Psychometric properties of two implementation measures: Normalization MeAsure Development questionnaire (NoMAD) and organizational readiness for implementing change (ORIC).

Background: Effective interventions need to be implemented successfully to achieve impact. Two theory-based measures exist for measuring the effectiveness of implementation strategies and monitor implementation progress. The Normalization MeAsure Development questionnaire (NoMAD) explores the four core concepts (Coherence, Cognitive Participation, Collective Action, Reflexive Monitoring) of the Normalization Process Theory. The Organizational Readiness for Implementing Change (ORIC) is based on the theory of Organizational Readiness for Change, measuring organization members' psychological and behavioral preparedness for implementing a change. We examined the measurement properties of the NoMAD and ORIC in a multi-national implementation effectiveness study. Method: Twelve mental health organizations in nine countries implemented Internet-based cognitive behavioral therapy (iCBT) for common mental disorders. Staff involved in iCBT service delivery (n = 318) participated in the study. Both measures were translated into eight languages using a standardized forward-backward translation procedure. Correlations between measures and subscales were estimated to examine convergent validity. The theoretical factor structures of the scales were tested using confirmatory factor analysis (CFA). Test-retest reliability was based on the correlation between scores at two time points 3 months apart. Internal consistency was assessed using Cronbach's alpha. Floor and ceiling effects were quantified using the proportion of zero and maximum scores. Results: NoMAD and ORIC measure related but distinct latent constructs. The CFA showed that the use of a total score for each measure is appropriate. The theoretical subscales of the NoMAD had adequate internal consistency. The total scale had high internal consistency. The total ORIC scale and subscales demonstrated high internal consistency. Test-retest reliability was suboptimal for both measures and floor and ceiling effects were absent. Conclusions: This study confirmed the psychometric properties of the NoMAD and ORIC in multi-national mental health care settings. While measuring on different but related aspects of implementation processes, the NoMAD and ORIC prove to be valid and reliable across different language settings.

Why was the study done?: Effective interventions need to be implemented successfully to achieve impact. Reliable measurement instruments are needed to determine if an implementation was successful or not. Two theory-based instruments exist for measuring the effectiveness of implementation strategies and monitor progress. The NoMAD measures aspects of normalization related to sense-making, willingness to implement, the work people do, and reflection. The Organizational Readiness for Implementing Change (ORIC) measures organization members' preparedness for implementing a change. What did we do?: This study examined whether the NoMAD and ORIC measure what they are supposed to measure. We translated the instruments from English to eight languages (Albanian, Danish, Dutch, French, German, Italian, and Spanish/Catalan) We applied various statistical methods to confirm the measurement properties, including correlations of scales, factor structures, test­retest reliability, consistency and floor and ceiling effects. 318 mental health professionals from nine countries participated in the study. What did we find?: For both instruments, total scores can be used as well as the subscale scores. Internal consistency for ORIC was high and for NoMAD adequate. Test­retest reliability was demonstrated, and floor and ceiling effects were rare. What does this mean?: NoMAD and ORIC are reliable instruments for measuring implementation processes and outcomes across mental health care settings in different countries and languages. They measure related but different aspects of implementation processes and outcomes. The measures are brief, and theory supported. However, more work is to be done on interpreting scores in relation to implementation success and regarding changes over time.

Outcome assessment of a complex mental health intervention in the workplace. Results from the MENTUPP pilot study.

