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The optimal duration for maintaining antidepressant treatment in individuals with obsessive-compulsive disorder (OCD) who achieve symptom stabilization remains unclear.
Methods
This systematic review and pairwise meta-analysis of double-blind randomized placebo-controlled trials (DBRPCTs) compared antidepressant maintenance and antidepressant discontinuation groups in terms of relapse rate at each DBRPCT study endpoint (primary outcome), OCD symptom improvement, all-cause discontinuation, and adverse event-related discontinuation. Furthermore, relapse rates at 4, 8, 12, 16, 20, and 24 weeks were compared between the groups. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated. The absolute risk reduction (ARR) and number needed to treat to benefit (NNTB) for relapse rates were also estimated.
Results
Nine trials (n = 1084; mean age: 32.8 years; proportion of males: 53.3%) were included. The antidepressant maintenance group had lower relapse rates at each DBRPCT study endpoint (RR [95% CI] = 0.53 [0.42–0.68]; ARR = 21.0%; NNTB = 5) and lower all-cause and adverse event-related discontinuation rates than the antidepressant discontinuation group. The maintenance group also exhibited lower relapse rates at 4 weeks (RR [95% CI] = 0.47 [0.31–0.70]; ARR: not significant; NNTB: not significant), 8 weeks (0.42 [0.31–0.57]; 12.0%; 8), 12 weeks (0.43 [0.32–0.56]; 18.0%; 6), 16 weeks (0.41 [0.32–0.52]; 25.0%; 4), 20 weeks (0.43 [0.34–0.53]; 26.0%; 4), and 24 weeks (0.42 [0.33–0.52]; 27.0%; 4) than the discontinuation group. Moreover, the maintenance group outperformed the discontinuation group regarding OCD symptom improvement.
Conclusions
Individuals with OCD may benefit from continued antidepressant treatment, provided that it is well tolerated.
The management of persistent physical symptoms poses a challenge in many healthcare settings, including primary care. Psychological treatments that involve exposure have shown promise for several conditions where patients suffer from persistent physical symptoms and unwanted responses to these. It is unclear, however, to what extent exposure therapy has effects beyond existing routine care interventions and who benefits the most.
Methods
A randomized controlled trial at a primary care center in Stockholm, Sweden compared 10 weeks of internet-delivered exposure therapy (n = 80) to healthy lifestyle promotion (HLP; n = 81) for patients bothered by at least one persistent physical symptom. The primary outcome was the mean reduction in subjective somatic symptom burden (Patient Health Questionnaire 15) as measured week-by-week up to the post-treatment assessment. Secondary outcomes included symptom preoccupation, anxiety, depression symptoms, and functional impairment.
Results
Patients contributed 1544 datapoints during treatment. The primary analysis showed no significant advantage of exposure therapy versus HLP in the reduction of mean somatic symptom burden (d = 0.14; p = 0.220). In secondary analyses, exposure showed superiority in the reduction of symptom preoccupation (d = 0.31; p = 0.033) but not anxiety, depression symptoms, or functional impairment. A higher somatic symptom burden or symptom preoccupation before treatment was predictive of a larger advantage of exposure versus HLP.
Conclusions
Exposure therapy does not appear to show noteworthy average benefit over HLP, with the exception of symptom preoccupation. Substantial benefits are seen in patients with very high symptom burden or symptom preoccupation.
Providing psychotherapy at 50 sessions in a year (starting twice weekly) led to faster and greater improvements in depression and personality functioning compared to 25 sessions, starting weekly for patients with depression and personality disorder (PD). This study reports long-term dosage effects at 18 and 24 months.
Methods
In a pragmatic, double-randomized clinical trial, 246 outpatients with depression and PD were assigned to (1) 25 or 50 sessions and (2) Short-term Psychodynamic Supportive Psychotherapy (SPSP) or Schema Therapy (ST). Depression severity was assessed with the Beck Depression Inventory-II. Secondary outcomes included diagnostic remission of depression (MINI-plus), PD (SCID-II/SCID-5-P), and treatment-specific measures. Intention-to-treat analyses were conducted.
