is still lacking. We found that escitalopram treatment had a limited effect in improving depression symptoms in heroin-dependent patients. In mice, we demonstrated prolonged (4weeks) but not acute (24 h) withdrawal from morphine induced depressive-like behaviors. The number of c-Fos positive cells and the expression of KOR in the nucleus accumbens (NAc), were significantly increased in the prolonged morphine withdrawal mice. Conditional KOR knockdown in NAc significantly improved depressive-like behaviors. Repeated but not acute treatment with the KOR antagonist norBNI improved depressive-like behaviors and reversed PSD95, synaptophysin, p-ERK, p-CREB, and BDNF in NAc. This study demonstrated the important role of striatal KOR in morphine withdrawal-related depressive-like behaviors and offered therapeutic potential for the treatment of withdrawal-related depression.

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study.

Treatment-resistant depression (TRD) is a chronic illness requiring long-term treatment. Esketamine nasal spray (ESK) has been studied in several long-term trials of patients with TRD, including SUSTAIN-1 (NCT02493868) and SUSTAIN-3 (NCT02782104). This subgroup analysis of SUSTAIN-3 evaluated patients with TRD who received a second induction (IND) and maintenance treatment with ESK plus oral antidepressant (AD) after a relapse in SUSTAIN-1. Patients aged 18-64 years who achieved stable remission or response with ESK and subsequently relapsed after randomization to continue ESK or switch to placebo nasal spray (PBO) in SUSTAIN-1 and entered the IND phase of SUSTAIN-3 were included in this interim analysis. Response (≥50% improvement in total score from baseline for Montgomery-Åsberg Depression Rating Scale [MADRS] and Patient Health Questionnaire 9-item [PHQ-9]), remission (MADRS score ≤12; PHQ-9 total score <5), changes in depression rating scores (measured as mean change from baseline), and safety were evaluated (incidence of treatment-emergent and serious adverse events [AE]). Of the 96 eligible patients who entered IND in SUSTAIN-3, 32 (33.3%) were taking ESK+AD at the time of relapse in SUSTAIN-1 and 64 (66.7%) were taking AD+PBO. Substantial improvements in depressive symptoms were observed over the second IND phase in both groups and were maintained over the optimization/maintenance (OP/M) phase. MADRS response rates following a second IND were 71.9% and 73.4% for previously relapsed (PR) ESK+AD and PR-AD+PBO, respectively; remission rates were 62.5% and 60.9%, respectively. During the IND and OP/M phases, 58.3% and 83.3% of patients experienced a treatment-emergent AE, respectively. No patients discontinued due to an AE during the second IND. Patients with TRD benefitted from receiving a second IND and maintenance treatment with ESK and no new safety signals were identified.

Sustained improvement in depression seen in study of esketamine nasal spray

Interim results from a Phase 3 study of esketamine nasal spray in patients with treatment‐resistant depression showed no emerging safety concerns and sustained improvement in depressive symptoms. Nearly half of study participants met criteria for remission at the end of the study's optimization/maintenance phase, the investigators reported. Study results were published online May 12, 2023, in Neuropsychopharmacology.

Adjunctive lumateperone leads to significant improvement in bipolar depression

The higher of two tested doses of adjunctive lumateperone led to significantly greater improvement over placebo in a Phase 3 trial involving patients with bipolar depression. A lower dose of lumateperone led to numerical improvement in depressive symptoms compared with placebo.

The evaluation of cognitive-behavioral therapy-based intervention on type 2 diabetes patients with comorbid metabolic syndrome: a randomized controlled trial