OBJECTIVE: Multicomponent interventions are recommendable to achieve the greatest mental health benefits, but are difficult to evaluate due to their complexity. Defining long-term outcomes, arising from a Theory of Change (ToC) and testing them in a pilot phase, is a useful approach to plan a comprehensive and meaningful evaluation later on. This article reports on the pilot results of an outcome evaluation of a complex mental health intervention and examines whether appropriate evaluation measures and indicators have been selected ahead of a clustered randomised control trial (cRCT). METHODS: The MENTUPP pilot is an evidence-based intervention for Small and Medium Enterprises (SMEs) active in three work sectors and nine countries. Based on our ToC, we selected the MENTUPP long-term outcomes, which are reported in this article, are measured with seven validated scales assessing mental wellbeing, burnout, depression, anxiety, stigma towards depression and anxiety, absenteeism and presenteeism. The pilot MENTUPP intervention assessment took place at baseline and at 6 months follow-up. RESULTS: In total, 25 SMEs were recruited in the MENTUPP pilot and 346 participants completed the validated scales at baseline and 96 at follow-up. Three long-term outcomes significantly improved at follow-up (p < 0.05): mental wellbeing, symptoms of anxiety, and personal stigmatising attitudes towards depression and anxiety. CONCLUSIONS: The results of this outcome evaluation suggest that MENTUPP has the potential to strengthen employees' wellbeing and decrease anxiety symptoms and stigmatising attitudes. Additionally, this study demonstrates the utility of conducting pilot workplace interventions to assess whether appropriate measures and indicators have been selected. Based on the results, the intervention and the evaluation strategy have been optimised.

Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. OBJECTIVE: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. METHODS: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. RESULTS: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04686-4.

Supporting employees with mental illness and reducing mental illness-related stigma in the workplace: an expert survey.

An expert survey was designed to support the development of a workplace-based multi-country intervention tackling depression, anxiety, and mental illness-related stigma in small- and medium-sized enterprises (SMEs). Academic experts and representatives of SME organisations, specific sector organisations, labour or advocacy groups, and occupational health organisations, were contacted across eight European countries and Australia. The survey comprised closed and open text questions to assess expert opinion about interventions for employees with mental health difficulties, interventions supporting their managers, and anti-stigma interventions. The survey was available in six languages. The online platform Qualtrics was used for data collection. Quantitative data was analysed through descriptive statistics and qualitative data was analysed through thematic analysis. Sixty-five of 146 experts responded, representing a 42% response rate. Results showed only 26.2% of experts agreed that employees could speak openly about mental health issues, and 81.5% of experts indicated a large or medium unmet need for support for employees with mental health issues. Psychoeducational materials, face-to-face workshops and interventions based on cognitive behavioural therapy were ranked most likely to be taken up by employees. Experts rated as most useful for managers' guidelines on how to act if an employee has mental health issues (67.7%). The greatest number of experts indicated workshops of people with lived experience of mental illness (80.0%) and awareness campaigns (78.5%) were most required to tackle stigma. Responses were consistent between experts from different countries and areas of expertise. Experts in this multinational survey assessed that interventions supporting mental health in the workplace and tackling stigma are greatly needed. A multicomponent intervention with a wide range of materials and tools is supported.

Practitioners' experience of the working alliance in a blended cognitive-behavioural therapy intervention for depression: qualitative study of barriers and facilitators.

BACKGROUND: Digital technologies have been widely acknowledged as a potentially useful resource for increasing mental healthcare access. The working alliance is a key influence on outcomes in conventional psychotherapy, but little is known about therapists' experiences of forming an effective working alliance in blended interventions that involve in-person psychotherapy and a digital programme. AIMS: To investigate psychological well-being practitioners' (PWPs') experiences of the working alliance in a trial of blended cognitive-behavioural therapy (b-CBT) for depression. Trial registration ISRCTN12388725. METHOD: Semi-structured qualitative interviews were conducted with 13 PWPs who delivered b-CBT in a two-arm, non-inferiority randomised controlled trial investigating the effectiveness of b-CBT compared with face-to-face CBT. Thematic analysis was used to analyse the data. RESULTS: Participants reported four facilitating factors when building and maintaining a working alliance in b-CBT: having more time to deliver treatment, access to a wider toolkit, capacity to tailor components of b-CBT and receiving appropriate training and support. Participants also identified four barriers to building and maintaining a working alliance: time and resource constraints, usability challenges, limited flexibility to tailor the digital programme to patients' needs and lack of confidence in delivering b-CBT. CONCLUSIONS: Our study is the first specifically to investigate practitioners' perceived facilitators and barriers to forming a working alliance in b-CBT for depression. Findings suggest that PWPs' experiences of the working alliance can be improved by: accounting for the time required to deliver b-CBT in service workflows to reduce time pressures; increasing opportunities to tailor the digital programme through offering transdiagnostic tools and adaptable features; and providing appropriate b-CBT training and technical support.

