Estimating the prognostic value of cross-sectional network connectivity for treatment response in depression.

BACKGROUND: Tightly connected symptom networks have previously been linked to treatment resistance, but most findings come from small-sample studies comparing single responder v. non-responder networks. We aimed to estimate the association between baseline network connectivity and treatment response in a large sample and benchmark its prognostic value against baseline symptom severity and variance. METHODS: N = 40 518 patients receiving treatment for depression in routine care in England from 2015-2020 were analysed. Cross-sectional networks were constructed using the Patient Health Questionnaire-9 (PHQ-9) for responders and non-responders (N = 20 259 each). To conduct parametric tests investigating the contribution of PHQ-9 sum score mean and variance to connectivity differences, networks were constructed for 160 independent subsamples of responders and non-responders (80 each, n = 250 per sample). RESULTS: The baseline non-responder network was more connected than responders (3.15 v. 2.70, S = 0.44, p < 0.001), but effects were small, requiring n = 750 per group to have 85% power. Parametric analyses revealed baseline network connectivity, PHQ-9 sum score mean, and PHQ-9 sum score variance were correlated (r = 0.20-0.58, all p < 0.001). Both PHQ-9 sum score mean (ß = -1.79, s.e. = 0.07, p < 0.001), and PHQ-9 sum score variance (ß = -1.67, s.e. = 0.09, p < 0.001) had larger effect sizes for predicting response than connectivity (ß = -1.35, s.e. = 0.12, p < 0.001). The association between connectivity and response disappeared when PHQ-9 sum score variance was accounted for (ß = -0.28, s.e. = 0.19, p = 0.14). We replicated these results in patients completing longer treatment (8-12 weeks, N = 22 952) and using anxiety symptom networks (N = 70 620). CONCLUSIONS: The association between baseline network connectivity and treatment response may be largely due to differences in baseline score variance.

An online tiered screening procedure to identify mental health problems among refugees.

BACKGROUND: Many refugees suffer from mental health problems due to stressful and traumatic events before, during, and after migration. However, refugees are facing a wide variety of barriers, limiting their access to mental health care. Internet-based tools, available in several languages, could be one way to increase the availability of mental health services for refugees. The present study aimed to develop and test a screening tool to screen for clinically relevant symptoms of psychiatric disorders common among refugees (i.e. Depression, Anxiety, Post-traumatic stress disorder, and Insomnia). We, designed, translated, and adapted an internet-based tiered screening procedure suitable for use with the largest refugee populations residing in Sweden. The tool aims to accurately identify symptoms of mental distress (Tier 1), differentiate between symptoms of specific psychiatric disorders (Tier 2), and assess symptom severity (Tier 3). We tested the overall efficiency of using a tiered screening procedure. METHODS: Seven hundred fifty-seven refugees residing in Sweden, speaking any of the languages Arabic, Dari, Farsi, English, or Swedish, completed an online questionnaire following a three-tiered procedure with screening instruments for each tier. In this study, the Tier 3 scales were used as reference standards for clinically relevant symptoms, to evaluate screening efficiency in terms of accuracy and reduction of item burden in previous tiers. RESULTS: The results show that the tiered procedure could reduce the item burden while maintaining high accuracy, with up to 86% correctly assessed symptoms and few false negatives with moderate symptoms and above (at most 9%), and very few with severe symptoms (at most 1.3%). DISCUSSION: This study generated an accurate screening tool that efficiently identifies clinically relevant symptoms of common psychiatric disorders among refugees. Using an adapted online tiered procedure to screen for multiple mental health issues among refugees has the potential to facilitate screening and increase access to mental health services for refugees. We discuss the utility of the screening tool and the necessity of further evaluation.

The Precision in Psychiatry (PIP) study: Testing an internet-based methodology for accelerating research in treatment prediction and personalisation.

