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Background: In view of goal directed therapies, the predictive value of the course of peripheral perfusion parameters over time has not been studied. Moreover serial assessment of peripheral perfusion index (PI) can be more predictive for mortality when compared to a single assessment of peripheral perfusion. Successfully normalized PI (≥1.4) during treatment might be an indication to stop the resuscitation, whereas pursuing normalized PI (≥1.4) might not result in better outcomes compared with mild-to moderate PI impairment after a normalized arterial lactate level. Complementing arterial lactate assessment with PI during resuscitation can better identify the endpoint of resuscitation and patients at higher risk of adverse outcomes. By simple clinical assessment of peripheral perfusion immediately during and after resuscitation, clinicians will be able to discriminate patients at high risk for developing severe complications even in the rural setups. Methods: This prospective study was conducted on 100 patients admitted at Dr. Kiran C. Patel Medical College and Research Institute, over a period of 12months (Janury 2022 to December 2022). Patients of sepsis were selected on the basis of criteria for tissue hypoperfusion and classification of sepsis. Results: On statistical analysis, PI was found to have significant correlation with arterial lactate levels (P1.4. SOFA score & metabolic parameters were also found to have statistical significance. Conclusions: We inferred that peripheral perfusion index monitoring could provide useful information to determine the possibility of hyperlactatemia in critically ill patients thus providing a noninvasive source of tissue-bed perfusion monitoring even in the absence of facilities and infrastructure to measure the lactate levels thereby providing a gross insight in the perfusion haemodynamics of the patients of sepsis even in the primary healthcare setups too.

Perinatal depression is the onset of depressive symptoms during pregnancy and up to one year after childbirth. Migrant women are at higher risk of experiencing perinatal depression due to numerous psychosocial stressors related to their experiences. This qualitative review aims to aggregate the experiences and barriers to care faced by immigrant and refugee women in Canada who have perinatal depression. Qualitative research can elucidate the barriers to treatment and culturally-impacted experiences of Canadian migrant women with perinatal depression. Following PRISMA and Joanna Briggs Institute (JBI) guidelines for conducting qualitative systematic reviews, 13 eligible studies representing 10 samples (N = 262 participants) were identified and included in this review. Participants included service providers, immigrant women, and refugee women. Three synthesized themes were identified by this review using the JBI meta-aggregative approach: (1) culture-related challenges; (2) migration-related challenges; and (3) service accessibility and quality. Within these themes were experiences of migrant women that encompass six categories: (1) conceptualization of perinatal depression; (2) childbirth-specific challenges; (3) migration-related challenges; (4) social isolation; (5) accessibility of services; and (6) quality of care. The role of family, cultural differences, financial challenges, and the effects of these on service accessibility are impactful in the experiences of migrant women. A greater understanding of the role of both culture and migration in the delivery of care, especially regarding service provider attitudes in more representative samples, is recommended.

There is a critical need to better understand psychological treatments from a culturally sensitive lens. Using a process-oriented model, we examined treatment satisfaction among perinatal patients who received behavioral activation (BA) within a large psychotherapy trial for perinatal depression and anxiety, and explored how to optimize culturally sensitive delivery through a multistakeholder perspective.In this mixed methods study, we estimated treatment satisfaction through mean client satisfaction scores (Client Satisfaction Questionnaire [CSQ]-8) among perinatal participants (CSQ-8 scores were similar across ethnic groups,BA offers one psychotherapeutic model that uses an idiosyncratic and process-oriented approach that fosters intersectional humility and benefits from cultural humility, comfort, and opportunities. We identify key recommendations to inform culturally sensitive, evidence-based psychological treatments that include explicitly acknowledging and eliciting topics of race, ethnicity, and culture during sessions and supervision and ongoing training and supervision. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

BACKGROUND: The aim of these clinical standards is to provide guidance on ‘best practice´ for diagnosis, treatment and management of drug-susceptible pulmonary TB (PTB).METHODS: A panel of 54 global experts in the field of TB care, public health, microbiology, and pharmacology were identified; 46 participated in a Delphi process. A 5-point Likert scale was used to score draft standards. The final document represents the broad consensus and was approved by all 46 participants.RESULTS: Seven clinical standards were defined: Standard 1, all patients (adult or child) who have symptoms and signs compatible with PTB should undergo investigations to reach a diagnosis; Standard 2, adequate bacteriological tests should be conducted to exclude drug-resistant TB; Standard 3, an appropriate regimen recommended by WHO and national guidelines for the treatment of PTB should be identified; Standard 4, health education and counselling should be provided for each patient starting treatment; Standard 5, treatment monitoring should be conducted to assess adherence, follow patient progress, identify and manage adverse events, and detect development of resistance; Standard 6, a recommended series of patient examinations should be performed at the end of treatment; Standard 7, necessary public health actions should be conducted for each patient. We also identified priorities for future research into PTB.CONCLUSION: These consensus-based clinical standards will help to improve patient care by guiding clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment for PTB.

Even before the COVID-19 pandemic, the needs for care of persons with mental illness remained largely unmet worldwide, testifying to the inadequacy of current approaches to mental health care and their unsuitability for the rising demand. One hurdle to improved access to quality care is the reliance on expensive specialist providers, particularly for the delivery of psychosocial interventions. This article describes EMPOWER, a not-for-profit program that builds on the clinical science demonstrating the effectiveness of brief psychosocial interventions for a range of psychiatric conditions; implementation science demonstrating the effectiveness of delivery of these interventions by non-specialist providers (NSPs); and pedagogical science demonstrating the effectiveness of digital approaches for training and quality assurance. The EMPOWER program leverages digital tools for training and supervising NSPs, designing competency-based curricula, assessing treatment-specific competencies, implementing measurement-based peer supervision for support and quality assurance, and evaluating impacts to enhance the effectiveness of the delivery system.

