Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Pain reduction
研究概览
简要总结
Bipolar disorders are chronic mental health disorders that often result in functional impairment, constituting a significant disease burden. It also accounts for seven per cent of disability-adjusted life years caused by mental disorders. Four out of ten persons with a probable diagnosis of bipolar disorders received no mental health care within the preceding twelve months. Compared to the general population, individuals with bipolar disorders tend to have a significantly higher rate of associated suicide mortality. Within the last decade, these mortality rates have substantially increased, suggesting the need for targeted research to address the unresolved needs of individuals suffering from bipolar disorders. A recent meta-analysis found that compared to the general population, bipolar patients had reduced life expectancy with about thirteen years of potential life loss.
Bipolar disorders are historically under-researched compared to other mental health disorders, especially in Sub-Saharan Africa and Nigeria. Our recent study on bipolar disorders in Nigeria provided insight into contextual knowledge and beliefs about bipolar disorders, including the lived experiences of patients with bipolar disorders, their caregivers, and clinicians in Nigeria. The study recommended culturally adapted psychosocial intervention for bipolar patients, hence the proposed research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of DSM IV bipolar affective disorder
- •currently euthymic (BDI < 12 and YMRS < 8)
- •age 18-65 years, participants engaged with the mental health services for the preceding 6 months
- •able to give written informed consent
- •resident of the trial catchment area and
- •the ability to speak English.
排除标准
- •severe cognitive impairment
- •currently experiencing relapse (mania, hypomania, mixed or depressive)
- •being actively suicidal
- •the presence of any comorbid psychiatric illness such as substance misuse or alcohol dependence according to DSM IV criteria.
研究组 & 干预措施
Culturally adapted Psychoeducation (CaPE)
干预措施: Culturally adapted Psychoeducation (CaPE) (Behavioral)
Treatment as Usual (TaU)
干预措施: Treatment as Usual (TaU) (Drug)
结局指标
主要结局
Pain reduction
时间窗: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Patients' pain reduction would be assessed by the Visual Analogue Scale. For example, 0 = No pain and 10 = worst pain.
次要结局
- Medication adherence(Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention)
- Quality of life(Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention)
- Bipolar knowledge and attitude(Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention)
- Severity of mood symptoms(Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention)
研究者
Dr Dung Jidong, PhD
Principal Investigator
Nottingham Trent University