BACKGROUND: Evidence-based treatments for depression exist but not all patients benefit from them. Efforts to develop predictive models that can assist clinicians in allocating treatments are ongoing, but there are major issues with acquiring the volume and breadth of data needed to train these models. We examined the feasibility, tolerability, patient characteristics, and data quality of a novel protocol for internet-based treatment research in psychiatry that may help advance this field. METHODS: A fully internet-based protocol was used to gather repeated observational data from patient cohorts receiving internet-based cognitive behavioural therapy (iCBT) (N = 600) or antidepressant medication treatment (N = 110). At baseline, participants provided > 600 data points of self-report data, spanning socio-demographics, lifestyle, physical health, clinical and other psychological variables and completed 4 cognitive tests. They were followed weekly and completed another detailed clinical and cognitive assessment at week 4. In this paper, we describe our study design, the demographic and clinical characteristics of participants, their treatment adherence, study retention and compliance, the quality of the data gathered, and qualitative feedback from patients on study design and implementation. RESULTS: Participant retention was 92% at week 3 and 84% for the final assessment. The relatively short study duration of 4 weeks was sufficient to reveal early treatment effects; there were significant reductions in 11 transdiagnostic psychiatric symptoms assessed, with the largest improvement seen for depression. Most participants (66%) reported being distracted at some point during the study, 11% failed 1 or more attention checks and 3% consumed an intoxicating substance. Data quality was nonetheless high, with near perfect 4-week test retest reliability for self-reported height (ICC = 0.97). CONCLUSIONS: An internet-based methodology can be used efficiently to gather large amounts of detailed patient data during iCBT and antidepressant treatment. Recruitment was rapid, retention was relatively high and data quality was good. This paper provides a template methodology for future internet-based treatment studies, showing that such an approach facilitates data collection at a scale required for machine learning and other data-intensive methods that hope to deliver algorithmic tools that can aid clinical decision-making in psychiatry.

Citizen science to improve patient and public involvement in GUideline Implementation in oral health and DEntistry (the GUIDE platform).

BACKGROUND: Citizen science is a way to democratise science by involving groups of citizens in the research process. Clinical guidelines are used to improve practice, but their implementation can be limited. Involving patients and the public can enhance guideline implementation, but there is uncertainty about the best approaches to achieve this. Citizen science is a potential way to involve patients and the public in improving clinical guideline implementation. We aimed to explore the application of citizen science methods to involve patients and the public in the dissemination and implementation of clinical guidelines in oral health and dentistry. METHODS: We developed GUIDE (GUideline Implementation in oral health and DEntistry), a citizen science online platform, using a participatory approach with researchers, oral health professionals, guideline developers and citizens. Recruitment was conducted exclusively online. The platform focused on prespecified challenges related to oral health assessment guidelines, and asked citizens to generate ideas, as well as vote and comment on other citizens' ideas to improve those challenges. Citizens also shared their views via surveys and two online synchronous group meetings. Data were collected on participant's demographics, platform engagement and experience of taking part. The most promising idea category was identified by an advisory group based on engagement, feasibility and relevance. We presented quantitative data using descriptive statistics and analysed qualitative data using inductive and deductive thematic analysis. RESULTS: The platform was open for 6 months and we recruited 189 citizens, from which over 90 citizens actively engaged with the platform. Most citizens were over 34 years (64%), female (58%) and had a university degree (50%). They generated 128 ideas, 146 comments and 248 votes. The challenge that led to most engagement was related to prevention and oral health self-care. To take this challenge forward, citizens generated a further 36 ideas to improve a pre-existing National Health Service oral care prevention leaflet. Citizens discussed motivations to take part in the platform (understanding, values, self-care), reasons to stay engaged (communication and feedback, outputs and impact, and relevance of topics discussed) and suggestions to improve future platforms. CONCLUSION: Citizen science is an effective approach to generate and prioritise ideas from a group of citizens to improve oral health and dental services. Prevention and oral health self-care were of particular interest to citizens. More research is needed to ensure recruitment of a diverse group of citizens and to improve retention in citizen science projects. PATIENT OR PUBLIC CONTRIBUTION: This project was inherently conducted with the input of public partners (citizen scientists) in all key aspects of its conduct and interpretation. In addition, two public partners were part of the research team and contributed to the design of the project, as well as key decisions related to its conduct, analysis, interpretation and dissemination and are co-authors of this manuscript.

The Effectiveness of Low-Intensity Psychological Interventions for Comorbid Depression and Anxiety in Patients with Long-Term Conditions: A Real-World Naturalistic Observational Study in IAPT Integrated Care.