BackgroundCognitive behavior therapy (CBT) has been applied in intervention research in diabetes patients with satisfying results. However, there was no research on type 2 diabetes (T2DM) patients with comorbidities. This study aimed to investigate the effectiveness of CBT on psychological variables, behavior variables, quality of life, sleep quality, and physical variables among adult T2DM patients with comorbid metabolic syndrome (MS).Methods281 patients aged 18–75 years were recruited from Ningbo First Hospital in China from October 2021 to March 2022. Patients were randomized to the intervention group (IG, N = 148) or control group (CG, N = 133). Patients in the IG received 12 CBT-based sessions during a six-month intervention time. Patients in the CG received the usual care only. Univariate General Linear Model was used to analyze the effect of CBT-based interventions. The analysis was conducted by SPSS Version 28.ResultsResults indicated that CBT-based intervention was superior in the following aspects: relieving depression symptoms: IG (4.11 ± 4.35 vs. 1.99 ± 2.12), CG (3.40 ± 3.26 vs. 2.32 ± 1.88), interaction effect (F = 4.074, P = 0.044); enhancing diabetes self-care behaviors: IG (26.79 ± 12.18 vs. 37.49 ± 10.83), CG (25.82 ± 13.71 vs. 31.96 ± 11.72), interaction effect (F = 5.242, P = 0.022); promoting the efficacy of CBT: IG (47.45 ± 6.83 vs. 50.76 ± 4.98), CG (46.74 ± 6.94 vs. 47.87 ± 5.11), interaction effect (F = 5.198, P = 0.023); improving subjective sleep quality: IG (0.93 ± 0.68 vs. 0.69 ± 0.63), CG (1.03 ± 0.72 vs. 1.01 ± 0.68), interaction effect (F = 3.927, P = 0.048).ConclusionsThe CBT-based intervention was beneficial in improving depression symptoms, diabetes self-care behaviors, the efficacy of CBT, and sleep quality in T2DM patients with comorbid MS. The downtrend of body mass index, systolic blood pressure, diastolic pressure, and glycated hemoglobin was larger in the intervention group but not to a significant level.Trial registration: This study has been prospectively registered at Australia New Zealand Clinical Trials Registry (Registration ID: ACTRN12621001348842 website: https://www.anzctr.org.au/trial/MyTrial.aspx).

Neuronavigated repetitive transcranial magnetic stimulation improves depression, anxiety and motor symptoms in Parkinson’s disease

BackgroundRepetitive transcranial magnetic stimulation (rTMS) is a potential treatment option for Parkinson’s disease patients with depression (DPD), but conflicting results in previous studies have questioned its efficacy. MethodTo investigate the safety and efficacy of neuronavigated high-frequency rTMS at the left DLPFC in DPD patients, we conducted a randomized, double-blind, sham-controlled study (NCT04707378). Sixty patients were randomly assigned to either a sham or active stimulation group and received rTMS for ten consecutive days. The primary outcome was HAMD, while secondary outcomes included HAMA, MMSE, MoCA and MDS-UPDRS-III. Assessments were performed at baseline, immediately after treatment, 2 weeks, and 4 weeks post-treatment. ResultsThe GEE analysis showed that the active stimulation group had significant improvements in depression, anxiety, and motor symptoms at various time points. Specifically, there were significant time-by-group interaction effects in depression immediately after treatment (β, −4.34 [95% CI, −6.90 to −1.74; P = 0.001]), at 2 weeks post-treatment (β, −3.66 [95% CI, −6.43 to −0.90; P = 0.010]), and at 4 weeks post-treatment (β, −4.94 [95% CI, −7.60 to −2.29; P < 0.001]). Similarly, there were significant time-by-group interaction effects in anxiety at 4 weeks post-treatment (β, −2.65 [95% CI, −4.96 to −0.34; P = 0.024]) and in motor symptoms immediately after treatment (β, −5.72 [95% CI, −9.10 to −2.34; P = 0.001] and at 4 weeks post-treatment (β, −5.43 [95% CI, −10.24 to −0.61; P = 0.027]). ConclusionThe study suggested that neuronavigated high-frequency rTMS at left DLPFC is effective for depression, anxiety, and motor symptoms in PD patients.