Results
At 18 and 24 months, BDI-II means did not differ between dosage groups (19.0 for 25 sessions versus 19.1 for 50 sessions; d = −0.01; 95% CI = −0.35-0.37, p = 0.96). The lower-dosage group improved during follow-up (−2.6 BDI points, p = 0.031), which may be partly attributed to additional therapy received by a subgroup. Remission rates at 24 months were 66% for depression and 76% for PD, with no differences between conditions.
Conclusions
Higher psychotherapy dosage led to faster initial improvements, but long-term outcomes were not superior to those achieved with a lower dosage. These results should be interpreted with caution, as unregulated treatment during follow-up reduced the power to detect significant dosage effects. Both SPSP and ST provide viable alternatives to treatments focused solely on depression.
Adolescents are at a heightened risk of suicide reattempts following hospital discharge, but few evidence-based interventions exist. This study evaluated the efficacy of the self-awareness of mental health (SAM) program combined with treatment as usual (TAU) versus TAU alone in reducing reattempts among high-risk adolescents.
Methods
A randomized clinical trial was conducted across nine Spanish hospitals (January 2021–March 2024) with 261 adolescents (12–17 years) who had attempted suicide within the last 15 days. Participants were assigned to SAM + TAU (n=128) or TAU (n=133), with 12-month follow-up. The primary outcome was suicide reattempts within 12 months; secondary analyses examined time to reattempt and associated risk factors.
Results
After 12-months, no significant differences were found in reattempt rates [22.6% (SAM) versus 27.8% (TAU); OR=0.610, 95%CI (0.321–1.151), p=0.127] or time to reattempt [HR=0.606, 95%CI (0.390–1.021), p=0.060]. In SAM, attentional impulsivity emerged as a significant risk factor [HR=1.126, 95% CI (1.004–1.263), p=0.043], while nonplanning impulsivity was protective [HR=0.878, 95%CI (0.814–0.948), p<0.001]. In TAU, increased suicide risk was linked to suicidal intentionality [HR=1.341, 95%CI (1.009–1.782), p=0.044] and more prior attempts [HR=1.230, 95%CI (1.039–1.457), p=0.016]. Conversely, fewer psychiatric diagnoses emerged as a protective factor [HR=0.821, 95%CI (0.677–0.996), p=0.045].
Conclusions
While no significant differences were found between groups, SAM identified important psychological factors influencing suicide risk. These findings provide a foundation for targeted interventions to prevent reattempts in adolescents.
The analysis of data from experiments in economics routinely involves testing multiple null hypotheses simultaneously. These different null hypotheses arise naturally in this setting for at least three different reasons: when there are multiple outcomes of interest and it is desired to determine on which of these outcomes a treatment has an effect; when the effect of a treatment may be heterogeneous in that it varies across subgroups defined by observed characteristics and it is desired to determine for which of these subgroups a treatment has an effect; and finally when there are multiple treatments of interest and it is desired to determine which treatments have an effect relative to either the control or relative to each of the other treatments. In this paper, we provide a bootstrap-based procedure for testing these null hypotheses simultaneously using experimental data in which simple random sampling is used to assign treatment status to units. Using the general results in Romano and Wolf (Ann Stat 38:598–633, 2010), we show under weak assumptions that our procedure (1) asymptotically controls the familywise error rate—the probability of one or more false rejections—and (2) is asymptotically balanced in that the marginal probability of rejecting any true null hypothesis is approximately equal in large samples. Importantly, by incorporating information about dependence ignored in classical multiple testing procedures, such as the Bonferroni and Holm corrections, our procedure has much greater ability to detect truly false null hypotheses. In the presence of multiple treatments, we additionally show how to exploit logical restrictions across null hypotheses to further improve power. We illustrate our methodology by revisiting the study by Karlan and List (Am Econ Rev 97(5):1774–1793, 2007) of why people give to charitable causes.