Background We examined the implementation of a brief, behavioural activation (BA) model, via telemedicine, for perinatal populations during a confluence of significant global events in 2020. We conducted a rigorous qualitative study to identify relevant barriers and facilitators from the perspectives of both perinatal participants and treatment providers. We also present two case studies where BA was used and adapted to provide patient-centered care. Methods Within the ongoing SUMMIT non-inferiority randomized controlled trial in Canada and USA, we interviewed a random selection of perinatal participants (n = 23) and all treatment providers (n = 28). A content analysis framework was developed to identify relevant barriers and facilitators and frequencies were calculated for each emergent theme within and across respondent groups. Results Key facilitators reported by participants receiving BA were that BA helped with support and social connection (73.9%), creative problem solving (26.1%) and attending to pandemic-related symptoms (21.7%). Key facilitators endorsed by providers delivering BA were the use of telemedicine (35.7%) and loosening of government restrictions (21.4%). Both participant groups reported similar barriers to BA during the pandemic such as a lack of privacy and limited activities due to pandemic restrictions. However, providers were more likely to endorse pandemic-related life stressors as a barrier to treatment delivery compared to participants (64.3% vs. 34.8%). Both participant groups experienced explicit discussion of race and the racial justice movements during sessions as beneficial and reported harms of not doing so to the therapeutic alliance. Conclusions BA offers a person-centered model to facilitate social connection through creative problem-solving for women with perinatal depressive and anxiety symptoms within the context of the COVID-19 pandemic. Explicit discussion of race and racial injustice during sessions is an important and helpful aspect in psychological treatments.

BACKGROUND: Increasing evidence suggests that post-TB lung disease (PTLD) causes significant morbidity and mortality. The aim of these clinical standards is to provide guidance on the assessment and management of PTLD and the implementation of pulmonary rehabilitation (PR).METHODS: A panel of global experts in the field of TB care and PR was identified; 62 participated in a Delphi process. A 5-point Likert scale was used to score the initial ideas for standards and after several rounds of revision the document was approved (with 100% agreement).RESULTS: Five clinical standards were defined: Standard 1, to assess patients at the end of TB treatment for PTLD (with adaptation for children and specific settings/situations); Standard 2, to identify patients with PTLD for PR; Standard 3, tailoring the PR programme to patient needs and the local setting; Standard 4, to evaluate the effectiveness of PR; and Standard 5, to conduct education and counselling. Standard 6 addresses public health aspects of PTLD and outcomes due to PR.CONCLUSION: This is the first consensus-based set of Clinical Standards for PTLD. Our aim is to improve patient care and quality of life by guiding clinicians, programme managers and public health officers in planning and implementing adequate measures to assess and manage PTLD.

Because most youth psychotherapies are developed and tested in high-income countries, relatively little is known about their effectiveness or moderators in low- and middle-income countries (LMICs). To address this gap, we conducted a meta-analysis of randomized controlled trials (RCTs) testing psychotherapies for youth with multiple psychiatric conditions in LMICs, and we tested candidate moderators.We searched nine international databases for RCTs of youth psychotherapies in LMICs published through January 2021. The RCTs targeted elevated symptoms of youth anxiety (including post-traumatic stress disorder [PTSD] and obsessive compulsive disorder [OCD]), depression, conduct, and attention problems. Using robust variance estimation, we estimated the pooled effect sizes (Hedges g) at post-treatment and follow-up for intervention versus control conditions.Of 5,145 articles identified, 34 (with 43 treatment-control comparisons and N=4176 participants) met methodological standards and were included. The overall pooled g with winsorized outliers was 1.01 (95% CI=0.72 1.29, p.001) at post-treatment and 0.68 (95% CI=0.29 1.07, p=.003) at follow-up. Interventions delivered by professional clinicians significantly outperformed those delivered by lay-providers (g=1.59 vs. 0.53). Interventions developed non-locally were more effective if not adapted to local contexts than if adapted locally (g=2.31 vs. 0.66), highlighting a need for further research on effective adaptations. Significant risk of bias was identified.Overall pooled effects of youth psychotherapies in LMICs were markedly larger than those in recent comparable non-LMIC meta-analyses, which have shown small-to-medium effects for youth psychotherapies. Findings highlight the potential benefits of youth psychotherapies in LMICs as well as a need for more RCTs and improved study quality.

Efforts to reduce the global burden of common mental disorders have focused on scaling up evidence-based training programs for non-specialist providers to deliver brief psychological interventions. To evaluate these provider training programs, appropriate and scalable assessments of competency need to be developed alongside them. We followed a systematic approach for the cultural adaptation and translation into Hindi of a valid, English, multiple-choice applied knowledge measure to assess non-specialists' competence to deliver a brief psychological intervention for depression in rural India. We then explored the relationship between the performance of 30 non-specialist providers on the same written measure compared with a structured performance-based measure consisting of two role-plays. The results of the multiple-choice assessment had an overall mean score of 37.40 (SD = 11.31) compared to the mean scores of role-play A (the easier role-play) of 43.25 (SD = 14.50) and role-play B (the more difficult role-play) of 43.25 (SD = 13.00). Role-play performance-based measures and written applied knowledge measures represent different approaches with unique strengths and challenges to measuring competence. Scaling up training programs requires the development of scalable methods for competency assessment. Exploring the relationship between these two measures, our team found no apparent differences between the two modes of assessment. Continued comparison of these approaches is needed to determine the consistency of outcomes across the two formats and to link the scores on these measures with clinical performance as reflected by the quality of care and patient outcomes.Trial Registration: ClinicalTrials.gov Identifier: NCT04157816; 8th November 2019.

