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Psychosocial safety climate (PSC) and working conditions, predictors of mental health and antidepressant and opioid use in Australia: a study protocol for longitudinal data linkage

Por: Crispin · C. N. · Afsharian · A. · Loh · M. Y. · Dollard · M. F. · Dormann · C. · Glozier · N. · Gill · T. · Taylor · A. W.
Introduction

Work-related stress is a social determinant of global health that represents a huge cost to workers’ health and reduces work performance. In Australia, mental well-being is a pressing national issue—with one in five Australians experiencing mental disorders. Antidepressants are a first-line medication commonly used to treat mental disorders. Recently, Australia has seen a dramatic increase in the use of prescribed antidepressant medications to treat mental health related illnesses. Australia has also seen a dramatic increase in the use of prescribed opioid analgesics for non-cancer pain including opioid use for psychological distress and social stressors. It is plausible a rise in mental health problems and antidepressant and opioid medication use is partly attributable to the corporate climate for worker mental health (ie, the psychosocial safety climate, PSC). This research aims to identify how PSC and workplace conditions contribute to employee well-being and distress that culminate in antidepressant and opioid medication use.

Methods/analysis

Data will be collected through creative data linkage from the Australian Workplace Barometer (AWB), to medication data (via the Pharmaceutical Benefits Scheme, PBS). The participant sample will include 1372 working Australians from the AWB project from 2009 to 2021. Four waves of longitudinal data from 2009 to 2021 will be used to investigate the plausible link between Australia’s high levels of antidepressant and opioid use and distress at work. The project advances theory by probing the role corporate climate plays in work design, distress, mental health problems and antidepressant and opioid use. It will determine if antidepressant and opioid use has led to an underestimation of work stress effects. Proposed theoretical models will be analysed through linked data, using continuous time structural equation modelling, hierarchical linear modelling, logistic regression and cost estimation.

Ethics and dissemination

The study has been approved by the Human Research Ethics Committee of the University of South Australia (Ethics Protocol: 203003). Further, approval from the Australian Institute of Health and Welfare Ethics Committee was also granted for linkage of AWB data and PBS data (EthOS Application EO2022/1/1190).

Results of the study will be disseminated through worldwide keynotes, key international settings, high-impact peer-reviewed journals, industry conference presentations and media outlets to reach managers, workers, and industry partners. Further, UniSA requires publications from public projects to be held in an institutional repository which fulfils the Australian Research Council’s Open Access Policy.

Suicidality Treatment Occurring in Paediatrics (STOP) Medication Suicidality Side Effects Scale in young people in two cohorts across Europe

Por: Santosh · P. · Sala · R. · Lievesley · K. · Singh · J. · Arango · C. · Buitelaar · J. K. · Castro-Fornieles · J. · Coghill · D. · Dittmann · R. W. · Flamarique · I. · Hoekstra · P. J. · Llorente · C. · Purper-Ouakil · D. · Schulze · U. · Zuddas · A. · Parnell · N. · Mohan · M. · Fiori · F
Objectives

As part of the ‘Suicidality: Treatment Occurring in Paediatrics (STOP)’ study, we developed and performed psychometric validation of an electronic-clinical-outcome-assessment (eCOA), which included a patient-reported-outcome (ePRO), an observer-rated-outcome (eObsRO) for parents/carers and a clinician-reported-outcome (eClinRO) that allows identification and monitoring of medication-related suicidality (MRS) in adolescents.

Design

STOP: Prospective study: A two phase validation study to assess the impact of medication on suicidal ideations.

Setting

Six participating countries: Netherlands, UK, Germany, France, Spain and Italy that were part of the Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 261411.

Participants

Cohort 1 consisted of 41 adolescent-completions, 50 parent-completions and 56 clinician-completions. Cohort 2 consisted of 244 adolescent-completions, 198 parent-completions and 240 clinician-completions from across the six countries. The scale was administered only to participants who have screened positive for the STOP-Suicidality Assessment Scale (STOP-SAS).

Results

A total of 24 items for the development of the STOP-Medication Suicidality Side Effects Scale (STOP-MS3) were identified and three versions (for patients, parents and clinicians) of the STOP-MS3 were developed and validated in two separate study cohorts comprising of adolescents, their parents and clinicians. Cronbach’s α coefficients were above 0.85 for all domains. The inter-rater reliability of the STOP-MS3 was good and significant for the adolescent (ePRO), clinician (eClinRO) (r=0.613), parent (eObsRO) versions of the scale (r=0.394) and parent and clinician (r=0.347). Exploratory factor analysis identified a 3-factor model across 24 items for the adolescent and parent version of the scale: (1) Emotional Dysregulation, (2) Somatic Dysregulation and (3) Behavioural Dysregulation. For the clinician version, a 4-factor model defined the scale structure: (1) Somatic Dysregulation, (2) Emotional Dysregulation, (3) Behavioural Dysregulation and (4) Mood Dysregulation.