BACKGROUND: Low-intensity psychological interventions may be a cost-effective, accessible solution for treating depression and anxiety in patients with long-term conditions, but evidence from real-world service settings is lacking. This study examined the effectiveness of low-intensity psychological interventions provided in the Improving Access to Psychological Therapies programme in England for patients with and without long-term conditions. METHODS: A retrospective analysis was conducted on patients (total N = 21,051, long-term conditions n = 4024) enrolled in three low-intensity psychological interventions, i.e. Internet-delivered cognitive behavioural therapy (iCBT), guided self-help (GSH), and psychoeducational group therapy (PGT) within a Talking Therapies service from 2016 to 2020. Primary outcomes included pre-post-treatment changes in depression (Patient Health Questionnaire-9) and anxiety (Generalised Anxiety Disorder-7). RESULTS: Overall, both cohorts significantly improved on all outcomes post-treatment, with large effect sizes. Patients with long-term conditions experienced a greater reduction in depression while those without experienced a greater reduction in anxiety, but these differences were marginal (< 1 score difference on both measures). No difference between the cohorts was shown when comparing the differential effectiveness across interventions, but those engaging in iCBT showed greater reduction in depression and anxiety than those in GSH and PGT, while those in GSH improved more than PGT. CONCLUSIONS: Low-intensity psychological interventions, particularly iCBT, were effective in treating depression and anxiety in patients with long-term conditions in a real-world service setting. Our large-scale study supports the continued and increased implementation of low-intensity psychological interventions for this subpopulation via integrated care.

The relationship between posttherapeutic Cognitive Behavior Therapy skills usage and follow-up outcomes of internet-delivered Cognitive Behavior Therapy.

BACKGROUND: Clients independently applying Cognitive Behavior Therapy (CBT) skills is an important outcome of CBT-based treatments. The relationship between posttherapeutic CBT skills usage and clinical outcomes remains under-researched-especially after internet-delivered CBT (iCBT). OBJECTIVE: Explore contemporaneous and lagged effects of posttherapeutic CBT skills usage frequency on iCBT follow-up outcomes. METHOD: Nested within a randomized controlled trial, 241 participants received 8-week supported iCBT for anxiety and/or depression, completing measures of anxiety, depression, functional impairment, and CBT skills usage frequency at 3-, 6-, 9-, and 12-month follow-up. Cross-lagged panel models evaluated primary aims. RESULTS: While analyses support a contemporaneous relationship between anxiety, depression, functional impairment, and CBT skills usage frequency, no consistent lagged effects were observed. CONCLUSION: Findings align with qualitative research but the role of CBT skills usage in the maintenance of iCBT effects remains unclear. Innovative research modeling temporal and possibly circular relationships between CBT skill usage and clinical outcomes is needed to inform iCBT optimization.

Estimating Cost-Effectiveness Using Alternative Preference-Based Scores and Within-Trial Methods: Exploring the Dynamics of the Quality-Adjusted Life-Year Using the EQ-5D 5-Level Version and Recovering Quality of Life Utility Index.

OBJECTIVES: This study aimed to explore quality-adjusted life-year (QALY) and subsequent cost-effectiveness estimates based on the more physical health-focused EQ-5D 5-level version (EQ-5D-5L) value set for England or cross-walked EQ-5D 3-level version UK value set scores or more mental health recovery-focused Recovering Quality of Life Utility Index (ReQoL-UI), when using alternative within-trial statistical methods. We describe possible reasons for the different QALY estimates based on the interaction between item scores, health state profiles, preference-based scores, and mathematical and statistical methods chosen. METHODS: QALYs are calculated over 8 weeks from a case study 2:1 (intervention:control) randomized controlled trial in patients with anxiety or depression. Complete case and with missing cases imputed using multiple-imputation analyses are conducted, using unadjusted and regression baseline-adjusted QALYs. Cost-effectiveness is judged using incremental cost-effectiveness ratios and acceptability curves. We use previously established psychometric results to reflect on estimated QALYs. RESULTS: A total of 361 people (241:120) were randomized. EQ-5D-5L crosswalk produced higher incremental QALYs than the value set for England or ReQoL-UI, which produced similar unadjusted QALYs, but contrasting baseline-adjusted QALYs. Probability of cost-effectiveness <£30 000 per QALY ranged from 6% (complete case ReQoL-UI baseline-adjusted QALYs) to 64.3% (multiple-imputation EQ-5D-5L crosswalk unadjusted QALYs). The control arm improved more on average than the intervention arm on the ReQoL-UI, a result not mirrored on the EQ-5D-5L nor condition-specific (Patient-Health Questionnaire-9, depression; Generalized Anxiety Disorder-7, anxiety) measures. CONCLUSIONS: ReQoL-UI produced contradictory cost-effectiveness results relative to the EQ-5D-5L. The EQ-5D-5L's better responsiveness and "anxiety/depression" and "usual activities" items drove the incremental QALY results. The ReQoL-UI's single physical health item and "personal recovery" construct may have influenced its lower 8-week incremental QALY estimates in this patient sample.

