Controlled Intervention Trial Research Articles

A pilot randomized controlled trial of a virtual peer-support exercise intervention for female older adults with cancer

BackgroundRegular exercise can mitigate side effects of cancer treatment. However, only a small proportion of adults with cancer meet exercise guidelines, and older adults (> 65 years) are underrepresented in cancer rehabilitation research. Peer support facilitates health-promoting behaviours in general populations, but interventions merging exercise and peer support for older adults with cancer are not examined. The purpose of this study was to determine the feasibility and preliminary effectiveness of a virtual partner-based peer support exercise intervention for older adult female cancer survivors.MethodsOlder adult female cancer survivors with internet access and currently participating in < 150 min of moderate-vigorous physical activity per week were included in this study. Participants were matched with a partner and given a peer support guide, exercise guidelines, and a Fitbit Inspire©. In addition, intervention group dyads (AgeMatchPLUS) had weekly 1-h virtual sessions with a qualified exercise professional for 10 weeks. Dyads randomized to the control group (AgeMatch) independently supported their partner around exercise for 10 weeks. The primary outcome was feasibility, measured using retention and adherence rates. Secondary outcomes included exercise volume, social support, quality of life, physical function, and physical activity enjoyment. Descriptive statistics were used to report feasibility and an ANCOVA was used to explore between group differences on secondary outcomes at post-intervention (10 weeks post baseline) and post-tapering timepoints (14 weeks post baseline).ResultsEighteen participants (9 dyads; mean age 72 years (SD: 5.7 years)) were included in the pilot trial. Retention and adherence rates to the AgeMatchPLUS intervention were 100% and 95% respectively. All but one participant was satisfied with the quality of their peer match. Preliminary effects were seen between group, favouring AgeMatchPLUS for exercise-related social support post-intervention (effect size (d) = 0.27, 95% CI = 0,0.54) and physical activity enjoyment at post-tapering (d = 0.25, 95% CI = 0,0.52) and favouring the AgeMatch group for 30 s sit-to-stand repetitions at post-tapering (d = 0.31, 95% CI = 0.004, 0.57). No other effects were found.ConclusionsA virtual partner-based exercise intervention for older adults with cancer is feasible and shows preliminary effect benefits. Findings inform future trials aimed at increasing exercise in older adults with cancer.Trial registrationClinicaltrials.gov (ID: NCT05549479, date: 22/09/22).

How is the quality of randomized controlled trials (RCTs) for acupuncture treatment of post-stroke aphasia? A report quality assessment.

This study aimed to assess the quality of randomized controlled trials (RCTs) that have reported the use of acupuncture for the treatment of post-stroke aphasia (PSA). We systematically searched PubMed, Embase, Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Wanfang data Information Site, and China Science and Technology Journal Database from January 2013 to June 2023. RCTs utilizing acupuncture as an intervention for the treatment of post-stroke aphasia were included in this study. The overall quality score (OQS) of RCTs was independently evaluated by two researchers using the Consolidated Standards for Reporting Trials (CONSORT) and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines, with the agreement between researchers calculated using Cohen's kappa statistics. In conclusion, we included 38 RCTs in this study. The median OQS of the 38 RCTs was 13 (minimum 8, maximum 20) based on the CONSORT statement. Out of all CONSORT items, 10 (27%) had a positive rate of greater than 80%, while 17 (46%) had a positive rate of less than 10%. The median OQS of the 38 RCTs was 12 (minimum 6, maximum 14) based on the STRICTA guideline. Within the STRICTA guideline, 6 items (35%) had a positive rate of greater than 80%, and 3 items (18%) had a positive rate of less than 10%. Most items based on the CONSORT and STRICTA guidelines were observed to have a perfect or good degree of agreement. The overall reporting quality of RCTs for acupuncture treatment of PSA was found to be suboptimal. Notably, the reporting quality of the STRICTA guideline is higher compared to the CONSORT statement. Therefore, strict adherence to both the CONSORT and STRICTA statements is recommended to enhance the quality of RCT reports on acupuncture treatment for post-stroke aphasia.

Safety behavior reduction for appearance concerns: A randomized controlled trial of a smartphone-based intervention.

