Shepherd, T, Ul Haq, M, Muktar Ul-Haq, Mian, Khan, MF, Afridi, Adil, Dikomitis, L, Robinson, ME, Lewis, M, Rahman, A, Dziedzic, KS, Saeed, U, Awan, NR, Mallen, CD and Farooq, S (2020) 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. BMJ Open, 10 (6). ISSN 2044-6055

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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.

Item Type: Article
Additional Information: Copyright information: © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:
Uncontrolled Keywords: Psychosis, Low and middle Income Countries (LMIC), Drug Treatment, Directly Observed Therapy (DOTS)
Subjects: B Philosophy. Psychology. Religion > BF Psychology
B Philosophy. Psychology. Religion > BF Psychology > BF173 Psychoanalysis
R Medicine > R Medicine (General)
R Medicine > RC Internal medicine > RC0321 Neuroscience. Biological psychiatry. Neuropsychiatry
R Medicine > RC Internal medicine > RC346 Neurology. Diseases of the nervous system, including speech disorders
R Medicine > RC Internal medicine > RC435 Psychiatry
Divisions: Faculty of Medicine and Health Sciences > School of Primary, Community and Social Care
Related URLs:
Depositing User: Symplectic
Date Deposited: 05 Jun 2020 08:50
Last Modified: 30 Jun 2021 01:30

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