Conclusion

These findings suggest that the STOP-MS3 scale, a web-based eCOA, allows identification and monitoring of MRS in the adolescent population and shows good reliability and validity.

Advancing Suicide Intervention Strategies for Teens (ASSIST): study protocol for a multisite randomised controlled trial

Por: Adrian · M. · McCauley · E. · Gallop · R. · Stevens · J. · Jobes · D. A. · Crumlish · J. · Stanley · B. · Brown · G. K. · Green · K. L. · Hughes · J. L. · Bridge · J. A.
Introduction

Brief interventions that reduce suicide risk following youth’s experience with acute care due to suicidality are needed.

Methods and analysis

The study will use a three-arm randomised controlled trial designed to test the effectiveness of the Safety Planning Intervention with structured follow-up (SPI+) and the Collaborative Assessment and Management of Suicidality (CAMS) compared with enhanced usual care. The primary outcomes measure will be suicidal events, defined as death by suicide, attempted suicide, preparatory acts toward imminent suicidal behaviour or suicidal ideation resulting in a change in emergency evaluation or inpatient admission. Secondary measures will be the number of suicide attempts and severity of suicidal ideation. The experimental interventions, SPI+ and CAMS, consist of up to eight sessions over approximately 8 weeks that are designed to manage (SPI+) or treat (CAMS) patient-identified ‘drivers’ of suicidal thoughts and behaviours. Mechanisms and moderators of change will be evaluated to understand treatment impacts.

Ethics and dissemination

This study has been approved by the Seattle Children’s Institutional Review Board and is monitored by external agencies including the University of Washington Institute for Translational Health Sciences, and a National Institute of Mental Health (NIMH)-appointed Data Safety and Monitoring Board. Trial results will help establish evidence towards safe and effective treatment strategies for youth transitioning from acute to outpatient care due to a suicidal crisis. The data will be shared with the NIMH Data Archives and disseminated through publications and conferences.

Trial registration number

NCT05078970.

Effectiveness, acceptability, and completeness and quality of intervention reporting of psychological interventions for people with dementia or mild cognitive impairment: protocol for a mixed-methods systematic review

Por: Svedin · F. · Blomberg · O. · Farrand · P. · Brantnell · A. · von Essen · L. · Aberg · A. C. · Woodford · J.
Introduction

Mental health difficulties such as anxiety and depression have negative impacts on psychological well-being and are common in people with dementia and mild cognitive impairment. However, access to psychological treatments is limited. This mixed-method systematic review will: (1) examine the effectiveness of psychological interventions to improve mental health and psychological well-being in people with dementia or mild cognitive impairment; (2) examine the effectiveness of these psychological interventions to improve mental health and psychological well-being in informal caregivers; (3) examine potential clinical and methodological moderators associated with effectiveness; (4) explore factors associated with the acceptability of psychological interventions from the perspective of key stakeholders; and (5) examine the completeness and quality of intervention reporting.

Methods and analysis

Electronic databases (ASSIA, CENTRAL, CINAHL, EMBASE, PsycINFO and MEDLINE) will be systematically searched and supplemented with expert contact, reference and citation checking, and grey literature searches. If possible, we will conduct a meta-analysis to examine the overall effectiveness of psychological interventions to improve mental health and psychological well-being in people with dementia or mild cognitive impairment and their informal caregivers; and examine potential clinical and methodological moderators associated with effectiveness. We will conduct a deductive framework synthesis, informed by the theoretical framework of acceptability, to explore factors associated with the acceptability of psychological interventions from the perspective of key stakeholders. In accordance with Joanna Briggs Institute guidance, we will adopt a convergent segregated approach to data synthesis and integration of quantitative and qualitative findings. We will examine the completeness and quality of intervention reporting according to the Template for Intervention Description and Replication checklist and guide.

Ethics and dissemination

No primary data will be collected, and therefore, ethical approval is not required. Results will be disseminated through a peer-reviewed publication, academic conferences, and plain language summaries.

PROSPERO registration number

CRD42023400514.

Comparing the efficacies of transcranial magnetic stimulation treatments using different targeting methods in major depressive disorder: protocol for a network meta-analysis

Por: Wang · S. · Kong · G. · Wu · G. · Cui · H. · Qian · Z. · Xu · L. · Wei · Y. · Wang · J. · Huang · J. · Wang · J. · Li · H. · Tang · Y.
Introduction

Transcranial magnetic stimulation (TMS) over the left dorsolateral prefrontal cortex (lDLPFC) has been widely used as a treatment for major depressive disorder (MDD) in the past two decades. Different methods for localising the lDLPFC target include the ‘5 cm’ method, the F3 method and the neuro-navigational method. However, whether TMS efficacies differ between the three targeting methods remains unclear. We present a protocol for a systematic review and network meta-analysis (NMA) to compare the efficacies of TMS treatments using these three targeting methods in MDD.

