We are excited to have our Trial published at BMC Trials this month!
You can read the full published protocol here
Abstract
Background
Severe mental illness (SMI) presents a major challenge worldwide, affecting approximately 5–8% of the world’s population. It causes significant distress to affected people, families and wider communities, generating high costs through loss of productivity and ongoing healthcare use. Over 75% of patients with psychosis receive inadequate care and experience a negative financial impact and reduced quality of life (QoL). It is therefore a priority to reduce the treatment gap by providing low-cost, effective interventions for people with psychosis.
Our research project, PIECEs, is designed to explore, adapt and test a low-cost, approach (DIALOG+) that makes use of existing resources to improve community-based care for patients with psychosis. The research will be conducted in two urban sites: Karachi, Pakistan and Chennai, India. DIALOG+ is a novel, technology-assisted and resource-oriented intervention, based on QoL research, concepts of patient-centred communication, IT developments and solution-focused therapy. However, the approach has not been rigorously tested within India and Pakistan. Our randomised controlled trial (RCT) aims to test the effectiveness and cost-effectiveness of DIALOG+ in improving the QoL and clinical outcomes for individuals with long-term psychosis being treated in the community in India and Pakistan.
Methods
To assess the acceptability, feasibility, and cost effectiveness of DIALOG+, we will conduct a cluster RCT with 210 patients and 14 clinicians in each country. The intervention will be used during a routine interaction between a clinician and a patient. It consists of a patient-centred assessment (the DIALOG scale) whereby the clinician invites the patient to rate their satisfaction with different life domains and treatment aspects, which forms the active control group. The intervention group will follow this up with a four-step solution-focused approach to identify the patient’s resources and develop solutions to deal with the patient’s concerns (DIALOG+).
Discussion
If shown to be effective DIALOG+ has the potential to improve community-based care and the QoL for millions of people within India and Pakistan who experience psychosis.
Trial registration
The trial was registered prospectively on the ISRCTN Registry: ISRCTN13022816 on 9 February 2022.
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