Durability of treatment effects following internet-delivered cognitive behavioural therapy for depression and anxiety delivered within a routine care setting.

OBJECTIVE: To investigate post-treatment relapse and remission rates 3, 6 and 9 months after completion of an acute phase of a clinician-supported internet-delivered cognitive-behavioural therapy (iCBT) for anxiety and depressive symptoms, within a routine care setting. METHOD: Secondary analysis from a 12-month pragmatic randomized-controlled trial delivered within the Improving Access to Psychological Therapies (IAPT) programme in England. Participants in the intervention arm were included if they met criteria for reliable recovery from depression (PHQ-9) and anxiety (GAD-7) at post-treatment assessment. Survival analysis was used to assess durability of treatment effects and determine predictors to relapse at 3-, 6- and 9-month follow-up. Hazard ratios predicting time-to-relapse were estimated with semi-parametric Cox proportional hazards model. RESULTS: Of the 241 participants in the intervention arm, 89 participants met the criteria for reliable recovery from depression and anxiety at the post-treatment assessment. Of these 89 eligible cases, 29.2% relapsed within the 9-month period, with 70.8% remaining in remission at 9 months post-treatment. Of those who relapsed, 53.8% experienced a relapse of depression and anxiety; 7.7% experienced a relapse of depression only; and 38.4% experienced a relapse of anxiety only. Younger age, having a long-term condition, and residual symptoms of anxiety at end-of-treatment were all significant predictors of relapse. CONCLUSIONS: This study is the first to explore the remission and relapse rates after an acute phase of iCBT treatment, within a routine, stepped-care setting. The results add to the scarce literature on the durability of the effects of iCBT treatment in routine care settings, where patients are not typically followed up after receiving a completed course of treatment.

Following up internet-delivered cognitive behaviour therapy (CBT): A longitudinal qualitative investigation of clients' usage of CBT skills.

BACKGROUND: While the acquisition and application of Cognitive Behaviour Therapy (CBT) skills is a core component and likely mechanism of effect maintenance in all CBT-based treatments, the extent of post-therapeutic CBT skills usage among internet-delivered CBT (iCBT) clients remains under-researched. METHOD: Nested within a pragmatic randomized controlled trial, 241 participants received an 8-week supported iCBT intervention for anxiety and/or depression and answered open-ended questions about their use and experience of CBT skills at 3-, 6-, 9-, and 12-month follow-up. Recurrent, cross-sectional qualitative analysis following the descriptive and interpretive approach was used to create a taxonomy, through which all qualitative data was coded. RESULTS: In total, 479 qualitative responses across 181 participants were analysed. Participants reported using a wide range of CBT skills and associated helpful and hindering experiences and impacts. The reasons for discontinued CBT skills usage were diverse, ranging from rare adverse effects to healthy adaptation. CONCLUSION: The study shows how clients receiving iCBT in routine care learn CBT skills during treatment and utilize them in productive ways post-treatment. Findings coincide with similar research in face-to-face CBT and may inform future research to drive innovation and iCBT intervention development.

The effectiveness of Internet-delivered treatment for generalized anxiety disorder: An updated systematic review and meta-analysis.

