ResearchPad - 1712 https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Internet-based cognitive–behavioural therapy for prevention of depression during pregnancy and in the post partum (iPDP): a protocol for a large-scale randomised controlled trial]]> https://www.researchpad.co/article/elastic_article_12556 The objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive–behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.Methods and analysisThe target study population will be pregnant women of 16–20 weeks gestation who are currently users of ‘Luna Luna Baby’, the most widely used app for pregnant women in Japan. Those who meet the eligibility criteria will be randomly allocated to the 6-module internet CBT programme that was newly developed for pregnant women (n=2500), or to a treatment-as-usual control group (n=2500). Participants in the intervention groups will be required to complete the programme by 32 weeks gestation. The primary outcomes are the number of new onsets of MDE, measured by using WHO Composite International Diagnostic Interview 3.0 at 32 weeks gestation and 3 months post partum. Survival analysis will be conducted to test for the effectiveness of the intervention on the time to the onset of MDE.Ethics and disseminationThe study plan has been approved by the Research Ethics Review Board of the Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (2019150NI). If the intervention programmes are found to produce a significant positive effect in this RCT, these programmes can be made available for all users of the app in the future.Trial registration numberUMIN000038190; Pre-results. ]]> <![CDATA[Mental health interventions for suicide prevention among indigenous adolescents: a systematic review protocol]]> https://www.researchpad.co/article/elastic_article_12519 There are more than 370 million indigenous people from 5000 cultures living in 90 countries worldwide. Although they make up 5% of the global population, they account for 15% of the extreme poor. Youth suicide is the second leading cause of mortality among 15–29 years old and disproportionately affects indigenous youth. This research protocol pertains to a systematic review of studies that use a comparator/control group to evaluate the effectiveness of suicide interventions targeting indigenous adolescents (aged 10–19 years).Methods and analysisWe will conduct a systematic search on MEDLINE, EMBASE, CINAHL, LILACS and PsycINFO from inception to September 2019 to identify articles that compare mental health interventions for suicide prevention among indigenous adolescents. Two reviewers will independently determine the eligibility of each study. Studies will be assessed for methodological quality using the risk of bias tool to assess non-randomised studies of interventions. We will conduct a meta-analysis if possible and use established statistical methods to identify and control for heterogeneity where appropriate.Ethics and disseminationThis systematic review will use published data and does not require ethics approval. However, this review is in preparation of a feasibility study that will examine how best to support the physical and mental health of indigenous adolescents in Brazil. Ethics approval for the feasibility study was obtained from National Research Ethics Commission. Findings will be disseminated through a peer-reviewed publication and will be made available to key decision-makers with authority for indigenous health and other relevant stakeholders.PROSPERO registration numberCRD42019141754. ]]> <![CDATA[Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trial]]> https://www.researchpad.co/article/elastic_article_9118 Previous studies show that university students experience higher psychological stress than the general population, resulting in increased vulnerability for mental disorders for the student population. Online mindfulness interventions will be delivered to students as a potentially promising and more flexible approach compared to face-to-face interventions with the aim of improving their mental health. This study purposes to investigate the effectiveness of a guided online mindfulness-focused intervention for university students by using both self-reported and psychobiological measures.Methods and analysesIn this multicentre, two-armed randomised controlled trial with a parallel design, a guided version of the online mindfulness-focused intervention ‘StudiCare Mindfulness’ will be compared with a waitlist control group. In total, 120 participants will be recruited at different universities (of Applied Sciences) in (Neu-) Ulm. Data will be assessed prior to randomisation, after eight weeks (post-intervention) and six months after randomisation (follow-up). The primary outcome measure is mindfulness. The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia. Psychobiological parameters comprise interoceptive accuracy, hair cortisol and FKBP5 genotype. Sociodemographic variables, treatment expectations, side and adverse side effects, as well as intervention satisfaction and adherence will be assessed. All data analyses will be conducted according to the intention-to-treat principle.Ethics and disseminationAll study procedures have been approved by the Ethics Committee of Ulm University (application No. 48/18). The findings will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration numberDRKS00014701. ]]> <![CDATA[Outcomes tested in non-pharmacological interventions in mild cognitive impairment and mild dementia: a scoping review]]> https://www.researchpad.co/article/Na7cba67d-81a0-495e-8f33-1b12bd7fb9ce Non-pharmacological treatments are an important aspect of dementia care. A wide range of interventions have been trialled for mild dementia and mild cognitive impairment (MCI). However, the variety of outcome measures used in these trials makes it difficult to make meaningful comparisons. The objective of this study is to map trends in which outcome measures are used in trials of non-pharmacological treatments in MCI and mild dementia.DesignScoping review.Data sourcesEMBASE, PsychINFO, Medline and the Cochrane Register of Controlled