Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan: a single-blind, cluster, randomised controlled trial

A. Rahman, M.N. Khan, S. U. Hamdani, A. Chiumento, P. Akhtar, H. Nazir, A. Nisar, A. Masood, I. U. Din, N.A. Khan, R. A. Bryant, K.S. Dawson, M. Sijbrandij, D. Wang, M. van Ommeren

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

conflict in low-income and middle-income countries, yet few scalable options for their mental health care exist. We aimed to establish the effectiveness of a brief group psychological intervention for women in a conflict-affected setting in rural Swat, Pakistan. METHODS: In a single-blind, cluster, randomised, controlled trial, 34 community clusters in two union councils of rural Swat, Pakistan, were randomised using block permutation at a 1:1 ratio to intervention (group intervention with five sessions incorporating behavioural strategies facilitated by non-specialists) or control (enhanced usual care) groups. Researchers responsible for identifying participants, obtaining consent, enrolment, and outcome assessments were masked to allocation. A community cluster was defined as neighbourhood of about 150 households covered by a lady health worker. Women aged 18-60 years who provided written informed consent, resided in the participating cluster catchment areas, scored at least 3 on the General Health Questionnaire-12, and at least 17 on the WHO Disability Assessment Schedule were recruited. The primary outcome, combined anxiety and depression symptoms, was measured 3 months after the intervention with the Hospital Anxiety and Depression Scale (HADS). Modified intention-to-treat analyses were done using mixed models adjusted for covariates and clusters defined a priori. The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12616000037404, and is now closed to new participants. FINDINGS: From 34 eligible community clusters, 306 women in the intervention group and 306 women in the enhanced usual care (EUC) group were enrolled between Jan 11, 2016, and Aug 21, 2016, and the results of 288 (94%) of 306 women in the intervention group and 290 (95%) of 306 women in the EUC group were included in the primary endpoint analysis. At 3 months, women in the intervention group had significantly lower mean total scores on the HADS than women in the control group (10·01 [SD 7·54] vs 14·75 [8·11]; adjusted mean difference [AMD] -4·53, 95% CI -7·13 to -1·92; p=0·0007). Individual HADS anxiety scores were also significantly lower in the intervention group than in the control group (5·43 [SD 4·18] vs 8·02 [4·69]; AMD -2·52, 95% CI -4·04 to -1·01), as were depression scores (4·59 [3·87] vs 6·73 [3·91]; AMD -2·04, -3·19 to -0·88). No adverse events were reported in either group. INTERPRETATION: Our group psychological intervention resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months, and might be a feasible and effective option for women with psychological distress in rural post-conflict settings. FUNDING: WHO through a grant from the Office for Foreign Disaster Assistance.
Original languageEnglish
Pages (from-to)1733-1744
Number of pages12
JournalLancet (London, England)
Volume393
Issue number10182
Early online date1 Apr 2019
DOIs
Publication statusPublished - 27 Apr 2019

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Pakistan
Randomized Controlled Trials
Psychology
Anxiety
Depression
Conflict (Psychology)
Control Groups
Intention to Treat Analysis
Organized Financing
Health
Disasters
Informed Consent
New Zealand
Registries
Appointments and Schedules
Mental Health
Research Personnel
Outcome Assessment (Health Care)
Clinical Trials
Delivery of Health Care

