Indigenously Adapted Community Based Psychological Intervention for Individuals Living with Disabilities: a Cluster Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Depression Anxiety Stress Scale (DASS-21)
研究概览
简要总结
Mental health problems are increasing in Pakistan and there is a 90% treatment gap in mental health services. Accessibility towards mental health services is limited due to range of factors including low income and resources, lack of the trained staff and lack of specialized and non-specialized mental health facilities. Therefore, there is a dire need to develop indigenous solution of the mental health issues grounded in Islamic teaching.
In this regard this study is designed to address the mental health issues at community level. Therefore, this study divided into two phases. In first phase the aim of the study is to adapt World Health Organization recommended psychological intervention for paraprofessionals and to train the paraprofessional on this indigenously adapted intervention. Subsequently, in second phase the study aims to assess the effectiveness of the indigenously adapted Problem Management Plus (IA-PM+) as an evidence based remedy in the treatment of psychological distress of person living with disabilities (PWDs).
详细描述
Prevalence of disability is higher in Low and middle income countries (LMICs). Persons living with disabilities are more vulnerable to develop psychopathology due to their low level of functioning, their complex and specific needs. Consequently, Persons living with disabilities (PWDs) are expected to experience more adverse psychological ailments as compared to the persons living without disabilities particularly in the rural parts of the countries. Accessibility towards mental health services in Pakistan has been limited due to range of factors including low income and resources, lack of the trained staff and lack of specialized and non-specialized mental health facilities. These challenges are required to be dealt at locally at micro and macro levels systemically and effectively. This requires development and innovation in the existing infrastructure by devising multidisciplinary community based treatment policy in building mental health care services. Therefore, to integrate the mental health care services at primary care level, there is a dire need to develop indigenous psychological interventions in a simplified form so that people can quickly learn their utilization not only from the health professionals but also from the para-professionals as well.
Due to the lack of specialized mental health services and human resources in low resource settings, task shifting is a well-known strategy, designed by World Health Organization to bridge the treatment gap in mental health problems. This strategy empowers the health workers, such as nurses and non-specialist to perform specific roles to bridge the available treatment gap. In addition to this, deliverance of evidence based psychological treatment by para-professionals/ non-specialists will not only help in reducing the financial and human resources but also might be able to reduce the stigma associated with mental illness.
Realizing the influence of religion on the general population, the American Psychological Association (APA) has recommended to view the religion as a significant aspect of human life and as such psychologists need to get special knowledge and training on religious psychotherapy.
In this regard this study is designed to address the mental health issues at community level. Therefore, this study divided into two phases. In first phase the aim of the study is to adapt World Health Organization recommended psychological intervention for paraprofessionals and to train the paraprofessional on this indigenously adapted intervention. Subsequently, in second phase the study aims to assess the effectiveness of the indigenously adapted Problem Management Plus (IA-PM+) as an evidence based remedy in the treatment of psychological distress of person living with disabilities (PWDs).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Single-blind cluster randomized controlled trial (c-RCT)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Score more than 16 (16>) On PSYCHLOPS
- •Participants living with permanent disabilities (more than 6 months)
排除标准
- •Temporary resident or people living outside the study area.
- •Participants who are unable to engage or respond to the research question
- •Diagnosed psychiatric patients
研究组 & 干预措施
Active Treatment (AT): PM+ intervention
Active Treatment (AT) group will receive 05 sessions of indigenously adapted problem management plus (IA-PM+) intervention.
干预措施: Indigenously adapted problem management plus (IA-PM+) (Behavioral)
Delayed Treatment Control (DTC): Treatment as usual
Delayed Treatment Control (DTC) group will receive routine treatment until the last follow-up.
结局指标
主要结局
Depression Anxiety Stress Scale (DASS-21)
时间窗: Assessments will be conducted at baseline (after the screening), 8th week (2 month) after the baseline, 20th week (5th month) after the baseline. The purpose of the outcome measure is to asses the change from baseline to follow-up.
DASS is a 21 items Likert-scale is used to assess the possibility of depression, anxiety and stress among the study population (Lovibond \& Lovibond, 1995).
WHO Disability Assessment Scale (WHODAS 2.0)
时间窗: Assessments will be conducted at baseline (after the screening), 8th week (2 month) after the baseline, 20th week (5th month) after the baseline. The purpose of the outcome measure is to asses the change from baseline to follow-up.
WHODAS 2.0 is a self-report instrument is used to assess health and disability. The WHODAS assess people's difficulties associated to their illness across six domains of functioning (mobility, cognition, self-care, getting along, life activities and participation). Its five-point Likert scale keeps record of the last 30 days. The 12-item WHODAS 2.0 version translated in Urdu will be used in this study. (World-Health-Organization, 2010).
次要结局
- Client Satisfaction Questionnaire (CSQ)(The questionnaire will be employed on the 8th week (2 month) after the baseline and at the 20th week (5th month) after the baseline.)
- Satisfaction with Life Scale (SWLC)(Assessments will be conducted at baseline (after the screening), 8th week (2 month) after the baseline, 20th week (5th month) after the baseline.)
- Multidimensional Scale of Perceived Social Support (MSPSS)(Assessments will be conducted at baseline (after the screening), 8th week (2 month) after the baseline, 20th week (5th month) after the baseline.)
研究者
Basharat Hussain
Lecturer/PhD Scholar
International Islamic University, Islamabad