Administrative information
Title {1} | Assessing the effectiveness and cost-effectiveness of a solution-focused resource-orientated approach (DIALOG+) to improving the quality of life for people with psychosis in India and Pakistan - a cluster RCT. |
Trial registration {2a and 2b}. | ISRCTN Registry Number: ISRCTN13022816 |
Protocol version {3} | Protocol version: V1.0, 15th Jan 2022 |
Funding {4} | This research was funded by National Institute of Health Research (NIHR-funded) Research and Innovation for Global Health Transformation (RIGHT) programme (NIHR200824) using UK aid from the UK Government to support global health research. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR or the UK Department of Health and Social Care. |
Author details {5a} | Victoria Jane Bird, Sana Zehra Sajun, Renata Peppl, Stefan Priebe – Queen Mary University of London, UK Sara Evans-Lacko – London School of Economics and Political Science, Care Policy and Evaluation Centre, UK Swaran Singh – Warwick University, UK Lakshmi Venkatraman, Padmavati Ramachandran – Schizophrenia Research Foundation, India Aneeta Pasha, Onaiza Qureshi – Interactive Research and Development, Pakistan Ashar Malik – Agha Khan University, Pakistan |
Name and contact information for the trial sponsor {5b} | Joint Research and Management Office (JRMO) Queen Mary University of London Mile End Road London, E1 4NS |
Role of sponsor {5c} | The sponsor and funder play no role in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
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Aged 18–65 years old
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Diagnosis of psychosis defined as an ICD-10 diagnosis of Schizophrenia, schizotypal, delusional and other non-mood psychotic disorders (F20-29) and/or bipolar disorder with psychotic features (F31.2, F31.5, F31.64)
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Currently not receiving inpatient treatment
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Duration of illness greater than 2 years
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Score < 5 on Manchester Short Assessment of Quality of Life (MANSA)
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Capacity to provide informed consent based on an adapted ‘University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)’ Scale score of 12 or above
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Ability to speak and understand the local language; Urdu (Pakistan), Tamil (India) or English
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Aged 18 years or over
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Has regular clinical contact with individuals with psychosis
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Experience of working with individuals with psychosis
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No plans to leave the current post within the next 6 months
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Ability to speak and understand the local language; Urdu (Pakistan), Tamil (India) or English
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Primary caregiver of a person with psychosis enrolled in the DIALOG+ RCT (primary caregiver defined as the main person responsible for helping with activities of daily living, supporting, and advocating on behalf of the patient)
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Has been the primary caregiver of a person with psychosis for more than 6 months
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Aged 18–75 years old
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Ability to speak and understand Urdu (Pakistan), Tamil (India) or English
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Dementia and/or significant cognitive impairment cognitive impairment and/or severe learning disability
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Organic psychosis or drug-induced psychosis if given as the primary diagnosis
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Unable to provide informed consent on the UBACC scale (score < 12)
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Does not have regular contact with individual(s) with chronic psychosis
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Unable to speak either English, Urdu or Tamil