Appearance concerns are a core feature of multiple psychiatric disorders (i.e., body dysmorphic disorder, eating disorders, and social anxiety disorders). Individuals with these concerns commonly engage in appearance-related safety behaviors (ARSB), behaviors intended to avoid, prevent, or manage the negative evaluation of one's physical appearance. The present study evaluated a brief ARSB reduction intervention for appearance concerns. Women with elevated appearance concerns (N = 203) were recruited from across the United States and randomized to receive one of two 1-month smartphone-based interventions targeting ARSBs or unhealthy behaviors (UHBs). Both consisted of daily text messages with links to behavior checklists and reminders to avoid the respective behaviors. Participants in both treatments saw substantial reductions in symptoms. Though the UHB fading condition showed significantly better treatment adherence than ARSB fading, ARSB fading led to significantly lower appearance concerns (sr² = .028, p = .014) and eating disorder symptoms (sr² = .024, p = .020) at posttreatment, and lower appearance concerns (sr² = .041, p = .004), eating disorder symptoms (sr² = .029, p = .006), social anxiety (sr² = .048, p = .005), and appearance importance at 1-month follow-up (sr² = .042, p = .011), relative to UHB fading. Changes in ARSBs were found to partially mediate the effect of treatment on appearance concerns. These preliminary findings provide novel evidence for the efficacy of targeting ARSBs and suggest that this text-based intervention may be an efficacious and accessible intervention for women with elevated appearance concerns. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

62 Outcomes from a randomized controlled trial of a brief virtual group intervention for adolescents with mild to moderate suicidal ideation and their caregivers: The BRAVA study

Abstract Background Building Resilience and Attachment in Vulnerable Adolescents (BRAVA) is a brief virtual group intervention designed for adolescents with mild to moderate suicidal ideation (SI) and their caregivers. The goal of BRAVA is to reduce SI in adolescents and increase family connection. The intervention consists of six independent, 90 minute modules that are delivered in a group setting on a weekly basis. Independent modules allow for rolling admission thereby reducing wait time to start the intervention. The modules include components of Dialectical Behaviour Therapy. Attachment Based Family Therapy, Cognitive Behavioral Therapy, Collaborative Problem Solving and psychoeducation. Adolescents and their parents attend separate groups. Adolescents focus on emotional regulation, coping skills, managing crisis situations and caregivers focus on connecting with their teen, validation and crisis management Objectives This randomized controlled trial (RCT) assessed the efficacy of BRAVA in reducing symptoms of SI, depression and anxiety in adolescents, and improving life stress and competency in caregivers. Design/Methods Ninety-nine eligible youth (13-17.5 years) presenting with mild to moderate SI (rated 1 on the suicide item of HEADS-ED MH screening tool) and their caregivers were recruited from hospital and community services. Families were randomized to BRAVA (n=50) or the control group (n=49). The control group intervention consisted of weekly text messages and the opportunity to join the BRAVA group post-exit assessment). Outcome measures were administered at intake and exit for adolescents (Suicidal Ideation Questionnaire-Junior, SIQ-JR; Revised Children’s Anxiety and Depression Scale, RCADS) and caregivers (Perceived Stress Scale, PSS; Parent Sense of Competency Scale, PSOC). Outcomes were analyzed using repeated measures of multivariable analysis of variance (MANOVA). Results Preliminary analyses showed no significant differences between groups at intake for any demographic or clinical variables. Most adolescents and caregivers completed their exit assessment (nBRAVA=37; nControl=39). Adolescents and caregivers attended a median of six and five groups, respectively. Comparing to the control group, BRAVA was superior in reducing SI (p = 0.05) and depression (p = 0.005) in adolescents and caregiver life stress (p = 0.026). Preliminary MANOVA of adolescent outcomes were significant for time [p &amp;lt;0.01, Effect size (ES) = 0.98] and between groups (p = 0.03, ES = 0.11). Caregiver outcomes were significant for time (p=0.051, ES=0.70). Conclusion This study demonstrates that a brief virtual group intervention can have a significant impact on adolescent SI and depression compared to an enhanced treatment as usual control group. In addition, BRAVA can reduce caregiver perceived stress, helping them view their lives as less unpredictable, uncontrollable and overloaded.

Quality-of-life measurement in randomised controlled trials of mental health interventions for autistic adults: A systematic review.

Autistic people are more likely to have health problems than the general population. They, and people who care about them, have said mental health research is very important, and some autistic adults have said quality of life is the most helpful area to research when focusing on mental health. Autistic people should also be more deeply involved in making decisions in research. Our review aimed to find out if and how quality of life is being measured when mental health treatments are being tested, and how autistic people and the wider autism community are involved in these studies. We searched four databases and other sources and found over 10,000 records. But just 19 research studies were testing mental health treatments for autistic adults, and only five of those measured quality of life. When they did measure quality of life, it was measured in different ways and there was not much information given on how communities were involved. We suggest mental health research should measure quality of life more often and in ways that are more helpful for autistic people. Our analysis found that mental health research needs to include a wider variety of autistic people, and autistic people should be more involved in the various parts of research.