Trials were searched from inception until February 2018. An additional search was conducted in April 2019EligibilityWe included randomised controlled trials (RCTs) testing non-pharmacological interventions for people diagnosed with MCI or mild dementia. Studies were restricted to full RCTs; observational, feasibility and pilot studies were not included.Charting methodsAll outcome measures used by included studies were extracted and grouped thematically. Trends in the types of outcome measures used were explored by type of intervention, country and year of publication.Results91 studies were included in this review. We extracted 358 individual outcome measures, of which 78 (22%) were used more than once. Cognitive measures were the most frequently used, with the Mini-Mental State Examination being the most popular.ConclusionsOur findings highlight an inconsistency in the use of outcome measures. Cognition has been prioritised over other domains, despite previous research highlighting the importance of quality of life and caregiver measures. To ensure a robust evidence base, more research is needed to highlight which outcome measures should be used over others.PROSPERO registration numberCRD42018102649. ]]> <![CDATA[Cognitive–behavioral therapy-based intervention to treat symptoms of anxiety in pregnancy in a prenatal clinic using non-specialist providers in Pakistan: design of a randomised trial]]> https://www.researchpad.co/article/N95da49aa-ba43-4859-a209-cc014fbb6b3f Prenatal anxiety is a prevalent condition that is harmful for women and a strong predictor of postpartum depression. This trial assesses an intervention initiated in early pregnancy to mid pregnancy among women with clinical or subclinical symptoms of anxiety in Pakistan.Methods and analysis Happy Mother, Healthy Baby (HMHB) is a phase three, two-arm, single-blind, individual randomised clinical trial conducted in the outpatient department of Holy Family Hospital, a large public tertiary care facility affiliated with Rawalpindi Medical University (RMU). Pregnant women (enrolled at ≤22 weeks of gestation) receive six individual HMHB sessions based on cognitive–behavioral therapy (CBT) and relaxation techniques that are administered by non-specialist providers and tailored to address anxiety symptoms. Two to six booster sessions are given between the fifth consecutive weekly core session and the sixth core session that occurs in the third trimester. Apart from baseline data, data are collected in the third trimester, at birth and at 6-weeks postpartum. Primary outcomes include diagnoses of postpartum common mental disorders. Secondary outcomes include symptoms of anxiety and of depression, and birth outcomes including small-for-gestational age, low birth weight and preterm birth. An economic analysis will determine the cost effectiveness of the intervention.EthicsEthics approval was obtained from the Johns Hopkins Bloomberg School of Health Institutional Review Board (Baltimore, USA), the Human Development Research Foundation Ethics Committee (Islamabad, Pakistan), the RMU Institutional Research Forum (Rawalpindi, Pakistan) and the National Institute of Mental Health-appointed Global Mental Health Data Safety and Monitoring Board.DisseminationResults from this trial will build evidence for the efficacy of a CBT-based intervention for pregnant women delivered by non-specialised providers. Identification of an evidence-based intervention for anxiety starting in early pregnancy to mid pregnancy may be transferable for use and scale-up in other low-income and middle-income countries.Trial registration number NCT03880032. ]]> <![CDATA[STEP.De study—a multicentre cluster-randomised effectiveness trial of exercise therapy for patients with depressive symptoms in healthcare services: study protocol]]> https://www.researchpad.co/article/Nda6fdd03-e7b8-4809-a92b-4abda5bac799 Although exercise therapy has widely been shown to be an efficacious treatment modality for depression, evidence for its effectiveness and cost efficiency is lacking. The Sport/Exercise Therapy for Depression study is a multicentre cluster-randomised effectiveness trial that aims to compare the effectiveness and cost efficiency of exercise therapy and psychotherapy as antidepressant treatment.Methods and analysis480 patients (aged 18–65) with an International Classification of Diseases diagnosis associated with depressive symptoms are recruited. Up to 30 clusters (psychotherapists) are randomly assigned to allocate patients to either an exercise or a psychotherapy treatment as usual in a 2:1 ratio. The primary outcome (depressive symptoms) and the secondary outcomes (work and social adjustment, quality of life) will be assessed at six measurement time points (t0: baseline, t1: 8 weeks after treatment initiation, t2: 16 weeks after treatment initiation, t3/4/5: 2, 6, 12 months after treatment). Linear regression analyses will be used for the primary endpoint data analysis. For the secondary endpoints, mixed linear and logistic regression models with fixed and random factors will be added. For the cost efficiency analysis, expenditures in the 12 months before and after the intervention and the outcome difference will be compared between groups in a multilevel model. Recruitment start date was 1 July 2018 and the planned recruitment end date is 31 December 2020.Ethics and disseminationThe study protocol was approved by the ethics committee of the University of Potsdam (No. 17/2018) and the Freie Universität Berlin (No. 206/2018) and registered in the ISRCTN registry. Informed written consent will be obtained from all participants. The study will be reported in accordance with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials statements. The results will be published in peer-reviewed academic journals and disseminated to the public.Trial registration number ISRCTN28972230. ]]> <![CDATA[Community treatment orders and associations with readmission rates and duration of psychiatric hospital admission: a controlled electronic case register study]]> https://www.researchpad.co/article/N5f8f39c5-3704-43db-90b1-a3a287046e4a