A Data-Driven Clustering Method for Discovering Profiles in the Dynamics of Major Depressive Disorder Using a Smartphone-Based Ecological Momentary Assessment of Mood.

Background: Although major depressive disorder (MDD) is characterized by a pervasive negative mood, research indicates that the mood of depressed patients is rarely entirely stagnant. It is often dynamic, distinguished by highs and lows, and it is highly responsive to external and internal regulatory processes. Mood dynamics can be defined as a combination of mood variability (the magnitude of the mood changes) and emotional inertia (the speed of mood shifts). The purpose of this study is to explore various distinctive profiles in real-time monitored mood dynamics among MDD patients in routine mental healthcare. Methods: Ecological momentary assessment (EMA) data were collected as part of the cross-European E-COMPARED trial, in which approximately half of the patients were randomly assigned to receive the blended Cognitive Behavioral Therapy (bCBT). In this study a subsample of the bCBT group was included (n = 287). As part of bCBT, patients were prompted to rate their current mood (on a 1-10 scale) using a smartphone-based EMA application. During the first week of treatment, the patients were prompted to rate their mood on three separate occasions during the day. Latent profile analyses were subsequently applied to identify distinct profiles based on average mood, mood variability, and emotional inertia across the monitoring period. Results: Overall, four profiles were identified, which we labeled as: (1) "very negative and least variable mood" (n = 14) (2) "negative and moderate variable mood" (n = 204), (3) "positive and moderate variable mood" (n = 41), and (4) "negative and highest variable mood" (n = 28). The degree of emotional inertia was virtually identical across the profiles. Conclusions: The real-time monitoring conducted in the present study provides some preliminary indications of different patterns of both average mood and mood variability among MDD patients in treatment in mental health settings. Such varying patterns were not found for emotional inertia.

Effect of Sleep Disturbance Symptoms on Treatment Outcome in Blended Cognitive Behavioral Therapy for Depression (E-COMPARED Study): Secondary Analysis.

BACKGROUND: Sleep disturbance symptoms are common in major depressive disorder (MDD) and have been found to hamper the treatment effect of conventional face-to-face psychological treatments such as cognitive behavioral therapy. To increase the dissemination of evidence-based treatment, blended cognitive behavioral therapy (bCBT) consisting of web-based and face-to-face treatment is on the rise for patients with MDD. To date, no study has examined whether sleep disturbance symptoms have an impact on bCBT treatment outcomes and whether it affects bCBT and treatment-as-usual (TAU) equally. OBJECTIVE: The objectives of this study are to investigate whether baseline sleep disturbance symptoms have an impact on treatment outcomes independent of treatment modality and whether sleep disturbance symptoms impact bCBT and TAU in routine care equally. METHODS: The study was based on data from the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment Versus Treatment-as-Usual) study, a 2-arm, multisite, parallel randomized controlled, noninferiority trial. A total of 943 outpatients with MDD were randomized to either bCBT (476/943, 50.5%) or TAU consisting of routine clinical MDD treatment (467/943, 49.5%). The primary outcome of this study was the change in depression symptom severity at the 12-month follow-up. The secondary outcomes were the change in depression symptom severity at the 3- and 6-month follow-up and MDD diagnoses at the 12-month follow-up, assessed using the Patient Health Questionnaire-9 and Mini-International Neuropsychiatric Interview, respectively. Mixed effects models were used to examine the association of sleep disturbance symptoms with treatment outcome and treatment modality over time. RESULTS: Of the 943 patients recruited for the study, 558 (59.2%) completed the 12-month follow-up assessment. In the total sample, baseline sleep disturbance symptoms did not significantly affect change in depressive symptom severity at the 12-month follow-up (ß=.16, 95% CI -0.04 to 0.36). However, baseline sleep disturbance symptoms were negatively associated with treatment outcome for bCBT (ß=.49, 95% CI 0.22-0.76) but not for TAU (ß=-.23, 95% CI -0.50 to 0.05) at the 12-month follow-up, even when adjusting for baseline depression symptom severity. The same result was seen for the effect of sleep disturbance symptoms on the presence of depression measured with Mini-International Neuropsychiatric Interview at the 12-month follow-up. However, for both treatment formats, baseline sleep disturbance symptoms were not associated with depression symptom severity at either the 3- (ß=.06, 95% CI -0.11 to 0.23) or 6-month (ß=.09, 95% CI -0.10 to 0.28) follow-up. CONCLUSIONS: Baseline sleep disturbance symptoms may have a negative impact on long-term treatment outcomes in bCBT for MDD. This effect was not observed for TAU. These findings suggest that special attention to sleep disturbance symptoms might be warranted when MDD is treated with bCBT. Future studies should investigate the effect of implementing modules specifically targeting sleep disturbance symptoms in bCBT for MDD to improve long-term prognosis.

Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study.

BACKGROUND: Behavioral activation (BA), either as a stand-alone treatment or as part of cognitive behavioral therapy, has been shown to be effective for treating depression. The theoretical underpinnings of BA derive from Lewinsohn et al's theory of depression. The central premise of BA is that having patients engage in more pleasant activities leads to them experiencing more pleasure and elevates their mood, which, in turn, leads to further (behavioral) activation. However, there is a dearth of empirical evidence about the theoretical framework of BA. OBJECTIVE: This study aims to examine the assumed (temporal) associations of the 3 constructs in the theoretical framework of BA. METHODS: Data were collected as part of the "European Comparative Effectiveness Research on Internet-based Depression Treatment versus treatment-as-usual" trial among patients who were randomly assigned to receive blended cognitive behavioral therapy (bCBT). As part of bCBT, patients completed weekly assessments of their level of engagement in pleasant activities, the pleasure they experienced as a result of these activities, and their mood over the course of the treatment using a smartphone-based ecological momentary assessment (EMA) application. Longitudinal cross-lagged and cross-sectional associations of 240 patients were examined using random intercept cross-lagged panel models. RESULTS: The analyses did not reveal any statistically significant cross-lagged coefficients (all P>.05). Statistically significant cross-sectional positive associations between activities, pleasure, and mood levels were identified. Moreover, the levels of engagement in activities, pleasure, and mood slightly increased over the duration of the treatment. In addition, mood seemed to carry over, over time, while both levels of engagement in activities and pleasurable experiences did not. CONCLUSIONS: The results were partially in accordance with the theoretical framework of BA, insofar as the analyses revealed cross-sectional relationships between levels of engagement in activities, pleasurable experiences deriving from these activities, and enhanced mood. However, given that no statistically significant temporal relationships were revealed, no conclusions could be drawn about potential causality. A shorter measurement interval (eg, daily rather than weekly EMA reports) might be more attuned to detecting potential underlying temporal pathways. Future research should use an EMA methodology to further investigate temporal associations, based on theory and how treatments are presented to patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02542891, https://clinicaltrials.gov/ct2/show/NCT02542891; German Clinical Trials Register, DRKS00006866, https://tinyurl.com/ybja3xz7; Netherlands Trials Register, NTR4962, https://www.trialregister.nl/trial/4838; ClinicalTrials.Gov, NCT02389660, https://clinicaltrials.gov/ct2/show/NCT02389660; ClinicalTrials.gov, NCT02361684, https://clinicaltrials.gov/ct2/show/NCT02361684; ClinicalTrials.gov, NCT02449447, https://clinicaltrials.gov/ct2/show/NCT02449447; ClinicalTrials.gov, NCT02410616, https://clinicaltrials.gov/ct2/show/NCT02410616; ISRCTN registry, ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725.

Organizational Readiness for Implementing an Internet-Based Cognitive Behavioral Therapy Intervention for Depression Across Community Mental Health Services in Albania and Kosovo: Directed Qualitative Content Analysis.