Methods and analysis

Relevant studies reported in English or Chinese and published up to May 2023 will be identified from searches of the following databases: PubMed, Cochrane Central Register of Controlled Trials, Embase, PsycINFO, China National Knowledge Infrastructure, Wan Fang Database, Chinese BioMedical Literature Database, and China Science and Technology Journal Database. We will include all randomised controlled trials assessing the efficacy of an active TMS treatment using any one of the three targeting methods compared with sham TMS treatment or comparing efficacies between active TMS treatments using different targeting methods. Interventions must include a minimum of 10 sessions of high-frequency TMS over the lDLPFC. The primary outcome is the reduction score of the 17-item Hamilton Depression Rating Scale, 24-item Hamilton Depression Rating Scale or Montgomery-Asberg Depression Rating Scale. The dropout rate is a secondary outcome representing the TMS treatment’s acceptability. Pairwise meta-analyses and a random-effects NMA will be conducted using Stata. We will use the surface under the cumulative ranking curve to rank the different targeting methods in terms of efficacy and acceptability.

Ethics and dissemination

This systematic review and NMA does not require ethics approval. The results will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023410273.

The moderating and mediating role of eating behaviour traits in acceptance and commitment therapy-based weight management interventions: protocol for an individual participant data meta-analysis

Por: Kudlek · L. · Mueller · J. · Eustacio Colombo · P. · Sharp · S. J. · Griffin · S. J. · Ahern · A.
Introduction

Precision medicine approaches to obesity aim to maximise treatment effectiveness by matching weight management interventions (WMIs) to characteristics of individuals, such as eating behaviour traits (EBTs). Acceptance and commitment therapy (ACT)-based WMIs may address EBTs such as emotional and uncontrolled eating more effectively than standard interventions, and might be most effective in people with high levels of these traits. However, few studies have examined this directly. We will examine (a) whether ACT-based interventions are more effective for people with certain levels of EBTs (ie, moderation) and (b) whether ACT-based interventions operate through changes in EBTs (ie, mediation).

Methods and analysis

This individual participant data (IPD) meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses of Individual Participant Data guidance. We will include studies on ACT-based WMIs that assessed EBTs in people with a body mass index ≥25 kg/m2. We identified studies by screening studies included in a previous review of third wave cognitive behavioural interventions, and updating the search to 20 June 2022. We will request IPD from eligible published and unpublished studies. We will harmonise and re-analyse data using a two-stage random effects meta-analysis pooling within-trial interactions to investigate moderating effects and using a one-stage simultaneous equation model to examine mediating effects. We will assess the risk of bias in included studies using the Cochrane Risk of Bias tool 2 and the Risk of Bias in Non-randomised Studies of Interventions tool.

Ethics and dissemination

Ethical approval has been obtained from the Cambridge Psychology Research Ethics Committee (Application No: PRE.2023.121). Data sharing will follow data transfer agreements and coauthorship will be offered to investigators contributing data. Findings will be disseminated through peer-reviewed journals and conferences and will contribute to the lead author’s PhD thesis.

PROSPERO registration number

CRD42022359691.

Family-focused intervention to promote adolescent mental health and well-being in Moldova and North Macedonia (FLOURISH): feasibility study protocol

Por: Shenderovich · Y. · Piolanti · A. · Babii · V. · Calovska-Hertzog · N. · Evans · R. E. · Heinrichs · N. · Burgund Isakov · A. · Lesco · G. · Moore · G. · Mueller · J. · Raleva · M. · Shimbov · B. · Simon · J. · Waller · F. · Wienand · D. · Foran · H. M.
Introduction

Family-Focused Adolescent & Lifelong Health Promotion (FLOURISH) project will adapt, implement and evaluate a programme to support adolescent mental health and well-being through strategies, such as strengthening parenting practices, adolescent-caregiver relationships, adolescent and parent socioemotional skills, and social support.

Methods and analysis

The project will focus on adolescents aged 10–14 years and their caregivers in North Macedonia and Moldova. The countries were selected based on implementation readiness of two organisations and a need for accessible evidence-informed services to help mitigate health risks due to economic, social and political challenges. Parenting for Lifelong Health (PLH) for Parents and Teens is a family-based programme developed for low-resource settings. PLH has been adapted with input from advisory groups. The programme includes additional components to strengthen impacts on adolescents: adolescent mental health tools, based on UNICEF’s Helping Adolescents Thrive, adolescent peer support and participation booster. This pilot is first of three study phases. The pilot will be a feasibility testing of the adapted intervention and the assessment and implementation procedures to determine further refinements. The pilot will examine if the adapted programme is acceptable for adolescents, their families and providers, explore contextual factors relevant to embedding this programme into longer-term scale-up and investigate whether the programme can be delivered with fidelity and participation; whether the participants report changes in adolescent emotional and behavioural problems, well-being and other outcomes; and whether the study tools are feasible and appropriate. Pre-post adolescent and caregiver questionnaires will provide outcome data. Process evaluation will include attendance and fidelity data, and focus groups. We will examine delivery cost and resource requirements.