Occupational future time perspective and mental health problems across adolescence: Random-intercept cross-lagged panel analysis and alternative variations.

Adolescence is a crucial developmental stage characterized by escalating mental health issues as well as an increasing awareness of future career possibilities. Occupational future time perspective has been shown to be a promotive factor for social functioning and mental health, and a component in evidence-based clinical practices and randomized controlled trial intervention studies. However, it requires more rigorous and ecological corroboration from longitudinal analysis at the within-person level. Random intercept cross-lagged panel models with several adjustments and sensitivity analyses were applied to the longitudinal data from the Zurich Project on the Social Development from Childhood to Adulthood (Zurich, Switzerland), to analyze how occupational future time perspective and psychological/neurodevelopmental outcomes (attention deficit hyperactivity disorder symptoms/externalizing/internalizing problems) covaried across ages 13 (N = 1365), 15 (N = 1446), and 17 (N = 1305) in the years 2016, 2018, and 2020, after controlling for sex (52% male), SES, and school type. A small effect was found in a random intercept cross-lagged panel model whereby occupational future time perspective at age 15 predicted externalizing problems at age 17 (β = .146, p = .05, [95% CI = 0.000, 0.292]), and in a random intercept (contemporaneous) reciprocal panel model specification attention deficit hyperactivity disorder symptoms at age 17 were contemporaneously associated with occupational future time perspective at age 17 (β = -.310, p < .05, [95% CI = -0.580, -0.041]). No cross-lagged associations were found to be robust across different model specifications/adjustments. These findings suggest that improving occupational future time perspective may have limited impact on enhancing mental health, offering valuable insights for school-based interventions. Further research and replication are necessary to confirm these results.

A randomized-controlled trial of parent-administered interventions to improve short-term motor outcomes in hospitalized very low birthweight infants.

Premature infants are at increased risk for cerebral palsy (CP). Early interventions with a motor focus and administered by parents may improve motor outcomes. Secondary study evaluating the short-term motor outcomes and risk for CP in very low birthweight (VLBW) infants randomized to multimodal interventions with a motor focus provided by parents versus usual care. Randomized controlled trial (intervention vs. usual care (control group)). Infants (<32 weeks' gestational age (GA) and/or <1500 grams birthweight) born between March 2019 and October 2020. Short-term motor outcomes and risk for CP was evaluated using the Hammersmith Infant Neurological Evaluation (HINE, primary motor outcome), the General Movement Assessment (GMA) and the Test of Infant Motor Performance (TIMP) at 3 months' postmenstrual age (PMA). 70 participants were enrolled (GA 28.3±2.7 weeks, birthweight 1139.2±376.6 grams, 64.3% male). The in-person follow-up rate was 73%, lower than expected, in part due to COVID-19 restrictions, resulting in 25 infants (intervention) and 26 infants (control) with outcome data available for analysis. There was not a significant difference in the HINE, GMA or TIMP at 3 months' PMA between groups. Multimodal interventions with a motor focus and provided by parents need further investigation to determine if they can improve short-term motor outcomes in VLBW infants. These interventions are evidence-based and the evaluation of broader implementation into routine care is also needed.

A Systematic Review of Dental Antibiotic Stewardship Interventions.

