Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trial

Background Bipolar disorder is a source of marked disability, morbidity and premature death. There is a paucity of research on personalised psychosocial interventions for bipolar disorder, especially in low-resource settings. A pilot randomised controlled trial (RCT) of a culturally adapted psychoed...

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Main Authors: M. Ishrat Husain, Madeha Umer, Muqaddas Asif, Ameer B. Khoso, Tayyeba Kiran, Moin Ansari, Huma Aslam, Moti Ram Bhatia, Farasat A. Dogar, M. Omair Husain, Hazrat A. Khan, Ali A. Mufti, Benoit H. Mulsant, Farooq Naeem, Haider A. Naqvi, Claire de Oliveira, M. Sajjad Siddiqui, Asad Tamizuddin, Wei Wang, Juveria Zaheer, Nusrat Husain, Nasim Chaudhry, Imran B. Chaudhry
Format: Article
Language:English
Published: Cambridge University Press 2022-11-01
Series:BJPsych Open
Subjects:
Online Access:https://www.cambridge.org/core/product/identifier/S2056472422005981/type/journal_article
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author M. Ishrat Husain
Madeha Umer
Muqaddas Asif
Ameer B. Khoso
Tayyeba Kiran
Moin Ansari
Huma Aslam
Moti Ram Bhatia
Farasat A. Dogar
M. Omair Husain
Hazrat A. Khan
Ali A. Mufti
Benoit H. Mulsant
Farooq Naeem
Haider A. Naqvi
Claire de Oliveira
M. Sajjad Siddiqui
Asad Tamizuddin
Wei Wang
Juveria Zaheer
Nusrat Husain
Nasim Chaudhry
Imran B. Chaudhry
author_facet M. Ishrat Husain
Madeha Umer
Muqaddas Asif
Ameer B. Khoso
Tayyeba Kiran
Moin Ansari
Huma Aslam
Moti Ram Bhatia
Farasat A. Dogar
M. Omair Husain
Hazrat A. Khan
Ali A. Mufti
Benoit H. Mulsant
Farooq Naeem
Haider A. Naqvi
Claire de Oliveira
M. Sajjad Siddiqui
Asad Tamizuddin
Wei Wang
Juveria Zaheer
Nusrat Husain
Nasim Chaudhry
Imran B. Chaudhry
author_sort M. Ishrat Husain
collection DOAJ
description Background Bipolar disorder is a source of marked disability, morbidity and premature death. There is a paucity of research on personalised psychosocial interventions for bipolar disorder, especially in low-resource settings. A pilot randomised controlled trial (RCT) of a culturally adapted psychoeducation intervention for bipolar disorder (CaPE) in Pakistan reported higher patient satisfaction, enhanced medication adherence, knowledge and attitudes regarding bipolar disorder, and improvement in mood symptom scores and health-related quality of life measures compared with treatment as usual (TAU). Aims The current protocol describes a larger multicentre RCT to confirm the clinical and cost-effectiveness of CaPE in Pakistan. Trial registration: NCT05223959. Method A multicentre individual, parallel-arm RCT of CaPE in 300 Pakistani adults with bipolar disorder. Participants over the age of 18, with a diagnosis of bipolar I or II disorder who are currently euthymic, will be recruited from seven sites: Karachi, Lahore, Multan, Rawalpindi, Peshawar, Hyderabad and Quetta. Time to recurrence will be the primary outcome assessed using the Longitudinal Interval Follow-up Evaluation (LIFE). Secondary measures will include mood symptoms, quality of life and functioning, adherence to psychotropic medications, and knowledge and attitudes regarding bipolar disorder. Results This trial will assess the effectiveness of the CaPE intervention compared with TAU in reducing the time to recurrence for people with bipolar disorder currently in remission in Pakistan and determine the effect on clinical outcomes, quality of life and functioning. Conclusions A successful trial might lead to rapid implementation of CaPE in clinical practice, not only in Pakistan, but also in other low-resource settings, including those in high-income countries, to improve clinical outcomes, social and occupational functioning, and quality of life in South Asian and other minority group patients with bipolar disorder.