BACKGROUND: Generalized anxiety disorder (GAD) is a highly prevalent, chronic disorder associated with impaired quality of life, societal burden, and poor treatment rates. Internet-delivered interventions may improve the accessibility of treatments and are increasingly being used. This study aimed to update a previous meta-analysis to determine the effectiveness of available Internet-delivered interventions in treating symptoms of GAD. METHOD: Systematic literature searches were conducted (through April 2020) using Embase, PubMed, PsychINFO, and Cochrane to find randomized controlled trials of Internet-delivered interventions for GAD. Risk of bias was evaluated, and Hedge's g was calculated at posttreatment and follow-up. RESULTS: Twenty studies met eligibility criteria and were included in the meta-analysis. Random-effect models detected large effect sizes for primary outcomes of anxiety (g = 0.79) and worry (g = 0.75), favoring treatment. Effect sizes for depression, functional impairment, and quality of life were moderate to large. Maintenance of effects at follow-up seems likely. CONCLUSIONS: Results support the effectiveness of Internet-delivered treatments for GAD. Considerable heterogeneity between studies appeared moderated by variability in the interventions themselves, highlighting the importance of further investigation into the characteristics that may optimize treatment outcomes. Overall, Internet-delivery appears to be a viable mode of treatment for GAD with potential to relieve existing gaps in the provision of treatment.

Psychometric assessment of EQ-5D-5L and ReQoL measures in patients with anxiety and depression: construct validity and responsiveness.

PURPOSE: Generic health measures have been questioned for quantifying mental-health-related outcomes. In patients with anxiety and/or depression, our aim is to assess the psychometric properties of the preference-based EQ-5D-5L (generic health) and ReQoL-UI (recovery-focussed quality of life) for economic evaluation against the PHQ-9 (depression) and GAD-7 (anxiety). EQ-5D-5L anxiety/depression item and ReQoL-10 are also assessed. METHODS: A 2:1 (intervention: control) randomised controlled trial collected measures at baseline and 8 weeks post baseline; in the intervention arm, data were also collected 3, 6, 9, and 12-months post baseline. EQ-5D-5L preference-based scores were obtained from the value set for England (VSE) and 'cross-walked' EQ-5D-3L United Kingdom (UK) value set scores. ReQoL-UI preference-based scores were obtained from its UK value set as applied to seven ReQoL-10 items. EQ-5D-5L and ReQoL measures' construct validity and responsiveness were assessed compared against PHQ-9 and GAD-7 scores and group cut-offs. RESULTS: 361 people were randomised to intervention (241) or control (120). ReQoL-UI/-10 had better construct validity with depression severity than the EQ-5D-5L (VSE/cross-walk scores), which had relatively better construct validity with anxiety severity than the ReQoL-UI/-10. Across all intervention-arm time-points relative to baseline, responsiveness was generally better for EQ-5D-5L (VSE in particular) than ReQoL-UI, but worse than ReQoL-10. CONCLUSION: There is insufficient evidence to recommend the ReQoL-UI over EQ-5D-5L for economic evaluations to capture anxiety severity. However, there may be rationale for recommending the ReQoL-UI over the EQ-5D-5L to capture depression severity given its better construct validity, albeit poorer responsiveness, and if recovery-focussed quality of life relative to condition-specific symptomology is the construct of interest.

An internet-delivered self-management programme for bipolar disorder in mental health services in Ireland: Results and learnings from a feasibility trial.

Bipolar disorder (BD) is a chronic condition that requires continued care. Psychological interventions are recommended by clinical guidelines but there are treatment barriers that prevent patients to access these services. Internet-delivered self-management interventions are promising alternatives to improve treatment accessibility in patients with BD. Several studies indicate that these interventions are acceptable and beneficial for patients with BD, but no studies have been conducted in routine care settings. This trial aimed to examine the feasibility, acceptability, and preliminary efficacy of implementing an internet-delivered, clinician-supported intervention for BD as an adjunct to treatment as usual at two secondary-care services in Ireland. This study used an uncontrolled design with mixed-methods evaluation. Feasibility and acceptability were assessed in terms of recruitment, use of the intervention, and satisfaction from both clinicians and patients' perspectives. Personal recovery, quality of life, and severity of symptoms were measured at baseline and post-intervention. Fifteen patients signed consent and used the programme for 10 weeks. Usage of the intervention was adequate with high frequency of tool usage. There was a significant improvement in patients' sense of personal recovery (z = 2.38, p = .017). The intervention was found acceptable and easy-to-use; however, implementation barriers will need to be overcome for scaling the intervention. This is the first study testing the feasibility of a digital intervention for patients with BD in public mental health services in Ireland. More research is needed in order to increase the understanding of how to promote the integration and the uptake of digital interventions for individuals with BD.