Antimicrobial resistance is a significant threat to global health. Antimicrobial stewardship is reducing inappropriate antimicrobial prescribing to counter it. Dentists prescribe ~10% of all antibiotics worldwide, yet up to 90% of antibiotic prescriptions by dentists are inappropriate. The aim of this systematic review was to update a 2017 review evaluating the effects of antibiotic stewardship interventions in dental settings, using the international consensus on core outcomes for dental antibiotic stewardship. Systematic database searches were undertaken in April 2023, of the: Cochrane Oral Health Group Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE via OVID, EMBASE via OVID, Dentistry and Oral Sciences Source, the US National Institutes of Health Trials Register, the World Health Organisation International Clinical Trials Registry Platform and the ISRCTN registry databases. Randomised controlled trials (or non-randomised studies with clearly reported mechanism of group formation and inclusion criteria) of interventions to optimise and/or reduce dental antibiotic prescribing were eligible for inclusion. Two authors independently screened for eligible studies. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool, certainty of evidence assessed using GRADE. Meta-analysis was planned whether the results of studies reported similar outcomes, otherwise narrative synthesis was undertaken. Three eligible studies randomising 2148 participants were included. The interventions were combinations of education, audit and feedback and written behaviour change messages, guideline summary, practice visits and patient leaflets. None of the control groups received an intervention. All three included studies measured the quantity of antibiotics prescribed and two measured the appropriateness of prescribing. None measured patient-reported or adverse outcomes. Two included studies were assessed as 'high risk' and one with 'low risk' of bias. There was high-certainty evidence that audit and personalised feedback with individualised behaviour change messages can be effective. Evidence for in-person education was low-certainty. Guideline dissemination alone was ineffective at improving antibiotic prescribing. Due to different outcomes reported, meta-analysis was inappropriate. Although various dental antibiotic stewardship interventions have been reported in the literature, none provided high-certainty evidence of effectiveness and only three have been evaluated using a randomised design. To strengthen the body of evidence, well-powered, robust, randomised controlled trials are required, with adequate follow-up, reporting the internationally-agreed core outcomes and including a parallel process evaluation is recommended. PROSPERO (CRD42023411476).

The impact of antidepressant discontinuation prior to treatment with psilocybin for treatment-resistant depression

It has been suggested that the recent use and discontinuation of antidepressant drugs compromises the action of psilocybin. As evidence is only available from small or uncontrolled samples, this post hoc analysis investigated this using data from the largest, phase II, randomized controlled trial of psilocybin treatment to date. Data from 233 participants with treatment-resistant depression (TRD) who received 25 mg, 10 mg, or 1 mg of investigational drug COMP360 psilocybin (a proprietary, pharmaceutical-grade synthetic psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.), administered with psychological support, were compared for groups of participants who either discontinued one or more antidepressant drugs during screening or entered the trial antidepressant drug free. Measures of depression symptom severity change during the antidepressant drug discontinuation period, baseline suicidality, acute subjective psychedelic effects, and the study's primary endpoint (change in depression symptom severity between Baseline and Week 3) are described for both groups. Antidepressant drug discontinuation was not related to worsening of depression severity before Baseline. Suicidality was comparable between groups at Baseline. Psilocybin treatment efficacy and the subjective psychedelic experience did not appear to be compromised by antidepressant drug discontinuation. Thus, it does not limit the feasibility of psilocybin treatment for the future. These findings also support the overall homogeneity of our findings with psilocybin treatment as a monotherapy for TRD. The prior contradictory reports may come to appear misleading.

Interventional Pharmacoepidemiology: Origins, Current Status, and Future Possibilities.

Interventional pharmacoepidemiology applies quantitative analysis of patterns of medication use and outcomes to help design, guide and then evaluate programs to improve prescription drug use and outcomes. Surveillance of prescribing and drug-taking in large populations is increasingly practical because of the proliferation of detailed data on medication use decisions, often based on paid claims billing data. At the same time, increasingly granular clinical information is available on patient characteristics and outcomes. This can offer important opportunities to identify problematic use, focus interventions to address them, and measure their impact. Alexander et al (Am J Epidemiol. 0000;000(00):0000-0000) review the need for such research and provide methodological guidance for its performance. While randomized controlled trials of such interventions are ideal, real-world considerations often require other evaluation strategies, including stepped-wedge designs and interrupted time-series analysis. As drug therapy becomes more powerful and more costly, and the risks of poor medication choices as well as under-use of effective treatments become even better understood, the health care system will increasingly rely on such approaches to assess current patterns of prescribing and patient adherence, target programs to address problem areas, and measure the effectiveness of such interventions.

Plant protein, fibre and physical activity solutions to address poor appetite and prevent undernutrition in older adults: study protocol for the APPETITE randomised controlled trial.

