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Supervised treatment in outpatients for schizophrenia plus (STOPS+): protocol for a cluster randomised trial of a community-based intervention to improve treatment adherence and reduce the treatment gap for schizophrenia in Pakistan

Shepherd, Thomas Andrew; Ul-Haq, Zia; Ul-Haq, Mian; Firaz Khan, Muhammad; Afridi, Adil; Dikomitis, Lisa; Robinson, Michelle E; Lewis, Martyn; Rahman, Atif; Dziedzic, Krysia; Saeed, Umaima; Riaz Awan, Naila; Mallen, Christian; Farooq, Saeed

Supervised treatment in outpatients for schizophrenia plus (STOPS+): protocol for a cluster randomised trial of a community-based intervention to improve treatment adherence and reduce the treatment gap for schizophrenia in Pakistan Thumbnail


Authors

Zia Ul-Haq

Mian Ul-Haq

Muhammad Firaz Khan

Adil Afridi

Lisa Dikomitis

Atif Rahman

Umaima Saeed

Naila Riaz Awan



Abstract

Introduction: There is a significant treatment gap, with only a few community-based services for people with schizophrenia in Low- and Middle-Income countries. Poor treatment adherence in schizophrenia is associated with poorer health outcomes, suicide attempts and death. We previously reported the effectiveness of STOPS (Supervised Treatment in Outpatients for Schizophrenia) for improving treatment adherence in patients with schizophrenia. However, STOPS was evaluated in a tertiary care setting with no primary care involvement, limiting its generalisability to the wider at-risk population. We aim to evaluate the effectiveness of STOPS+ in scaling up the primary care treatment of schizophrenia to a real-world setting.
Methods and analysis: The effectiveness of the STOPS+ intervention in improving the level of functioning and medication adherence in patients with schizophrenia in Pakistan will be evaluated using a cluster randomised controlled trial design. We aim to recruit 526 participants from 24 Primary Health Care Centres (PHCs) randomly allocated in 1:1 ratio to STOPS+ intervention and Enhanced Treatment as Usual (ETAU) arms. Participants will be followed-up for 12 months post recruitment. The sample size is estimated for two outcomes (i) The primary clinical outcome is level of functioning, measured using the Global Assessment of Functioning (GAF) scale, and (ii) the primary process outcome is adherence to treatment regimen measured using a validated measure. An intention-to-treat approach will be used for the primary analysis.
Ethics and Dissemination: Ethical approval has been obtained from Keele University Ethical Review Panel (ref: MH-190017) and Khyber Medical University Ethical Review Board (ref: DIR-KMU-EB/ST/000648). The results of the STOPS+ trial will be reported in peer reviewed journals and academic conferences and disseminated to local stakeholders and policy makers.

Journal Article Type Article
Acceptance Date May 29, 2020
Online Publication Date Jun 30, 2020
Publication Date Jun 30, 2020
Publicly Available Date May 26, 2023
Journal BMJ Open
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 10
Issue 6
DOI https://doi.org/10.1136/bmjopen-2019-034709
Keywords Psychosis, Low and middle Income Countries (LMIC), Drug Treatment, Directly Observed Therapy (DOTS)
Publisher URL https://bmjopen.bmj.com/content/10/6/e034709

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