Exploring the Relationship Between Usage and Outcomes of an Internet-Based Intervention for Individuals With Depressive Symptoms: Secondary Analysis of Data From a Randomized Controlled Trial.

BACKGROUND: Internet interventions can easily generate objective data about program usage. Increasingly, more studies explore the relationship between usage and outcomes, but they often report different metrics of use, and the findings are mixed. Thus, current evaluations fail to demonstrate which metrics should be considered and how these metrics are related to clinically meaningful change. OBJECTIVE: This study aimed to explore the relationship between several usage metrics and outcomes of an internet-based intervention for depression. METHODS: This is a secondary analysis of data from a randomized controlled trial that examined the efficacy of an internet-based cognitive behavioral therapy for depression (Space from Depression) in an adult community sample. All participants who enrolled in the intervention, regardless of meeting the inclusion criteria, were included in this study. Space from Depression is a 7-module supported intervention, delivered over a period of 8 weeks. Different usage metrics (ie, time spent, modules and activities completed, and percentage of program completion) were automatically collected by the platform, and composite variables from these (eg, activities per session) were computed. A breakdown of the usage metrics was obtained by weeks. For the analysis, the sample was divided into those who obtained a reliable change (RC)-and those who did not. RESULTS: Data from 216 users who completed pre- and posttreatment outcomes were included in the analyses. A total of 89 participants obtained an RC, and 127 participants did not obtain an RC. Those in the RC group significantly spent more time, had more log-ins, used more tools, viewed a higher percentage of the program, and got more reviews from their supporter compared with those who did not obtain an RC. Differences between groups in usage were observed from the first week in advance across the different metrics, although they vanished over time. In the RC group, the usage was higher during the first 4 weeks, and then a significant decrease was observed. Our results showed that specific levels of platform usage, 7 hours total time spent, 15 sessions, 30 tools used, and 50% of program completion, were associated with RC. CONCLUSIONS: Overall, the results showed that those individuals who obtained an RC after the intervention had higher levels of exposure to the platform. The usage during the first half of the intervention was higher, and differences between groups were observed from the first week. This study also showed specific usage levels associated with outcomes that could be tested in controlled studies to inform the minimal usage to establish adherence. These results will help to better understand how to use internet-based interventions and what optimal level of engagement can most affect outcomes. TRIAL REGISTRATION: ISRCTN Registry ISRCTN03704676; http://www.isrctn.com/ISRCTN03704676. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/1471-244X-14-147.

Helpful and Hindering Events in Internet-Delivered Cognitive Behavioural Treatment for Generalized Anxiety.

BACKGROUND: Anxiety disorders are a highly prevalent cause of impairment globally with generalized anxiety disorder (GAD) sharing many features with other anxiety disorders. AIMS: The present study investigated the helpful and hindering events and impacts for individuals with generalized anxiety who engaged with a supported 6-week online intervention based on cognitive behavioural therapy (iCBT). METHOD: Participants (n = 36) completed the Helpful and Hindering Aspects of Therapy (HAT) for each session. A descriptive-interpretative framework was used to analyse the data. RESULTS: Helpful events were identified by participants as CBT techniques including psychoeducation, monitoring, cognitive restructuring and relaxation, and found supporter interaction, mindfulness and reading personal stories helpful. The associated impacts were identified as support and validation; behavioural change/applying coping strategies; clarification, awareness, and insight; reassurance/relief; and self-efficacy/empowerment. Hindering events were identified as treatment content/form; and amount of work/technical issues, which led to impacts such as frustration/irritation; increased anxiety; and isolation. CONCLUSION: The implications of the results, potential future directions of research and limitations of the study are discussed.

Assessing the efficacy of a culturally adapted cognitive behavioural internet-delivered treatment for depression: protocol for a randomised controlled trial.