Objectives

Limited evidence is available regarding the effect of community treatment orders (CTOs) on mortality and readmission to psychiatric hospital. We compared clinical outcomes between patients placed on CTOs to a control group of patients discharged to voluntary community mental healthcare.

Design and setting

An observational study using deidentified electronic health record data from inpatients receiving mental healthcare in South London using the Clinical Record Interactive Search (CRIS) system. Data from patients discharged between November 2008 and May 2014 from compulsory inpatient treatment under the Mental Health Act were analysed.

Participants

830 participants discharged on a CTO (mean age 40 years; 63% male) and 3659 control participants discharged without a CTO (mean age 42 years; 53% male).

Outcome measures

The number of days spent in the community until readmission, the number of days spent in inpatient care in the 2 years prior to and the 2 years following the index admission and mortality.

Results

The mean duration of a CTO was 3.2 years. Patients receiving care from forensic psychiatry services were five times more likely and patients receiving a long-acting injectable antipsychotic were twice as likely to be placed on a CTO. There was a significant association between CTO receipt and readmission in adjusted models (HR: 1.60, 95% CI 1.42 to 1.80, p<0.001). Compared with controls, patients on a CTO spent 17.3 additional days (95% CI 4.0 to 30.6, p=0.011) in a psychiatric hospital in the 2 years following index admission and had a lower mortality rate (HR: 0.66, 95% CI 0.50 to 0.88, p=0.004).

Conclusions

Many patients spent longer on CTOs than initially anticipated by policymakers. Those on CTOs are readmitted sooner, spend more time in hospital and have a lower mortality rate. These findings merit consideration in future amendments to the UK Mental Health Act.

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<![CDATA[Supporting the emotional needs of young people in care: a qualitative study of foster carer perspectives]]> https://www.researchpad.co/article/Nad32ff35-ad11-4f6d-a7f6-885729b103ce

Objectives

Young people who have been removed from their family home and placed in care have often experienced maltreatment and there is well-developed evidence of poor psychological outcomes. Once in care, foster carers often become the adult who provides day-to-day support, yet we know little about how they provide this support or the challenges to and facilitators of promoting better quality carer–child relationships. The aim of this study was to understand how carers support the emotional needs of the young people in their care and their views on barriers and opportunities for support.

Design and participants

Participants were 21 UK foster carers, recruited from a local authority in England. They were predominantly female (86%), aged 42–65 years old and ranged from those who were relatively new to the profession (<12 months’ experience) to those with over 30 years of experience as a carer. We ran three qualitative focus groups to gather in-depth information about their views on supporting their foster children’s emotional well-being. Participants also completed short questionnaires about their training experiences and sense of competence.