Telemedicine has transformed our ability to access and offer mental healthcare. There remain key questions to facilitate scalable, patient-centered solutions for perinatal mental health. We critically evaluate the recent literature and propose potential future directions.The current literature highlights the promise of telemedicine in the prevention and treatment of perinatal depression, including the preference for and the potential efficacy of telemedicine-delivered mental healthcare when compared to in-person treatments. There remains a need for large, adequately powered randomized controlled trials; integration of trauma into depression and anxiety trials, transdiagnostic treatment of perinatal women, and scaling up these effective treatments into existing health and payer systems. Pragmatic, evidence-based solutions exist to effectively scale-up treatments for perinatal mental health. While research is underway to address the growing treatment gap, questions remain regarding who will deliver and pay for these treatments and how we can leverage telemedicine to treat perinatal mental health transdiagnostically.

Summary Background Early childhood development (ECD) programmes can help address early disadvantages for the 43% of children younger than 5 years in low-income and middle-income countries who have compromised development. We aimed to test the effectiveness of two group-based delivery models for an integrated ECD responsive stimulation and nutrition education intervention using Kenya's network of community health volunteers. Methods We implemented a multi-arm, cluster-randomised community effectiveness trial in three rural subcounties across 60 villages (clusters) in western Kenya. Eligible participants were mothers or female primary caregivers aged 15 years or older with children aged 6–24 months at enrolment. If married or in established relationships, fathers or male caregivers aged 18 years or older were also eligible. Villages were randomly assigned (1:1:1) to one of three groups: group-only delivery with 16 fortnightly sessions; mixed delivery combining 12 group sessions with four home visits; and a comparison group. Villages in the intervention groups were randomly assigned (1:1) to invite or not invite fathers and male caregivers to participate. Households were surveyed at baseline and immediately post-intervention. Assessors were masked. Primary outcomes were child cognitive and language development (score on the Bayley Scales of Infant Development third edition), socioemotional development (score on the Wolke scale), and parental stimulation (Home Observation for Measurement of the Environment inventory). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov , NCT03548558 . Findings Between Oct 1 and Nov 12, 2018, 1152 mother–child dyads were enrolled and randomly assigned (n=376 group-only intervention, n=400 mixed-delivery intervention, n=376 comparison group). At the 11-month endline survey (Aug 5–Oct 31, 2019), 1070 households were assessed for the primary outcomes (n=346 group only, n=373 mixed delivery, n=351 comparison). Children in group-only villages had higher cognitive (effect size 0·52 SD [95% CI 0·21–0·83]), receptive language (0·42 SD [0·08–0·77]), and socioemotional scores (0·23 SD [0·03–0·44]) than children in comparison villages at endline. Children in mixed-delivery villages had higher cognitive (0·34 SD [0·05–0·62]) and socioemotional scores (0·22 SD [0·05–0·38]) than children in comparison villages; there was no difference in language scores. Parental stimulation also improved for group-only (0·80 SD [0·49–1·11]) and mixed-delivery villages (0·77 SD [0·49–1·05]) compared with the villages in the comparison group. Including fathers in the intervention had no measurable effect on any of the primary outcomes. Interpretation Parenting interventions delivered by trained community health volunteers in mother–child groups can effectively promote child development in low-resource settings and have great potential for scalability. Funding Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health

Background:HIV (Human Immunodeficiency Virus) attacks the immune system and thereby weaken bodys natural defence mechanism against various diseases. Several pulmonary complications have been documented in HIV infected people among which Chronic Obstructive Pulmonary Disease (COPD) carries special importance. It has been postulated that COPD occurs more frequently in HIV infected people and occurs in younger aged HIV infected people than non HIV population. Methods:It was a cross sectional observational study, and convenience sampling method was adopted. COPD cases were selected from out-patient department. HIV testing was done as per national guideline with the HIV kits supplied by NATIONAL AIDS CONTROL ORGANIZATION (NACO). Objective:To study the occurrence of HIV seropositivity in the adult (older than 18 years of age) patients of COPD attending National Institute of Tuberculosis and Respiratory Diseases(NITRD). Results:HIV positivity was foundin 4% of COPD patients. COPD developed at an earlier age in HIV positive patients. Median age was 37.5 years in HIV positive patients compared to median age of 50 years in HIV negative patients. Smoking and nutritional status of the patients did not show any significant relationship with HIV. Final conclusion:Keeping in mind the limitations of this study we concluded that HIV testing may be helpful in young aged, uncontrolled COPD patients.But further studies are required with larger sample sizes to confirm these observations.

