Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial
Abstract Background The impact of humanitarian disasters upon mental health is well recognised. The evidence for psychological interventions for mental health is mounting, but few interventions have been rigorously tested in humanitarian settings. To be sustainable in humanitarian settings intervent...
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| Format: | Article |
| Language: | English |
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BMC
2017-04-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-1905-8 |
| _version_ | 1818972063818317824 |
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| author | Anna Chiumento Syed Usman Hamdani Muhammad Naseem Khan Katie Dawson Richard A. Bryant Marit Sijbrandij Huma Nazir Parveen Akhtar Aqsa Masood Duolao Wang Mark van Ommeren Atif Rahman |
| author_facet | Anna Chiumento Syed Usman Hamdani Muhammad Naseem Khan Katie Dawson Richard A. Bryant Marit Sijbrandij Huma Nazir Parveen Akhtar Aqsa Masood Duolao Wang Mark van Ommeren Atif Rahman |
| author_sort | Anna Chiumento |
| collection | DOAJ |
| description | Abstract Background The impact of humanitarian disasters upon mental health is well recognised. The evidence for psychological interventions for mental health is mounting, but few interventions have been rigorously tested in humanitarian settings. To be sustainable in humanitarian settings interventions need to be short, simple, deliverable by nonspecialists under supervision, and adopt a transdiagnostic approach where an array of mental health outcomes are addressed simultaneously. These elements have been incorporated into the newly developed WHO Problem Management Plus (PM+) Group intervention. The aim of this trial is to evaluate the locally adapted PM+ Group intervention for women in Swat, Pakistan. Methods This PM+ Group trial is a two-arm, single-blind, cluster randomised controlled trial conducted in a community-based setting with women in rural Pakistan. PM+ is delivered in partnership with the Lady Health Worker (LHW) Programme which provides community-based health care to women in Pakistan. Thirty-four LHW clusters will be randomised in a 1:1 allocation ratio using a permuted-block randomisation method. Participants screened and found to meet the inclusion criteria will be allocated to either the PM+ intervention group (n = 306), or the control arm (n = 306). The manualised PM+ intervention involves five sessions, each lasting 3 h, and introduces four strategies applied by participants to problems that they are facing. It is delivered by local female facilitators with a minimum of 16 years of education who are provided with targeted training and supervision. The primary outcome is individual psychological distress, measured by levels of anxiety and depression on the Hospital Anxiety and Depression Scale at 20 weeks after baseline. Secondary outcomes include major depression, post-traumatic stress disorder, levels of social support, levels of functioning, and economic effectiveness. Intervention acceptability will be explored through an embedded qualitative study. Discussion The PM+ Group trial will provide important evidence on the effectiveness of an empirically supported psychological treatment delivered by nonspecialists in a humanitarian setting. If proven effective, the qualitative component will inform strategies for PM+ Group scale-up in health systems in other humanitarian settings. Trial registration Australian New Zealand Clinical Trials Registry, identifier: ACTRN12616000037404. Registered on 19 January 2016; WHO Protocol ID RPC705, v.4, 2 November 2015. |
| first_indexed | 2024-12-20T15:02:19Z |
| format | Article |
| id | doaj.art-a2707e991d894c5f98a5635d37e21826 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-20T15:02:19Z |
| publishDate | 2017-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-a2707e991d894c5f98a5635d37e218262022-12-21T19:36:37ZengBMCTrials1745-62152017-04-0118111210.1186/s13063-017-1905-8Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trialAnna Chiumento0Syed Usman Hamdani1Muhammad Naseem Khan2Katie Dawson3Richard A. Bryant4Marit Sijbrandij5Huma Nazir6Parveen Akhtar7Aqsa Masood8Duolao Wang9Mark van Ommeren10Atif Rahman11University of LiverpoolUniversity of LiverpoolKhyber Medical UniversityUniversity of New South WalesUniversity of New South WalesVU University AmsterdamHuman Development Research FoundationHuman Development Research FoundationHuman Development Research FoundationLiverpool School of Tropical MedicineDepartment of Mental Health and Substance Abuse, World Health OrganisationUniversity of LiverpoolAbstract Background The impact of humanitarian disasters upon mental health is well recognised. The evidence for psychological interventions for mental health is mounting, but few interventions have been rigorously tested in humanitarian settings. To be sustainable in humanitarian settings interventions need to be short, simple, deliverable by nonspecialists under supervision, and adopt a transdiagnostic approach where an array of mental health outcomes are addressed simultaneously. These elements have been incorporated into the newly developed WHO Problem Management Plus (PM+) Group intervention. The aim of this trial is to evaluate the locally adapted PM+ Group intervention for women in Swat, Pakistan. Methods This PM+ Group trial is a two-arm, single-blind, cluster randomised controlled trial conducted in a community-based setting with women in rural Pakistan. PM+ is delivered in partnership with the Lady Health Worker (LHW) Programme which provides community-based health care to women in Pakistan. Thirty-four LHW clusters will be randomised in a 1:1 allocation ratio using a permuted-block randomisation method. Participants screened and found to meet the inclusion criteria will be allocated to either the PM+ intervention group (n = 306), or the control arm (n = 306). The manualised PM+ intervention involves five sessions, each lasting 3 h, and introduces four strategies applied by participants to problems that they are facing. It is delivered by local female facilitators with a minimum of 16 years of education who are provided with targeted training and supervision. The primary outcome is individual psychological distress, measured by levels of anxiety and depression on the Hospital Anxiety and Depression Scale at 20 weeks after baseline. Secondary outcomes include major depression, post-traumatic stress disorder, levels of social support, levels of functioning, and economic effectiveness. Intervention acceptability will be explored through an embedded qualitative study. Discussion The PM+ Group trial will provide important evidence on the effectiveness of an empirically supported psychological treatment delivered by nonspecialists in a humanitarian setting. If proven effective, the qualitative component will inform strategies for PM+ Group scale-up in health systems in other humanitarian settings. Trial registration Australian New Zealand Clinical Trials Registry, identifier: ACTRN12616000037404. Registered on 19 January 2016; WHO Protocol ID RPC705, v.4, 2 November 2015.http://link.springer.com/article/10.1186/s13063-017-1905-8Mental health and psychosocial supportCluster randomised controlled trialEffectivenessNonspecialist health workerHumanitarianGroup intervention |
| spellingShingle | Anna Chiumento Syed Usman Hamdani Muhammad Naseem Khan Katie Dawson Richard A. Bryant Marit Sijbrandij Huma Nazir Parveen Akhtar Aqsa Masood Duolao Wang Mark van Ommeren Atif Rahman Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial Trials Mental health and psychosocial support Cluster randomised controlled trial Effectiveness Nonspecialist health worker Humanitarian Group intervention |
| title | Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial |
| title_full | Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial |
| title_fullStr | Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial |
| title_full_unstemmed | Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial |
| title_short | Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial |
| title_sort | evaluating effectiveness and cost effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict affected rural pakistan study protocol for a randomised controlled trial |
| topic | Mental health and psychosocial support Cluster randomised controlled trial Effectiveness Nonspecialist health worker Humanitarian Group intervention |
| url | http://link.springer.com/article/10.1186/s13063-017-1905-8 |
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