Results

Only half of the sample strongly endorsed feeling competent in managing the emotional needs of their foster children. While all had completed extensive training, especially on attachment, diagnosis-specific training for mental health problems (eg, trauma-related distress, depression) was less common. Thematic analysis showed consistent themes around the significant barriers carers faced navigating social care and mental health systems, and mixed views around the best way to support young people, particularly those with complex mental health needs and in relation to reminders of their early experiences.

Conclusions

Findings have important implications for practice and policy around carer training and support, as well as for how services support the mental health needs of young people in care.

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<![CDATA[Supporting antidepressant discontinuation: the development and optimisation of a digital intervention for patients in UK primary care using a theory, evidence and person-based approach]]> https://www.researchpad.co/article/N958131c5-59f1-4dc2-9409-a9e50a21ea1a

Objectives

We aimed to develop a digital intervention to support antidepressant discontinuation in UK primary care that is scalable, accessible, safe and feasible. In this paper, we describe the development using a theory, evidence and person-based approach.

Design

Intervention development using a theory, evidence and person-based approach.

Setting

Primary Care in the South of England.

Participants

Fifteen participants with a range of antidepressant experience took part in ‘think aloud’ interviews for intervention optimisation.

Intervention

Our digital intervention prototype (called ‘ADvisor’) was developed on the basis of a planning phase consisting of qualitative and quantitative reviews, an in-depth qualitative study, the development of guiding principles and a theory-based behavioural analysis. Our optimisation phase consisted of ‘think aloud’ interviews where the intervention was iteratively refined.

Results

The qualitative systematic review and in-depth qualitative study highlighted the centrality of fear of depression relapse as a key barrier to discontinuation. The quantitative systematic review showed that psychologically informed approaches such as cognitive–behavioural therapy were associated with greater rates of discontinuation than simple advice to reduce. Following a behavioural diagnosis based on the behaviour change wheel, social cognitive theory provided a theoretical basis for the intervention. The intervention was optimised on the basis of think aloud interviews, where participants suggested they like the flexibility of the system and found it reassuring. Changes were made to the tone of the material and the structure was adjusted based on this qualitative feedback.

Conclusions

‘ADvisor’ is a theory, evidence and person-based digital intervention designed to support antidepressant discontinuation. The intervention was perceived as helpful and reassuring in optimisation interviews. Trials are now needed to determine the feasibility, clinical and cost-effectiveness of this approach.

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<![CDATA[Primary care treatment of insomnia: study protocol for a pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy to sleep hygiene (the HABIT trial)]]> https://www.researchpad.co/article/N5d87089c-c00d-4ad8-bdc4-4d0085672287

Introduction

Insomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared with sleep hygiene advice.

Methods and analysis

In the HABIT (Health-professional Administered Brief Insomnia Therapy) trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over 4 weekly sessions; total therapy time is approximately 1 hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the Insomnia Severity Index at 6 months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention-to-treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed.

Ethics and dissemination

Ethical approval was granted by the Yorkshire and the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focussed on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder.

Trial registration number

ISRCTN42499563

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<![CDATA[Suicidal behaviours and moderator support in online health communities: protocol for a scoping review]]> https://www.researchpad.co/article/Nb1598bee-e39b-4f58-bbcf-2586963c6616

Introduction

Suicidal ideation and suicidal behaviours are common yet complex mental health presentations that can pose significant challenges for health professionals. The inability to accurately predict the individuals who may move from experiencing suicidal ideation and associated behaviours, to completing suicide, presents one such challenge. This can make it difficult to provide interventions and support to those most in need. Online health communities are one possible source of support for individuals who experience suicidal ideation and behaviours. These communities are becoming an increasingly popular way of accessing support, often with life-saving consequences. Within online communities, support is offered by various individuals including, in some instances, health professionals from various backgrounds, who work as online health community moderators. Given the growth of online communities and the increasing number of health professionals working as moderators, this scoping review seeks to map the literature that has focused on health professionals working as online community moderators, who interact with members experiencing suicidal ideation and behaviours. Mapping the existing literature offers benefits to both research and practice by identifying gaps in the research and providing a beginning knowledge base of current practice that can inform the training and development of health professionals working as community moderators.

