This study sought to develop a user-friendly decision-making tool to explore country-specific estimates for costs and economic consequences of different options for scaling screening and psychosocial interventions for women with common perinatal mental health problems in Malawi. We developed a simple simulation model using a structure and parameter estimates that were established iteratively with experts, based on published trials, international databases and resources, statistical data, best practice guidance and intervention manuals. The model projects annual costs and returns to investment from 2022 to 2026. The study perspective is societal, including health expenditure and productivity losses. Outcomes in the form of health-related quality of life are measured in Disability Adjusted Life Years, which were converted into monetary values. Economic consequences include those that occur in the year in which the intervention takes place. Results suggest that the net benefit is relatively small at the beginning but increases over time as learning effects lead to a higher number of women being identified and receiving (cost‑)effective treatment. For a scenario in which screening is first provided by health professionals (such as midwives) and a second screening and the intervention are provided by trained and supervised volunteers to equal proportions in group and individual sessions, as well as in clinic versus community setting, total costs in 2022 amount to US$ 0.66 million and health benefits to US$ 0.36 million. Costs increase to US$ 1.03 million and health benefits to US$ 0.93 million in 2026. Net benefits increase from US$ 35,000 in 2022 to US$ 0.52 million in 2026, and return-on-investment ratios from 1.05 to 1.45. Results from sensitivity analysis suggest that positive net benefit results are highly sensitive to an increase in staff salaries. This study demonstrates the feasibility of developing an economic decision-making tool that can be used by local policy makers and influencers to inform investments in maternal mental health.

UNASSIGNED: Psychosocial intervention is imperative for treating alcohol use disorder (AUD), but there is no comprehensive evidence regarding its effectiveness. Therefore, this study aimed to determine the effectiveness of psychosocial interventions in treating AUD amongadolescents and young adults.
UNASSIGNED: In this systematic review and meta-analysis, articles were searched from EMBASE, PubMed, Medline, CINAHL, Web of Science, PsycINFO, and Scopus. Also, articles were retrieved from gray literature. The quality of articles has been assessed using the Cochrane risk of bias assessment.
UNASSIGNED: A total of 12 randomized controlled trials were included. Integrated family and CBT, CBT, guided self-change, and ecologically based family therapy had a mild effect in reducing alcohol use frequency. On the other hand, integrated motivational enhancement therapy and CBT (-0.71 [95% CI: -0.97, -0.45]) and common elements treatment approaches (4.5 [95% CI: 6.9, 2.2]) had the highest effect size for reducing alcohol use frequency and amount, respectively. In conclusion, most of the interventions had no significant effect on different drinking outcomes. Nonetheless, the effectiveness of combined interventions surpassed that of the single interventions. The effect of psychosocial interventions on abstinence was inconclusive. Therefore, future studies will explore alternative, newly emerged third-wave therapeutic approaches.
UNASSIGNED: PROSPERO, CRD42023435011, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=435011.

BACKGROUND: Many individuals receiving outpatient physical therapy have musculoskeletal pain and up to one-third use prescription opioids. The impact of physical therapist-led mindfulness-based interventions integrated with evidence-based physical therapy (I-EPT) to manage patients with chronic musculoskeletal pain and long-term opioid treatment has not been elucidated. This project evaluates the feasibility of conducting a cluster randomised trial to test the effectiveness of I-EPT.
METHODS: Study 1 aim: Refine and manualise the I-EPT treatment protocol. Our approach will use semistructured interviews of patients and physical therapists to refine an I-EPT training manual. Study 2 aim: Evaluate different intensities of physical therapist training programmes for the refined I-EPT treatment protocol. Physical therapists will be randomised 1:1:1 to high-intensity training (HighIT), low-IT (LowIT) training and no training arms. Following training, competency in the provision of I-EPT (LowIT and HighIT groups) will be assessed using standardised patient simulations. Study 3 aim: Evaluate the feasibility of the I-EPT intervention across domains of the Reach, Effectiveness, Adoption, Implementation, Maintenance implementation framework. The refined I-EPT treatment protocol will be tested in two different health systems with 90 patients managed by the randomised physical therapists. The coprimary endpoints for study 3 are the proportions of the Pain, Enjoyment of Life and General Activity Scale and the Timeline Followback for opioid use/dose collected at 12 weeks.
BACKGROUND: Ethics approval for the study was obtained from the University of Utah, University of Florida and Florida State University Institutional Review Boards. Informed consent is required for participant enrolment in all phases of this project. On completion, study data will be made available in compliance with NIH data sharing policies.
BACKGROUND: NCT05875207.

