TY - JOUR
T1 - A culturally adapted manual-assisted problem-solving intervention (CMAP) for adults with a history of self-harm
T2 - a multi-centre randomised controlled trial
AU - Husain, Nusrat
AU - Kiran, Tayyeba
AU - Chaudhry, Imran Bashir
AU - Williams, Christopher
AU - Emsley, Richard
AU - Arshad, Usman
AU - Ansari, Moin Ahmed
AU - Bassett, Paul
AU - Bee, Penny
AU - Bhatia, Moti Ram
AU - Chew-Graham, Carolyn
AU - Husain, Muhammad Omair
AU - Irfan, Muhammad
AU - Khaliq, Ayesha
AU - Minhas, Fareed A
AU - Naeem, Farooq
AU - Naqvi, Haider
AU - Nizami, Asad Tamizuddin
AU - Noureen, Amna
AU - Panagioti, Maria
AU - Rasool, Ghulam
AU - Saeed, Sofiya
AU - Bukhari, Sumira Qambar
AU - Tofique, Sehrish
AU - Zadeh, Zainab F
AU - Zafar, Shehla Naeem
AU - Chaudhry, Nasim
N1 - Funding Information:
Funding support for this study was provided by the MRC/Wellcome Trust/DFID (MR/N006062/1). The funders had no role in the study design, collection, analysis or interpretation of the data, writing of the manuscript, or the decision to submit the manuscript for publication.
Funding Information:
NC is the CEO of the Pakistan Institute of Living and Learning. She is Associate Director of the Global Mental Health and Cultural Psychiatry Research Group, Head of Psychological Medicine at the Remedial Centre Hospital, Consultant Psychiatrist at South City Hospital, Consultant for Manchester Global Foundation and Professor of Psychiatry, Dow University of Health Sciences. NC has received travel grants from Lundbeck and Pfizer pharmaceutical companies to attend one national and one international academic meeting and conference in the last three years. She is a chief investigator and co-investigator for a number of research projects funded by various grant bodies such as the Medical Research Council, Welcome Trust, NIH-R, and Global Challenges Research Fund.
Funding Information:
We would like to thank our Participant and Public Involvement and Engagement (PPIE) group, all the participants who participated in the trial, their families, and our community engagement officers. We want to thank our Trial Steering Committee (Chair Prof David Kingdon, Members: Trial Statistician – RE, Service user representative – SK, Funder observer—Mary Desilva) and Data Management and Ethics Committee (DMEC) (independent statisticians – Kimberley Goldsmith, clinicians – Prof Mowadat H Rana, Dr Rashid Qadir). We are thankful to authors Ulrike Schmidt and Kate Davidson for allowing us to translate, culturally adapt and use the self-help manual “Life after Self-Harm a Guide to the Future” as well as to the Manual Translation and Cultural Adaptation group of the Pakistan Institute of Living and Learning (PILL). We want to thank all the nurses, GPs, clinicians, heads of emergency departments, psychiatry and medical units of participating hospitals for their support in the screening and recruitment of participants for the trial. We would also like to thank all researchers and therapists involved throughout the trial (Ameer B Khoso, Shafaq Ijaz, Maham Rasheed, Majid Sanjrani, Ghulam Qadir, Sehrish Irshad, Zaib un Nisa, Tahira Khalid, Farooq Ahemd, Samia Shahid, Humera Khalid, Rab Dino, Rabia Sattar, Maheshwari Bebo, Sanum Hakro, Akhtar Zaman, Nawaz Khan, Muqaddas Jabeen, Shoaib Khalid, Raja M. Talha, Muhammad Asif, Maria Usman, Sana Farooque, Raheel Ahmed, Farhat ul Ain, Nayab Zafar, Mahum Izhar, Asif Ali (late), Ali Raza, Hadiyya tur Rehman, Muqaddas Asif, Farhat ul Ain, Qurat ul ain, Mehak Bano, Junaid Ikhlaq, Zainab Bibi, Umair Ahsan, Hira Jaffer, Sanaullah Kakar, Faster Gill, Summaiya Shahid, Uzma Attique Khan, Farah Naz, Shahida Kausar, Raees Jokhio, Bano, Nimra, Mehreen Khan, Najma Aziz). Special thanks to Sami Ansari – data manager.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/7/31
Y1 - 2023/7/31
N2 - BACKGROUND: Self-harm is an important predictor of a suicide death. Culturally appropriate strategies for the prevention of self-harm and suicide are needed but the evidence is very limited from low- and middle-income countries (LMICs). This study aims to investigate the effectiveness of a culturally adapted manual-assisted problem-solving intervention (CMAP) for patients presenting after self-harm.METHODS: This was a rater-blind, multicenter randomised controlled trial. The study sites were all participating emergency departments, medical wards of general hospitals and primary care centres in Karachi, Lahore, Rawalpindi, Peshawar, and Quetta, Pakistan. Patients presenting after a self-harm episode (n = 901) to participating recruitment sites were assessed and randomised (1:1) to one of the two arms; CMAP with enhanced treatment as usual (E-TAU) or E-TAU. The intervention (CMAP) is a manual-assisted, cognitive behaviour therapy (CBT)-informed problem-focused therapy, comprising six one-to-one sessions delivered over three months. Repetition of self-harm at 12-month post-randomisation was the primary outcome and secondary outcomes included suicidal ideation, hopelessness, depression, health-related quality of life (QoL), coping resources, and level of satisfaction with service