Zafar Shamsa, Sikander Siham, Hamdani Syed Usman, Atif Najia, Akhtar Parveen, Nazir Huma, Maselko Joanna, Rahman Atif
Human Development Research Foundation and Health Services Academy, Islamabad, Pakistan.
Human Development Research Foundation, Islamabad, Pakistan.
Trials. 2016 Apr 6;17:188. doi: 10.1186/s13063-016-1308-2.
Rates of perinatal depression in low and middle income countries are reported to be very high. Perinatal depression not only has profound impact on women's health, disability and functioning, it is associated with poor child health outcomes such as pre-term birth, under-nutrition and stunting, which ultimately have an adverse trans-generational impact. There is strong evidence in the medical literature that perinatal depression can be effectively managed with psychological treatments delivered by non-specialists. Our previous research in Pakistan led to the development of a successful perinatal depression intervention, the Thinking Healthy Program (THP). The THP is a psychological treatment delivered by community health workers. The burden of perinatal depression can be reduced through scale-up of this proven intervention; however, training of health workers at scale is a major barrier. To enhance access to such interventions there is a need to look at technological solutions to training and supervision.
METHODS/DESIGN: This is a non-inferiority, single-blinded randomized controlled trial. Eighty community health workers called Lady Health Workers (LHWs) working in a post-conflict rural area in Pakistan (Swat) will be recruited through the LHW program. LHWs will be randomly allocated to Technology-assisted Cascade Training and Supervision (TACTS) or to specialist-delivered training (40 in each group). The TACTS group will receive training in THP through LHW supervisors using a tablet-based training package, whereas the comparison group will receive training directly from mental health specialists. Our hypothesis is that both groups will achieve equal competence. Primary outcome measure will be competence of health workers at delivering THP using a modified ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale immediately post training and after 3 months of supervision. Independent assessors will be blinded to the LHW allocation status.
Women living in post-conflict areas are at higher risk of depression compared to the general population. Implementation of evidence-based interventions for depression in such situations is a challenge because health systems are weak and human resources are scarce. The key innovation to be tested in this trial is a Technology-assisted Cascade Training and Supervision system to assist scale-up of the THP.
Registered with ClinicalTrials.gov as GCC-THP-TACTS-2015, Identifier: NCT02644902 .
据报道，低收入和中等收入国家的围产期抑郁症发病率非常高。围产期抑郁症不仅对女性的健康、残疾状况和功能有深远影响，还与早产、营养不良和发育迟缓等不良儿童健康结局相关，而这些最终会产生不利的跨代影响。医学文献中有强有力的证据表明，围产期抑郁症可以通过非专科人员提供的心理治疗得到有效管理。我们之前在巴基斯坦的研究促成了一项成功的围产期抑郁症干预措施——健康思维计划（THP）的开发。THP是一种由社区卫生工作者提供的心理治疗。通过扩大这种经过验证的干预措施的规模，可以减轻围产期抑郁症的负担；然而，大规模培训卫生工作者是一个主要障碍。为了增加获得此类干预措施的机会，有必要研究培训和监督的技术解决方案。
方法/设计：这是一项非劣效性、单盲随机对照试验。将通过女性卫生工作者（LHW）计划招募80名在巴基斯坦冲突后农村地区（斯瓦特）工作的社区卫生工作者，即女性卫生工作者。LHW将被随机分配到技术辅助级联培训与监督（TACTS）组或由专科人员提供培训的组（每组40人）。TACTS组将通过LHW督导员使用基于平板电脑的培训包接受THP培训，而对照组将直接接受心理健康专科人员的培训。我们的假设是两组将达到同等能力水平。主要结局指标将是卫生工作者在培训后立即以及经过3个月监督后使用改良的常见治疗因素强化评估（ENACT）评分量表实施THP的能力。独立评估人员将对LHW的分配状态不知情。
与普通人群相比，生活在冲突后地区的女性患抑郁症的风险更高。在这种情况下实施基于证据的抑郁症干预措施是一项挑战，因为卫生系统薄弱且人力资源稀缺。本试验中要测试的关键创新是一种技术辅助级联培训与监督系统，以协助扩大THP的规模。
已在ClinicalTrials.gov注册，注册号为GCC - THP - TACTS - 2015，标识符：NCT02644902 。