We regret that this article is behind a paywall., BACKGROUND: Treatment of multidrug-resistant tuberculosis requires long-term therapy with a combination of multiple second-line drugs. These drugs are associated with numerous adverse events that can cause severe morbidity, such as deafness, and in some instances can lead to death. Our aim was to estimate the absolute and relative frequency of adverse events associated with different tuberculosis drugs to provide useful information for clinicians and tuberculosis programmes in selecting optimal treatment regimens. METHODS: We did a meta-analysis using individual-level patient data that were obtained from studies that reported adverse events that resulted in permanent discontinuation of anti-tuberculosis medications. We used a database created for our previous meta-analysis of multidrug-resistant tuberculosis treatment and outcomes, for which we did a systematic review of literature published between Jan 1, 2009, and Aug 31, 2015 (updated April 15, 2016), and requested individual patient-level information from authors. We also considered for this analysis studies contributing patient-level data in response to a public call made by WHO in 2018. Meta-analysis for proportions and arm-based network meta-analysis were done to estimate the incidence of adverse events for each tuberculosis drug. FINDINGS: 58 studies were identified, including 50 studies from the updated individual patient data meta-analysis for multidrug-resistant tuberculosis treatment. 35 of these studies, with 9178 patients, were included in our analysis. Using meta-analysis of proportions, drugs with low risks of adverse event occurrence leading to permanent discontinuation included levofloxacin (1·3% [95% CI 0·3-5·0]), moxifloxacin (2·9% [1·6-5·0]), bedaquiline (1·7% [0·7-4·2]), and clofazimine (1·6% [0·5-5·3]). Relatively high incidence of adverse events leading to permanent discontinuation was seen with three second-line injectable drugs (amikacin: 10·2% [6·3-16·0]; kanamycin: 7·5% [4·6-11·9]; capreomycin: 8·2% [6·3-10·7]), aminosalicylic acid (11·6% [7·1-18·3]), and linezolid (14·1% [9·9-19·6]). Risk of bias in selection of studies was judged to be low because there were no important differences between included and excluded studies. Variability between studies was significant for most outcomes analysed. INTERPRETATION: Fluoroquinolones, clofazimine, and bedaquiline had the lowest incidence of adverse events leading to permanent drug discontinuation, whereas second-line injectable drugs, aminosalicylic acid, and linezolid had the highest incidence. These results suggest that close monitoring of adverse events is important for patients being treated for multidrug-resistant tuberculosis. Our results also underscore the urgent need for safer and better-tolerated drugs to reduce morbidity from treatment itself for patients with multidrug-resistant tuberculosis.

Suppression of the extensor H-reflex by flexor afferent conditioning is thought to be produced by a long-lasting inhibition of extensor Ia-afferent terminals via primary afferent depolarization (PAD) activated by GABAAreceptors. Considering the recent finding that PAD does not produce presynaptic inhibition of Ia-afferent terminals, we examined if H-reflex suppression is instead mediated by post-activation depression of the test extensor Ia-afferents triggered by PAD-evoked spikes and/or by a long-lasting inhibition of the extensor motoneurons. A brief conditioning vibration of the flexor tendon suppressed both the extensor soleus H-reflex and the tonic discharge of soleus motor units for 300 ms, indicating that part of the H-reflex suppression was mediated by a long-lasting inhibition of the extensor motoneurons. When activating the flexor afferents electrically to produce conditioning, the soleus H-reflex was also suppressed for 300 ms, but only when a short-latency reflex was evoked in the soleus muscle by the conditioning input itself. In mice, a similar short-latency reflex was evoked when optogenetic or afferent activation of GABAergic (GAD2+) neurons produced PAD large enough to evoke orthodromic spikes in the test Ia-afferents, causing post-activation depression of subsequent monosynaptic excitatory-post-synaptic potentials. The time course of this post-activation depression and related H-reflex suppression (lasting 2 s) was like rate-dependent depression that is also due to post-activation depression. We conclude that extensor H-reflex inhibition by brief flexor afferent conditioning is produced by both post-activation depression of extensor Ia-afferents and long-lasting inhibition of extensor motoneurons, rather than from PAD directly inhibiting Ia afferent terminals.

Background There is a lack of empirical evidence on the level of cultural adaptation required for psychological interventions developed in Western, Educated, Industrialized, Rich, and Democratic (WEIRD) societies to be effective for the treatment of common mental disorders among culturally and ethnically diverse groups. This lack of evidence is partly due to insufficient documentation of cultural adaptation in psychological trials. Standardised documentation is needed in order to enhance empirical and meta-analytic evidence. Process A “Task force for cultural adaptation of mental health interventions for refugees” was established to harmonise and document the cultural adaptation process across several randomised controlled trials testing psychological interventions for mental health among refugee populations in Germany. Based on the collected experiences, a sub-group of the task force developed the reporting criteria presented in this paper. Thereafter, an online survey with international experts in cultural adaptation of psychological interventions was conducted, including two rounds of feedback. Results The consolidation process resulted in eleven reporting criteria to guide and document the process of cultural adaptation of psychological interventions in clinical trials. A template for documenting this process is provided. The eleven criteria are structured along A) Set-up; B) Formative research methods; C) Intervention adaptation; D) Measuring outcomes and implementation. Conclusions Reporting on cultural adaptation more consistently in future psychological trials will hopefully improve the quality of evidence and contribute to examining the effect of cultural adaptation on treatment efficacy, feasibility, and acceptability.