Ethics and dissemination

The study was approved at the University of Klagenfurt (Austria), Medical Faculty at St. Cyril and Methodius University (North Macedonia) and National Committee of Ethical Expertise for Clinical Trials (Moldova). Through stakeholder engagement and dissemination, FLOURISH will advance scale-up of open-source family interventions.

Trial registration number

Trial registration: ID101095528; project page: https://www.flourish-study.org/about.html; https://www.linkedin.com/company/flourish-study/

Employing telepsychiatry services to assess the prevalence and identify mental health disorders using the PHQ-9 and GAD-7 in resource-constrained regions of Dadar Mansehra, Pakistan: an observational cross-sectional study

Por: Aga · I. Z. · Khurram · S. S. · Karim · M. · Muzzamil · M. · Hashmi · S. · Shafique · K.
Objective

This study aims to measure the prevalence of mental health disorders in low-resource settings through telepsychiatry and evaluate data from Pakistan’s Sehat Kahani nurse-assisted online clinics serving low-income communities. This will help to understand the magnitude and nature of the demand for contextual therapies to promote mental health. The paper will discuss the challenges faced in these settings, such as limited access to mental health facilities, stigma and opportunities telemedicine brings.

Design

An observational cross-sectional study of telepsychiatry consultations using Patient Health Questionnaire-9 and Generalised Anxiety Disorder-7 to screen for depression and anxiety was conducted between October and December 2022.

Setting

This research was conducted at Dadar Mansehra e-health clinics of Sehat Kahani with telepsychiatry services in Pakistan.

Participants

The study included 2660 participants who visited Sehat Kahani e-health clinics between October and December 2022 and voluntarily completed the questionnaire for data collection.

Results

The study was comprised of 2660 participants with a mean age of 34.3 years. The study findings show that the majority of participants were females (98.4%), 16.9% of participants had moderate depression, and 20.8% had severe depression. Furthermore, the participants who were widowed/divorced were more likely to have depression than those who were single (OR=3.3, 95% CI (2.0 to 5.2)).

Conclusions

Based on the findings, most study participants were female, and their mental health was negatively impacted. Women in Pakistan are disproportionately affected by the rising rates of depression and anxiety, and telepsychiatry therapies effectively respond to this growing need. Potentially, it is a game-changer for dealing with mental health problems. Telepsychiatry can help policymakers and mental health professionals to develop effective low-income mental health initiatives.

Psychosocial interventions promoting personal recovery in people with schizophrenia: a scoping review protocol

Por: Quistgaard · M. · Myklebust · O. L. P. · Aure · T. · Austin · S. F. · Berring · L. L. · Vernal · D. L. · Storebo · O. J.
Introduction

Personal recovery is an important aspect for many individuals diagnosed with schizophrenia, as people can live rich, fulfilling lives despite ongoing symptoms. Prior reviews have found several factors to be associated with personal recovery, but a comprehensive overview of the psychosocial interventions aimed at improving personal recovery in schizophrenia is needed.

Methods and analysis

Key terms relating to personal recovery and psychosocial interventions to promote personal recovery will be searched for in the following databases: PubMed, EMBASE, PsycINFO, CINAHL, MEDLINE, Google Scholar, Web of Science Core Collection and Cochrane. Additionally, a simple search for grey literature will be conducted in The Networked Digital Library of Theses and Dissertations. Two reviewers will individually screen and extract the data, and the selection of sources will be documented in a Preferred Reporting Items for Systematic reviews and Meta-Analyses flow chart. A content analysis will be conducted on the data, and the findings will be presented in tables, and narratively synthesised. Lastly, research gaps will be identified, and recommendations for future research will be proposed.

Ethics and dissemination

Ethics approval was not required for the development or publishing of this protocol. Findings will be disseminated through conferences, meeting with patient organisations and consumers, and published in a peer-reviewed scientific journal.

Randomised controlled trial of automated VR therapy to improve positive self-beliefs and psychological well-being in young people diagnosed with psychosis: a study protocol for the Phoenix VR self-confidence therapy trial

Por: Freeman · D. · Freeman · J. · Rovira · A. · Miguel · A. L. · Ward · R. · Bousfield · M. · Riffiod · L. · Leal · J. · Kabir · T. · Yu · L.-M. · Beckwith · H. · Waite · F. · Rosebrock · L.
Introduction

The confidence of young people diagnosed with psychosis is often low. Positive self-beliefs may be few and negative self-beliefs many. A sense of defeat and failure is common. Young people often withdraw from many aspects of everyday life. Psychological well-being is lowered. Psychological techniques can improve self-confidence, but a shortage of therapists means that very few patients ever receive such help. Virtual reality (VR) offers a potential route out of this impasse. By including a virtual coach, treatment can be automated. As such, delivery of effective therapy is no longer reliant on the availability of therapists. With young people with lived experience, we have developed a staff-assisted automated VR therapy to improve positive self-beliefs (Phoenix). The treatment is based on established cognitive behavioural therapy and positive psychology techniques. A case series indicates that this approach may lead to large improvements in positive self-beliefs and psychological well-being. We now aim to conduct the first randomised controlled evaluation of Phoenix VR.