Neurocysticercosis (NCC) is a neglected parasitic disease that causes neurological symptoms. However, little is known about the long-term impact of this infection on health. We contacted participants from a randomized controlled trial on albendazole treatment for NCC in Ecuador 12 years after trial completion (14–16 years after NCC diagnosis) about their long-term health. We described the symptoms experienced post-trial and investigated if albendazole treatment, the presence of calcified NC cysts, and cysts in extraparenchymal locations at last imaging predicted symptoms. All analyses were standardized by adjusting for participant age and sex. In the 12 years post-trial, 52.1% reported some health problem, with 48.9% reporting neurological symptoms such as seizures (16.6% of participants) and headaches (26.6% of participants). At the end of the trial, 11 participants had complete NCC cyst resolution, of whom 3 (27.3%) reported seizures and 1 (9.1%) reported headaches post-trial. Twenty-four participants had only calcified cysts (residual calcification sometimes left after the parasite dies) by trial end, of whom 8 (33.3%) reported seizures and 9 (37.5%) headaches post-trial. None of the predictors examined were significantly associated with long-term symptoms. A high proportion of people diagnosed with NCC continue experiencing symptoms years after treatment, and while slightly fewer people experienced continued symptoms in the albendazole group, the difference was not statistically significant. Eleven participants with no live parasites at last imaging (8 with residual calcifications) had seizures post-trial, which may be unprovoked and an indication of epilepsy risk. Research is urgently needed to improve NCC treatment to mitigate long-term outcomes.
Migraine is a prevalent and debilitating neurological disorder that significantly affects quality of life. While pharmacological treatments exist, they can have limitations such as side effects, contraindications, and incomplete relief, prompting interest in non-pharmacological approaches for better symptom management.
Objective
This study aimed to assess the effectiveness of alternate nostril breathing (ANB) as a non-pharmacological intervention to reduce the frequency and severity of migraine attacks and associated disability in adult patients.
Methods
A single-center, open-label, two-arm, parallel-group randomized controlled trial was conducted at six Family Health Centers (FHCs) of Dokuz Eylul University, Izmir, Turkey. A total of 86 migraine patients aged 18–50 years, diagnosed with migraine based on ICD-10 criteria, were randomized into control (n = 43) and intervention (n = 43) groups. The intervention group practiced ANB three times daily for three months, while the control group continued their usual care. The primary outcomes were changes in migraine frequency and severity. Secondary outcomes included changes in migraine-related disability, both outcomes measured using the Migraine Disability Assessment Scale (MIDAS).
Results
The intervention group showed a significant reduction in migraine attack frequency (P = 0.002) and MIDAS scores (P = 0.003) compared to the control group. Both groups experienced a reduction in attack severity (P = 0.001), though no significant difference was observed between the groups (P = 0.074). Within-group comparisons showed significant improvements in attack frequency, severity, and MIDAS scores in the intervention group (P = 0.001 for all).
Conclusion
ANB significantly reduced migraine frequency and disability, making it a promising non-invasive and accessible treatment option for migraine management. Further research with longer follow-up periods is needed to explore its long-term effects and broader applicability.
Evidence suggests that death anxiety is a transdiagnostic construct underlying numerous anxiety-related conditions. A previous phase I trial of Overcome Death Anxiety (ODA), a novel online stand-alone psychological intervention to reduce death anxiety, demonstrated preliminary evidence of efficacy and acceptability in a clinical population. However, this trial was limited by a small sample size (n=20).
Aims:
To further evaluate the efficacy of this intervention in reducing death anxiety in a clinical population, compared with a waitlist control.
Method:
This paper describes the protocol of a phase II randomized controlled, unblinded trial of ODA. A total sample of 256 adults living in Australia, diagnosed with an anxiety-related condition, will be recruited. These participants will be randomised to ODA or a waitlist control. Primary outcomes will be measured as changes in scores on death anxiety questionnaires, reflecting treatment efficacy. The secondary outcomes to be measured are depression, anxiety, stress, suicidality, insomnia, and meaning of life, as well as feedback about treatment program acceptability. This trial will assess the efficacy of ODA for reducing death anxiety in a population diagnosed with various anxiety-related conditions, as well as the overall acceptability and tolerability of the intervention.