Intimate partner violence (IPV) strongly predicts depression, but it is unknown if women experiencing IPV can benefit from depression treatments in contexts where depression and IPV are prevalent. This study explored whether women experiencing IPV in Goa, India, can benefit from the Healthy Activity Program (HAP), a culturally adapted behavioral activation treatment, compared with enhanced usual care (EUC). Cross-sectional and longitudinal analyses were performed on data from a clinical trial. Measures assessed at baseline and 3 and 12 months included depressive symptoms. Measures assessed at 3 and 12 months included activation and IPV. Independent t tests were conducted to assess if participants experiencing IPV had higher depressive symptoms and lower activation at 3 and 12 months; hierarchical linear regression was conducted to determine if 3-month IPV predicted 12-month depressive symptoms across trial arms (Hypothesis 1). Hierarchical linear regression was then conducted to examine if the relationship between 3-month activation and 12-month depressive symptoms was moderated by 3-month IPV within each trial arm (Hypothesis 2). As expected, participants experiencing IPV had significantly lower activation levels and higher depressive symptoms compared with participants who did not experience IPV at 3 and 12 months in cross-sectional analyses. Similarly, IPV endorsed at 3 months significantly predicted depressive symptoms at 12 months. However, activation was significantly associated with less severe depressive symptoms at 12 months, irrespective of IPV endorsement among HAP participants. For EUC participants, IPV remained the only significant predictor of depressive symptoms at 12 months. Results suggest that women experiencing IPV can still benefit from behavioral activation. Electronic supplementary material The online version of this article (10.1007/s00737-019-00992-2) contains supplementary material, which is available to authorized users.

Background: Patient-centered research has emerged as a promising model to adequately address the needs and preferences of patient populations with mental disorders. The Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) Trial aims to increase access to psychological treatment and implements a multi-stakeholder perspective to understand the needs/preferences of perinatal populations with symptoms of depression and anxiety. Specifically, this pragmatic, non-inferiority randomized effectiveness trial examines whether Behavioral Activation (BA) delivered via telemedicine is as effective as in-person treatment. However, due to COVID-19, the study suspended in-person BA sessions and completely shifted to telemedicine. To ensure BA remains widely accessible, the SUMMIT team strives to resume in-person treatment in the near future. Objective: To gain perspectives of key stakeholders on the potential barriers and facilitators for SUMMIT participants to resume in-person BA sessions in a COVID-19 context. Methods: A focus group discussion (1 hour) was conducted via Zoom with N=9 stakeholders, including patient advocates, nurses, clinicians, and researchers. Qualitative data was coded using NVivo and content analysis was performed to quantify frequently endorsed themes. Results: The majority of stakeholders considered resuming in-person BA sessions to be a challenge amidst COVID-19, with more barriers than facilitators mentioned overall. Most commonly endorsed barriers that participants may face when attending in-person treatment included arranging childcare (n=8; 89%) and discomfort/fear of coming to the hospital (n=6; 67%). The most widely endorsed facilitators for resuming in-person treatment during COVID-19 were clearly communicating hospital and transportation safety precautions to participants (n=7; 78%) and conducting in-person sessions at an off-site location (n=6; 67%). Conclusion: This study identified critical facilitators of resuming in-person BA sessions that can inform: (1) how to resume in-person BA sessions and (2) the development and implementation of strategies to make BA more patient-centered for perinatal populations during COVID-19. Objective: To gain perspectives of key stakeholders on the potential barriers and facilitators for SUMMIT participants to resume in-person BA sessions in a COVID-19 context. Methods: A focus group discussion (1 hour) was conducted via Zoom with N=9 stakeholders, including patient advocates, nurses, clinicians, and researchers. Qualitative data was coded using NVivo and a content analysis was performed to quantify frequently endorsed themes. Results: The majority of stakeholders considered resuming in-person BA sessions to be a challenge amidst COVID-19, with more barriers than facilitators mentioned overall. Most commonly endorsed barriers that participants may face when attending in-person treatment included arranging childcare (n=8; 89%) and discomfort/fear of coming to the hospital (n=6; 67%). The most widely endorsed facilitators for resuming in-person treatment during COVID-19 were clearly communicating hospital and transportation safety precautions to participants (n=7; 78%) and conducting in-person sessions at an off-site location (n=6; 67%). Conclusion: This study identified critical facilitators of resuming in-person BA sessions that can inform: (1) how to resume in-person BA sessions and (2) the development and implementation of strategies to make BA more patient-centered for perinatal populations during COVID-19.

Recent literature supports the efficacy and efficiency of telemedicine in improving various health outcomes despite the wide variability in results. Understanding site-specific issues in the implementation of telemedicine trials for broader replication and generalizability of results is needed. Lessons can be learned from existing trials, and a blueprint can guide researchers to conduct these challenging studies using telemedicine more efficiently and effectively. This viewpoint presents relevant challenges and solutions for conducting multisite telemedicine trials using 7 ongoing and completed studies funded by the Patient-Centered Outcomes Research Institute portfolio of large multisite trials to highlight the challenges in implementing telemedicine trials. Critical issues of ensuring leadership and buy-in, appropriate funding, and diverse and representative trials are identified and described, as well as challenges related to clinical, informatics, regulatory, legal, quality, and billing. The lessons learned from these studies were used to create a blueprint of key aspects to consider for the design and implementation of multisite telemedicine trials.