Methods and analysis

This scoping review will follow the methodological framework of Arksey and O’Malley, later adapted by Levac et al. To ensure appropriate rigour, this protocol uses the 20-item Preferred Reporting Items for Systematic Reviews and Meta-Analyses and extension for Scoping Reviews. Literature will be identified using a search strategy developed in consultation with a specialist research librarian at the university where the researchers are employed. Ten multidisciplinary databases will be independently searched by two researchers, and both researchers will screen for inclusion, and undertake the data extraction. The first author will perform a quality assessment of the articles that are selected for inclusion. A second researcher will complete a random audit of 20% of the included articles to assess for quality and suitability in answering the research questions. The first author will complete the analysis and synthesis of the data. A numerical and narrative synthesis of the included studies will be provided.

Ethics and dissemination

The scoping review has been deemed as being exempt from ethical review as no data will be collected from human participants. The results of the scoping review may be published in a peer-reviewed journal, thesis, presented at relevant conferences, and shared with relevant knowledge users.

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<![CDATA[Relationships between cognitive leisure activities and cognitive function in older adults with depressive symptoms: a cross-sectional study]]> https://www.researchpad.co/article/Na8fa9e8a-8f6e-416f-8ef4-afe33ac277cf

Objectives

The current study aimed to elucidate the associations between cognitive leisure activities and cognitive function in an older population stratified by having or not having depressive symptoms.

Design

A retrospective cross-sectional study based on a self-report questionnaire.

Setting

Annual health check-ups in a rural community in Japan.

Participants

A total of 11 010 community-dwelling older adults aged ≥65 years (mean age: 74.0±5.4 years) was examined. Participants with missing data for the main outcome (n=1630) were excluded.

Outcome measures

Cognitive impairment was defined as at least 1.5 SD below the reference threshold (age-adjusted and education-adjusted score) on two of more of the tests in the National Center for Geriatrics and Gerontology-Functional Assessment Tool. Depressive symptoms were defined by a 15-item Geriatric Depression Scale score ≥6. We assessed the frequency of participation in cognitive leisure activities using the validated scale (score: 0–42). A score of ≥8 points was defined as frequent participation in cognitive leisure activities.

Results

A total of 12.6% (n=1186) of the participants had depressive symptoms. There was a significant association between cognitive leisure activities and cognitive impairment in older adults (adjusted OR=0.77, 95% CI=0.65 to 0.94). In older adults with depressive symptoms, a higher frequency of cognitive leisure activities was negatively associated with cognitive impairment (adjusted OR=0.45, 95% CI=0.28 to 0.70). In contrast, there was no significant association in older adults without depressive symptoms (adjusted OR=0.85, 95% CI=0.70 to 1.02).

Conclusions

Engaging in cognitive leisure activities in late life is associated with better cognitive function in older adults with depressive symptoms.

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<![CDATA[FACT: a randomised controlled trial to assess the feasibility of QbTest in the assessment process of attention deficit hyperactivity disorder (ADHD) for young people in prison—a feasibility trial protocol]]> https://www.researchpad.co/article/Nc7b58740-2910-4795-9ff5-c6545c42ca35

Introduction

The prevalence of attention deficit hyperactivity disorder (ADHD) within the Children and Young People Secure Estate (CYPSE) is much higher than seen in the general population. To make a diagnosis of ADHD, clinicians draw on information from multiple sources, including parents and teachers. However, obtaining these is particularly difficult for young people in the secure estate. There is increasing evidence in the community that QbTest is able to assist in the accurate and earlier diagnosis of ADHD. The objective of this study is to assess the feasibility and acceptability of QbTest in the assessment of ADHD within the CYPSE.

Methods and analysis

A single-centre parallel group feasibility randomised controlled trial will be conducted. Sixty young people within the CYPSE identified as displaying possible symptoms of ADHD will be randomised to the intervention arm (n=30; QbTest plus usual care) or control arm (n=30; usual care). Primary analyses will be descriptive and a process evaluation will be conducted to assess the contexts involved in implementing the intervention. Interviews will be conducted to explore acceptability and thematic analysis will be used to analyse the data.

Ethics and dissemination

This study was approved by National Health Service Wales research ethics committee 3 (18/WA/0347) on 15 February 2019. The findings will be published in peer-reviewed journals, presented at relevant conferences and disseminated to the public via summaries cocreated with our patient and public involvement group.