BACKGROUND: The use of digital mental health programs such as internet-based cognitive behavioral therapy (iCBT) holds promise in increasing the quality and access of mental health services. However very little research has been conducted in understanding the feasibility of implementing iCBT in Eastern Europe. OBJECTIVE: The aim of this study was to qualitatively assess organizational readiness for implementing iCBT for depression within community mental health centers (CMHCs) across Albania and Kosovo. METHODS: We used qualitative semistructured focus group discussions that were guided by Bryan Weiner's model of organizational readiness for implementing change. The questions broadly explored shared determination to implement change (change commitment) and shared belief in their collective capability to do so (change efficacy). Data were collected between November and December 2017. A range of health care professionals working in and in association with CMHCs were recruited from 3 CMHCs in Albania and 4 CMHCs in Kosovo, which were participating in a large multinational trial on the implementation of iCBT across 9 countries (Horizon 2020 ImpleMentAll project). Data were analyzed using a directed approach to qualitative content analysis, which used a combination of both inductive and deductive approaches. RESULTS: Six focus group discussions involving 69 mental health care professionals were conducted. Participants from Kosovo (36/69, 52%) and Albania (33/69, 48%) were mostly females (48/69, 70%) and nurses (26/69, 38%), with an average age of 41.3 years. A directed qualitative content analysis revealed several barriers and facilitators potentially affecting the implementation of digital CBT interventions for depression in community mental health settings. While commitment for change was high, change efficacy was limited owing to a range of situational factors. Barriers impacting "change efficacy" included lack of clinical fit for iCBT, high stigma affecting help-seeking behaviors, lack of human resources, poor technological infrastructure, and high caseload. Facilitators included having a high interest and capability in receiving training for iCBT. For "change commitment," participants largely expressed welcoming innovation and that iCBT could increase access to treatments for geographically isolated people and reduce the stigma associated with mental health care. CONCLUSIONS: In summary, participants perceived iCBT positively in relation to promoting innovation in mental health care, increasing access to services, and reducing stigma. However, a range of barriers was also highlighted in relation to accessing the target treatment population, a culture of mental health stigma, underdeveloped information and communications technology infrastructure, and limited appropriately trained health care workforce, which reduce organizational readiness for implementing iCBT for depression. Such barriers may be addressed through (1) a public-facing campaign that addresses mental health stigma, (2) service-level adjustments that permit staff with the time, resources, and clinical supervision to deliver iCBT, and (3) establishment of a suitable clinical training curriculum for health care professionals. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883.

Workplace interventions to reduce depression and anxiety in small and medium-sized enterprises: A systematic review.

BACKGROUND: Depression and anxiety are the most prevalent mental health difficulties in the workplace, costing the global economy $1 trillion each year. Evidence indicates that symptoms may be reduced by interventions in the workplace. This paper is the first to systematically review psychosocial interventions for depression, anxiety, and suicidal ideation and behaviours in small-to medium-size enterprises (SMEs). METHODS: A systematic search following PRISMA guidelines, registered in PROSPERO (CRD42020156275), was conducted for psychosocial interventions targeting depression, anxiety, and suicidal ideation/behaviour in SMEs. The PubMed, PsycINFO, Scopus, and two specific occupational health databases were searched, as well as four databases for grey literature, without time limit until 2nd December 2019. RESULTS: In total, 1283 records were identified, 70 were retained for full-text screening, and seven met the inclusion criteria: three randomised controlled trials (RCTs), three before and after designs and one non-randomised trial, comprising 5111 participants. Study quality was low to moderate according to the Quality Assessment Tool for Quantitative Studies. Five studies showed a reduction in depression and anxiety symptoms using techniques based on cognitive behavioural therapy (CBT), two reported no significant change. LIMITATIONS: Low number and high heterogeneity of interventions and outcomes, high attrition and lack of rigorous RCTs. CONCLUSIONS: Preliminary evidence indicates CBT-based interventions can be effective in targeting symptoms of depression and anxiety in SME employees. There may be unique challenges to implementing programmes in SMEs. Further research is needed in this important area.

Lay-delivered talk therapies for adults affected by humanitarian crises in low- and middle-income countries.