Hidden Markov model detection of interpersonal interaction dynamics in predicting patient depression improvement in psychotherapy: Proof-of-concept study

BackgroundPrevious human ethology studies have demonstrated that the interpersonal interactions displayed in therapy by both patients and therapists influences a patient's depression improvement. Pairing novel statistical techniques such as the hidden Markov model (HMM), interpersonal interaction dynamics can be uncovered by partitioning time into empirically-derived nonverbal behavioral states. This approach allows for better patient-therapist behavioral dynamics distinctions in predicting depression improvement and, subsequently, for the processes behind depression improvement. MethodsFor the 39 participating patients, the first 15 min of the first or second therapy session was recorded on video to examine the interpersonal interaction behaviors of patients and therapists. The video recordings were encoded for vocalization, looking and leg movement behavior events at a 1 s frequency. A Bayesian multivariate multilevel HMM was fitted on the behavioral event data. ResultsIt is demonstrated that patients that show improvement in the depression score are characterized by interpersonal interaction dynamics of hyperfocus when listening to their therapist in psychotherapy when compared to non-improving patients. The data supports evidence for the emergence of differences in interpersonal interaction dynamics through changed durations of the patient hyper focused listening states, but not through changed state-switching dynamics over time. LimitationsDue to our relatively small sample size we could not fit multilevel HMMs composed of more than three hidden states. ConclusionsWe suggest that applying HMMs will aid human ethological behavior studies in uncovering interpersonal interaction dynamics that occur in therapy and be able to use these dynamics to predict patient depression symptom improvement.

Examining Predictors of Depression and Anxiety Symptom Change in Cognitive Behavioral Immersion: Observational Study

Background Depressive and anxiety disorders are the most common mental disorders, and there is a critical need for effective, affordable, and accessible interventions. Cognitive Behavioral Immersion (CBI) is a novel group-based cognitive behavioral skills training program delivered by lay coaches in the metaverse that can be accessed through various modalities including virtual reality (VR) head-mounted displays or flat-screen devices. Combining its ability to offer empirically supported therapy skills in a digital setting that can still facilitate interpersonal variables (eg, working alliance and sense of social support) with the aid of lay coaches, CBI has the potential to help fill this critical need. Objective This study had 2 primary aims. First, we aimed to examine changes in depression and anxiety symptoms in a sample of individuals who participated in CBI. Second, we aimed to examine 2 interpersonal process variables (working alliance and web-based social support) as predictors of symptom changes. We predicted CBI participants would experience depression and anxiety symptom improvements and that such improvements would be associated with an increase in both interpersonal process variables. Methods The study sample consists of 127 participants who endorsed clinical levels of depression or anxiety symptoms during their first CBI session and attended at least 2 sessions. Participants were asked to complete self-report measures of depression symptoms, anxiety symptoms, alliance, and web-based social support throughout their participation in CBI. Results Repeated measures ANOVAs determined that depression and anxiety symptom scores differed significantly across sessions (Ps&lt;.01). We also found participants’ web-based social support predicted improvement in depression symptoms (P=.01), but neither the alliance nor web-based social support predicted change in anxiety symptoms (Ps&gt;.05). We also observed a significant difference in anxiety symptoms between participants who used a VR head-mounted display to access CBI and those who did not, such that participants who used VR head-mounted displays endorsed lower anxiety symptoms than those who did not at nearly every session (P=.04). Conclusions Participation in CBI is associated with both depression and anxiety symptom improvement. Web-based social support may play an important role in fostering changes in depression symptoms. Future studies are encouraged to continue examining the process of change in CBI with special attention paid to methods that can elucidate causal mechanisms of change.

Moxibustion for medical personnel with negative emotion and insomnia during COVID-19 pandemic: A randomized, controlled trial