received, assessed at baseline, 3-, 6-, 9-, and 12-month post-randomisation. The trial is registered on ClinicalTrials.gov. NCT02742922 (April 2016).RESULTS: We screened 3786 patients for eligibility and 901 eligible, consented patients were randomly assigned to the CMAP plus E-TAU arm (n = 440) and E-TAU arm (N = 461). The number of self-harm repetitions for CMAP plus E-TAU was lower (n = 17) compared to the E-TAU arm (n = 23) at 12-month post-randomisation, but the difference was not statistically significant (p = 0.407). There was a statistically and clinically significant reduction in other outcomes including suicidal ideation (- 3.6 (- 4.9, - 2.4)), depression (- 7.1 (- 8.7, - 5.4)), hopelessness (- 2.6 (- 3.4, - 1.8), and improvement in health-related QoL and coping resources after completion of the intervention in the CMAP plus E-TAU arm compared to the E-TAU arm. The effect was sustained at 12-month follow-up for all the outcomes except for suicidal ideation and hopelessness. On suicidal ideation and hopelessness, participants in the intervention arm scored lower compared to the E-TAU arm but the difference was not statistically significant, though the participants in both arms were in low-risk category at 12-month follow-up. The improvement in both arms is explained by the established role of enhanced care in suicide prevention.CONCLUSIONS: Suicidal ideation is considered an important target for the prevention of suicide, therefore, CMAP intervention should be considered for inclusion in the self-harm and suicide prevention guidelines. Given the improvement in the E-TAU arm, the potential use of brief interventions such as regular contact requires further exploration.
AB - BACKGROUND: Self-harm is an important predictor of a suicide death. Culturally appropriate strategies for the prevention of self-harm and suicide are needed but the evidence is very limited from low- and middle-income countries (LMICs). This study aims to investigate the effectiveness of a culturally adapted manual-assisted problem-solving intervention (CMAP) for patients presenting after self-harm.METHODS: This was a rater-blind, multicenter randomised controlled trial. The study sites were all participating emergency departments, medical wards of general hospitals and primary care centres in Karachi, Lahore, Rawalpindi, Peshawar, and Quetta, Pakistan. Patients presenting after a self-harm episode (n = 901) to participating recruitment sites were assessed and randomised (1:1) to one of the two arms; CMAP with enhanced treatment as usual (E-TAU) or E-TAU. The intervention (CMAP) is a manual-assisted, cognitive behaviour therapy (CBT)-informed problem-focused therapy, comprising six one-to-one sessions delivered over three months. Repetition of self-harm at 12-month post-randomisation was the primary outcome and secondary outcomes included suicidal ideation, hopelessness, depression, health-related quality of life (QoL), coping resources, and level of satisfaction with service received, assessed at baseline, 3-, 6-, 9-, and 12-month post-randomisation. The trial is registered on ClinicalTrials.gov. NCT02742922 (April 2016).RESULTS: We screened 3786 patients for eligibility and 901 eligible, consented patients were randomly assigned to the CMAP plus E-TAU arm (n = 440) and E-TAU arm (N = 461). The number of self-harm repetitions for CMAP plus E-TAU was lower (n = 17) compared to the E-TAU arm (n = 23) at 12-month post-randomisation, but the difference was not statistically significant (p = 0.407). There was a statistically and clinically significant reduction in other outcomes including suicidal ideation (- 3.6 (- 4.9, - 2.4)), depression (- 7.1 (- 8.7, - 5.4)), hopelessness (- 2.6 (- 3.4, - 1.8), and improvement in health-related QoL and coping resources after completion of the intervention in the CMAP plus E-TAU arm compared to the E-TAU arm. The effect was sustained at 12-month follow-up for all the outcomes except for suicidal ideation and hopelessness. On suicidal ideation and hopelessness, participants in the intervention arm scored lower compared to the E-TAU arm but the difference was not statistically significant, though the participants in both arms were in low-risk category at 12-month follow-up. The improvement in both arms is explained by the established role of enhanced care in suicide prevention.CONCLUSIONS: Suicidal ideation is considered an important target for the prevention of suicide, therefore, CMAP intervention should be considered for inclusion in the self-harm and suicide prevention guidelines. Given the improvement in the E-TAU arm, the potential use of brief interventions such as regular contact requires further exploration.
KW - Humans
KW - Adult
KW - Quality of Life
KW - Self-Injurious Behavior/prevention & control
KW - Suicide
KW - Cognitive Behavioral Therapy
KW - Suicidal Ideation
UR - http://www.scopus.com/inward/record.url?scp=85166040417&partnerID=8YFLogxK
U2 - 10.1186/s12916-023-02983-8
DO - 10.1186/s12916-023-02983-8
M3 - Article
C2 - 37525207
SN - 1741-7015
VL - 21
SP - 282
JO - BMC Medicine
JF - BMC Medicine
IS - 1
M1 - 282
ER -