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

Atif Rahman, Muhammad Naseem Khan, Syed Usman Hamdani, Anna Chiumento, Parveen Akhtar, Huma Nazir, Anum Nisar, Aqsa Masood, Iftikhar Ud Din, Nasir Ali Khan, Richard A. Bryant, Katie S. Dawson, Marit Sijbrandij, Duolao Wang, Mark van Ommeren

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

BACKGROUND: Many women are affected by anxiety and depression after armed 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, Atif ; Khan, Muhammad Naseem ; Hamdani, Syed Usman ; Chiumento, Anna ; Akhtar, Parveen ; Nazir, Huma ; Nisar, Anum ; Masood, Aqsa ; Din, Iftikhar Ud ; Khan, Nasir Ali ; Bryant, Richard A. ; Dawson, Katie S. ; Sijbrandij, Marit ; Wang, Duolao ; van Ommeren, Mark. / 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 = "BACKGROUND: Many women are affected by anxiety and depression after armed 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 = "Atif Rahman and Khan, {Muhammad Naseem} and Hamdani, {Syed Usman} and Anna Chiumento and Parveen Akhtar and Huma Nazir and Anum Nisar and Aqsa Masood and Din, {Iftikhar Ud} and Khan, {Nasir Ali} and Bryant, {Richard A.} and Dawson, {Katie S.} and Marit Sijbrandij and Duolao Wang and {van Ommeren}, Mark",
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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, Atif; Khan, Muhammad Naseem; Hamdani, Syed Usman; Chiumento, Anna; Akhtar, Parveen; Nazir, Huma; Nisar, Anum; Masood, Aqsa; Din, Iftikhar Ud; Khan, Nasir Ali; Bryant, Richard A.; Dawson, Katie S.; Sijbrandij, Marit; Wang, Duolao; van Ommeren, Mark.

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

Research output: Contribution to JournalArticleAcademicpeer-review

TY - JOUR

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, Atif

AU - Khan, Muhammad Naseem

AU - Hamdani, Syed Usman

AU - Chiumento, Anna

AU - Akhtar, Parveen

AU - Nazir, Huma

AU - Nisar, Anum

AU - Masood, Aqsa

AU - Din, Iftikhar Ud

AU - Khan, Nasir Ali

AU - Bryant, Richard A.

AU - Dawson, Katie S.

AU - Sijbrandij, Marit

AU - Wang, Duolao

AU - van Ommeren, Mark

PY - 2019/4/27

Y1 - 2019/4/27

N2 - BACKGROUND: Many women are affected by anxiety and depression after armed 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 - BACKGROUND: Many women are affected by anxiety and depression after armed 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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