Trial registration number

ISRCTN17402196

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<![CDATA[Digital phenotyping for assessment and prediction of mental health outcomes: a scoping review protocol]]> https://www.researchpad.co/article/Nd861103e-e1f3-40e4-8521-1f21f5dad072

Introduction

Rapid advancements in technology and the ubiquity of personal mobile digital devices have brought forth innovative methods of acquiring healthcare data. Smartphones can capture vast amounts of data both passively through inbuilt sensors or connected devices and actively via user engagement. This scoping review aims to evaluate evidence to date on the use of passive digital sensing/phenotyping in assessment and prediction of mental health.

Methods and analysis

The methodological framework proposed by Arksey and O’Malley will be used to conduct the review following the five-step process. A three-step search strategy will be used: (1) Initial limited search of online databases namely, MEDLINE for literature on digital phenotyping or sensing for key terms; (2) Comprehensive literature search using all identified keywords, across all relevant electronic databases: IEEE Xplore, MEDLINE, the Cochrane Database of Systematic Reviews, PubMed, the ACM Digital Library and Web of Science Core Collection (Science Citation Index Expanded and Social Sciences Citation Index), Scopus and (3) Snowballing approach using the reference and citing lists of all identified key conceptual papers and primary studies. Data will be charted and sorted using a thematic analysis approach.

Ethics and dissemination

The findings from this systematic scoping review will be reported at scientific meetings and published in a peer-reviewed journal.

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<![CDATA[Improving mental health and physiological stress responses in mothers following traumatic childbirth and in their infants: study protocol for the Swiss TrAumatic biRth Trial (START)]]> https://www.researchpad.co/article/Nea673cff-94da-4d79-9e26-129375a8aae3

Introduction

Emergency caesarean section (ECS) qualifies as a psychological trauma, which may result in postnatal post-traumatic stress disorder (PTSD). Maternal PTSD may not only have a significant negative impact on mother–infant interactions, but also on long-term infant development. The partner’s mental health may also affect infant development. Evidence-based early interventions to prevent the development of postpartum PTSD in mothers are lacking. Immediately after a traumatic event, memory formation is vulnerable to interference. There is accumulating evidence that a brief behavioural intervention including a visuospatial task may result in a reduction in intrusive memories of the trauma.

Methods and analysis

This study protocol describes a double-blind multicentre randomised controlled phase III trial testing an early brief maternal intervention including the computer game ‘Tetris’ on intrusive memories of the ECS trauma (≤1 week) and PTSD symptoms (6 weeks, primary outcome) of 144 women following an ECS. The intervention group will carry out a brief behavioural procedure including playing Tetris. The attention-placebo control group will complete a brief written activity log. Both simple cognitive tasks will be completed within the first 6 hours following traumatic childbirth. The intervention is delivered by midwives/nurses in the maternity unit.

The primary outcome will be differences in the presence and severity of maternal PTSD symptoms between the intervention and the attention-placebo control group at 6 weeks post partum. Secondary outcomes will be physiological stress and psychological vulnerability, mother–infant interaction and infant developmental outcomes. Other outcomes will be psychological vulnerability and physiological regulation of the partner and their bonding with the infant, as well as the number of intrusive memories of the event.

Ethics and dissemination

Ethical approval was granted by the Human Research Ethics Committee of the Canton de Vaud (study number 2017–02142). Dissemination of results will occur via national and international conferences, in peer-reviewed journals, public conferences and social media.

Trial registration number

NCT 03576586.

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<![CDATA[Examining risk factors for self-harm and suicide in LGBTQ+ young people: a systematic review protocol]]> https://www.researchpad.co/article/N0f20aee2-7b92-4449-be60-44b6b02c41d7

Introduction

Young people who identify as Lesbian, Gay, Bisexual, Transgender, Queer or Questioning (LGBTQ+) are at increased risk for self-harm, suicide ideation and behaviours. However, there has yet to be a comprehensive understanding of what risk factors influence these behaviours within LGBTQ+ young people as a whole. The purpose of this systematic review is to examine risk factors associated with self-harm, suicidal ideation and behaviour in LGBTQ+) young people.