BACKGROUND: Adolescents and young adults (AYAs) with cancer are at risk of poor psychosocial outcomes. AYAs grew up with the internet and digital technology, and mobile Health (mHealth) psychosocial interventions have the potential to overcome care access barriers.
OBJECTIVE: This pilot randomized controlled trial (RCT) aimed to establish the feasibility, acceptability, and preliminary efficacy of a fully automated mobile app version of the Promoting Resilience in Stress Management intervention (mPRISM). Promoting Resilience in Stress Management is an evidence-based intervention developed in collaboration with AYAs, based on stress and coping theory, resilience theory, and evidence-based coping strategies. We hypothesized that mPRISM would be feasible, acceptable, and appropriate.
METHODS: This is a parallel, 2-arm, single-site pilot RCT with a waitlist control design. The study will recruit 80 AYAs with cancer from a clinic. Eligible AYAs are aged 12 to 25 years, within 12 months of a new cancer diagnosis, receiving chemotherapy or radiation therapy, speak, read, or write in English, and are cognitively able to participate in study procedures. Recruitment by clinical research coordinators will occur remotely by phone, video, or text. Participants will be randomized to psychosocial usual care (UC) alone or UC plus mPRISM for an 8-week intervention period, and will remain unblinded to study condition. Enrolled participants will complete surveys at baseline before randomization, 8 weeks, and 3-month follow-up. Using a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys. Those in the UC arm will complete 2 additional measurement points at immediate posttreatment and 3 months later. The primary outcomes of interest are feasibility, defined as ≥60% enrollment and ≥70% retention (ie, percentage of participants who completed the study), and \"feasibility, acceptability, and appropriateness\" as defined by cut-off scores ≥4/5 on 3 brief validated implementation outcome measures (feasibility of implementation measure, acceptability of intervention measure [AIM], intervention appropriateness measure [IAM]). We will apply top-box scoring for the implementation measures. Exploratory outcomes of interest include patient-reported health-related quality of life, resilience, distress, anxiety, depression, pain, and sleep. We will conduct an intention-to-treat analysis to compare the outcomes of the mPRISM arm versus the control arm with covariate-adjusted regression models. We will summarize individual digital usage metrics using descriptive statistics.
RESULTS: Since September 2023, we have enrolled 20 participants and recruitment is ongoing.
CONCLUSIONS: Although our previous work suggests AYAs with cancer are interested in mHealth psychosocial interventions, such interventions have not yet been sufficiently evaluated or implemented among AYA oncology patients. mPRISM may serve as a potential mHealth intervention to fill this gap. In this study, we will test the feasibility, acceptability, and preliminary efficacy of mPRISM. This work will inform future larger-scale RCTs powered for efficacy outcomes.
BACKGROUND: ClinicalTrials.gov NCT05842902; https://clinicaltrials.gov/study/NCT05842902.
UNASSIGNED: DERR1-10.2196/57950.