BackgroundWe conducted this randomized controlled trial (RCT) to evaluate the effectiveness and safety of moxibustion at Sanyinjiao (SP6) acupoint for treatment of negative mood and sleep quality in healthcare workers during the 2019 coronavirus disease (COVID-19). MethodsA total of 180 participants were divided in a 1:1 ratio into two groups, the treatment group (for moxibustion) and the control group (for no treatment). The treatment group had a 30-minute moxibustion therapy once a day for two weeks, followed by a two-week follow-up. The Hamilton Anxiety Scale (HAMA) was used to assess the degree of the participants' anxiety, and the Patient Health Questionnaire-9 (PHQ-9) was utilized to examine their depressed condition. The Maslach Burnout Inventory-General Survey (MBI-GS) was used to measure the level of burnout among healthcare workers. To determine the severity of insomnia, the Sleep Dysfunction Rating Scale (SDRS) was utilized. At baseline, week 2, and week 4, all scales were evaluated. ResultsCompared to the control group, the treatment group improved more significantly in the HAMA at week 2 (MD = -19.01, 95% CI: -21.89 to -16.14; P<0.001) and at week 4 follow-up visits (MD = -8.96, 95% CI: -11.19 to -6.73; P<0.001). A subgroup study of HAMA scores revealed that position and education had significant impact on treatment effectiveness. During the 2-week intervention period, the treatment group showed more significant improvements in depressive symptoms measured by PHQ-9 (13.00±2.41 vs. 15.60±3.65; P<0.001), work burnout symptoms measured by MBI-GS (MD = -11.88, 95% CI, -15.73 to -8.03; P<0.001), and insomnia symptoms measured by SDRS (MD = -2.45, 95% CI, -4.24 to -0.66; P<0.01). There were no significant adverse effects reported. ConclusionMoxibustion at SP6 may be an effective treatment to improve anxiety, depression, sleep quality, and quality of life for healthcare workers during COVID-19. Trial registrationThis trial was registered at Chinese Clinical Trial Registry (ChiCTR): ChiCTR-2200059327.

Effectiveness of an Integrated Mobile Application for Lifestyle Modifications in Overweight Women with Polycystic Ovarian Syndrome: A Randomized Controlled Trial.

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women, characterized by hormonal imbalances and metabolic disturbances. Lifestyle modifications, including weight loss, are crucial for the management of PCOS symptoms. Mobile applications have emerged as promising tools to support lifestyle modifications. This study aimed to evaluate the effectiveness of a 12-week integrated lifestyle modification program, which used a mobile application, among overweight women with PCOS. A randomized controlled trial was conducted with 28 participants, who were assigned to either treatment group, which received a 12-week lifestyle modification program facilitated by a mobile application, or the control group, who were instructed to maintain their usual lifestyle and received an evidence-based leaflet containing information on PCOS. The primary outcome measure was a change in weight over 12 weeks. Insulin resistance, levels of sex hormones, hirsutism, acne, and depressive symptoms were measured as secondary outcomes. The results showed significant weight loss in the treatment group compared to the control group (3.19 vs. 0.79 kg; p < 0.05). Similarly, significant improvements were observed across time in postprandial insulin levels (22.25 vs. 9.29 μIU/mL), hirsutism (2.98 vs. -0.16 points), and depression (7.73 vs. 1.7 points) (p < 0.05) between the two groups. This study highlights the potential benefits of using a mobile application to support lifestyle modifications, including weight loss and improvement in depressive symptoms, in overweight women with PCOS. Further research is needed to explore the long-term effects and incorporation of advanced technologies to enhance PCOS management outcomes. Mobile applications for lifestyle modifications offer a promising avenue for addressing the unique challenges faced by women with PCOS and provide accessible and personalized support for their health needs.

Implementing an APRN-Led Integrated Behavioral Health Clinic in a Rural Community.

A rural primary care clinic implemented an advance practice providers, including nurse practitioner (APRN)-led integrated behavioral health program to facilitate holistic health care delivery. Implementation was facilitated by Health Resources and Services Administration Grant funding to a state University College of Nursing. The College formed an academic-practice partnership with a Federally Qualified Health Center (FQHC) to implement integrated care in a rural satellite clinic administered by the FQHC. An interdisciplinary team (two family APRNs, a psychiatric APRN, a licensed behavioral health provider, and the Grant Project Director who is a Psychiatric APRN and a licensed Psychologist) provided the integrated care based on the University of Washington's Collaborative Care Model. This brief report describes the implementation of integrated care during the clinic's first year, services provided, lessons learned, community response, and improvement in anxiety and depressive symptoms for patients who were treated for behavioral health problems. An exemplar illustrates how collaborative care addressed one patient's behavioral health and primary care needs. APRN-led collaborative care can expand access to holistic, affordable care in rural areas to improve mental health. Adaptation and flexibility in traditional roles may be necessary and determining post-grant access to funding for services will be necessary for sustainability.