BACKGROUND: During the COVID-19 pandemic, essentially all outpatient psychotherapy with perinatal patients transitioned to telemedicine. The aim of this study was to examine how to resume in-person psychotherapy with perinatal patients within the Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) trial as the pandemic abates. METHODS: We conducted focus groups and individual interviews with perinatal participants (n=23), providers (n=28), and a range of stakeholders (n=18) who participated in the SUMMIT trial from August 2020 to March 2021. Content analysis was used to examine (1) previous barriers that impacted perinatal participants access or decision to access in-person healthcare during COVID-19; (2) perceived future barriers for perinatal participants to attend in-person sessions; and (3) potential facilitators to resuming in-person sessions with perinatal participants. RESULTS: Perinatal participants (69.6%) and providers (57.1%) reported that COVID-19 previously impacted perinatal SUMMIT patients’ access or decision to access in-person healthcare. Specifically, “external barriers” such as institutional regulations due to COVID-19 (100% perinatal participants and 68.8% providers) and “internal barriers” such as concerns about being exposed to COVID-19 (75.0% perinatal participants and 56.3% providers) impacted perinatal participants access to in-person care. Perceived barriers to resuming in-person psychotherapy sessions included concerns about virus exposure in a hospital setting (77.8% stakeholders, 73.9% perinatal participants, 71.4% providers); virus exposure while taking public transportation (50.0% stakeholders, 26.1% perinatal participants, 25.0% providers). Stakeholders (50.0%) were more likely than providers (25.0%) and participants (13.0%) to endorse wearing a mask during sessions as a barrier. Key facilitators to resuming in-person psychotherapy sessions were the implementation and effective communication of robust safety protocols (72.2% stakeholders, 47.8% perinatal participants, 39.3% providers) and providing alternative locations to where sessions are delivered, e.g., using large rooms (44.4% stakeholders, 32.1% providers, 17.4% perinatal participants). CONCLUSION: The results suggest that a significant majority of perinatal participants experienced barriers to accessing in-person healthcare during the pandemic, and concerns about contracting the virus within and en route to the hospital remain while the COVID-19 pandemic persists. To overcome these barriers, our study suggests that implementing and effectively communicating robust safety protocols may be the most effective methods to address these concerns when resuming in-person psychotherapy sessions.

UNSTRUCTURED Recent literature supports the efficacy and efficiency of telemedicine in improving various health outcomes despite the wide variability in results. Understanding site-specific issues in the implementation of telemedicine trials for broader replication and generalizability of results is needed. Lessons can be learned from existing trials, and a blueprint can guide researchers to conduct these challenging studies using telemedicine more efficiently and effectively. This viewpoint presents relevant challenges and solutions for conducting multisite telemedicine trials using 7 ongoing and completed studies funded by the Patient-Centered Outcomes Research Institute portfolio of large multisite trials to highlight the challenges in implementing telemedicine trials. Critical issues of ensuring leadership and buy-in, appropriate funding, and diverse and representative trials are identified and described, as well as challenges related to clinical, informatics, regulatory, legal, quality, and billing. The lessons learned from these studies were used to create a blueprint of key aspects to consider for the design and implementation of multisite telemedicine trials.

IMPORTANCE: Task sharing—or training of nonspecialist providers with no formal training in counseling—is an effective strategy to improve access to evidence-based counseling interventions and has the potential to address the burden of perinatal depression and anxiety. OBJECTIVES: To identify the relevant implementation processes (who, what, where, and how) and to assess the effectiveness of counseling interventions delivered by nonspecialist providers for perinatal depression and anxiety in high-income countries. DATA SOURCES: CINAHL, Ovid MEDLINE, Ovid MEDLINE In-Process, PsycINFO, Web of Science, Cochrane Central Register of Controlled Trials, and Embase through December 31, 2019. Relevant systematic reviews were also considered. STUDY SELECTION: Randomized clinical trials of counseling interventions that assessed depression or anxiety after intervention, delivered by a nonspecialist provider for adults, and that targeted perinatal populations in a high-income country were included. Self-help interventions that did not include a provider component were excluded. DATA EXTRACTION AND SYNTHESIS: Four researchers independently reviewed abstracts and full-text articles, and 2 independently rated the quality of included studies. Random-effects meta-analysis was used to estimate the benefits of the interventions. The Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline was followed. MAIN OUTCOMES AND MEASURES: For implementation processes, the frequencies represented by a total or percentage were estimated, where the denominator is the total number of eligible trials, unless otherwise indicated. For effectiveness, primary and secondary outcome data of depression, anxiety, or both symptoms were used, with separate analyses for prevention and treatment, stratified by depression or anxiety. Subgroup analyses compared outcome types (anxiety vs depression) and study objectives (treatment vs prevention). RESULTS: In total, 46 trials (18 321 participants) were included in the systematic review; 44 trials (18 101 participants) were included in the meta-analysis. Interventions were implemented across 11 countries, with the majority in Australia, UK, and US. Two-thirds (65%) of counseling interventions were provided by nurses and midwives, lasted a mean of 11.2 weeks (95% CI, 6.4-16.0 weeks), and most were delivered face to face (31 [67.4%]). Only 2 interventions were delivered online. A dearth of information related to important implementation processes, such as supervision, fidelity, and participant sociodemographic characteristics, was observed in many articles. Compared with controls, counseling interventions were associated with lower depressive symptoms (standardized mean difference [SMD], 0.24 [95% CI, 0.14-0.34]; 43 trials; I(2) = 81%) and anxiety scores (SMD, 0.30 [95% CI, 0.11-0.50]; 11 trials; I(2) = 80%). Treatment interventions were reported to be effective for both depressive symptoms (SMD, 0.38 [95% CI, 0.17-0.59]; 15 trials; I(2) = 69%) and anxiety symptoms (SMD, 0.34 [95% CI, 0.09-0.58]; 6 trials; I(2) = 71%). However, heterogeneity was high among the trials included in this analysis. CONCLUSIONS AND RELEVANCE: This study found evidence in high-income countries indicating that nonspecialist providers may be effective in delivering counseling interventions. Additional studies are needed to assess digital interventions and ensure the reporting of implementation processes to inform the optimal delivery and scale-up of these services.