BACKGROUND: Cognitive behavioural therapy for insomnia (CBT-I) is recommended as the first-line treatment for insomnia yet remains underutilised in general practice. Understanding patient motivations and barriers to engaging in psychological interventions for insomnia is critical. Theoretical frameworks, such as the theory of planned behaviour, are needed to identify variables related to intentions and behaviour change.
OBJECTIVE: To explore key influences that motivate individuals\' intention to engage with psychological interventions for insomnia.
METHODS: Qualitative study consisting of an online survey and interviews with 20 community-dwelling participants with insomnia aged 26-75 years residing in Victoria, Australia.
METHODS: Guided by the theory of planned behaviour, reflexive thematic analysis was used to identify factors influencing participants\' intention to engage with psychological interventions for insomnia.
RESULTS: Participants reported positive attitudes towards psychological interventions for insomnia, stemming from negative beliefs about pharmacological sleep aids and the perceived benefits of a structured and evidence-based intervention. Important others positively influenced participants\' intention to engage; however, the GP influence was less consistent and often indirect. Participants believed in the efficacy of psychological interventions, but several barriers hampered their ability to benefit from them. Accessibility was identified as a key facilitator, whereas lack of knowledge and clear referral pathways were the main barriers having an impact on uptake.
CONCLUSIONS: This study highlights key factors influencing patients\' intention to engage in psychological interventions for insomnia as well as opportunities for GPs to support uptake and engagement. Routine conversations about sleep health are essential to reduce the burden of untreated insomnia in the community, and the active promotion of evidence-based psychological interventions is needed.

BACKGROUND: Emotional problems in adolescents living in low-income and middle-income countries (LMICs) remain largely unaddressed; key reasons include a scarcity of trained mental health professionals and unavailability of evidence-based, scalable psychological interventions. We aimed to evaluate the effectiveness of a non-specialist-delivered, group psychological intervention to reduce psychosocial distress in school-going adolescents in Pakistan.
METHODS: In a two-arm, single-blind, cluster randomised controlled trial, eligible public school clusters from a rural subdistrict of Gujar Khan, Rawalpindi, Pakistan, were randomised (1:1, stratified by sex) using permuted block randomisation into intervention (n=20) and wait-list control (n=20) groups. Adolescents aged 13-15 years who provided informed assent and caregivers\' consent were screened for psychosocial distress using the youth-reported Pediatric Symptoms Checklist (PSC; total psychosocial distress scores from 0 to 70), and those scoring 28 or more and their caregivers were enrolled into the trial. Adolescents in the intervention group received seven weekly group sessions and their caregivers received three biweekly group sessions in school settings from trained non-specialists. The primary outcome was change from baseline in the total PSC scores at 3 months post-intervention. The trial was registered prospectively with the International Standard Randomised Controlled Trial Number registry, ISRCTN17755448.
RESULTS: From the 40 school clusters that were included, 282 adolescents in the intervention group and 284 adolescents in the wait-list control group were enrolled between Nov 2 and Nov 30, 2021. At 3 months, adolescents in the intervention group had significantly lower mean total score on the PSC compared with adolescents in the control group (mean difference in change from baseline 3·48 [95% CI 1·66-5·29], p=0·0002, effect size 0·38 [95% CI 0·18-0·57]; adjusted mean difference 3·26 (95% CI 1·46-5·06], p=0·0004, effect size 0·35 (0·16-0·55). No adverse events were reported in either group.
CONCLUSIONS: The group psychological intervention most likely represents a feasible and effective option for adolescents with psychosocial distress in school settings.
BACKGROUND: UK Medical Research Council, Foreign Commonwealth and Development Office, Department of Health and Social Care.
UNASSIGNED: For the Urdu translation of the abstract see Supplementary Materials section.

UNASSIGNED: Person-centered goals capture individual priorities in personal contexts. Goal Attainment Scaling (GAS) has been used in drug trials involving people living with dementia (PLWD) but GAS has been characterized as difficult to incorporate into trials and clinical practice. We used GAS in a trial of New Interventions for Independence in Dementia Study (NIDUS)-family, a manualized care and support intervention, as the primary outcome and to tailor the interventions to goals set. We aimed to assess the feasibility and content of baseline goal-setting.
UNASSIGNED: We developed training for nonclinical facilitators to set individualized GAS goals remotely with PLWD and family carer dyads, or carers alone, in the intervention trial, during the COVID-19 pandemic. A qualitative content analysis of the goals set explored participants\' priorities and unmet needs, to consider how existing GAS goal domains might be extended in a psychosocial intervention trial context.
UNASSIGNED: Eleven facilitators were successfully trained to set and score GAS goals. A total of 313/328 (95%) participants were able to collaboratively set three to five goals with the facilitators. Of these, 302 randomized participating dyads set 1043 (mean 3.5, range 3 to 5) goals. We deductively coded 719 (69%) goals into five existing GAS domains (mood, behavior, self-care, cognition, and instrumental activities of daily living); 324 (31%) goals were inductively coded into four new domains: carer break, carer mood, carer behavior, and carer sleep. The most frequently set goals pertained to social support. There was little variation in types of goals set based on the context of who set them or level of pandemic restrictions in place.
UNASSIGNED: It is feasible for people without clinical training to set GAS holistic goals for PLWD and family carers in the community. GAS has potential to facilitate personalization of care and support interventions, such as NIDUS-family, and facilitate the roll out of more personalized care.
UNASSIGNED: Goal Attainment Scaling (GAS) can capture meaningful priorities of people with dementia and their family carers.A psychosocial intervention RCT used GAS as the primary outcome measure and goals were set collaboratively by non-clinically trained facilitators.The findings underscore the feasibility of using GAS as an outcome measure with this population.The content analysis findings unveiled the diversity in experiences and priorities of the study participants.GAS has the potential to support the implementation of more person-centred approaches to dementia care.