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spelling doaj.art-bfbe11feca3f4cf2a1d07fe388e1c7582023-03-09T12:29:24ZengCambridge University PressBJPsych Open2056-47242022-11-01810.1192/bjo.2022.598Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trialM. Ishrat Husain0Madeha Umer1https://orcid.org/0000-0003-0958-1211Muqaddas Asif2Ameer B. Khoso3Tayyeba Kiran4https://orcid.org/0000-0003-2478-4148Moin Ansari5Huma Aslam6Moti Ram Bhatia7Farasat A. Dogar8M. Omair Husain9https://orcid.org/0000-0002-8575-3364Hazrat A. Khan10Ali A. Mufti11Benoit H. Mulsant12Farooq Naeem13Haider A. Naqvi14Claire de Oliveira15https://orcid.org/0000-0003-3961-6008M. Sajjad Siddiqui16Asad Tamizuddin17Wei Wang18Juveria Zaheer19https://orcid.org/0000-0001-5071-8078Nusrat Husain20Nasim Chaudhry21https://orcid.org/0000-0003-4142-868XImran B. Chaudhry22Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; and Department of Psychiatry, University of Toronto, Toronto, Ontario, CanadaCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; and Pakistan Institute of Living and Learning, Karachi, PakistanPakistan Institute of Living and Learning, Karachi, PakistanPakistan Institute of Living and Learning, Karachi, PakistanPakistan Institute of Living and Learning, Karachi, PakistanDepartment of Psychiatry, Liaquat University of Medical and Health Sciences, Hyderabad, PakistanDepartment of Psychiatry and Behavioral Sciences, Allama Iqbal Medical College/Jinnah Hospital, Lahore, PakistanDepartment of Psychiatry, Peoples University of Medical and Health Sciences for Women, Nawabshah-Shaheed Benazirabad, PakistanPunjab Institute of Mental Health, Lahore, PakistanCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; and Department of Psychiatry, University of Toronto, Toronto, Ontario, CanadaBalochistan Institute of Psychiatry and Behavioral Sciences, Quetta, PakistanJinnah Medical College, Peshawar, PakistanCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; and Department of Psychiatry, University of Toronto, Toronto, Ontario, CanadaCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; and Department of Psychiatry, University of Toronto, Toronto, Ontario, CanadaDepartment of Psychiatry, DOW University of Health Sciences, Karachi, PakistanCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; and Department of Psychiatry, University of Toronto, Toronto, Ontario, CanadaNational Psychiatric Hospital, Multan, PakistanInstitute of Psychiatry, WHO Collaborating Centre for Mental Health Research and Training, Rawalpindi, PakistanCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, CanadaCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; and Department of Psychiatry, University of Toronto, Toronto, Ontario, CanadaDivision of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, UK; and Mersey Care NHS Foundation Trust, Liverpool, UKPakistan Institute of Living and Learning, Karachi, PakistanPakistan Institute of Living and Learning, Karachi, Pakistan; Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, UK; and Department of Psychiatry, Ziauddin University, Karachi, PakistanBackground Bipolar disorder is a source of marked disability, morbidity and premature death. There is a paucity of research on personalised psychosocial interventions for bipolar disorder, especially in low-resource settings. A pilot randomised controlled trial (RCT) of a culturally adapted psychoeducation intervention for bipolar disorder (CaPE) in Pakistan reported higher patient satisfaction, enhanced medication adherence, knowledge and attitudes regarding bipolar disorder, and improvement in mood symptom scores and health-related quality of life measures compared with treatment as usual (TAU). Aims The current protocol describes a larger multicentre RCT to confirm the clinical and cost-effectiveness of CaPE in Pakistan. Trial registration: NCT05223959. Method A multicentre individual, parallel-arm RCT of CaPE in 300 Pakistani adults with bipolar disorder. Participants over the age of 18, with a diagnosis of bipolar I or II disorder who are currently euthymic, will be recruited from seven sites: Karachi, Lahore, Multan, Rawalpindi, Peshawar, Hyderabad and Quetta. Time to recurrence will be the primary outcome assessed using the Longitudinal Interval Follow-up Evaluation (LIFE). Secondary measures will include mood symptoms, quality of life and functioning, adherence to psychotropic medications, and knowledge and attitudes regarding bipolar disorder. Results This trial will assess the effectiveness of the CaPE intervention compared with TAU in reducing the time to recurrence for people with bipolar disorder currently in remission in Pakistan and determine the effect on clinical outcomes, quality of life and functioning. Conclusions A successful trial might lead to rapid implementation of CaPE in clinical practice, not only in Pakistan, but also in other low-resource settings, including those in high-income countries, to improve clinical outcomes, social and occupational functioning, and quality of life in South Asian and other minority group patients with bipolar disorder. https://www.cambridge.org/core/product/identifier/S2056472422005981/type/journal_articleBipolar disorderpsychoeducationclinical trialPakistanpsychosocial interventions
spellingShingle M. Ishrat Husain
Madeha Umer
Muqaddas Asif
Ameer B. Khoso
Tayyeba Kiran
Moin Ansari
Huma Aslam
Moti Ram Bhatia
Farasat A. Dogar
M. Omair Husain
Hazrat A. Khan
Ali A. Mufti
Benoit H. Mulsant
Farooq Naeem
Haider A. Naqvi
Claire de Oliveira
M. Sajjad Siddiqui
Asad Tamizuddin
Wei Wang
Juveria Zaheer
Nusrat Husain
Nasim Chaudhry
Imran B. Chaudhry
Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trial
BJPsych Open
Bipolar disorder
psychoeducation
clinical trial
Pakistan
psychosocial interventions
title Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trial
title_full Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trial
title_fullStr Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trial
title_full_unstemmed Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trial
title_short Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trial
title_sort culturally adapted psychoeducation for bipolar disorder in a low resource setting protocol for a multicentre randomised controlled trial
topic Bipolar disorder
psychoeducation
clinical trial
Pakistan
psychosocial interventions
url https://www.cambridge.org/core/product/identifier/S2056472422005981/type/journal_article
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