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

Journal article

Thomas Andrew Shepherd, Zia Ul-Haq, Mian Ul-Haq, Muhammad Firaz Khan, Adil Afridi, Lisa Dikomitis, Michelle E Robinson, Martyn Lewis, Atif Rahman, Krysia Dziedzic, Umaima Saeed, Naila Riaz Awan, Christian Mallen and Saeed Farooq 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. 2020 (10), p. e034709. https://doi.org/10.1136/bmjopen-2019-034709
AuthorsThomas Andrew Shepherd, Zia Ul-Haq, Mian Ul-Haq, Muhammad Firaz Khan, Adil Afridi, Lisa Dikomitis, Michelle E Robinson, Martyn Lewis, Atif Rahman, Krysia Dziedzic, Umaima Saeed, Naila Riaz Awan, Christian Mallen and Saeed Farooq
Abstract

Introduction
There is a significant treatment gap, with only a few community-based services for people with schizophrenia in low-income 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 supervised treatment in outpatients for schizophrenia (STOPS) 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 healthcare centres randomly allocated in 1:1 ratio to STOPS+ intervention and enhanced treatment as usual arms. Participants will be followed-up for 12 months postrecruitment. The sample size is estimated for two outcomes (1) the primary clinical outcome is level of functioning, measured using the Global Assessment of Functioning scale and (2) 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 policymakers.

KeywordsSchizophrenia; Pakistan
Year2020
JournalBMJ Open
Journal citation2020 (10), p. e034709
PublisherBMJ Publishing Group
ISSN2044-6055
2044-6055
Digital Object Identifier (DOI)https://doi.org/10.1136/bmjopen-2019-034709
Official URLhttps://bmjopen.bmj.com/content/10/6/e034709
Publication dates
Online30 Jun 2020
Publication process dates
Accepted29 May 2020
Deposited15 Jun 2023
Publisher's version
License
Output statusPublished
Additional information

Trial registration number ISRCTN93243890.

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Chris Littlewood, Marcus Bateman, Kendra Cooke, Susie Hennnings, Tina Cookson, Kieran Bromley, Martyn Lewis, Lennard Funk, Jean Denton, Maria Moffatt, Rachel Winstanley, Saurabh Mehta, Gareth Stephens, Lisa Dikomitis, Linda Chesterton and Nadine E. Foster 2019. Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study). Trials. 20 (328). https://doi.org/10.1186/s13063-019-3407-3
Exploring differences in individual and group judgements in standard setting
Peter Yeates, Natalie Cope, Eva Luksaite, Andrew Hassell and Lisa Dikomitis 2019. Exploring differences in individual and group judgements in standard setting. Medical Education. 53 (9), pp. 941-962. https://doi.org/10.1111/medu.13915
Images depicting headache pain – a tool to aid the diagnosis of cluster headache: a pilot study
Dikomitis, L. 2019. Images depicting headache pain – a tool to aid the diagnosis of cluster headache: a pilot study. Journal of Multidisciplinary Healthcare. 2019 (12), pp. 691-698. https://doi.org/10.2147/JMDH.S207128
Images depicting pain: a screening tool for cluster headache
Buture, A., Dikomitis, L., Boland, L. and Ahmed, F. 2018. Images depicting pain: a screening tool for cluster headache. Cephalalgia. 38 (Supp 1), pp. 114-115. https://doi.org/10.1177/0333102418789865
Delays in the diagnosis and misdiagnosis of cluster headache – a systematic literature review
Buture, A., Boland, J. W., Dikomitis, L. and Ahmed, F. 2018. Delays in the diagnosis and misdiagnosis of cluster headache – a systematic literature review. Cephalalgia. 38 (Supp 1), pp. MTIS2018-145.
Systematic literature review on the delays in the diagnosis and misdiagnosis of cluster headache
Buture, A., Boland, J. W., Dikomitis, L. and Ahmed, F. 2018. Systematic literature review on the delays in the diagnosis and misdiagnosis of cluster headache. Neurological Sciences. 40, pp. 25-39. https://doi.org/10.1007/s10072-018-3598-5
Visual images: an additional tool for the screening of cluster headache
Buture, A., Dikomitis, L., Boland, J. W. and Ahmed, F. 2017. Visual images: an additional tool for the screening of cluster headache. Cephalalgia. 37, p. 219.
So looking at this, you look like you've got some issues going on with your joints: Exploring case-finding in long-tern condition review consultations - the ENHANCE pilot trial
Liddle, J., Chew-Graham, C. A., Mallen, C. D., Healey, E. L., Jinks, C. and Dikomitis, L. 2017. So looking at this, you look like you've got some issues going on with your joints: Exploring case-finding in long-tern condition review consultations - the ENHANCE pilot trial. Rheumatology. 56 (IS 2). https://doi.org/10.1093/rheumatology/kex062.181
'"The man who closed the asylums": Franco Basaglia and the revolution in mental health care', by John Foot (Verso, 2015)
Dikomitis, L. 2016. '"The man who closed the asylums": Franco Basaglia and the revolution in mental health care', by John Foot (Verso, 2015). Durham University Institute for Medical Humanities.
How do clinicians think about cluster headache
Dikomitis, L., Paemeleire, K., Goadsby, P. J. and Ahmed, F. 2016. How do clinicians think about cluster headache. Cephalalgia. 36 (S 1).
Developing a diagnostic tool for the early diagnosis of cluster headache
Buture, A., Dikomitis, L. and Ahmed, F. 2016. Developing a diagnostic tool for the early diagnosis of cluster headache. Cephalalgia.
Perceptions, understandings and experiences of cluster headache patients in the north of England: a qualitative study
Dikomitis, L., Quarshie, V., Paemeleire, K., Goadsby, P. J. and Ahmed, F. 2015. Perceptions, understandings and experiences of cluster headache patients in the north of England: a qualitative study. Cephalalgia. 25 (S6).
[Review of] The Past in Pieces: Belonging in the New Cyprus, by Rebecca Bryant. Contemporary Ethnography series. Philadelphia: University of Pennsylvania Press, 2010. 224 pp.
Dikomitis, L. 2014. [Review of] The Past in Pieces: Belonging in the New Cyprus, by Rebecca Bryant. Contemporary Ethnography series. Philadelphia: University of Pennsylvania Press, 2010. 224 pp. American Anthropologist. 116 (1), pp. 194-195. https://doi.org/10.1111/aman.12085_9
Perceptions and experiences of cluster headache among patients, general practitioners and neurologists in the north of england: A qualitative study
Ahmed, F., Dikomitis, L., Zafar, H. W., Goadsby, P. and Paemeliere, P. 2014. Perceptions and experiences of cluster headache among patients, general practitioners and neurologists in the north of england: A qualitative study. Journal of Headache and Pain. 15 (S1).
Patients perceptions of the causes of migraine in Flanders (Belgium): A qualitative study
Dikomitis, L., Bonte, M., Willems, S. and Paemeleire, K. 2013. Patients perceptions of the causes of migraine in Flanders (Belgium): A qualitative study. Cephalalgia. 33 (S 8), p. 198. https://doi.org/10.1177/0333102413490487