This study compares medication and psychosocial treatments for opioid use disorder, as well as treatments offered at opioid and nonopioid treatment program facilities for commonly co-occurring substance use disorders and mental disorders.

BACKGROUND: Adolescents living with HIV (ALHIV) are an extremely vulnerable population, with the burden of mental health problems carefully documented together with the constraints for receiving timely and adequate management of the problems, especially in rural settings. Problem Management Plus (PM+) is a scalable psychological intervention for individuals impaired by distress in communities exposed to adversity. Initially developed for adult populations, few studies have assessed its potential to address adolescent distress. This study aims to co-adapt PM+ with an adherence component (PM+Adherence) for ALHIV and to evaluate its acceptability and feasibility in rural Kwa-Zulu Natal Province, South Africa.
METHODS: We will use a mixed-methods approach over three phases. The first phase will include a realist synthesis and collection of formative data from up to 60 ALHIV, caregivers and healthcare providers to inform the adaptation of WHO PM+, including the components of an adherence module. During the second phase, we will undertake the cultural adaptation of the PM+Adherence intervention. The third phase will involve a hybrid type 3 implementation strategy among ALHIV aged 16-19 years (n=50) to implement and evaluate the feasibility of the culturally co-adapted PM+Adherence. The feasibility indicators to be evaluated include reach, adoption, attrition, implementation and acceptability of the adapted intervention, which will be assessed qualitatively and quantitatively. In addition, we will assess preliminary effectiveness using an intention-to-treat approach on HIV-related indicators and mental health outcomes at baseline, end intervention, 2-month follow-up during the 6-month implementation.
CONCLUSIONS: We expect that the PM+Adherence will be acceptable and can feasibly be delivered by lay counsellors in resource-limited rural KwaZulu-Natal.
BACKGROUND: Ethical clearance has been obtained from the University of KwaZulu-Natal Biomedical Research Ethics Committee, (BREC/00005743/2023). Dissemination plans include presentations at scientific conferences, peer-reviewed publications and community level.

UNASSIGNED: Depression is a leading cause of disability worldwide yet its underlying factors, particularly microbial associations, are poorly understood.
UNASSIGNED: We examined the longitudinal interplay between the microbiome and immune system in the context of depression during an immersive psychosocial intervention. 142 multi-omics samples were collected from 52 well-characterized participants before, during, and three months after a nine-day inquiry-based stress reduction program.
UNASSIGNED: We found that depression was associated with both an increased presence of putatively pathogenic bacteria and reduced microbial beta-diversity. Following the intervention, we observed reductions in neuroinflammatory cytokines and improvements in several mental health indicators. Interestingly, participants with a Prevotella-dominant microbiome showed milder symptoms when depressed, along with a more resilient microbiome and more favorable inflammatory cytokine profile, including reduced levels of CXCL-1.
UNASSIGNED: Our findings reveal a protective link between the Prevotella-dominant microbiome and depression, associated with a less inflammatory environment and moderated symptoms. These insights, coupled with observed improvements in neuroinflammatory markers and mental health from the intervention, highlight potential avenues for microbiome-targeted therapies in depression management.