Reduced appetite with ageing is a key factor that may increase risk of undernutrition. The objective of this study is to determine the impact of innovative plant protein fibre (PPF) products within a personalised optimised diet (PD), a physical activity (PA) programme, and their combination on appetite, and other nutritional, functional and clinical outcomes in community-dwelling older adults in a multi-country randomised controlled intervention trial. One hundred and eighty community-dwelling adults (approximately sixty per trial centre in Germany, Ireland and Italy) aged 65 years and over will be recruited to participate in a 12-week, parallel-group, controlled trial. Participants will be randomised into one of four groups: 1, PD (incorporating two PPF products): 2, PA; 3, PD + PA; and 4, no intervention (control). The primary outcome is appetite measured by visual analogue scales and energy intake from an ad libitum test meal. Secondary outcomes include fasting and postprandial appetite-related gut hormones, Simplified Nutritional Appetite Questionnaire score, body composition, cardiorespiratory fitness, muscle strength, physical function and PA. In addition, self-efficacy, cognitive status, dietary restraint, depressive symptoms and compliance and acceptability of the intervention will be assessed. Metabolomic profiles, RMR, muscle motor unit properties and gut microbiome will also be assessed to explore potential underlying mechanisms. This multi-centre randomised controlled trial will advance knowledge on how PD (incorporating PPF products), PA and their combination influence appetite, nutritional status and related health outcomes in community-dwelling older adults and contribute to the prevention of undernutrition. Trial registration: Clinical Trials.gov Registry NCT05608707 (registered on 2 November 2022). Protocol Version: NCT05608707 Version 4 (registered on 29 September 2023).

Effect of pharmacist interventions in chronic kidney disease: a meta-analysis.

Pharmacists are uniquely placed with their therapeutic knowledge to manage people with chronic kidney disease (CKD). Data is limited regarding the impact of pharmacist interventions on economic, clinical, and humanistic outcomes (ECHO). A systematic review and meta-analysis of randomized controlled trials (RCTs) of interventions with pharmacist input was conducted, which included adults with a diagnosis of CKD, including those with and without kidney replacement therapy. Data was extracted on ECHO: economic (e.g. healthcare-associated costs), clinical (e.g. mortality), and humanistic (e.g. patient satisfaction) outcomes. Where appropriate, a random-effects model meta-analysis generated a pooled estimate of effect. A direction of effect plot was used to summarize the overall effects for clinical outcome domains. 32 RCTs reported a total of 10 economic, 211 clinical, and 18 humanistic outcomes. Pharmacist interventions resulted in statistically significant improvements in systolic blood pressure and hemoglobin levels, but not in diastolic blood pressure, estimated glomerular filtration rate, creatinine, and low-density lipoprotein cholesterol levels. Mixed findings were reported for clinical and economic outcomes, whilst pharmacist interventions resulted in an improvement in humanistic outcomes such as patient satisfaction and patient knowledge. Findings showed pharmacist interventions had mixed results for various outcomes. Future studies should be more robustly designed and take into consideration the role of the pharmacist in prescribing and deprescribing, the findings of which will help inform research and clinical practice.

A scoping review of randomized controlled trials of parenting and family-based interventions for 10 – 17 year-olds with severe and persistent conduct problems

ABSTRACT Purpose A scoping review of randomized controlled trials (RCTs) of parenting and family-based interventions that aim to reduce severe and persistent conduct problems among 10–17 year-olds. The review also examined feasibility for conducting a network meta-analysis of common therapy elements measured by RCTs. Materials and methods The review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA- ScR). Searches were conducted in ERIC, PsycINFO, and MEDLINE without limits on publication year, language or publication country. Study methodological quality was assessed using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for RCTs. Results Twenty-five eligible RCTs were identified. The studies trialed nine interventions, with Multisystemic Therapy (MST) being the most evaluated (N = 10), followed by Functional Family Therapy (FFT, N = 4), and Treatment Foster Care Oregon (TFCO, N = 3). Only 10 of the 25 RCTs revealed treatment effect on conduct problems, including 6 of 9 MST, 1 of 4 FFT and all 3 TFCO trials. Discussion Surprisingly few RCTs of parenting and family-based interventions have been carried out exclusively with this population. Available data suggests that MST and FFT have uncertain effectiveness for reducing severe and persistent conduct problems. While the quality of the reviewed studies was generally high, only two reported substantive data on common therapy elements. Conclusion There is need for more RCTs of parenting and family-based interventions delivered for older children and adolescents with severe and persistent conduct problems. Future RCTs should systematically measure common therapy elements with a view to advancing intervention science.

Soundscape augmentation as a nonpharmacological intervention to reduce the behavioural effect of dementia: a randomized controlled trial

Soundscape is an important environmental factor that influences people's behaviour and well-being. People with dementia can benefit from a personalized soundscape to improve the behavioural and psychological syndrome of dementia. This paper is based on a single-blind, repeated-measure pilot randomized clinical trial of soundscape augmentation on the treatment effect of people with severe dementia. Participants were randomized to a personalized soundscape intervention delivered in their room in the morning and evening or treatment-as-usual, with two baseline weeks and four weekly post-randomization assessments of the primary and secondary behavioural outcomes. A linear mixed effects model showed that the soundscape intervention was possible and acceptable. There were improvements in the Neuropsychiatric Inventory (resistance to care) and a significant reduction in aggression in the soundscape group. This study is the first pilot randomized controlled trial of a soundscape intervention for older adults with dementia to improve the behavioural and psychological syndrome of dementia. In this pilot study, soundscape augmentation was a feasible and effective non-pharmacological approach to reducing resistance and improving participants' behaviour. Further studies with larger samples are recommended to confirm our findings. Longitudinal studies are necessary to investigate the long-term effect of an augmented sonic environment on people with dementia.