Conclusions:
This study will provide evidence to evaluate the efficacy of ODA in people diagnosed with an anxiety-related condition.
Stigma of mental health conditions hinders recovery and well-being. The Honest, Open, Proud (HOP) program shows promise in reducing stigma but there is uncertainty about the feasibility of a randomized trial to evaluate a peer-delivered, individual adaptation of HOP for psychosis (Let's Talk).
Methods
A multi-site, Prospective Randomized Open Blinded Evaluation (PROBE) design, feasibility randomised controlled trial (RCT) comparing the peer-delivered intervention (Let's Talk) to treatment as usual (TAU). Follow-up was 2.5 and 6 months. Randomization was via a web-based system, with permuted blocks of random size. Up to 10 sessions of the intervention over 10 weeks were offered. The primary outcome was feasibility data (recruitment, retention, intervention attendance). Primary outcomes were analyzed by intention to treat. Safety outcomes were reported by as treated status. The study was prospectively registered: https://doi.org/10.1186/ISRCTN17197043.
Results
149 patients were referred to the study and 70 were recruited. 35 were randomly assigned to intervention + TAU and 35 to TAU. Recruitment was 93% of the target sample size. Retention rate was high (81% at 2.5 months primary endpoint), and intervention attendance rate was high (83%). 21% of 33 patients in Let's talk + TAU had an adverse event and 16% of 37 patients in TAU. One serious adverse event (pre-randomization) was partially related and expected.
Conclusions
This is the first trial to show that it is feasible and safe to conduct a RCT of HOP adapted for people with psychosis and individual delivery. An adequately powered trial is required to provide robust evidence.
Schools are central places for adolescent social lives, which is a major factor greatly affecting adolescent mental health; school climate (i.e. quality of the school social environments) can be a proximal social determinant for adolescent mental health. Supportive school environments may serve as a protective factor during crises like COVID-19, which disrupt social lives and worsen adolescent mental health. This is the first study examining whether the pandemic effects differed based on the levels of school climate on depressive symptoms (DS) and psychotic experiences (PEs) among adolescents.
Methods
School climate (score range: 0–28), DS (0–26), and PEs (0–5) were self-reported in a population-based cohort (Tokyo Teen Cohort; N = 3171) at four timepoints (10y, 12y, 14y, and 16y) before and during COVID-19. COVID-19 occurred midway through the 16y survey, allowing us to examine its impact and interaction effect with school climate while accounting for within-person changes over time using mixed-effects models.
Results
Significant interaction effects were found on DS (unstandardized coefficient [B] = −0.166, 95% confidence interval [CI] −0.225 to −0.107) and PEs (B = −0.020, 95% CI −0.028 to −0.012). The pandemic effects were not significant for adolescents with high school climate scores (around the 80th percentile or higher), although the pandemic significantly worsened these outcomes among the overall sample.
Conclusions
The negative mental health effects of the pandemic were significantly mitigated among adolescents experiencing a supportive school climate. A positive school climate can protect adolescent mental health during challenging social conditions, such as pandemics.
Breast cancer patients and survivors deal with physical and psychological challenges due to oncological treatments. The existing literature highlights the importance of compassion in reducing the main cancer-related effects in terms of emotions, quality of life, and dysfunctional coping skills. Over the past few years, compassion-based interventions (CBIs) have been considered an interesting approach to reduce anxiety and depression symptoms and improve quality of life and well-being. However, there have not been many studies that show the benefits of these interventions in breast cancer patients and survivors. The primary objective of this systematic review is to provide evidence of the impact of CBIs on specific variables identified in the literature as affected by this pathology. The variables that will be studied are (a) emotional issues (e.g., anxiety, stress, and depression symptoms); (b) quality of life; and (c) positive coping skills. A systematic search during the previous 10 years up to November 2023 was conducted following the PRISMA guidelines across multiple databases, such as PubMed, Web of Science, PsycINFO, and Scopus. Nine eligible randomized controlled trials were included in this article, with a total of 813 breast cancer patients and survivors. Findings show that CBIs increased compassion, mindful observation, and acting with awareness skills, leading to a significant reduction of anxiety and stress levels, depression, and negative affect. Additionally, less body image distress and greater body appreciation were reported as a consequence of the interventions. This review shows the CBI’s efficacy on emotions, positive coping skills, and quality of life in breast cancer patients and survivors. Guidelines for future studies are listed to promote CBIs as a clinically useful intervention for breast cancer patients and survivors.