BACKGROUND: Depression is the principal cause of disability in the world. High prevalence rates of depression in general populations and college students have been found worldwide and in various cultural groups. Low-intensity cognitive behavioural internet-delivered treatment has demonstrated efficacy in high-income-countries (HICs). However little is known of their potential for adaptation and efficacy in low and middle-income countries. METHODS: Study (1) involves the cultural adaptation of the Space from Depression cognitive-behaviour internet-delivered programme with an asynchronous support for depressive symptoms. This includes initial researcher/clinician adaptation and the integration of cultural assessment feedback of the programme by a panel of experts and users through the theoretically-based Cultural Relevance Questionnaire (CRQ). Study (2) describes the implementation of the culturally adapted intervention using a randomised controlled trial methodology. The efficacy trial will include an active treatment group and a waiting-list control group of participants meeting eligibility criteria (mild to moderate depression symptoms). The active condition will consist of 7 weekly modules of internet-delivered cognitive behavioural therapy (iCBT) Space from Depression, with post-session feedback support. The primary outcome will be the Patient Health Questionnaire (PHQ-9). The study also involves collection of client reported significant events and client satisfaction with the internet-delivered treatment. Data will be collected at baseline and at post-treatment (week 7), and at follow-up (week 20/3 months). Analysis will be conducted on the intention-to-treat basis. DISCUSSION: The study seeks to establish a theoretically robust methodology for culturally adapting internet-delivered interventions for mental health disorders and to evaluate the efficacy of a culturally adapted internet-delivered treatment for depression in Colombia, with support. The study will be a first contribution to a method for culturally adapting internet-delivered interventions and also a first to examine the efficacy of such an adapted intervention in Latin America. TRIAL REGISTRATION: Clinical trials NCT03062215. Retrospectively registered 14th February 2017.

Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial.

BACKGROUND: Depression and anxiety are common mental health disorders worldwide. The UK's Improving Access to Psychological Therapies (IAPT) programme is part of the National Health Service (NHS) designed to provide a stepped care approach to treating people with anxiety and depressive disorders. Cognitive Behavioural Therapy (CBT) is widely used, with computerised and internet-delivered cognitive behavioural therapy (cCBT and iCBT, respectively) being a suitable IAPT approved treatment alternative for step 2, low- intensity treatment. iCBT has accumulated a large empirical base for treating depression and anxiety disorders. However, the cost-effectiveness and impact of these interventions in the longer-term is not routinely assessed by IAPT services. The current study aims to evaluate the clinical and cost-effectiveness of internet-delivered interventions for symptoms of depression and anxiety disorders in IAPT. METHODS: The study is a parallel-groups, randomised controlled trial examining the effectiveness and cost-effectiveness of iCBT interventions for depression and anxiety disorders, against a waitlist control group. The iCBT treatments are of 8 weeks duration and will be supported by regular post-session feedback by Psychological Wellbeing Practitioners. Assessments will be conducted at baseline, during, and at the end of the 8-week treatment and at 3, 6, 9, and 12-month follow-up. A diagnostic interview will be employed at baseline and 3-month follow-up. Participants in the waitlist control group will complete measures at baseline and week 8, at which point they will receive access to the treatment. All adult users of the Berkshire NHS Trust IAPT Talking Therapies Step 2 services will be approached to participate and measured against set eligibility criteria. Primary outcome measures will assess anxiety and depressive symptoms using the GAD-7 and PHQ-9, respectively. Secondary outcome measures will allow for the evaluation of long-term outcomes, mediators and moderators of outcome, and cost-effectiveness of treatment. Analysis will be conducted on a per protocol and intention-to-treat basis. DISCUSSION: This study seeks to evaluate the immediate and longer-term impact, as well as the cost effectiveness of internet-delivered interventions for depression and anxiety. This study will contribute to the already established literature on internet-delivered interventions worldwide. The study has the potential to show how iCBT can enhance service provision, and the findings will likely be generalisable to other health services. TRIAL REGISTRATION: Current Controlled Trials ISRCTN ISRCTN91967124. DOI: https://doi.org/10.1186/ISRCTN91967124 . Web: http://www.isrctn.com/ISRCTN91967124 . Clinicaltrials.gov : NCT03188575. Trial registration date: June 8, 2017 (prospectively registered).

Bicycle helmet use and facial injuries.