Cascade effects of a parenting-focused program for divorced families on three health-related outcomes in emerging adulthood.

Using data from a 15-year longitudinal follow-up of a randomized controlled trial of a parenting-focused preventive intervention for divorced families (N = 240) with children aged 9-12, the current study examined alternative cascading pathways through which the intervention led to improvements in offspring's perceived health problems, BMI, and cigarette smoking in emerging adulthood. It was hypothesized that the program would lead to improvements in these health-related outcomes during emerging adulthood through progressive associations between program-induced changes in parenting and offspring outcomes, including mental health problems, substance use, and competencies. Intervention-induced improvements in positive parenting at posttest led to improvements in mental health problems in late childhood/early adolescence, which led to lower levels of mental health and substance use problems as well as higher levels of competencies in adolescence, which led to improvements in the health-related outcomes. Academic performance predicted all three health-related outcomes and other aspects of adolescent functioning showed different relations across outcomes. Results highlight the potential for intervention effects of preventive parenting interventions in childhood to cascade over time to affect health-related outcomes in emerging adulthood.

A pilot randomised controlled trial of a multidomain lifestyle intervention for outpatients with chronic or severe mental illness

Lifestyle-related problems are common in people with mental illness, contributing to a decreased life expectancy and high societal and personal burden. This study aimed to investigate the feasibility, acceptability, and preliminary effectiveness on recovery of a multidomain lifestyle intervention in patients with severe or chronic mental illnesses. Twenty transdiagnostic outpatients were 1:1 randomised in intervention or control. The lifestyle intervention consisted of 11 three-hour group sessions about physical activity, nutrition, relaxation, sleep, substance use, and purpose and meaning. Self-report questionnaires, physical measurements, diary questions, and accelerometers were administered at baseline, halfway and post intervention. Outcomes included attrition, retention rates, protocol deviations, quantitative evaluations and effectiveness. Both the intervention and research protocol appeared feasible and acceptable, with relaxation, purpose and meaning and nutrition as highest appreciated themes. Intervention simplification and deepening was necessary to suit the heterogeneous participants. Preliminary effects were found in all recovery domains, with biggest effects in societal recovery and smallest effects in clinical recovery. To prevent dropout and match the outpatient population, small intervention adaptations are recommended. Effects can be expected in all domains of recovery and should be measured accordingly. Research with greater sample sizes is necessary.

Practical Resources for Effective Postpartum Parenting (PREPP): a randomized controlled trial of a novel parent-infant dyadic intervention to reduce symptoms of postpartum depression: RCT of the PREPP intervention for postpartum depression