Psychodrama (PD), supported by extensive global research, is increasingly becoming a vital method for alleviating psychological symptoms and promoting mental well-being in diverse populations across China. However, comprehensive evidence based on rigorous interventions is currently lacking.
Methods
This article systematically reviews the literature on randomized controlled experimental intervention studies of PD in the Chinese Mainland from 1982 to 2023.
Findings
Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework, this article included seven studies (N = 332, 25 effect sizes). The results demonstrate that PD interventions have a promotional effect (standardized mean difference SMD = 0.768, 95% CI [0.591, 0.946]) across different age groups and settings in randomized controlled trial interventions. In accordance with previous literature, we categorized the effect sizes into two major groups: illness reduction (IR) and health promotion (HP). Subgroup analysis based on these two categories revealed consistent findings. In the IR category, the overall effect size was notably significant (SMD = −0.711, 95% CI [−0.976, −0.446]), and in the HP category, the overall effect was also highly significant (SMD = 0.889, 95% CI [0.705, 1.074]). This finding aligns with previous research in other nations, supporting the significant effectiveness of PD as a counseling method in alleviating psychological illnesses and promoting mental health within the Chinese context.
Conclusion
PD serves not only as a therapeutic tool but also as a preventive and developmental intervention. Moving forward, there is a call for increased emphasis on standardized and randomized controlled experimental studies to further the advancement of PD within China.
Childhood bullying is a public health priority. We evaluated the effectiveness and costs of KiVa, a whole-school anti-bullying program that targets the peer context.
Methods
A two-arm pragmatic multicenter cluster randomized controlled trial with embedded economic evaluation. Schools were randomized to KiVa-intervention or usual practice (UP), stratified on school size and Free School Meals eligibility. KiVa was delivered by trained teachers across one school year. Follow-up was at 12 months post randomization. Primary outcome: student-reported bullying-victimization; secondary outcomes: self-reported bullying-perpetration, participant roles in bullying, empathy and teacher-reported Strengths and Difficulties Questionnaire. Outcomes were analyzed using multilevel linear and logistic regression models.
Findings
Between 8/11/2019–12/02/2021, 118 primary schools were recruited in four trial sites, 11 111 students in primary analysis (KiVa-intervention: n = 5944; 49.6% female; UP: n = 5167, 49.0% female). At baseline, 21.6% of students reported being bullied in the UP group and 20.3% in the KiVa-intervention group, reducing to 20.7% in the UP group and 17.7% in the KiVa-intervention group at follow-up (odds ratio 0.87; 95% confidence interval 0.78 to 0.97, p value = 0.009). Students in the KiVa group had significantly higher empathy and reduced peer problems. We found no differences in bullying perpetration, school wellbeing, emotional or behavioral problems. A priori subgroup analyses revealed no differences in effectiveness by socioeconomic gradient, or by gender. KiVa costs £20.78 more per pupil than usual practice in the first year, and £1.65 more per pupil in subsequent years.
Interpretation
The KiVa anti-bullying program is effective at reducing bullying victimization with small-moderate effects of public health importance.
Funding
The study was funded by the UK National Institute for Health and Care Research (NIHR) Public Health Research program (17-92-11). Intervention costs were funded by the Rayne Foundation, GwE North Wales Regional School Improvement Service, Children's Services, Devon County Council and HSBC Global Services (UK) Ltd.