Early childhood development (ECD) parenting interventions can improve child developmental outcomes in low-resource settings, but information about their implementation lags far behind evidence of their effectiveness, hindering their generalizability. This study presents results from an implementation evaluation of Msingi Bora (“Good Foundation” in Swahili), a group-based responsive stimulation and nutrition education intervention recently tested in a cluster randomized controlled trial across 60 villages in rural western Kenya. Msingi Bora successfully improved child cognitive, receptive language, and socioemotional outcomes, as well as parenting practices. We conducted a mixed methods implementation evaluation of the Msingi Bora trial between April 2018 and November 2019 following the Consolidated Advice for Reporting ECD implementation research (CARE) guidelines. We collected qualitative and quantitative data on program inputs, outputs, and outcomes, with a view to examining how aspects of the program's implementation, such as program acceptance and delivery fidelity, related to observed program impacts on parents and children. We found that study areas had initially very low levels of familiarity or knowledge of ECD among parents, community delivery agents, and even supervisory staff from our partner non-governmental organization (NGO). We increased training and supervision in response, and provided a structured manual to enable local delivery agents to successfully lead the sessions. There was a high level of parental compliance, with median attendance of 13 out of 16 fortnightly sessions over 8 months. For delivery agents, all measures of delivery performance and fidelity increased with program experience. Older, more knowledable delivery agents were associated with larger impacts on parental stimulation and child outcomes, and delivery agents with higher fidelity scores were also related to improved parenting practices. We conclude that a group-based parenting intervention delivered by local delivery agents can improve multiple child and parent outcomes. An upfront investment in training local trainers and delivery agents, and regular supervision of delivery of a manualized program, appear key to our documented success. Our results represent a promising avenue for scaling similar interventions in low-resource rural settings to serve families in need of ECD programming. This trial is registered at ClinicalTrials.gov, {"type":"clinical-trial","attrs":{"text":"NCT03548558","term_id":"NCT03548558"}}NCT03548558, June 7, 2018. https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT03548558","term_id":"NCT03548558"}}NCT03548558.

Background Depression and anxiety impact up to 1 in 5 pregnant and postpartum women worldwide. Yet, as few as 20% of these women are treated with frontline interventions such as evidence-based psychological treatments. Major barriers to uptake are the limited number of specialized mental health treatment providers in most settings, and problems with accessing in-person care, such as childcare or transportation. Task sharing of treatment to non-specialist providers with delivery on telemedicine platforms could address such barriers. However, the equivalence of these strategies to specialist and in-person models remains unproven. Methods This study protocol outlines the Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) randomized trial. SUMMIT is a pragmatic, non-inferiority test of the comparable effectiveness of two types of providers (specialist vs. non-specialist) and delivery modes (telemedicine vs. in-person) of a brief, behavioral activation (BA) treatment for perinatal depressive and anxiety symptoms. Specialists (psychologists, psychiatrists, and social workers with ≥ 5 years of therapy experience) and non-specialists (nurses and midwives with no formal training in mental health care) were trained in the BA protocol, with the latter supervised by a BA expert during treatment delivery. Consenting pregnant and postpartum women with Edinburgh Postnatal Depression Scale (EPDS) score of ≥ 10 (N = 1368) will be randomized to one of four arms (telemedicine specialist, telemedicine non-specialist, in-person specialist, in-person non-specialist), stratified by pregnancy status (antenatal/postnatal) and study site. The primary outcome is participant-reported depressive symptoms (EPDS) at 3 months post-randomization. Secondary outcomes are maternal symptoms of anxiety and trauma symptoms, perceived social support, activation levels and quality of life at 3-, 6-, and 12-month post-randomization, and depressive symptoms at 6- and 12-month post-randomization. Primary analyses are per-protocol and intent-to-treat. The study has successfully continued despite the COVID-19 pandemic, with needed adaptations, including temporary suspension of the in-person arms and ongoing randomization to telemedicine arms. Discussion The SUMMIT trial is expected to generate evidence on the non-inferiority of BA delivered by a non-specialist provider compared to specialist and telemedicine compared to in-person. If confirmed, results could pave the way to a dramatic increase in access to treatment for perinatal depression and anxiety. Trial registration ClinicalTrials.gov NCT 04153864. Registered on November 6, 2019.

Increased interest in disseminating and implementing psychological treatments has focused on the need for evidence-based training programs for providers, especially those without specialized training. To evaluate provider-training programs, validated outcome measures are necessary; however, the scalable measurement of training outcomes has been largely overlooked. Current methods of assessing providers' ability to deliver psychological treatments are generally time-consuming and costly, representing a major bottleneck in scaling up mental health care for commonly occurring disorders such as depression. The present study describes the development and initial validation of a scalable measure for assessing provider competence in delivering a brief behavioral activation treatment for depression, called the Healthy Activity Program, adapted for primary care settings. The measure focuses on testing knowledge about the treatment and applied knowledge regarding how to skillfully deliver the treatment, both essential features of competence. The measure was tested on a sample of 531 respondents with a variety of educational levels and professional backgrounds and found to meet the requirements of the Rasch model. Three versions of the measure each of equal difficulty were derived to allow repeat testing of training outcomes over time. A scalable measure of provider competence is an essential first step towards supporting the wider dissemination and implementation of brief psychological interventions for depression, especially in low-resource settings.

