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)

Abstract

BackgroundIn 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). MethodsA hybrid type II effectiveness-implementation, cluster randomised trial was conducted in five SEE countries: Bosnia and Herzegovina, Kosovo*, Montenegro, North Macedonia, and Serbia. The DIALOG+ 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 operationalised as adherence to the protocol in terms of frequency, duration, content, and coverage. Data were analysed using multilevel regression. ResultsA total of 81 clinicians and 468 patients with psychosis were randomised to DIALOG+ or standard care. The intervention was delivered with high fidelity. The average number of delivered DIALOG+ sessions was 5.5 (SD=2.3) across 12 months. Patients in the intervention arm had better quality of life (measured by 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. ConclusionDIALOG+ improved subjective quality of life of individuals with psychosis at 6 months (after 4 sessions), albeit with small effect size. The intervention has the potential to contribute to holistic care of patients with psychosis in SEE.

Cost-effectiveness of implementing a digital psychosocial intervention for patients with psychotic spectrum disorders in low- and middle-income countries in Southeast Europe: Economic evaluation alongside a cluster randomised trial

“…Time horizon for the economic evaluation was 6 months, starting from implementation of the intervention at baseline. This was consistent with the time horizon for the effectiveness evaluation of DIALOG+ in the IMPULSE trial [14].…”

“…In this trial, we observed modest improvements of quality of life measured by three instruments. Only the difference in MANSA scores (i.e., the primary clinical effectiveness outcome in the IMPULSE trial) between the intervention and control groups was statistically significant [14]. The primary economic evaluation relied on QALYs derived from the EQ-5D-5L data as the outcome measure.…”

“…A final limitation of the study relates to the COVID-19 pandemic. The trial was designed to last 12 months, but only the first 6 months of data was interpretable due to disruptions in the study's delivery relating to pandemic restrictions [14].…”

“…Although the trial intervention was originally designed to last 12 months, interruption due to the COVID-19 pandemic from March 2020 onward led to significant changes in the intervention, patient assessments, data collection, and retention in the last stage of the trial [14]. Only Serbia completed the 6 sessions and the last assessment (at month 12) as per protocol before the introduction of local restrictions.…”

“…Previous studies have shown that using DIALOG+ is effective in improving the quality of life for patients with psychosis in UK community-based settings [8,10]. Furthermore, the effectiveness of DIALOG+ has been extensively studied in mental health care across multiple countries and in different healthcare settings [11][12][13][14].…”