Since its inception, Health Technology Assessment (HTA) has typically determined the value of a technology by collecting information derived from randomized clinical trials (RCTs), in line with the principles of evidence-based medicine (EBM). However, data from RCTs did not constitute the sole source of information, as other types of evidence (such as primary qualitative research) have often been utilized. Recent advances in both generating and collecting other types of evidence are broadening the landscape of evidence, adding complexity to the discussion of “robustness of evidence.” What are the consequences of these recent developments for the methodology and conduct of HTA, the HTA community, and its ethical commitments? The aim of this article is to explore some ethical challenges that are emerging in the current evolving evidence landscape, particularly changes in evidence generation and collection (e.g., diversification of data sources), and shifting standards of evidence in the field of HTA (e.g., increasing acceptability of evidence that is thought of as lower quality). Our conclusion is that deciding how to best maintain trustworthiness is common to all these issues.
Self-guided Internet-based cognitive behavior therapy (iCBT) for migraine interventions could improve access to care, but there is poor evidence of their efficacy.
Methods:
A three-arm randomized controlled trial compared: iCBT focused on psychoeducation, self-monitoring and skills training (SPHERE), iCBT focused on identifying and managing personal headache triggers (PRISM) and a waitlist control. The primary treatment outcome was a ≥ 50% reduction in monthly headache days at 4 months post-randomization.
Results:
428 participants were randomized (mean age = 30.1). 240 participants (56.2%) provided outcome data at 4 months. Intention-to-treat (ITT) analysis with missing data imputed demonstrated that the proportion of responders with a ≥ 50% reduction was similar between combined iCBTs and waitlist (48.5/285, 17% vs. 16.6/143, 11.6%, p = 0.20), but analysis of completers showed both iCBT programs to be superior to the waitlist (24/108, 22.2% vs. 13/113, 11.5%, p = 0.047). ITT analysis with missing data imputed showed no difference between the two iCBTs (SPHERE: 24.8/143, 17.3% vs. PRISM: 23.7/142, 16.7%, p = 0.99). Uptake rates of the iCBTs were high (76.9% and 81.69% logged in at least once into SPHERE and PRISM, respectively), but adherence was low (out of those who logged in at least once, 19.01% [21/110] completed at least 50% modules in SPHERE and 7.76% [9/116] set a goal for trying out a given trigger-specific recommendation in PRISM). Acceptability ratings were intermediate.
Conclusions:
Self-guided iCBTs were not found to be superior in our primary ITT analysis. Low adherence could explain the lack of effects as completer analysis showed effects for both interventions. Enhancement of adherence should be a focus of future research.
In VIVRE (NCT04448431), vortioxetine was associated with significantly higher rates of symptomatic and functional remission, better daily and social functioning, and greater treatment satisfaction than desvenlafaxine in patients with major depressive disorder (MDD) and partial response to selective serotonin reuptake inhibitor (SSRI) therapy. This analysis further explored the relative improvement in patient functioning with vortioxetine versus desvenlafaxine.
Methods
VIVRE was a randomized, double-blind study of vortioxetine (10 or 20 mg/day) versus desvenlafaxine (50 mg/day) in adults with MDD and partial response to initial SSRI monotherapy. Mean percentage changes from baseline to week 8 in Functioning Assessment Short Test (FAST) total and domain scores were analyzed by treatment group in the overall population and in working patients.
Results
In the overall population, the mean reduction in FAST total score from baseline after 8 weeks of treatment was 37.2% in vortioxetine-treated patients versus 31.8% in desvenlafaxine-treated patients (P = 0.04). Significantly greater improvements versus desvenlafaxine were seen in vortioxetine-treated patients for FAST autonomy, cognitive functioning, and interpersonal-relationships scores (all P < 0.05). In working patients, the mean reduction in FAST total score from baseline at week 8 was 38.7% versus 32.1% in the vortioxetine and desvenlafaxine groups, respectively (P = 0.04). Significant correlations were seen between absolute changes in patient functioning, and those in depression severity and health-related quality of life.