BACKGROUND: Published by the World Health Organization (WHO) and United Nations High Commissioner for Refugees (UNHCR) in 2015, the mental health Gap Action Programme Humanitarian Intervention Guide (mhGAP-HIG) recommends brief versions of structured psychological interventions for people experiencing symptoms of common mental disorders (CMDs). mhGAP-HIG acknowledges a growing body of evidence suggesting these interventions can be delivered by lay workers to people affected by humanitarian crises in low- and middle-income countries (LMICs). However, there has not yet been a systematic review and synthesis of this evidence. This paper reports the results of a systematic review of qualitative, quantitative, and mixed-methods studies assessing the implementation and/or effectiveness of talk therapies for CMDs when provided by lay workers in LMICs to adults who have survived or are currently living in humanitarian situations. METHODS: Seven electronic databases were searched: MEDLINE, Embase, PsycINFO, PsycEXTRA, Global Health, Cochrane Library, and ClinicalTrials.gov . We also hand-searched the contents pages of three academic journals, reference lists of 30 systematic reviews, and online resource directories of two mental health networks. A preliminary list of included studies was circulated to topical experts for review, and all included studies were backward and forward searched. All titles, abstracts, and full-texts were independently double-screened. Quality appraisal and data extraction were carried out by a single reviewer and checked by a second reviewer, using standardised tools. Any disagreements were discussed and referred to a third reviewer as needed. RESULTS: We identified 23 unique studies and carried out a narrative synthesis of patient and implementation outcome data. Every evaluation of the effectiveness of lay-delivered talk therapies for adults affected by humanitarian crises in LMICs showed some treatment effect for at least one CMD, and often multiple CMDs. Implementation research generally found these interventions to be acceptable, appropriate and feasible to implement, with good fidelity to manualised therapies. CONCLUSION: Although results are promising, particularly for individually-delivered talk therapies based on cognitive behavioural therapy techniques, there is a high degree of heterogeneity in this literature. We make several recommendations on how to improve the quality and generalisability of research on this topic, to facilitate further evidence synthesis. TRIAL REGISTRATION: PROSPERO registration number: CRD42017058287 .

Evidence for implementation of interventions to promote mental health in the workplace: a systematic scoping review protocol.

BACKGROUND: Mental health problems are common in the working population and represent a growing concern internationally, with potential impacts on workers, organisations, workplace health and compensation authorities, labour markets and social policies. Workplace interventions that create workplaces supportive of mental health, promote mental health awareness, destigmatise mental illness and support those with mental disorders are likely to improve health and economical outcomes for employees and organisations. Identifying factors associated with successful implementation of these interventions can improve intervention quality and evaluation, and facilitate the uptake and expansion. Therefore, we aim to review research reporting on the implementation of mental health promotion interventions delivered in workplace settings, in order to increase understanding of factors influencing successful delivery. METHODS AND ANALYSIS: A scoping review will be conducted incorporating a stepwise methodology to identify relevant literature reviews, primary research and grey literature. This review is registered with Research Registry (reviewregistry897). One reviewer will conduct the search to identify English language studies in the following electronic databases from 2008 through to July 1, 2020: Scopus, PROSPERO, Health Technology Assessments, PubMed, Campbell Collaboration, Joanna Briggs Library, PsycINFO, Web of Science Core Collection, CINAHL and Institute of Occupational Safety and Health (IOSH). Reference searching, Google Scholar, Grey Matters, IOSH and expert contacts will be used to identify grey literature. Two reviewers will screen title and abstracts, aiming for 95% agreement, and then independently screen full texts for inclusion. Two reviewers will assess methodological quality of included studies using the Mixed Methods Appraisal Tool and extract and synthesize data in line with the RE-AIM framework, Nielson and Randall's model of organisational-level interventions and Moore's sustainability criteria, if the data allows. We will recruit and consult with international experts in the field to ensure engagement, reach and relevance of the main findings. DISCUSSION: This will be the first systematic scoping review to identify and synthesise evidence of barriers and facilitators to implementing mental health promotion interventions in workplace settings. Our results will inform future evaluation studies and randomised controlled trials and highlight gaps in the evidence base. SYSTEMATIC REVIEW REGISTRATION: Research Registry ( reviewregistry897 ).

Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial.

BACKGROUND: Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union's Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities. METHODS: A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study. DISCUSSION: The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883 . Retrospectively registered on 29 August 2018.

Cultural adaptation of Hap-pas-Hapi, an internet and mobile-based intervention for the treatment of psychological distress among Albanian migrants in Switzerland and Germany.

