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.

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.

Depression Measured by PHQ-9 in Kosovo during the COVID-19 Outbreak: An Online Survey.

BACKGROUND: There are reports from countries and in the scientific literature that COVID-19 affect also mental health worldwide. The aim of this study was to understand the level of depression as a result of the COVID-19 situation and possible associations with sociodemographic variables. SUBJECTS AND METHODS: It's a cross-sectional study. The participants were 155 respondents recruited online in the period 27.04.2020 until 05.06.2020, who completed the Albanian version of PHQ-9. RESULTS: Mean score of depression resulted 10.94 (SD=9.22). 63% of participants agreed that the situation has worsened their psychological state; 35.6% had a mild to severe form of depression and 18.7% had minimal symptoms. 13.4% of participants saw iCBT as helpful, 16.8% a little while 65.8% wanted to try it. Significantly higher depression resulted for females and age-group 18 to 24 years. No significant differences by levels of education, marital status, employment, socio-economic status and by expectations regarding iCBT. Gender and perception of worsened psychological state showed predictive abilities for depression. CONCLUSION: The situation with Covid-19 has increased depression levels especially among females and 18 to 24 years old and thus expectations for e-psychotherapy. Online treatments seem feasible solutions for outbreak times. Studies in future are needed to better scientifically elaborate these findings.

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.