Methods and analysis

80 patients with psychosis, aged between 16 and 30 years old and with low levels of positive self-beliefs, will be recruited from National Health Service (NHS) secondary care services. They will be randomised (1:1) to the Phoenix VR self-confidence therapy added to treatment as usual or treatment as usual. Assessments will be conducted at 0, 6 (post-treatment) and 12 weeks by a researcher blind to allocation. The primary outcome is positive self-beliefs at 6 weeks rated with the Oxford Positive Self Scale. The secondary outcomes are psychiatric symptoms, activity levels and quality of life. All main analyses will be intention to treat.

Ethics and dissemination

The trial has received ethical approval from the NHS Health Research Authority (22/LO/0273). A key output will be a high-quality VR treatment for patients to improve self-confidence and psychological well-being.

Trial registration number

ISRCTN10250113.

Effect of synchronous remote-based interventions on suicidal behaviours: protocol for a systematic review and meta-analysis

Por: Comendador · L. · Jimenez-Villamizar · M. P. · Losilla · J.-M. · Sanabria-Mazo · J. P. · Mateo-Canedo · C. · Cebria · A. I. · Sanz · A. · Palao · D. J.
Introduction

Suicide is among the leading causes of preventable death worldwide. The impact of suicide affects the personal, social and economic levels. Therefore, its prevention is a priority for public health systems. Previous studies seem to support the efficacy of providing active contact to people who have made a suicide attempt. The current systematic review and meta-analysis aims to investigate the efficacy of distance suicide prevention strategies implemented through synchronous technology-based interventions.

Methods and analysis

This protocol is designed according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. The bibliographical searches were conducted in the databases PubMed, PsycINFO, Scopus and Web of Science in April 2022, with no restrictions on the time of publication and limited to publications in English or Spanish. The search strategy was performed using free-text terms and Medical Subject Headings terms: suicide, follow-up, synchronous, remote, telehealth, telephone, hotline, video-conference and text message. Two reviewers will independently conduct study screening, selection process, data extraction and risk of bias assessment. The analysis and synthesis of the results will be both qualitative and quantitative. A narrative synthesis, presented in a comprehensive table, will be performed and meta-analysis will be conducted, as appropriate, if sufficient data are provided.

Ethics and dissemination

The present review and meta-analysis will not require ethical approval, as it will use data collected from previously published primary studies. The findings of this review will be published in peer-reviewed journals and widely disseminated.

PROSPERO registration number

CRD42021275044.

Use of social media in recruiting young people to mental health research: a scoping review

Por: Smith · M. V. A. · Grohmann · D. · Trivedi · D.
Objectives

This review explored the literature on the use of social media in recruiting young people, aged 13–18 years, to mental health research. It aimed to identify barriers and facilitators to recruitment and strategies to improve participation in future research.

Design

Scoping review.

Data sources

Articles published between January 2011 and February 2023 were searched for on PubMed, Scopus, Medline (via EBSCOhost) and Cochrane Library databases.

Eligibility criteria

Studies that outlined social media as a recruitment method and recruited participants aged 13–18 years.

Data extraction and synthesis

Data was extracted by two reviewers independently and cross-checked by a third reviewer. Data on study design, aims, participants, recruitment methods and findings related specifically to social media as a recruitment tool were collected.

Results

24 journal articles met the inclusion criteria. Studies were predominantly surveys (n=13) conducted in the USA (n=16) recruiting via Facebook (n=16) and/or Instagram (n=14). Only nine of the included articles provided a summary of success and reviewed the efficacy of social media recruitment for young people in mental health research. Type of advertisement, the language used, time of day and the use of keywords were all found to be factors that may influence the success of recruitment through social media; however, as these are based on findings from a small number of studies, such potential influences require further investigation.

Conclusion

Social media recruitment can be a successful method for recruiting young people to mental health research. Further research is needed into recruiting socioeconomically marginalised groups using this method, as well as the effectiveness of new social media platforms.

Registration

Open Science Framework Registry (https://osf.io/mak75/).

Self-reported and parent-reported mental health in children from low-income families in Agder, Norway: results from baseline measurements of New Patterns project participants

Por: Boe · T. · Ostojic · H. A. · Haraldstad · K. · Abildsnes · E. · Wilson · P. · Vigsnes · K. · Molland · E.
Background

Poverty may pose risks to child and adolescent mental health, but few studies have reported on this association among children and adolescents in low-income families in Norway.