Methods and analysis

A systematic review will be conducted, conforming to the reporting guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement recommendations. Electronic databases (MEDLINE, Scopus, EMBASE, PsycINFO and Web of Science) will be systematically searched for cross-sectional, prospective, longitudinal, cohort and case–control designs which examine risk factors for self-harm and/or suicidal ideation and behaviour in LGBTQ+ young people (aged 12–25 years). Only studies published in English will be included. No date restrictions will be applied. Study quality assessment will be conducted using the original and modified Newcastle-Ottawa Scales. Meta-analysis or narrative synthesis will be used, dependent on findings.

Ethics and dissemination

This is a systematic review of published literature and thereby ethical approval was not sought. The review will be submitted to a peer-reviewed journal, be publicly disseminated at conferences focusing on mental health, self-harm and suicide prevention. The findings will also be shared through public engagement and involvement, particularly those related to young LGBTQ+ individuals.

PROSPERO registration number

CRD42019130037.

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<![CDATA[Effectiveness of internet-delivered cognitive behavioural therapy in reducing sickness absence among young employees with depressive symptoms: study protocol for a large-scale pragmatic randomised controlled trial]]> https://www.researchpad.co/article/N45ea0332-1111-472a-9d07-fedf13734195

Introduction

Depression is a highly prevalent condition with typical onset in early adulthood. Internet-delivered cognitive behavioural therapy (iCBT) is a promising cost-effective and more widely available alternative to face-to-face CBT. However, it is not known whether it can reduce sickness absence in employees showing depressive symptoms. The randomised controlled trial component of the DAQI (Depression and sickness absence in young adults: a quasi-experimental trial and web-based treatment intervention) project aims to investigate if iCBT is effective in reducing sickness absence compared with care as usual (CAU) among young employees with depressive symptoms in primary care provided in an occupational health setting.

Methods and analysis

This study will use a randomised controlled single-centre service-based trial of an existing iCBT programme (Mental Hub iCBT for Depression) to evaluate whether or not this treatment can reduce the number of sickness absence days in public sector employees aged 18–34 years who present at the occupational health service with mild depressive symptoms (score 9 on the Beck Depression Inventory-IA). Control participants will be offered CAU, with no constraints regarding the range of treatments. The active condition will consist of seven weekly modules of iCBT, with support from a web therapist. Primary outcome will be participants’ all-cause sickness absence as indicated in employer’s and national administrative records up to 6 months from study entry. Secondary outcomes relating to long-term sickness absence (over 11 calendar days) for mental and musculoskeletal disorders and psychotropic medication use will be obtained from the Finnish Social Insurance Institution’s administrative records; and short sickness absence spells (up to 11 calendar days) will be extracted from employer’s records. Analyses will be conducted on an intention-to-treat basis.

Ethics and dissemination

The Coordinating Ethics Committee of the Hospital District of Helsinki and Uusimaa has approved the study (HUS/974/2019). The results will be published in peer-reviewed scientific journals and in publications for lay audience.

Trial registration number

ISRCTN10877837

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<![CDATA[Keep the fire burning: a survey study on the role of personal resources for work engagement and burnout in medical residents and specialists in the Netherlands]]> https://www.researchpad.co/article/N992a2b23-e7ed-45e0-a5da-d00a7c6497c7

Objectives

The high prevalence of burnout among medical residents and specialists raises concerns about the stressful demands in healthcare. This study investigated which job demands and job resources and personal resources are associated with work engagement and burnout and whether the effects of these demands and resources differ for medical residents and specialists.

Design

In a survey study among residents and specialists, we assessed job demands, job resources, personal resources, work engagement and burnout symptoms using validated questionnaires (January to December 2017). Results were analysed using multivariate generalised linear model, ordinary least squares regression analyses and path analyses.

Setting

Five academic and general hospitals in the Netherlands.

Participants

A total number of 124 residents and 69 specialists participated in this study. Participants worked in the fields of pediatrics, internal medicine and neurology.

Results

The associations of job and personal resources with burnout and work engagement differed for residents and specialists. Psychological capital was associated with burnout only for specialists (b=−0.58, p<0.001), whereas psychological flexibility was associated with burnout only for residents (b=−0.31, p<0.001). Colleague support (b=0.49, p<0.001) and self-compassion (b=−0.33, p=0.004) were associated with work engagement only for specialists.