Data sourcesPubMed/Medline, Google Scholar and Cochrane Library databasesStudy selectionTwo reviewers independently selected studies. Observational studies involving patients >16 years comparing facial injuries in those wearing and not wearing cycle helmets were included. Studies were excluded if they examined the effects of helmet legislation, reported facial injuries with other injuries, compared different types of helmet or were wholly paediatric studies.Data extraction and synthesisSelection, reporting, attrition and detection bias of studies were assessed. Data were extracted on the incidence of all facial injuries reported in helmet users and non-helmet users by two reviewers independently. Odds ratios (OR) were extracted for facial injuries and facial fractures and meta-analysis conducted.ResultsThis review suggests that bicycle helmets may offer a protective benefit against facial fractures. However, it is noted that previous analyses have shown that this protection is not uniform across the face and that the upper and middle face may be protected.ConclusionsThis review suggests that bicycle helmets may offer a protective benefit against facial fractures. However, it is noted that previous analyses have shown that this protection is not uniform across the face and that the upper and middle face may be protected.

The effectiveness of interproximal oral hygiene aids.

Data sourcesMedline, Embase and Web of Science databases. This was supplemented with searches of the journals; Journal of Periodontology, Journal of Clinical Periodontology, The International Journal of Periodontics and Restorative Dentistry and International Journal of Dental Hygiene.Study selectionRandomised controlled trials assessing interproximal oral hygiene (IOH) aids in physically competent patients reporting gingival inflammation, plaque or probing depth with at least two weeks follow-up were included.Data extraction and synthesisStudy selection and data abstraction were carried out independently by two reviewers. Risk of bias was assessed using the Cochrane tool. The primary outcomes were gingival index (GI) and bleeding on probing (BOP), and a random effects network meta-analysis (NMA) was carried out for each outcome.ResultsTwenty-two studies involving a total of 2,030 patients were included. Sample sizes of the studies ranged from ten to 110 patients with follow-up periods of between four to 24 weeks. One study was considered to have a high risk of bias, 17 an unclear risk and four a low risk. A range of interproximal oral hygiene aids were tested including flossing (FL), powered flossing (FL2), toothpicks (TP), toothpicks and intensive oral hygiene instructions (TO), water jet irrigation devices (WJ), interdental brushes (IB), gum massaging devices (MD), toothbrush only (Ctrl), powered, electric, sonic toothbrush (Powered Ctrl) and powered control and water jet (PW). NMA for bleeding on probing saw the greatest reduction with toothpick and intensive oral hygiene instruction (26.4% [95% CI: 7.50, 45.4]); waterjet had the next largest reduction with an average of 19.3% (95% CI: 16.2%, 22.4%) with relatively smaller reductions for floss. The interdental brush was seen to be more efficacious than the majority of the alternative oral hygiene aids with a mean effect of 0.34 reduction in GI as compared with control (95% CI: 0.12, 0.56).ConclusionsIn the absence of strong evidence about IOH aids differences in the impact on patients, practitioners should customise IOH aid recommendations and offer alternatives rather than insisting on instruction on the use of a universally recommended cleaning aid. Further well designed and appropriately powered clinical trials are warranted to provide more authoritative guidelines on IOH selection.

Prevalence of oral potentially malignant disorders.

Data sourcesThe Latin American and Caribbean Health Sciences (LILACS), LIVIVO, PubMed/Medline, Science Direct, Web of Science, Google Scholar, Open Gray and ProQuest database.Study selectionObservational studies conducted in adults aged over 18 where oral potentially malignant disorders (OPMDs) had clinical diagnoses histologically confirmed were included.Data extraction and synthesisStudy selection and data abstraction were undertaken by two reviewers independently. The Joanna Briggs Institute checklist of prevalence data was used to assess risk of bias. The prevalence of OMPDs expressed as a percentage was the main outcome. Random effects meta-analysis and sensitivity analysis were conducted.ResultsTwenty two studies were included, seven from South America or the Caribbean, five from Asia, five from Europe and two each from North America and the Middle East. Three studies were considered to have a low risk of bias, twelve a moderate risk and seven a high risk of bias. The overall pooled prevalence of OPMD in this study was 4.47% (95% CI; 2.43 - 7.08). OPMDs were more common in males 59.99% (95% CI; 41.27 - 77.30%). Prevalence was highest in Asian populations 10.54% (95% CI; 4.60 - 18.55%).ConclusionsThe overall prevalence of OPMD worldwide was 4.47%, and males were more frequently affected by these disorders. The prevalence of OPMD differs between populations; therefore, further population-based studies may contribute to the better understanding of these differences.