Implementing a psychosocial intervention DIALOG+ for patients with psychotic disorders in low and middle income countries in South Eastern Europe: protocol for a hybrid effectiveness-implementation cluster randomized clinical trial (IMPULSE)

Psychotic disorders have large treatment gap in low- and middle-income countries (LMICs) in South-Eastern Europe, where up to 45% of affected people do not receive care for their condition. This study will assess the implementation of a generic psychosocial intervention called DIALOG+ in mental health care services and its effectiveness at improving patients’ clinical and social outcomes.This is a protocol for a multi-country, pragmatic, hybrid effectiveness–implementation, cluster-randomised, clinical trial. The trial aims to recruit 80 clinicians and 400 patients across 5 South-Eastern European LMICs: Bosnia and Herzegovina, Kosovo*, Montenegro, Republic of North Macedonia and Serbia. Clusters are clinicians working with patients with psychosis, and each clinician will deliver the intervention to five patients. After patient baseline assessments, clinicians will be randomly assigned to either the DIALOG+ intervention or treatment as usual, with an allocation ratio of 1:1. The intervention will be delivered six times over 12 months during routine clinical meetings. TThe primary outcome measure is the quality of life at 12 months [Manchester Short Assessment of Quality of Life (MANSA)]; the secondary outcomes include mental health symptoms [Brief Psychiatric Rating Scale (BPRS), Clinical Assessment Interview for Negative Symptoms (CAINS), Brief Symptom Inventory (BSI)], satisfaction with services [Client Satisfaction Questionnaire (CSQ-8)] and economic costs at 12 months [based on Client Service Receipt Inventory (CSRI), EQ-5D-5L and Recovering Quality of Life (ReQOL-10)]. The study will assess the intervention fidelity and the experience of clinicians and patients’ about implementing DIALOG+ in real-life mental health care settings. In the health economic assessment, the incremental cost-effectiveness ratio is calculated with effectiveness measured by quality-adjusted life year. Data will also be collected on sustainability and reach to inform guidelines for potentially scaling up and implementing the intervention widely. Conclusion: The study is expected to generate new scientific knowledge on the treatment of people with psychosis in health care systems with limited resources. The learning from LMICs could potentially help other countries to expand the access to care and alleviate the suffering of patients with psychosis and their families. Trial registration: ISRCTN 11913964This study has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 779334

Improving treatment of patients with psychosis in low-and-middle-income countries in Southeast Europe: Results from a hybrid effectiveness-implementation, pragmatic, cluster-randomized clinical trial (IMPULSE)

Background In Southeast Europe (SEE) standard treatment of patients with psychosis is largely based on pharmacotherapy with psychosocial interventions rarely available. DIALOG+ is a digital psychosocial intervention designed to make routine care therapeutically effective. This trial simultaneously examined effectiveness of DIALOG+ versus standard care on clinical and social outcomes (Aim 1) and explored intervention fidelity (Aim 2). Methods A hybrid type II effectiveness–implementation, cluster-randomized trial was conducted in five SEE countries: Bosnia and Herzegovina, Kosovo*, Montenegro, North Macedonia, and Serbia. The intervention was offered to patients six times across 12 months instead of routine care. The outcomes were subjective quality of life (primary), clinical symptoms, satisfaction with services, and economic costs. Intervention fidelity was operationalized as adherence to the protocol in terms of frequency, duration, content, and coverage. Data were analyzed using multilevel regression. Results A total of 81 clinicians and 468 patients with psychosis were randomized to DIALOG+ or standard care. The intervention was delivered with high fidelity. The average number of delivered sessions was 5.5 (SD = 2.3) across 12 months. Patients in the intervention arm had better quality of life (MANSA) at 6 months (p = 0.03). No difference was found for other outcomes at 6 months. Due to disruptions caused by the COVID-19 pandemic, 12-month data were not interpretable. Conclusions DIALOG+ improved subjective quality of life of individuals with psychosis at 6 months (after four sessions), albeit with small effect size. The intervention has the potential to contribute to holistic care of patients with psychosis

Attentional Bias Among High and Low Ruminators: Eye Tracking Study in a Non-Clinical Population

Rumination, which can be studied through its associated attentional biases, and is a part of the RDoC Negative Valence Systems constructs of Loss, has been proposed as a key transdiagnostic feature in depression. The current study uses eye tracking measurements to explore how different levels of brooding and reflection rumination interact with attentional biases in a non-clinical sample of high and low ruminators. Methodology: 123 adults were administered questionnaires of rumination, depression and participated in passive viewing task in which they watched sets of angry, happy, sad and neutral faces, while their eye movements were tracked. Findings indicate greater sustained attention toward sad and angry faces and away from happy faces among non-clinical individuals with high levels of brooding rumination, even when controlling for depression scores. The study adds further evidence that brooding rumination and attentional biases to negative stimuli are associated with one another. Behavioral parameters such as attention bias to help us to distinguish high ruminators among non-clinical sample

Implementing a digital mental health intervention for individuals with psychosis-a multi-country qualitative study

BACKGROUND: Implementation of psychosocial interventions in mental health services has the potential to improve the treatment of psychosis spectrum disorders (PSD) in low- and middle-income countries (LMICs) where care is predominantly focused on pharmacotherapy. The first step is to understand the views of key stakeholders. We conducted a multi-language qualitative study to explore the contextual barriers and facilitators to implementation of a cost-effective, digital psychosocial intervention, called DIALOG+, for treating PSD. DIALOG+ builds on existing clinician-patient relationships without requiring development of new services, making it well-fitting for healthcare systems with scarce resources. METHODS: Thirty-two focus groups were conducted with 174 participants (patients, clinicians, policymakers and carers), who were familiarized with DIALOG+ through a presentation. The Southeast European LMICs included in this research were: Bosnia and Herzegovina, Kosovo, (Kosovo is referred throughout the text by United Nations resolution) North Macedonia, Montenegro and Serbia. Framework analysis was used to analyse the participants’ accounts. RESULTS: Six major themes were identified. Three themes (Intervention characteristics; Carers’ involvement; Patient and organisational benefits) were interpreted as perceived implementation facilitators. The theme Attitudes and perceived preparedness of potential adopters comprised of subthemes that were interpreted as both perceived implementation facilitators and barriers. Two other themes (Frequency of intervention delivery; Suggested changes to the intervention) were more broadly related to the intervention’s implementation. Participants were exceedingly supportive of the implementation of a digital psychosocial intervention such as DIALOG+. Attractive intervention characteristics, efficient use of scarce resources for its implementation and potential to improve mental health services were seen as the main implementation facilitators. The major implementation barrier identified was psychiatrists’ time constrains. CONCLUSIONS: This study provided important insights regarding implementation of digital psychosocial interventions for people with PSD in low-resource settings by including perspectives from four stakeholder groups in five LMICs in Southeast Europe – a population and region rarely explored in the literature. The perceived limited availability of psychiatrists could be potentially resolved by increased inclusion of other mental health professionals in service delivery for PSD. These findings will be used to inform the implementation strategy of DIALOG+ across the participating countries. The study also offers insights into multi-country qualitative research. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12888-021-03466-x