A Randomized Controlled Trial of Brief Culturally Adapted CBT for Schizophrenia in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- PANSS (Positive and Negative Syndrome Scale of Schizophrenia)Positive symptoms
研究概览
简要总结
While Cognitive behavior therapy for psychosis (CBTp) is now established as an effective and evidence based therapy for psychotic illnesses in the west and is recommended by the national organizations both in Europe and in the USA. However, CBT remains limited to the western clients. We have adapted CBT for psychosis in Pakistan for use with local clients. Initial evaluations have found that these therapies are effective. Due to the financial restraints we would like to test a brief version of the Culturally adapted CBTp (CaCBTp) in Pakistan. We want to see if brief CaCBTp (6 sessions of CBT) would be effective in non western cultures in educing symptoms of schizophrenia. This study will test brief CaCBTp against care as usual in Pakistan in secondary care.
详细描述
BACKGROUND A number of systematic reviews and meta-analyses (for example, Wykes, Steel, Everitt, & Tarrier, 2008) have concluded that Cognitive Behaviour Therapy (CBT) is effective in treating people with schizophrenia. Most of this work was however, conducted in the West. In a literature search no study of CBT for psychosis in English language literature was found from a low or middle income country, including from Pakistan. Only two studies of psychological interventions for schizophrenia were found from Pakistan (Farooq et al., 2011; Nasr, Kausar, & others, 2009).
It has been suggested that cultural differences can influence the process of Cognitive Behaviour Psychotherapy, and therefore therapy might need adapting to the cultural needs of a given country. Our group has adapted Cognitive Therapy for depression in Pakistan (F. Naeem, Ayub, Gobbi, & Kingdon, 2009; F. Naeem, Gobbi, Ayub, Kingdon, & others, 2010; Farooq Naeem, Ayub, Kingdon, & Gobbi, 2012; Farooq Naeem, Gobbi, Ayub, & Kingdon, 2009) , which was found to be effective in a small trial (Farooq Naeem, Waheed, Gobbi, Ayub, & Kingdon, 2011). Same methodology was useed to adapt CBT for schizophrenia for local use (Naeem et al, under review). A small pilot found it to be effective in inpatient settings. (Habib et al, under review). This is a RCT to test the effectiveness of Culturally adapted CBT for psychosis (CaCBTp).
METHODS Aims The aim of this RCT is to test brief culturally adapted Cognitive Therapy for Schizophrenia against Treatment As Usual in Pakistan.
Study area and population:
Study participants will be recruited mainly from hospitals in Lahore/Karachi, Pakistan.
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, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •being able to engage with a therapist,
- •living within travelling distance of the hospital, and
- •with a diagnosis of Schizophrenia according to DSM-IV-TR (Association & DSM-IV, 2000),
- •age between 18 to 65 years.
排除标准
- •co-morbid alcohol or substance dependence,
- •organic brain syndrome or learning disability and high levels of disturbed behavior, or
- •high risk of suicide or homicide.
结局指标
主要结局
PANSS (Positive and Negative Syndrome Scale of Schizophrenia)Positive symptoms
时间窗: Participants will be assessed at baseline and then end of therapy at 12 weeks
Measurement of positive symptoms
次要结局
- PANSS (Positive and Negative Syndrome Scale of Schizophrenia)Negative symptoms(Participants will be assessed at baseline and then end of therapy at 12 weeks)
- PSYRATS (Psychotic Symptom Rating Scales)(Participants will be assessed at baseline and then end of therapy at 12 weeks)
- Schedule for Assessment of Insight(Participants will be assessed at baseline and then end of therapy at 12 weeks)
研究者
Fraooq Naeem
President, Pakistan Association of Cognitive Therapists
Pakistan Association of Cognitive Therapists