BackgroundThere is little known about the effectiveness of psychological interventions to prevent postpartum depression that focus on the birthing parent and infant dyad. Risk factors for PPD include depression during pregnancy, low parenting self-efficacy, and disrupted parental nocturnal sleep. The brief Practical Resources for Effective Postpartum Parenting (PREPP) intervention is designed for pregnant individuals at-risk for postpartum depression, providing them with 1) caregiving strategies aimed at reducing infant fuss and cry behavior and increasing infant sleep, 2) self-reflection and mindfulness skills and 3) psychoeducation about the postpartum period and infant behavior. The aims are to set more realistic postpartum expectations, enhance parenting confidence and sleep via supporting infant regulatory behavior, improve parental affect regulation and ultimately reduce the risk of postpartum depression. ObjectivesAssess the effectiveness of PREPP compared to enhanced treatment as usual in reducing symptoms of depression and anxiety and episodes of infant fuss and cry behavior and improving parental and infant sleep in the early postpartum. Study designA randomized controlled trial was conducted of 175 pregnant individuals. Inclusion criteria were standard prenatal care for a singleton pregnancy, aged 18 to 45 and at increased risk of PPD as determined by a score of ≥19 on the Predictive Index of Postnatal Depression or ≥7 on the Edinburgh Postnatal Depression Scale. Participants assigned to the PREPP group (n=88) received three coaching sessions and two phone check-ins. Participants assigned to the enhanced treatment as usual group (n=87) received three sessions which included psychoeducation, mood assessments, and clinical referral and follow-up as indicated. Assessments were conducted at 28 to 32 weeks and 34 to 39 weeks gestation, and at six, 12 and 16 weeks postpartum and included measures of parental depression, anxiety and sleep (Edinburgh Postnatal Depression Scale, Patient Health Questionnaire (PHQ-9), Hamilton Rating Scales of Depression and Anxiety and Pittsburgh Sleep Quality Index) and infant sleep and fuss and cry behavior (Baby Day Diary). ResultsCompared to enhanced treatment as usual, PREPP significantly reduced depressive symptoms at six, 12 and 16 weeks postpartum with medium to large effect sizes (d=0.7-0.98). Compared to enhanced treatment as usual, participants receiving PREPP reported less of a decline in sleep quality at six weeks postpartum (p=0.035) and the effect size was large (d=0.83). Moreover, parents receiving the PREPP intervention reported less infant fussing and crying, with the largest effect for morning crying (p<0.001; d=-1.48). ConclusionsThe results provide evidence that PREPP, initiated during pregnancy, reduced symptoms of parental depression and infant fuss and cry behavior in the early postpartum, compared to enhanced treatment as usual, in a sample at-risk for postpartum depression.

Effect of a perineal protection device in vacuum-assisted births – a prospective randomized controlled interventional trial

BackgroundBirth tears are common after vaginal birth with a prevalence of up to 85%, especially in vaginal-assisted births. As birth trauma can cause physical and psychological short-term and long-term maternal morbidity, it is essential to improve maternal outcome at birth. ObjectiveTo evaluate the effect of a perineal protection device on the rate of spontaneous birth tears in the posterior compartment in vacuum-assisted births, as well as the feasibility and safety of the device. Study DesignIn a prospective, randomized controlled interventional trial from July 2020 to October 2022 we evaluated the application of a perineal protection device in vacuum-assisted vaginal births in a tertiary care center. 1998 patients were asked for participation, and 1574 patients with singletons ≥ 36 weeks of gestation gave their informed consent before birth. Ultimately, 209 were included according to a power calculation performed in advance with a statistical power of 80% and a significance level of 5% in expectation to reduce the rate for the primary composite outcome by 20%. The primary composite outcome was the rate of low-grade perineal and/or vaginal tears in the posterior compartment. Secondary outcomes were the rate of high-grade perineal tears and episiotomies, the feasibility of the device, and its safety for mother and child. Descriptive statistics and a logistic regression analysis were performed in an “intention-to-treat” (ITT), a “per-protocol” (PP), and an “as-treated” (AT) analysis, using SPSS version 29.0.0.0 (IBM SPSS, Armonk, New York, USA) and the software “R” (The R Project for Statistical Computing, version 3.5.0). A p-value < 0.05 was considered statistically significant. ResultsOf the 1574 patients, 249 (15.8%) had an indication for vacuum-assisted vaginal birth, of which 217 (13.8%) were randomized. Another eight patients (0.5%) were excluded because of birth ending without vacuum-assistance. Of the remaining 209 patients, 105 formed the intervention group (application of the device), whereas 104 formed the control group (without application of the device). No differences in primary and secondary outcomes were found in the ITT and PP analysis. In the ITT analysis, 79 patients (75.2%) in the intervention group compared to 73 patients (70.2%) in the control group (p = 0.4) met the primary endpoint. In the PP analysis, the primary composite outcome was seen 53 patients (77.9%) in the intervention group compared to 73 patients (70.2%) in the control group (p = 0.27). For the AT analysis, 68 of the 105 patients (65%) remained in the intervention group after exclusion of 37 (35%) patients with failed application of the device. Consequently, 141 formed the control group. In the AT analysis, there was also no difference in the primary composite outcome between the two groups (53 patients (77.9%) in the intervention group compared to 99 patients (70.2%) in the control group). However, within the secondary outcomes, we found a significantly lower rate of mediolateral episiotomies in the intervention group (29% vs 45%, p = 0.034). No adverse outcomes for mother and child were seen. In one third of cases, the device was difficult to place correctly and/or to keep correctly in place. ConclusionThe perineal protection device was not able to reduce the primary composite outcome of the study in women giving birth by vacuum-assistance. Although this was not the primary end point, a lower rate of mediolateral episiotomies was observed, if the device had been used correctly. As a limitation, difficulties with the application of the device occurred in 33% of cases. Nevertheless, no adverse events in association with the device were observed for either mother or child in our cohort. Video Abstract [Display omitted]