Background Training non-specialist health workers (NSHWs) at scale is a major barrier to increasing the coverage of depression care in India. This trial will test the effectiveness of two forms of digital training compared to conventional face-to-face training in changing the competence of NSHWs to deliver a brief evidence-based psychological treatment for depression. Methods This protocol is for a three-arm, parallel group randomized controlled trial comparing three ways of training NSHWs to deliver the Healthy Activity Program (HAP), a brief manualized psychotherapy for depression, in primary care. The arms are: digital training (DGT); digital training combined with individualized coaching support (DGT+); and conventional face-to-face training (F2F). The target sample comprises N = 336 government contracted NSHWs in Madhya Pradesh, India. The primary outcome is change of competence to deliver HAP; secondary outcomes include cost-effectiveness of the training programs, change in participants' mental health knowledge, attitudes and behavior, and satisfaction with the training. Assessors blind to participant allocation status will collect outcomes pre- (baseline) and post- (endpoint) training to ascertain differences in outcomes between arms. Training program costs will be collected to calculate incremental costs of achieving one additional unit on the competency measure in the digital compared to face-to-face training programs. Health worker motivation, job satisfaction, and burnout will be collected as exploratory outcome variables. Discussion This trial will determine whether digital training is an effective, cost-effective, and scalable approach for building workforce capacity to deliver a brief evidence-based psychological treatment for depression in primary care in a low-resource setting. Trial Registration ClinicalTrials.gov Identifier: NCT04157816

The Healthy Activity Program (HAP), a brief, lay-counselor-delivered, behavioral activation psychological treatment, was found to be effective in reducing depressive symptoms among primary care attendees in India. We now examine whether early response predicts depression (PHQ-9) outcomes at the primary endpoint of 3 months and sustained recovery at 12 months after enrollment and the extent to which this effect is influenced by sudden gains in the context of the larger randomized controlled trial. HAP participants ( N = 245) who exhibited an early response (150 of 245 or 61.2%), as defined by a 50% reduction in depressive symptoms from baseline to Session 3, had lower depressive symptom scores than those who did not at 3 months (5.29 vs. 10.75, F = 33.21, p < .001) and at 12 months (6.56 vs. 11.02, F = 21.84, p < .001). Further exploratory analyses suggested that this advantage was largely confined to the subset of early responders who also showed sudden gains (87 of 150).

BackgroundThe current study explored the temporal pathways of change within two treatments, the Healthy Activity Program (HAP) for depression and the Counselling for Alcohol Problems (CAP) Program for harmful drinking.MethodsThe study took place in the context of two parallel randomized controlled trials in Goa, India. N = 50 random participants who met a priori criteria were selected from each treatment trial and examined for potential direct and mediational pathways. In HAP, we examined the predictive roles of therapy quality and patient-reported activation, assessing whether activation mediated the effects of therapy quality on depression (Patient Health Questionnaire-9) outcomes. In CAP, we examined the predictive roles of therapy quality and patient change- and counter-change-talk, assessing whether change- or counter-change-talk mediated the effects of therapy quality on daily alcohol consumption.ResultsIn HAP, therapy quality (both general and treatment-specific skills) was associated with patient activation; patient activation but not therapy quality significantly predicted depression outcomes, and patient activation mediated the effects of higher general skills on subsequent clinical outcomes [a × b = −2.555, 95% confidence interval (CI) −5.811 to −0.142]. In CAP, higher treatment-specific skills, but not general skills, were directly associated with drinking outcomes, and reduced levels of counter-change talk both independently predicted, and mediated the effects of higher general skills on, reduced alcohol consumption (a × b = −24.515, 95% CI −41.190 to −11.060). Change talk did not predict alcohol consumption and was not correlated with counter-change talk.ConclusionThese findings suggest that therapy quality in early sessions operated through increased patient activation and reduced counter-change talk to reduce depression and harmful drinking respectively.

Purpose Adolescence encompasses a critical developmental phase, which fosters or hinders psychological, physical, and social health. Whole-school interventions take a universal approach in targeting the entire school environment (“school climate”) to improve adolescent outcomes; however, little is known about the mediating role of school climate on these effects. Methods Our study (N = 5,539) was situated within the Strengthening Evidence base on scHool-based intErventions for pRomoting randomized controlled trial, which demonstrated the effectiveness of a lay counselor–delivered school intervention among secondary school students in Bihar, India. We examined the potential mediating role of school climate and its subcomponents (relationships at school, sense of belonging, commitment to academic achievement, and participation in school events) at 8 months postrandomization of the Strengthening Evidence base on scHool-based intErventions for pRomoting intervention on longer term adolescent health outcomes (depressive symptoms, experiences of bullying, and perpetration of violence) at 17 months postrandomization. The trial was registered with ClinicalTrials.gov ( NCT02484014 ). Results School climate mediated the effects of the intervention on all three outcomes of interest. A nurturing school environment, characterized by supportive and engaged relationships with teachers and peers, a sense of belonging, and active participation in school climate predicted lower rates of depressive symptoms, experiences of bullying, and perpetration of violence. Noteworthy, it was the quality of these relationships, rather than the commitment to learning, which was most predictive of outcomes. Conclusion Educational policies should consider bolstering the school’s social environment to directly impact adolescent health and well-being.