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Rahman, A. ; Khan, M.N. ; Hamdani, S. U. ; Chiumento, A. ; Akhtar, P. ; Nazir, H. ; Nisar, A. ; Masood, A. ; Din, I. U. ; Khan, N.A. ; Bryant, R. A. ; Dawson, K.S. ; Sijbrandij, M. ; Wang, D. ; van Ommeren, M. / Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan : a single-blind, cluster, randomised controlled trial. In: Lancet (London, England). 2019 ; Vol. 393, No. 10182. pp. 1733-1744.
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abstract = "conflict in low-income and middle-income countries, yet few scalable options for their mental health care exist. We aimed to establish the effectiveness of a brief group psychological intervention for women in a conflict-affected setting in rural Swat, Pakistan. METHODS: In a single-blind, cluster, randomised, controlled trial, 34 community clusters in two union councils of rural Swat, Pakistan, were randomised using block permutation at a 1:1 ratio to intervention (group intervention with five sessions incorporating behavioural strategies facilitated by non-specialists) or control (enhanced usual care) groups. Researchers responsible for identifying participants, obtaining consent, enrolment, and outcome assessments were masked to allocation. A community cluster was defined as neighbourhood of about 150 households covered by a lady health worker. Women aged 18-60 years who provided written informed consent, resided in the participating cluster catchment areas, scored at least 3 on the General Health Questionnaire-12, and at least 17 on the WHO Disability Assessment Schedule were recruited. The primary outcome, combined anxiety and depression symptoms, was measured 3 months after the intervention with the Hospital Anxiety and Depression Scale (HADS). Modified intention-to-treat analyses were done using mixed models adjusted for covariates and clusters defined a priori. The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12616000037404, and is now closed to new participants. FINDINGS: From 34 eligible community clusters, 306 women in the intervention group and 306 women in the enhanced usual care (EUC) group were enrolled between Jan 11, 2016, and Aug 21, 2016, and the results of 288 (94{\%}) of 306 women in the intervention group and 290 (95{\%}) of 306 women in the EUC group were included in the primary endpoint analysis. At 3 months, women in the intervention group had significantly lower mean total scores on the HADS than women in the control group (10·01 [SD 7·54] vs 14·75 [8·11]; adjusted mean difference [AMD] -4·53, 95{\%} CI -7·13 to -1·92; p=0·0007). Individual HADS anxiety scores were also significantly lower in the intervention group than in the control group (5·43 [SD 4·18] vs 8·02 [4·69]; AMD -2·52, 95{\%} CI -4·04 to -1·01), as were depression scores (4·59 [3·87] vs 6·73 [3·91]; AMD -2·04, -3·19 to -0·88). No adverse events were reported in either group. INTERPRETATION: Our group psychological intervention resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months, and might be a feasible and effective option for women with psychological distress in rural post-conflict settings. FUNDING: WHO through a grant from the Office for Foreign Disaster Assistance.",
author = "A. Rahman and M.N. Khan and Hamdani, {S. U.} and A. Chiumento and P. Akhtar and H. Nazir and A. Nisar and A. Masood and Din, {I. U.} and N.A. Khan and Bryant, {R. A.} and K.S. Dawson and M. Sijbrandij and D. Wang and {van Ommeren}, M.",
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Rahman, A, Khan, MN, Hamdani, SU, Chiumento, A, Akhtar, P, Nazir, H, Nisar, A, Masood, A, Din, IU, Khan, NA, Bryant, RA, Dawson, KS, Sijbrandij, M, Wang, D & van Ommeren, M 2019, 'Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan: a single-blind, cluster, randomised controlled trial' Lancet (London, England), vol. 393, no. 10182, pp. 1733-1744. https://doi.org/10.1016/S0140-6736(18)32343-2

Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan : a single-blind, cluster, randomised controlled trial. / Rahman, A.; Khan, M.N. ; Hamdani, S. U.; Chiumento, A.; Akhtar, P.; Nazir, H.; Nisar, A.; Masood, A.; Din, I. U.; Khan, N.A.; Bryant, R. A.; Dawson, K.S.; Sijbrandij, M.; Wang, D.; van Ommeren, M.

In: Lancet (London, England), Vol. 393, No. 10182, 27.04.2019, p. 1733-1744.

Research output: Contribution to JournalArticleAcademicpeer-review

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T1 - Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan

T2 - a single-blind, cluster, randomised controlled trial

AU - Rahman, A.

AU - Khan, M.N.

AU - Hamdani, S. U.

AU - Chiumento, A.

AU - Akhtar, P.

AU - Nazir, H.

AU - Nisar, A.

AU - Masood, A.

AU - Din, I. U.

AU - Khan, N.A.

AU - Bryant, R. A.

AU - Dawson, K.S.

AU - Sijbrandij, M.

AU - Wang, D.

AU - van Ommeren, M.