Methods

Based on a sample participating in an intervention for low-income families in Norway, we report data from the survey administered at the start of the intervention. Mental health problems were measured using the Strengths and Difficulties Questionnaire (SDQ; self-report (SR) n = 148; parent/proxy-report (PR) n = 153, mean age = 10.8). Demographic and family characteristics were obtained from parent reported data. Results are presented by gender and migration background. Regression analysis was used to investigate the relative contribution of background factors to mental health symptoms. The distribution of scores is compared to UK norms.

Results

Participants reported relatively high scores on the Strengths and Difficulties Questionnaire (SDQ) Total Difficulties Scale (parent/proxy-report, PR mean=10.7; self-report, SR mean=10.1). Participants with non-immigrant backgrounds scored considerably higher on the Total Difficulties Scale (PR mean difference=2.9; SR 5.3) and on most other domains measured with the SDQ compared with their peers with immigration backgrounds. Participants generally scored higher than or equal to UK norms.

Conclusion

Participants in the current study had many symptoms of mental health problems, with large differences between those with and without a migrant background. Interventions for low-income families should be based on detailed knowledge about differences in family risks, resources and needs.

Prevention of psychosocial distress consequences in somatic hospital inpatients via a stepped and collaborative care model: protocol of SomPsyNet, a stepped wedge cluster randomised trial

Por: Meinlschmidt · G. · Frick · A. · Baenteli · I. · Karpf · C. · Studer · A. · Bachmann · M. · Dörner · A. · Tschudin · S. · Trost · S. · Wyss · K. · Fink · G. · Schwenkglenks · M. · Caviezel · S. · Rocco · T. · Schaefert · R. · The SomPsyNet consortium · Aebi · Bachmann · Caviezel · Baen
Introduction

Approximately 30% of somatic hospital inpatients experience psychosocial distress, contributing to increased (re-)hospitalisation rates, treatment resistance, morbidity, and direct and indirect costs. However, such distress often remains unrecognised and unaddressed. We established ‘SomPsyNet’, a ‘stepped and collaborative care model’ (SCCM) for somatic hospital inpatients, aiming at alleviating this issue through early identification of distress and provision of appropriate care, providing problem-focused pathways and strengthening collaborative care. We report the protocol of the ‘SomPsyNet’ study, aiming to evaluate implementation and impact of the SCCM on distressed patients’ health-related quality of life. Secondary objectives include assessing efficacy of the screening procedures, influence of SCCM on other health outcomes and associated costs.

Methods and analysis

Our stepped wedge cluster randomised trial conducted at three tertiary hospitals comprises three conditions: treatment as usual (TAU) without screening for distress (phase 0), TAU with screening but without consequences (phase I, main comparator) and TAU with screening and psychosomatic-psychiatric consultations for those distressed (phase II). The time-of-transition between phases I and II was randomised. Sample size target is N=2200–2500 participants, with 6 month follow-up for distressed (anticipated n=640–700) and a subsample of non-distressed (anticipated n=200) patients. Primary outcome is mental health-related quality of life (SF-36 ‘Mental Health Component Summary score’); secondary outcomes include psychosocial distress, anxiety, depressive and somatic symptoms, symptom burden and distress, resilience, social support and qualitative of life, assessed by internationally accepted instruments, with good psychometric properties. Further, health claims data will be used to assess SCCM’s impact on direct and indirect costs.

Ethics and dissemination

SomPsyNet adheres to the Helsinki Declaration and is approved by the ‘Ethikkommission Nordwest- und Zentralschweiz’ (2019–01724). Findings will be published in peer-reviewed journals and communicated to participants, healthcare professionals and the public.

Trial registration number

Swiss National Clinical Trials Portal; ClinicalTrials.gov (NCT04269005, updated 19.09.2023).

Clinical staging across eating disorders: a scoping review protocol

Por: Hyam · L. E. · Phillips · M. · Gracie · L. · Allen · K. · Schmidt · U.
Introduction

Clinical staging models in psychiatry assert that there are earlier, less severe or more malleable forms of illness that are distinguishable from later, more chronic forms of illness, and that these stages may have different prognostic and treatment implications. Previous reviews on clinical staging in eating disorders (EDs) suggest a staging heuristic could be useful for anorexia nervosa, but less research is available on how this applies to other EDs. An up-to-date review is required to synthesise new and heterogenous avenues of research. This scoping review aims to explore the extent and types of evidence in relation to illness staging for EDs and how these concepts are associated with treatment response and outcomes.

Methods and analysis

This protocol was developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol extension for Scoping Reviews checklist and the Joanna Briggs Institute Reviewer’s Manual. We will consider any documents providing evidence for clinical staging such as those which describe full or partial staging models, for all EDs, across various domains of assessment and functioning. Participants will include clinical or non-clinical population samples with full-syndrome EDs or disordered eating behaviour. PubMed, PsycINFO, MEDLINE and Web of Science databases will be systematically searched for relevant literature. Two authors will export documents and screen titles, abstracts and full texts. Data will be extracted into a charting form drafted by the authors. A narrative summary of the documents will be conducted in line with the study aims. Finally, clinical and research recommendations will be outlined.