Conclusion
Vortioxetine was significantly better than desvenlafaxine in improving overall functioning as well as daily, social, and cognitive functioning in patients with MDD with inadequate response to prior SSRI therapy.
The eastern Democratic Republic of Congo (DRC) has faced dual burdens of poor mental health and heightened levels of violence against women and children within the home. Interventions addressing family violence prevention may offer a path to mitigate mental distress within the eastern DRC. This exploratory analysis uses data from a pilot cluster randomized controlled trial conducted in North Kivu, DRC, assessing the impact of Safe at Home, a violence prevention intervention. Mental health was assessed at endline using the Patient Health Questionnaire-4. Statistical analyses employed multilevel linear regression.
Assuming successful randomization, impact of the Safe at Home intervention on mental health differed by participant gender. Women enrolled in the Safe at Home intervention reported statistically significant decreases in mental distress symptoms [β (95%CI) = −1.01 (−1.85, −0.17)], whereas men enrolled in Safe at Home had similar scores in mental distress to the control group [β (95%CI) = −0.12 (−1.32, 1.06)].
Ultimately, this exploratory analysis provides evidence of the potential for a family violence prevention model to improve women’s mental health in a low-resource, conflict-affected setting, although further research is needed to understand the impact on men’s mental health.
Theory and research indicated that executive functioning (EF) correlated with, preceded, and stemmed from worry in generalized anxiety disorder (GAD). The present secondary analysis (Zainal & Newman, 2023b) thus determined whether EF domains mediated the effect of a 14-day (5 prompts/day) mindfulness ecological momentary intervention (MEMI) against a self-monitoring control (SM) for GAD.
Method
Participants (N = 110) diagnosed with GAD completed self-reported (Attentional Control Scale, GAD Questionnaire, Perseverative Cognitions Questionnaire) and performance-based tests (Letter-Number Sequencing, Stroop, Trail Making Test-B, Verbal Fluency) at baseline, post-treatment, and one-month follow-up (1MFU). Causal mediation analyses determined if pre-post changes in EF domains preceded and mediated the effect of MEMI against SM on pre-1MFU changes in GAD severity and trait repetitive negative thinking (RNT).
Results
MEMI was more efficacious than SM in improving pre–post inhibition (β = −2.075, 95% [−3.388, −0.762], p = .002), working memory (β = 0.512, 95% [0.012, 1.011], p = .045), and set-shifting (β = −2.916, 95% [−5.142, −0.691], p = .010) but not verbal fluency and attentional control. Within groups, MEMI but not SM produced improvements in all examined pre–post EF outcomes except attentional control. Only pre–post improvements in inhibition mediated the effect of MEMI against SM on pre-1MFU reductions in GAD severity (β = −0.605, 95% [−1.357, −0.044], p = .030; proportion mediated = 7.1%) and trait RNT (β = −0.024, 95% [−0.054, −0.001], p = .040; proportion mediated = 7.4%). These patterns remained after conducting sensitivity analyses with non-linear mediator-outcome relations.
Conclusions
Optimizing MEMI for GAD might entail specifically boosting inhibition plausibly by augmenting it with dialectical behavioral therapy, encouraging high-intensity physical exercises, and targeting negative emotional contrast avoidance.
Approximately five million individuals have traumatic injuries annually. Implementing prehospital blood-component transfusion (PHBT), encompassing packed red blood cells (p-RBCs), plasma, or platelets, facilitates early hemostatic volume replacement following trauma. The lack of uniform PHBT guidelines persists, relying on diverse parameters and physician experience.
Aim:
This study aims to evaluate the efficacy of various components of PHBT, including p-RBCs and plasma, on mortality and hematologic-related outcomes in traumatic patients.
Methods:
A comprehensive search strategy was executed to identify pertinent literature comparing the transfusion of p-RBCs, plasma, or a combination of both with standard resuscitation care in traumatized patients. Eligible studies underwent independent screening, and pertinent data were systematically extracted. The analysis employed pooled risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous variables, each accompanied by their respective 95% confidence intervals (CI).