PY - 2019/4/27

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N2 - conflict in low-income and middle-income countries, yet few scalable options for their mental health care exist. We aimed to establish the effectiveness of a brief group psychological intervention for women in a conflict-affected setting in rural Swat, Pakistan. METHODS: In a single-blind, cluster, randomised, controlled trial, 34 community clusters in two union councils of rural Swat, Pakistan, were randomised using block permutation at a 1:1 ratio to intervention (group intervention with five sessions incorporating behavioural strategies facilitated by non-specialists) or control (enhanced usual care) groups. Researchers responsible for identifying participants, obtaining consent, enrolment, and outcome assessments were masked to allocation. A community cluster was defined as neighbourhood of about 150 households covered by a lady health worker. Women aged 18-60 years who provided written informed consent, resided in the participating cluster catchment areas, scored at least 3 on the General Health Questionnaire-12, and at least 17 on the WHO Disability Assessment Schedule were recruited. The primary outcome, combined anxiety and depression symptoms, was measured 3 months after the intervention with the Hospital Anxiety and Depression Scale (HADS). Modified intention-to-treat analyses were done using mixed models adjusted for covariates and clusters defined a priori. The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12616000037404, and is now closed to new participants. FINDINGS: From 34 eligible community clusters, 306 women in the intervention group and 306 women in the enhanced usual care (EUC) group were enrolled between Jan 11, 2016, and Aug 21, 2016, and the results of 288 (94%) of 306 women in the intervention group and 290 (95%) of 306 women in the EUC group were included in the primary endpoint analysis. At 3 months, women in the intervention group had significantly lower mean total scores on the HADS than women in the control group (10·01 [SD 7·54] vs 14·75 [8·11]; adjusted mean difference [AMD] -4·53, 95% CI -7·13 to -1·92; p=0·0007). Individual HADS anxiety scores were also significantly lower in the intervention group than in the control group (5·43 [SD 4·18] vs 8·02 [4·69]; AMD -2·52, 95% CI -4·04 to -1·01), as were depression scores (4·59 [3·87] vs 6·73 [3·91]; AMD -2·04, -3·19 to -0·88). No adverse events were reported in either group. INTERPRETATION: Our group psychological intervention resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months, and might be a feasible and effective option for women with psychological distress in rural post-conflict settings. FUNDING: WHO through a grant from the Office for Foreign Disaster Assistance.

AB - conflict in low-income and middle-income countries, yet few scalable options for their mental health care exist. We aimed to establish the effectiveness of a brief group psychological intervention for women in a conflict-affected setting in rural Swat, Pakistan. METHODS: In a single-blind, cluster, randomised, controlled trial, 34 community clusters in two union councils of rural Swat, Pakistan, were randomised using block permutation at a 1:1 ratio to intervention (group intervention with five sessions incorporating behavioural strategies facilitated by non-specialists) or control (enhanced usual care) groups. Researchers responsible for identifying participants, obtaining consent, enrolment, and outcome assessments were masked to allocation. A community cluster was defined as neighbourhood of about 150 households covered by a lady health worker. Women aged 18-60 years who provided written informed consent, resided in the participating cluster catchment areas, scored at least 3 on the General Health Questionnaire-12, and at least 17 on the WHO Disability Assessment Schedule were recruited. The primary outcome, combined anxiety and depression symptoms, was measured 3 months after the intervention with the Hospital Anxiety and Depression Scale (HADS). Modified intention-to-treat analyses were done using mixed models adjusted for covariates and clusters defined a priori. The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12616000037404, and is now closed to new participants. FINDINGS: From 34 eligible community clusters, 306 women in the intervention group and 306 women in the enhanced usual care (EUC) group were enrolled between Jan 11, 2016, and Aug 21, 2016, and the results of 288 (94%) of 306 women in the intervention group and 290 (95%) of 306 women in the EUC group were included in the primary endpoint analysis. At 3 months, women in the intervention group had significantly lower mean total scores on the HADS than women in the control group (10·01 [SD 7·54] vs 14·75 [8·11]; adjusted mean difference [AMD] -4·53, 95% CI -7·13 to -1·92; p=0·0007). Individual HADS anxiety scores were also significantly lower in the intervention group than in the control group (5·43 [SD 4·18] vs 8·02 [4·69]; AMD -2·52, 95% CI -4·04 to -1·01), as were depression scores (4·59 [3·87] vs 6·73 [3·91]; AMD -2·04, -3·19 to -0·88). No adverse events were reported in either group. INTERPRETATION: Our group psychological intervention resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months, and might be a feasible and effective option for women with psychological distress in rural post-conflict settings. FUNDING: WHO through a grant from the Office for Foreign Disaster Assistance.

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