BACKGROUND: Internet- and mobile-based mental health interventions have the potential to narrow the treatment gap in ethnic groups. Little evidence exists on the cultural adaptation of such interventions. Cultural adaptation of evidence-based interventions distinguishes between surface and deep structure adaptation. Surface refers to matching materials (e.g., illustrations, language) or methods of treatment delivery to the target population, whereas deep structure adaptation considers cultural concepts of distress (CCD). So far, CCD have only been considered to a limited extent in cultural adaptation of psychological interventions, and there is a lack of well documented adaptation procedures. AIMS: With a cross-disciplinary and mixed-method approach, following a new conceptual framework for cultural adaptation of scalable psychological interventions, this study aimed to develop both surface and deep structure adaptations of an internet- and mobile-based intervention called Hap-pas-Hapi for the treatment of psychological distress among Albanian migrants in Switzerland and Germany. METHODS: A qualitative ethnopsychological study was conducted to examine the target group's CCD. Focus group discussions, an online survey, and individual key informant interviews were utilised to evaluate the original intervention, adaptation drafts and the final adapted intervention. A reporting system was developed to support the decision-making process and to report all adaptations in a transparent and replicable way. RESULTS: The ongoing involvement of target population key informants provided valuable feedback for the development of a more person-centred intervention, which might enhance treatment acceptance, motivation and adherence. DISCUSSION: This study provides empirical and theory-based considerations and suggestions for future implementation that may foster acceptability and effectiveness of culturally adapted evidence-based interventions.

Towards a conceptual framework of the working alliance in a blended low-intensity cognitive behavioural therapy intervention for depression in primary mental health care: a qualitative study.

OBJECTIVES: To examine and adapt a conceptual framework of the working alliance (WA) in the context of a low-intensity blended (psychological well-being practitioner (PWP) plus computerised program) cognitive behavioural therapy intervention (b-CBT) for depression. DESIGN: Patient involvement was enlisted to collaboratively shape the design of the project from the onset, before data collection. In-depth semi-structured interviews were carried out with participants who experienced b-CBT as part of the E-compared trial. A thematic analysis was conducted using a constant comparative method informed by grounded theory. SETTING: Recruitment was carried out in four psychological primary care services across the UK. PARTICIPANTS: Nineteen trial participants with major depressive disorder who completed at least one computerised program and face-to-face session with a PWP in the b-CBT arm were recruited to the study. RESULTS: Qualitative interviews that were guided by WA theory and patient involvement, revealed four themes: (1) a healthcare provider (PWP and computerised program) with good interpersonal competencies for building a working relationship with the client ('bond'); (2) collaborative efforts between the client and the provider to appropriately identify what the client hopes to achieve through therapy ('goals'); (3) the selection of acceptable therapeutic activities that address client goals and the availability of responsive support ('task') and (4) the promotion of active engagement and autonomous problem solving ('usability heuristics'). Participants described how the PWP and computerised program uniquely and collectively contributed to different WA needs. CONCLUSIONS: This study is the first to offer a preliminary conceptual framework of WA in b-CBT for depression, and how such demands can be addressed through blended PWP-computerised program delivery. These findings can be used to promote WA in technological design and clinical practice, thereby promoting engagement to b-CBT interventions and effective deployment of practitioner and program resources. TRIAL REGISTRATION NUMBER: ISRCTN12388725.

Added value or added burden? A qualitative investigation of blending internet self-help with face-to-face cognitive behaviour therapy for depression.

Objectives: Numerous studies and reviews have explored the value of adding therapist support to internet self-help for improving client adherence and outcomes. This study is different as it explores the value of adding internet self-help to face-to-face therapy, from the perspective of practitioners who used both. This study explores practitioners' experiences of whether-and how-internet self-help blended with face-to-face therapy may confer an added value or become an added burden to their routine practice. Methods: Using a structured topic guide, we collected narrative data via 3 focus groups and 1 telephone interview from 11 practitioners across two sites in England. We carried out a thematic analysis within two domains, "value vs. burden". Results: Practitioners reported that internet self-help can confer added value to face-to-face therapy by: fostering client engagement with face-to-face sessions; making therapy ubiquitous beyond sessions; and preventing therapeutic drift between sessions. Conversely, internet self-help can add burden to face-to-face therapy when it is experienced as disruptive, overwhelming and time-consuming. Conclusions: Recognizing and mitigating factors that can turn internet self-help from an added value to an added burden will help practitioners adopt and make the most out of blended therapy.