Results:
Forty studies were included in the qualitative analysis, while 26 of them were included in the quantitative analysis. Solely P-RBCs alone or combined with plasma showed no substantial effect on 24-hour or long-term mortality (RR = 1.13; 95% CI, 0.68 - 1.88; P = .63). Conversely, plasma transfusion alone exhibited a 28% reduction in 24-hour mortality with a RR of 0.72 (95% CI, 0.53 - 0.99; P = .04). In-hospital mortality and length of hospital stay were mostly unaffected by p-RBCs or p-RBCs plus plasma, except for a notable three-day reduction in length of hospital stay with p-RBCs alone (MD = -3.00; 95% CI, -5.01 to -0.99; P = .003). Hematological parameter analysis revealed nuanced effects, including a four-unit increase in RBC requirements with p-RBCs (MD = 3.95; 95% CI, 0.69 - 7.21; P = .02) and a substantial reduction in plasma requirements with plasma transfusion (MD = -0.73; 95% CI, -1.28 to -0.17; P = .01).
Conclusion:
This study revealed that plasma transfusion alone was associated with a substantial decrease in 24-hour mortality. Meanwhile, p-RBCs alone or combined with plasma did not significantly impact 24-hour or long-term mortality. In-hospital mortality and length of hospital stay were generally unaffected by p-RBCs or p-RBCs plus plasma, except for a substantial reduction in length of hospital stay with p-RBCs alone.
Despite high levels of psychological distress, mental health service use among Syrian refugees in urban settings is low. To address the mental healthcare gap, the World Health Organization developed group problem management plus (gPM+), a scalable psychological intervention delivered by non-specialist peer facilitators. The study aimed to evaluate the effectiveness of gPM+ in reducing symptoms of depression and anxiety among Syrian refugees in Istanbul, Türkiye.
Methods
A randomized controlled trial was conducted among 368 distressed (Kessler Psychological Distress Scale, K10 > 15) adult Syrian refugees with impaired functioning (World Health Organization Disability Assessment Schedule, WHODAS 2.0 > 16). Participants were recruited between August 2019 and September 2020 through a non-governmental organization providing services to refugees. Participants were randomly allocated to gPM+ and enhanced care as usual (gPM+/E-CAU) (184 participants) or E-CAU only (184 participants). Primary outcomes were symptoms of depression and anxiety (Hopkins Symptom Checklist (HSCL-25)) at 3-month follow-up. Secondary outcomes were post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5; PCL-5), functional impairment (WHODAS 2.0), and self-identified problems (psychological outcome profiles).
Results
Intent-to-treat analyses showed no significant effect of gPM+ on symptoms of anxiety, depression, PTSD and self-identified problems. Yet, there was a significant reduction in functional impairment in gPM+/E-CAU compared to E-CAU at 3-month follow-up (adjusted mean difference 1.66, 95 % CI 0.04, 3.27, p = 0.045, d = 0.19). Post-hoc subgroup analyses among participants with probable baseline depression or anxiety showed that there was a small but significant reduction in depression (adjusted mean difference −0.17, 95 % CI −0.32, −0.02, p = 0.028, d = 0.27) and anxiety (adjusted mean difference −0.21, 95 % CI −0.37, −0.05, p = 0.009, d = 0.30) symptoms comparing gPM+/E-CAU to E-CAU only at 1-week post assessment, but not at 3-month follow-up. There was a significant difference between conditions on functional impairment at 3-month follow-up, favouring gPM+/E-CAU condition (adjusted mean difference −1.98, 95 % CI −3.93, −0.02, p = 0.048, d = 0.26).
Conclusion
In this study in an urban setting in Türkiye, gPM+ did not alleviate symptoms of depression and anxiety among Syrian refugees experiencing psychological distress and daily living difficulties. However, participants with higher distress at baseline seemed to benefit from gPM+, but treatment gains disappeared in the long term. Current findings highlight the potential benefit of tailored psychosocial interventions for highly distressed refugees in volatile low-resource settings.