Network effects of Stanford Neuromodulation Therapy (SNT) in treatment-resistant major depressive disorder: a randomized, controlled trial

Here, we investigated the brain functional connectivity (FC) changes following a novel accelerated theta burst stimulation protocol known as Stanford Neuromodulation Therapy (SNT) which demonstrated significant antidepressant efficacy in treatment-resistant depression (TRD). In a sample of 24 patients (12 active and 12 sham), active stimulation was associated with significant pre- and post-treatment modulation of three FC pairs, involving the default mode network (DMN), amygdala, salience network (SN) and striatum. The most robust finding was the SNT effect on amygdala-DMN FC (group*time interaction F(1,22) = 14.89, p < 0.001). This FC change correlated with improvement in depressive symptoms (rho (Spearman) = −0.45, df = 22, p = 0.026). The post-treatment FC pattern showed a change in the direction of the healthy control group and was sustained at the one-month follow-up. These results are consistent with amygdala-DMN connectivity dysfunction as an underlying mechanism of TRD and bring us closer to the goal of developing imaging biomarkers for TMS treatment optimization.Trial registration: ClinicalTrials.gov NCT03068715

The contribution of the cingulate cortex: treating depressive symptoms in first-episode drug naïve schizophrenia.

Our previous study has shown the cingulate cortex abnormalities in first-episode drug naïve (FEDN) schizophrenia patients with comorbid depressive symptoms. However, it remains largely unknown whether antipsychotics may induce morphometric change in cingulate cortex and its relationship with depressive symptoms. The purpose of this study was to further clarify the important role of cingulate cortex in the treatment on depressive symptoms in FEDN schizophrenia patients. In this study, 42 FEDN schizophrenia patients were assigned into depressed patients group (DP, n=24) and non-depressed patients group (NDP, n=18) measured by the 24-item Hamilton Depression Rating Scale (HAMD). Clinical assessments and anatomical images were obtained from all patients before and after 12-week treatment with risperidone. Although risperidone alleviated psychotic symptoms in all patients, depressive symptoms were decreased only in DP. Significant group by time interaction effects were found in the right rostral anterior cingulate cortex (rACC) and other subcortical regions in the left hemisphere. After risperidone treatment, the right rACC were increased in DP. Further, the increasing volume of right rACC was negatively associated with improvement in depressive symptoms. These findings suggested that the abnormality of the rACC is the typical characteristics in schizophrenia with depressive symptoms. It's likely key region contributing to the neural mechanisms underlying the effects of risperidone treatment on depressive symptoms in schizophrenia.

Longitudinal mental health trends in cystic fibrosis

BackgroundMental health screening in accordance with consensus guidelines became routine clinical practice in our cystic fibrosis (CF) Center in 2015. We hypothesized improvement in anxiety and depression symptoms over time and associations between elevated screening scores and disease severity. We aimed to observe the impact of the COVID-19 pandemic and modulator use on mental health symptoms. MethodsRetrospective chart reviews were conducted for people 12 years and older with at least one Generalized Anxiety Disorder-7 (GAD-7) or Patient Health Questionnaire-9 (PHQ-9) screening for six years. Descriptive statistics were used to summarize demographic variables and logistic regression and linear mixed models were used to evaluate the relationship between screening scores and clinical variables. ResultsAnalyses included 150 participants (ages 12–22 years). The percentage of minimal to no symptom scores increased over time for anxiety and depression. Increased mental health visits and CFRD were associated with higher PHQ-9 and GAD-7 scores. Higher FEV1pp was associated with lower GAD-7 and PHQ-9 scores. More effective modulator use was associated with lower PHQ-9 scores. Mean PHQ-9 and GAD-7 scores were not significantly different when comparing pre-pandemic and pandemic scores. ConclusionDisruptions in screening during the pandemic were minimal and symptom scores remained stable. Individuals with higher mental health screening scores were more likely to have CFRD and utilization of mental health services. Consistent mental health monitoring and support is needed so individuals with CF can endure anticipated and unanticipated stressors including changes in physical health, healthcare, and societal stressors such as COVID-19 pandemic.