Improving Reading in Adolescents and Adults With High-Functioning Autism Through an Assistive Technology Tool: A Cross-Over Multinational Study.

People with autism spectrum disorder (ASD) experience reading comprehension difficulties, often misinterpreting complex texts, metaphors, and idioms. We have developed and tested a new assistive technology tool for adaptive, personalized text simplification, called Open Book. This tool is an open-sourced, online platform that uses Natural Language Processing with the specific aim of assisting reading and aiding understanding of written text for people with ASD. The accessibility and effectiveness of Open Book was tested by examining the differences in text comprehension scores between the original texts and texts that were simplified by Open Book tool, randomly allocated to study participants. Two hundred forty-three participants (153 adults and 90 adolescents) with high-functioning ASD were recruited in the UK, Spain, and Bulgaria. Regarding the primary outcome, results showed that both adults and adolescents with ASD gave more correct answers for the simplified (M = 11.2, SD = 4.1) than original texts (M = 10, SD = 4.1; p < 0.001). This finding was consistent across age groups and countries. Regarding the secondary outcome, when participants were asked to blindly rate how easy was to understand each text, simplified texts were rated as easier (M = 7.6, SD = 2.4) to understand than the original texts (M = 8.7, SD = 2.6; p < 0.001). The Open Book software seems to have the potential to be a useful tool in assisting reading among people with ASD. Our findings support our primary hypothesis that texts simplified through Open Book were easier to comprehend compared to original texts.

A blind spot on the global mental health map: a scoping review of 25 years' development of mental health care for people with severe mental illnesses in central and eastern Europe.

Just over 25 years have passed since the major sociopolitical changes in central and eastern Europe; our aim was to map and analyse the development of mental health-care practice for people with severe mental illnesses in this region since then. A scoping review was complemented by an expert survey in 24 countries. Mental health-care practice in the region differs greatly across as well as within individual countries. National policies often exist but reforms remain mostly in the realm of aspiration. Services are predominantly based in psychiatric hospitals. Decision making on resource allocation is not transparent, and full economic evaluations of complex interventions and rigorous epidemiological studies are lacking. Stigma seems to be higher than in other European countries, but consideration of human rights and user involvement are increasing. The region has seen respectable development, which happened because of grassroots initiatives supported by international organisations, rather than by systematic implementation of government policies.

Attitudes towards digital treatment for depression: A European stakeholder survey.

BACKGROUND: The integration of digital treatments into national mental health services is on the agenda in the European Union. The E-COMPARED consortium conducted a survey aimed at exploring stakeholders' knowledge, acceptance and expectations of digital treatments for depression, and at identifying factors that might influence their opinions when considering the implementation of these approaches. METHOD: An online survey was conducted in eight European countries: France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland and The United Kingdom. Organisations representing government bodies, care providers, service-users, funding/insurance bodies, technical developers and researchers were invited to participate in the survey. The participating countries and organisations reflect the diversity in health care infrastructures and e-health implementation across Europe. RESULTS: A total of 764 organisations were invited to the survey during the period March-June 2014, with 175 of these organisations participating in our survey. The participating stakeholders reported moderate knowledge of digital treatments and considered cost-effectiveness to be the primary incentive for integration into care services. Low feasibility of delivery within existing care services was considered to be a primary barrier. Digital treatments were regarded more suitable for milder forms of depression. Stakeholders showed greater acceptability towards blended treatment (the integration of face-to-face and internet sessions within the same treatment protocol) compared to standalone internet treatments. Organisations in countries with developed e-health solutions reported greater knowledge and acceptability of digital treatments. CONCLUSION: Mental health stakeholders in Europe are aware of the potential benefits of digital interventions. However, there are variations between countries and stakeholders in terms of level of knowledge about such interventions and their feasibility within routine care services. The high acceptance of blended treatments is an interesting finding that indicates a gradual integration of technology into clinical practice may fit the attitudes and needs of stakeholders. The potential of the blended treatment approach, in terms of enhancing acceptance of digital treatment while retaining the benefit of cost-effectiveness in delivery, should be further explored. FUNDING: The E-COMPARED project has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 603098.