Ethics and dissemination

Ethical approval will not be required to synthesise published and unpublished literature. The study will be published in a peer-reviewed journal and shared at conferences, via social media, and in other communications.

Digital health interventions to improve adherence to oral antipsychotics among patients with schizophrenia: a scoping review

Por: Wu · T. · Xiao · X. · Yan · S. · Fang · Y. · Wang · M. · Zu · F. · Zhang · Y. · Qian · R.
Objectives

To assess the current evidence on the potential of digital health interventions (DHIs) to improve adherence to oral antipsychotics among patients with schizophrenia by assessing the methodologies, feasibility and effectiveness of DHIs as well as the perceptions of relevant stakeholders.

Design

The scoping review was conducted based on the methodologies outlined by Levac et al and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Data sources

PubMed, Embase, Web of Science, Scopus, CINAHL, PsycINFO and the Cochrane Library were searched in August 2023 to identify relevant publications from the previous decade.

Eligibility criteria

Studies published in English focused on improving medication adherence among adult patients with schizophrenia or schizoaffective disorder via DHIs were selected. Protocols, editorials, comments, perspectives, reviews, correspondence and conference abstracts were excluded.

Data extraction and synthesis

The extracted data included general information about the study, framework, participants, features and strategies of DHIs, measurement tools for adherence used, and main findings.

Results

In total, 64 studies were included in the qualitative synthesis. Features used in DHIs to improve medication adherence included phone calls, text messages, mobile apps, sensors, web-based platforms and electronic devices. Strategies included medication reminders and monitoring, providing medication-related information and suggestions, other illness management suggestions and individual support. Texting and mobile apps were commonly used as medication reminders and monitoring methods. Additionally, the use of sensors combined with other digital technologies has garnered significant attention. All the interventions were considered acceptable and feasible, and several were assessed in pilot trials. Preliminary findings suggest that DHIs could enhance medication adherence in patients with schizophrenia. However, further validation of their effectiveness is required.

Conclusion

DHIs are a promising approach to enhancing medication adherence among patients with schizophrenia. Future interventions should be interactive, focusing on user preference, experience and privacy.

Treatment of schizotypal disorder: a protocol for a systematic review of the evidence and recommendations for clinical practice

Por: Gundersen · K. B. · Rasmussen · A. R. · Sandström · K. O. · Albert · N. · Polari · A. · Ebdrup · B. H. · Nelson · B. · Glenthoj · L. B.
Introduction

Schizotypal disorder is associated with a high level of disability at an individual level and high societal costs. However, clinical recommendations for the treatment of schizotypal disorder are scarce and based on limited evidence. This review aims to synthesise the current evidence on treatment for schizotypal disorder making recommendations for clinical practice.

Methods and analysis

This systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic literature search will be performed in PsychArticles, Embase, Medline and Cochrane Central Register of Controlled Trials. Additionally, we will search for relevant articles manually. Inclusion criteria are published studies including individuals diagnosed with schizotypal personality disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria, or schizotypal disorder according to International Classification of Diseases (ICD) criteria. We will include interventional studies comprising any pharmacological and non-pharmacological treatment trials for patients with schizotypal disorder, and all relevant outcome measures will be reported. Risk of bias will be assessed by Cochrane risk-of-bias tools. Data will be synthesised using narrative or thematic analysis and, if suitable, through meta-analysis.

Ethics and dissemination

No original data will be collected as part of this study and ethics approval is, therefore, not applicable. The results will be disseminated through peer-reviewed publication and presented at international scientific meetings. We will aim at submitting the final paper for publication within 4 months of completion of analyses. Furthermore, this systematic review will inform clinicians and researchers on the current state of evidence on treatment for schizotypal disorder. Findings may guide proposals for further research and potentially guide recommendations for clinical practice using the Grading of Recommendations Assessment, Development and Evaluation.

PROSPERO registration number

CRD42022375001.

Health-related quality of life and associated factors among patients with schizophrenia at comprehensive specialised hospitals in the Northwest Ethiopia: a multicentre cross-sectional study

Por: Tamene · F. B. · Sema · F. D. · Mihiretie · E. A. · Siyum · T. S. · Sendekie · A. K.
Objectives

The aim of this study was to assess the health-related quality of life (HRQoL) and associated factors among patients with schizophrenia at comprehensive specialised hospitals in Northwest Ethiopia.

Design and setting

A cross-sectional study was conducted among 422 patients with schizophrenia who were followed at comprehensive specialised hospitals in Northwest Ethiopia from 1 June to 30 August 2022.

Participants

All adult patients with schizophrenia who had regular follow-up in the outpatient departments of the selected hospitals were study participants.

