Culturally Adapted Cognitive Behavior Therapy (CBT) Informed Mobile-Application for First Episode Psychosis (FEP). A Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Feasibility measures
研究概览
简要总结
Onset of First Episode Psychosis (FEP) is at a young age and is a critical period influencing the long-term course of the disorder. Failure to identify FEP can lead to serious implications such as disruption of education, reduced long-term employment, huge economic burden, and is associated with significantly higher mortality. The prevalence of psychosis increases rapidly from age 14 onwards with a peak incidence in the late teens and early 20s. The aim of the project is to examine the acceptability and feasibility of a mobile phone application-based intervention 'TechCare-PK', for individuals with psychosis in Pakistan. The main objectives are to determine whether appropriate individuals could be identified and recruited to the study and whether the TechCare App would be an acceptable intervention for individuals with psychosis.
详细描述
Onset of First Episode Psychosis (FEP) is at a young age and is a critical period influencing the long-term course of the disorder. Failure to identify FEP can lead to serious implications such as disruption of education, reduced long-term employment, huge economic burden, and is associated with significantly higher mortality. The prevalence of psychosis increases rapidly from age 14 onwards with a peak incidence in the late teens and early 20s. The aim of the project is to examine the acceptability and feasibility of a mobile phone application-based intervention 'TechCare-PK', for individuals with psychosis in Pakistan. The main objectives are to determine whether appropriate individuals could be identified and recruited to the study and whether the TechCare App would be an acceptable intervention for individuals with psychosis.
Where there are challenges related to distance, inconvenience, being homebound or reluctance to face-to-face interventions, Mobile Health (mHealth) approaches that leverage mobile devices such as cellular phones and smartphones can be used to support healthcare system. Research has found mobile based interventions as highly acceptable to families and may meet carers' needs in respect of information, guidance, professional and emotional support. These services has been considered as a good and easy mode of exchanging information, providing health related education and advice, management of symptoms, to early recognize the complications, giving reassurance and for providing quality services.
Methods:
Study Design: A multi-center single blind Randomised Controlled Trial (RCT) comparing with Treatment as Usual (TAU) with participants with First Episode Psychosis (FEP) to be recruited from different psychiatric units across four cities in Pakistan i.e., Karachi, Lahore, Hyderabad and Rawalpindi, Pakistan. If required additional centers will be added i.e., Quetta, Multan and Peshawar following proper ethics amendments.
Aim The aim of this study is to design, and test culturally adapted mobile based CBT intervention for patients with FEP.
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
- Single (Outcomes Assessor)
盲法说明
Researchers doing outcome assessments will be kept masked of the treatment allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria for the study will be:
- •Male and Females patients diagnosed with FEP- Schizophrenia or Schizoaffective disorder.
- •Over the age of 18 years.
- •A score of three or more on any of the positive symptoms on the PANSS
- •A Minimum score of one on the Calgary Depression scale (CDS)
- •Having smart phone and able to use smart phone functions.
- •Able to understand written and spoken Urdu.
排除标准
- •Exclusions will be any evidence of organic brain disease, clinically significant concurrent medical illness, learning disability.
- •unable to use simple functions of an android phone
结局指标
主要结局
Feasibility measures
时间窗: From baseline to 3rd month (at the end of intervention)
Feasibility will be determined by recruitment rates, adherence rate and retention rates. The criterion for success of feasibility is to recruit \>50% of eligible participants, adherence rate (number of home assignments completed; \> 50%) and retention rate of 70%
Acceptability measure
时间窗: From baseline to 3rd month (at the end of intervention)
Acceptability will be determined using participant feedback on the use of app
次要结局
- Psychotic Symptom Rating Scales (PSYRATS)(Changes from baseline to week-12)
- Calgary Depression Scale (CDS)(Changes from baseline to week-12)
- EuroQol-5 Dimensions EQ5-D(Changes from baseline to week-12)
- Positive and Negative Syndrome Scale(Changes from baseline to week-12)
- The Work and Social Adjustment Scale (WSAS)(Changes from baseline to week-12)
- Client Service Receipt Inventory (CSRI):(Changes from baseline to week-12)