Conclusion

This study suggests that particularly personal resources safeguard the work engagement and lessen the risk of burnout of residents and specialists. Both residents and specialists benefit from psychological capital to maintain optimal functioning. In addition, residents benefit from psychological flexibility, while specialists benefit from colleague support. Personal resources seem important protective factors for physicians’ work engagement and well-being. When promoting physician well-being, a one-size-fits-all approach might not be effective but, instead, interventions should be tailored to the specific needs of specialists and residents.

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<![CDATA[Changes in alcohol consumption after treatment for depression: a secondary analysis of the Swedish randomised controlled study REGASSA]]> https://www.researchpad.co/article/N5a5830dc-6b7c-4dd8-8c2d-51280c1b7257

Objectives

Mental health problems and hazardous alcohol consumption often co-exist. Hazardous drinking could have a negative impact on different aspects of health and also negatively influence the effect of mental health treatment. The aims of this study were to examine if alcohol consumption patterns changed after treatment for depression and if the changes differed by treatment arm and patient sex.

Methods

This study of 540 participants was conducted in a large randomised controlled trial (RCT) that aimed to compare the effect of internet-based cognitive behavioural therapy, physical exercise and treatment as usual on 945 participants with mild-to-moderate depression. Treatment lasted for 12 weeks; alcohol consumption (Alcohol Use Disorder Identification Test (AUDIT)) and depression (Montgomery Åsberg Depression Rating Scale (MADRS)) were assessed at baseline and 12-month follow-up. Changes in alcohol consumption were examined in relation to depression severity, treatment arm and patient sex.

Results

The AUDIT distribution for the entire group remained unchanged after treatment for depression. Hazardous drinkers exhibit decreases in AUDIT scores, although they remained hazardous drinkers according to the cut-off scores. Hazardous drinkers experienced similar improvements in symptoms of depression compared with non-hazardous drinkers, and there was no significant relation between changes in AUDIT score and changes in depression. No differences between treatment arm and patient sex were found.

Conclusion

The alcohol consumption did not change, despite treatment effects on depression. Patients with depression should be screened for hazardous drinking habits and offered evidence-based treatment for hazardous alcohol use where this is indicated.

Trial registration number

DRKS00008745.

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<![CDATA[Biomarker Research in ADHD: the Impact of Nutrition (BRAIN) - study protocol of an open-label trial to investigate the mechanisms underlying the effects of a few-foods diet on ADHD symptoms in children]]> https://www.researchpad.co/article/Ne8a63d67-ad24-4a95-a0ba-636fe3008b94

Introduction

Attention deficit hyperactivity disorder (ADHD) is the most common childhood behavioural disorder, causing significant impediment to a child’s development. It is a complex disorder with numerous contributing (epi)genetic and environmental factors. Currently, treatment consists of behavioural and pharmacological therapy. However, ADHD medication is associated with several side effects, and concerns about long-term effects and efficacy exist. Therefore, there is considerable interest in the development of alternative treatment options. Double-blind research investigating the effects of a few-foods diet (FFD) has demonstrated a significant decrease in ADHD symptoms following an FFD. However, an FFD requires a considerable effort of both child and parents, limiting its applicability as a general ADHD treatment. To make FFD intervention less challenging or potentially obsolete, we need to understand how, and in which children, an FFD affects ADHD behaviour and, consequently, the child’s well-being. We hypothesise that an FFD affects brain function, and that the nutritional impact on ADHD is effectuated by a complex interplay between the microbiota, gut and brain, that is, the microbiota–gut–brain axis.

Methods and analysis

The Biomarker Research in ADHD: the Impact of Nutrition (BRAIN) study is an open-label trial with researchers blinded to changes in ADHD symptoms during sample processing and initial data analyses.

Ethics and dissemination

The Medical Research and Ethics Committee of Wageningen University has approved this study (NL63851.081.17, application 17/24). Results will be disseminated through peer-reviewed journal publications, conference presentations, (social) media and the BRAIN study website. A summary of the findings will be provided to the participants.

Trial registration number

NCT03440346.

Study dates

Collection of primary outcome data started in March 2018 and will be ongoing until 100 children have participated in the study. Sample data analysis will start after all samples have been collected.

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