Main outcome measures

The main outcome of this study was HRQoL which was measured using the WHO Quality of Life Scale–Bref Version. Data entry and analysis were done using Epi-data version 4.6.1 and SPSS version 24, respectively. Linear regression was used to assess the association between quality of life and independent variables. Variables with a p value

Results

The mean score of the overall Quality of Life Scale–Brief Version was 22.42±3.60. No formal education (ß=–1.53; 95% CI: –2.80 to –0.27), duration of treatment (ß = –3.08; 95% CI: –4.71 to –1.45), comorbidity (ß=–1.14; 95% CI: –1.99 to –0.29), substance use (ß=–0.89; 95% CI: –1.56 to –0.23), extrapyramidal side effects (ß=–2.02; 95% CI: –2.90 to –1.14), non-adherence (ß=–0.83; 95% CI: –1.44 to –0.23), and antipsychotic polypharmacy (ß=–1.77; CI: –2.57 to –0.96) were negatively associated with quality of life.

Conclusion and recommendation

In this study, the social domain was recorded as having the lowest mean score, which may indicate that patients with schizophrenia could need better psychosocial support. Patients with a longer duration of treatment, who had comorbid illnesses, were substance users, developed EPS, were non-adherent to medications and were on antipsychotic polypharmacy, needs critical follow-up to improve HRQoL.

Cohort profile: the U-BIRTH study on peripartum depression and child development in Sweden

Por: Tu · H.-F. · Fransson · E. · Kunovac Kallak · T. · Elofsson · U. · Ramklint · M. · Skalkidou · A.
Purpose

The current U-BIRTH cohort (Uppsala Birth Cohort) extends our previous cohort Biology, Affect, Stress, Imaging and Cognition (BASIC), assessing the development of children up to 11 years after birth. The U-BIRTH study aims to (1) assess the impact of exposure to peripartum mental illness on the children’s development taking into account biological and environmental factors during intrauterine life and childhood; (2) identify early predictors of child neurodevelopmental and psychological problems using biophysiological, psychosocial and environmental variables available during pregnancy and early post partum.

Participants

All mothers participating in the previous BASIC cohort are invited, and mother–child dyads recruited in the U-BIRTH study are consecutively invited to questionnaire assessments and biological sampling when the child is 18 months, 6 years and 11 years old. Data collection at 18 months (n=2882) has been completed. Consent for participation has been obtained from 1946 families of children having reached age 6 and from 698 families of children having reached age 11 years.

Findings to date

Based on the complete data from pregnancy to 18 months post partum, peripartum mental health was significantly associated with the development of attentional control and gaze-following behaviours, which are critical to cognitive and social learning later in life. Moreover, infants of depressed mothers had an elevated risk of difficult temperament and behavioural problems compared with infants of non-depressed mothers. Analyses of biological samples showed that peripartum depression and anxiety were related to DNA methylation differences in infants. However, there were no methylation differences in relation to infants’ behavioural problems at 18 months of age.

Future plans

Given that the data collection at 18 months is complete, analyses are now being undertaken. Currently, assessments for children reaching 6 and 11 years are ongoing.

Delphi consensus study to develop guidelines for the management of adults with borderline personality disorder in the emergency department: a protocol

Por: Prosser · A. · Hong · V. · Helfer · B. · Fudge · D. · Patterson · J. · Rosebush · P. · Frey · B. N. · Links · P.
Introduction

Clinicians caring for adults with borderline personality disorder (BPD) in acute settings such as the emergency department (ED) have little evidence/guidance to base decisions on. Specific/detailed guidance for managing BPD in the ED is needed given the morbidity and mortality risks, high service utilisation, unique challenges and risk of iatrogenic interventions. The primary objective of this study is to use a consensus method to develop a guideline for managing adults with BPD in the ED. This protocol and the key questions for the guideline were developed with the advice of people with BPD and their family members/support persons.

Methods and analysis

We will perform a four-phase Delphi study of an expert panel of clinicians, researchers, adults with BPD and their family members/support persons. Various disciplines (psychiatry, psychology, emergency medicine, nursing, social work) and treatment approaches will be included in the expert panel. An online questionnaire will be developed from systematic reviews, qualitative assessments of pivotal literature, and opinions suggested by the panel (phase 1). The panel will rate their agreement on opinions for each key question covering areas of emergency care of adults with BPD using two rounds of this questionnaire (phases 2 and 3). Opinions meeting predefined thresholds for consensus will be brought to consensus meetings moderated by an independent chair (phase 4). The purpose of these meetings is to finalise the set and phrasing of the opinions for each area of emergency care. These final opinions will be the recommendations in the guideline. If there are significant differences of opinion, the guideline will present both recommendations alongside one another.

Ethics and dissemination

This study has received ethics approval by the Hamilton Integrated Research Ethics Board in Hamilton, Ontario, Canada. The results of this study will be disseminated through peer-reviewed publications, conferences and national professional and patient/family/support associations.

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