Open-label study of consecutive ibogaine and 5-MeO-DMT assisted-therapy for trauma-exposed male Special Operations Forces Veterans: prospective data from a clinical program in Mexico

ABSTRACT Background: Research in psychedelic medicine has focused primarily on civilian populations. Further study is needed to understand whether these treatments are effective for Veteran populations. Objectives: Here, we examine the effectiveness of psychedelic-assisted therapy among trauma-exposed Special Operations Forces Veterans (SOFV) seeking treatment for cognitive and mental health problems in Mexico. Methods: Data were collected from an ibogaine and 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) clinical treatment program for SOFV with a history of trauma exposure. This clinical program collects prospective clinical program evaluation data, such as background characteristics, symptom severity, functioning (e.g., satisfaction with life, posttraumatic stress disorder symptoms, depression symptoms, anxiety symptoms, sleep disturbance, psychological flexibility, disability in functioning, cognitive functioning, neurobehavioral symptoms, anger, suicidal ideation), and substance persisting/enduring effects through online surveys at four timepoints (baseline/pre-treatment, one-, three-, and six-months after treatment). Results: The majority of the sample (n = 86; Mean Age = 42.88, SD = 7.88) were Caucasian (87.2%), non-Hispanic (89.5%), and males (100%). There were significant and large improvements in self-reported PTSD symptoms (p < .001, d = .414), depression (p < .001, d = .275), anxiety (p < .001, d = .276), insomnia severity (p < .001, d = .351), and post-concussive symptoms (p < .001, d = .389) as well as self-reported satisfaction with life (p < .001, d = .371), psychological flexibility (p < .001, d = .313) and cognitive functioning (p < .001, d = .265) from baseline to one-month follow-up. Conclusions: Data suggest combined ibogaine and 5-MeO-DMT assisted therapy has potential to provide rapid and robust changes in mental health functioning with a signal of durable therapeutic effects up to 6-months. Future research in controlled settings is warranted.

EFFICACY AND SAFETY OF "SACHI SAHELI" POLYHERBAL FORMULATIONS IN GYNAECOLOGICAL DISORDERS: A PROSPECTIVE, NON-RANDOMISED, OPEN-LABEL STUDY

Background and aim: Symptoms of gynaecological disorders, including dysmenorrhea, leukorrhea, and premenopausal syndrome (PMS), are a common health concern, particularly among women of reproductive age. Due to the adverse effects of conventional treatments, the use of herbal remedies to treat various gynaecological disorders has increased. This study aimed to assess the efficacy and safety of Sachi Saheli formulations in subjects suffering from dysmenorrhea, leucorrhoea, and PMS. Methods: This was a single-arm, open-label, non-randomised prospective study. Female participants were recruited based on the inclusion and exclusion criteria. Study interventions were given to all participants for 90 days. Changes in blood haemoglobin levels were assessed from the baseline to the end of the study. Subjective symptoms and the investigators' severity assessment on 27 questionnaires were evaluated at baseline and the end of the study. Safety was also assessed by measuring liver and kidney function's haematological and biochemical markers. Results: A total of 120 female subjects were enrolled. After treatment with Sachi Saheli syrup and tablets, blood haemoglobin levels increased significantly compared to baseline (p &lt; 0.0001). All subjects showed significant improvement in anxiety, menstrual pain, depression, and vaginal discharge symptoms. A significant improvement in the severity of physical and affective symptoms across 27 parameters was also observed. There were no significant changes observed in laboratory safety parameters. None of the subjects reported any adverse events during the treatment period. Conclusions: Sachi Saheli syrup and tablet may improve the symptoms of dysmenorrhea, leukorrhea and PMS.