The OBS UK Dashboard: an interactive tool for representative trial site selection to facilitate equality and diversity in maternity research

BackgroundObstetric Bleeding Study UK (OBS UK) (award ID: 152057) is a National Institute for Health and Care Research (NIHR)-funded stepped wedge cluster randomised controlled trial of a complex intervention for postpartum haemorrhage. This was developed in Wales and evaluated in a feasibility study, with improvements in maternal outcomes observed. Generalisability of the findings is limited by lack of control data and limited ethnic diversity in the Welsh obstetric patient population compared to the United Kingdom (UK): 94% of the Welsh population identifies as White, versus 82% in the UK. Non-White ethnicity and socioeconomic deprivation are linked to increased risk of adverse maternal outcomes. Traditionally, decisions regarding site selection are based on desire to complete trials on target in ‘tried and tested’ research active institutions. To ensure widespread applicability of the results and investigate the impact of ethnicity and social deprivation on trial outcomes, maternity units were recruited that represent the ethnic diversity and social deprivation profiles of the UK.MethodUsing routinely collected, publicly available data, an interactive dashboard was developed that demonstrates the demographics of the population served by each maternity unit in the UK, to inform site recruitment. Data on births per year, ethnic and socioeconomic group of the population for each maternity unit, across the UK, were integrated into the dashboard.ResultsThe dashboard demonstrates that OBS UK trial sites reflect the ethnic and socioeconomic diversity of the UK (study vs UK population ethnicity: White 79.2% vs 81.7%, Asian 10.5% vs 9.3%, Black 4.7% vs 4.0%, Mixed 2.5% vs 2.9%, Other 3.0% vs 2.1%) with variation in site demography, size and location. Missing data varied across sites and nations and is presented.ConclusionThe NIHR equality, diversity and inclusion strategy states studies must widen participation, facilitating individuals from all backgrounds to engage. The development of this novel interactive dashboard demonstrates an innovative way of achieving this. National Health Service (NHS) maternity researchers should consider using this tool to enhance diversity in research, address health disparities and improve generalisability of findings. This approach could be applied to healthcare settings beyond maternity care and across different global populations.Trial registrationISRCTN 17679951. Registered on August 30, 2023.

Ayurveda Management of Allergic Rhinitis: Protocol for a Randomized Controlled Trial.

Allergic rhinitis (AR) is the inflammation of the membranes lining the nose due to allergen exposure and is characterized by sneezing, nasal congestion, itching of the nose, or postnasal discharge. The prevalence varies worldwide, perhaps due to the geographic and aeroallergen differences, with 10% to 30% of the world's population experiencing AR. In this study, Anu Taila Nasya, Naradiya Laxmivilas Rasa, and Shirishadi Kwath will be compared to a fluticasone nasal spray. The primary aim is to assess the efficacy of Ayurvedic management for AR (or vataja pratishyaya) by comparing it to a conventional control group. The secondary aims are to determine the mean change in the nasal endoscopy index and the mean change in the laboratory tests. This ongoing study is an open-label randomized controlled interventional trial, with a sample size of 90 both in the trial and standard control group (including dropouts, 20%), and will be carried out for 24 months. Participants in the trial group will receive Ayurvedic treatment, that is, Anu Taila Nasya (6 drops in each nostril for 7 days for 3 consecutive weeks), Naradiya Laxmivilas Rasa (250 mg twice per day), and Shirishadi Kwath (40 ml twice per day for 45 days). The participants in the control group will receive a fluticasone propionate nasal spray (2 sprays once per day for 45 days). The primary outcome will include the mean change in the Control of Allergic Rhinitis and Asthma Test score, and the secondary outcomes will include the mean change in the nasal endoscopy index (assessment of nasal membrane color, pale or hyperemia; rhinorrhea, watery or yellow; and inferior turbinate swelling, hypertrophy) and the mean change in the laboratory tests. As of May 2024, 72 patients have been enrolled in both groups. Data analysis should be completed by February 2025. The study will be reported following standard guidelines for reporting randomized controlled trials. Clinical results will be disseminated through conferences and peer-reviewed publication in a relevant journal. The Ayurvedic approach could be an evidence-based therapeutic tactic for the management of AR. Clinical Trials Registry India CTRI/2023/06/053395; https://tinyurl.com/564d2zz8. DERR1-10.2196/56063.