Culturally Adapted Manual-Assisted Problem-Solving Intervention for Women With Suicidal Ideation in Postnatal Period in Pakistan: A Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Feasibility and Acceptability
研究概览
简要总结
The aim of this study is to determine the feasibility and acceptability of culturally adapted CMAP for suicidal Ideation for women in postnatal period.
Objectives
- To adapt existing CMAP Intervention for suicidal ideation (CMAP-SI) in postnatal period.
- To investigate whether CMAP-SI is feasible and acceptable among women presenting suicidal Ideations in postnatal period; and
- To test whether there is an indication for the effects of the CMAP in reducing suicidal thoughts among women in postnatal period.
- To explore participants experiences with CMAP-SI Intervention.
详细描述
Suicide is a major public health concern globally, affecting not only the individuals but also family members and society through increased resource costs and productivity loss. Although suicides and suicide attempts occur at a lower rate during pregnancy and the postpartum period than in general population, the prevalence of suicidal thoughts during these periods ranges from 5-14% worldwide and this may result in suicide attempts and completions. There is a growing evidence suggesting that suicidal thoughts and behaviour among women in postnatal period in Low-and Middle-Income Countries (LMICs) are comparable to postnatal women in high resource settings. For instance, in observational studies based on hospital samples of women in postnatal period, 11% women had suicidal behaviour (i.e., thoughts and attempts) in Pakistan, 14% in Ethiopia and 13.6% in Nepal. The causes of these high prevalence rates point to the underlying maternal health issues such as antenatal depression and common mental disorders such as anxiety and depression. Evidence based interventions exists in prevention, care and treatment of suicidal thoughts such as Cognitive Behavioural Therapy (CBT). To deliver a CBT based intervention in Pakistani context, Husain and colleagues tailored a treatment manual: "Life after Self-Harm" to the general population in Pakistan. This Culturally Adapted Manual Assisted Problem solving (CMAP) aims at suicide prevention by reducing the probability of self-harm. Pakistan being a low resource setting faces a huge challenge to provide health care to its population. Therefore, it is important to screen women in postnatal period for risk for suicidal thoughts and behaviour, as well as, the maternal health problems. It is equally important to deliver culturally sensitive interventions which are addressing the psycho-social context wherein suicidal behaviour occurs. Thus, the main aim of this study is to determine the feasibility and acceptability of culturally adapted CMAP for suicidal Ideation for women in postnatal period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 44 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •16 to 44-year-old mothers with children 0 - 30 months old
- •Residents of the trial site catchments area
- •Able to provide informed consent
- •Presenting with suicidal ideation as measured by the Beck Suicidal Ideation Scale (BSSI) (must score 1 or 2 on item 4 and 5)
- •Not requiring in-patient psychiatric treatment.
排除标准
- •We will exclude mothers with any physical or psychiatric condition severe enough to prevent study participation.
研究组 & 干预措施
Culturally Adapted Manual Assisted Therapy (CMAP-SI)
Participants in this arm will be offered the CMAP-SI intervention. The intervention will be delivered by trained researchers.
干预措施: Culturally Adapted Manual Assisted Therapy (CMAP-SI) (Behavioral)
Treatment as Usual (TAU)
Local medical, psychiatric, and primary care services provide standard routine care in Pakistan. Participants will receive an initial assessment along with TAU as ascertained by their treating primary care physician (General Practitioner, GP). As part of the safety protocol, we will obtain the contact details of the participants GP. We will also obtain the details of any treatment received by each participant. Research psychologists delivering the interventions will not be involved with the participants allocated to the TAU.
结局指标
主要结局
Feasibility and Acceptability
时间窗: At 3 months after baseline
The feasibility is defined as engagement with the intervention, its usability in daily life, as well as its potential for delivering a full trial in future. The feasibility of the study procedures will be assessed through monitoring recruitment and retention rates. Acceptability operationalised as the extent to which the participants receiving the intervention considered it to be appropriate, will be assessed through each participant's attendance rates in the intervention session. Additionally, the feasibility and acceptability will also be measured through qualitative interviews at post intervention
次要结局
- Beck Depression Inventory (BDI) (Beck et al., 1961)(Baseline and 3 months)
- Beck Scale for Suicidal Ideation (BSS) (Beck et al., 1988)(Baseline and 3 months)
- Suicide Attempt and Self-Harm (SASH) (Eylem, 2011)(Baseline and 3 months)
- Edinburgh postnatal depression scale (EPDS) (Cox et al., 1987)(Baseline and 3 months)
- Euro Quol (EQ-5D) (Rabin & Charro, 2001)(Baseline and 3 months)
- Life Events Checklist (Husain et al., 2000)(Baseline and 3 months)
- Oslo- 3 Social Support Scale (O3SSS) (Dalgard, 2009)(Baseline and 3 months)