Personalized training as a promoter for physical activity in people with depressive disorder-a randomized controlled trial in Germany.

Adopting an active lifestyle is an important goal, but can be difficult to achieve for people with depressive disorders. Current guidelines recommend the integration of physical activity in the multimodal treatment of depressive disorders. However, the possibilities to provide individual support for physical activities are frequently limited. The aim of our study was to examine how physical activity can be increased in a real-world setting by combining physical training and psychological interventions. In this randomized-controlled interventional study, 31 outpatients diagnosed with moderate to severe depression were recruited from the region of Hannover. The intervention group (n = 16) was offered six weekly individual sessions lasting between 60 and 90 min with a sports scientist, including Motivational Interviewing and accompanied exercise activities. The control group (n = 15) received a written booklet with information on steps toward becoming more active. Moderate-to-vigorous physical activity (MVPA) as the primary outcome was analyzed using activity sensors before and after the 6-week intervention, and 3 months subsequently. Secondary outcomes included the Six-Minute Walk Test (6MWT), Sit-to-Stand test (STS), and mental health assessed with self-rating questionnaires. In the intervention group, MVPA increased significantly between baseline and the first follow-up and remained at an increased level at the second follow-up in comparison to decreased levels in the control group (difference of 15.5 min/day between groups over time, SE = 6.2 min/day, 95%-CI[2.7, 28.3], p = 0.020). The increased activity level was associated with markers of increased fitness (6MWT and STS) in the intervention group. Both groups showed comparable improvements in depressive symptoms, while the number of patients receiving antidepressants increased in the control group and decreased in the intervention group. Two patients dropped out of the intervention group during the trial. The intervention proved to be a feasible and effective aid to promote a physically active lifestyle for patients diagnosed with depression. Furthermore, the higher level of physical activity was maintained for the follow-up period. Given the success of the approach evaluated in this project, individual support for physical activity should be investigated in larger sample sizes and potentially be considered in the multimodal treatment of depression. [https://clinicaltrials.gov/], identifier [DRKS00023257].

E-Health intervention for subthreshold depression: Reach and two-year effects of a randomized controlled trial

BackgroundThere is evidence for e-Health interventions for full-blown depression. Little is known regarding commonly untreated subthreshold depression in primary care. This randomized controlled multi-centre trial assessed reach and two-year-effects of a proactive e-Health intervention (ActiLife) for patients with subthreshold depression. MethodsPrimary care and hospital patients were screened for subthreshold depression. Over 6 months, ActiLife participants received three individualized feedback letters and weekly messages promoting self-help strategies against depression, e.g., dealing with unhelpful thoughts or behavioural activation. The primary outcome depressive symptom severity (Patient Health Questionnaire;PHQ-8) and secondary outcomes were assessed 6, 12 and 24 months. ResultsOf those invited, n = 618(49.2 %) agreed to participate. Of them, 456 completed the baseline interview and were randomized to ActiLife (n = 227) or assessment only (n = 226). Generalised estimation equation analyses adjusting for site, setting and baseline depression revealed that depressive symptom severity declined over time, with no significant group differences at 6 (mean difference = 0.47 points; d = 0.12) and 24 months (mean difference = −0.05 points; d = −0.01). Potential adverse effects were observed at 12 months, with higher depressive symptom severity for ActiLife than control participants (mean difference = 1.33 points; d = 0.35). No significant differences in rates of reliable deterioration or reliable improvement of depressive symptoms were observed. ActiLife increased applied self-help strategies at 6 (mean difference = 0.32; d = 0.27) and 24 months (mean difference = 0.22; d = 0.19), but not at 12 months (mean difference = 0.18; d = 0.15). LimitationsSelf-report measures and lack of information on patients' mental health treatment. DiscussionActiLife yielded satisfactory reach and increased the use of self-help strategies. Data were inconclusive in terms of depressive symptom changes.