跳至主要内容
临床试验/NCT01799551
NCT01799551已完成不适用

A Randomised Controlled Trial of Brief Culturally Adapted CBT for Depression in Pakistan

Pakistan Association of Cognitive Therapists1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2012年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Hospital Anxiety and depression Rating Scale- Depression subscale

研究概览

简要总结

Cognitive behaviour therapy (CBT) has an effective evidence base in the west and is recommended by the national bodies in many countries in the West. Our group has adapted CBT for depression and psychosis in Pakistan for use with local clients. Initial evaluations have found that these therapies are effective. However, due to the financial restraints it would be useful if the investigators find that brief version of the CBT might be applicable and effective in non western cultures. Therefore in this study, the investigators will be testing effectiveness of brief version of culturally adapted CBT for depression in a randomized controlled trial (RCT) in Pakistan.

详细描述

BACKGROUND There is a strong evidence base in favour of the CBT on its role in treating Depression and Anxiety (Embling et. al., 2002; Thase et. al., 2000; Rief. et .al, 2000)). CBT has been shown to be effective for prophylaxis (Shaw, 1989) and for the prevention of depressive relapse (Paykel et al, 1999, Fava et al; 1999). The current evidence suggests that Cognitive Behaviour Therapy (CBT) is as effective as antidepressants for treating depression (DeRubeis, Hollon et al. 1982; Murphy, Simons et al. 1984; Simons, Murphy et al. 1986), and is more effective than antidepressants in preventing relapse (Evans, Hollon et al. 1992; Hollon, DeRubeis et al. 1992). CBT is now included in national treatment guidelines in the USA and the UK (e.g. APA, 2004; NICE, 2004). However, in spite of the large body of the evidence suggesting effectiveness of the CBT for depression in the West, little progress has been made in its delivery in developing countries.

Cognitive behavioral therapy for depression was developed by Beck (Beck et al, 1979). CBT focuses on "how depressed people think and perceive themselves, others and their future". The key aspects of therapy include, taking an educative approach, working in collaboration with the client and develop insights through a Socratic dialogue. The therapist helps the depressed person to learn to recognize his "negative thinking patterns" and to re-evaluate his thinking. Clients are asked to carry out exercises at home to learn new ways of dealing with their problems (called homework). Modern psychotherapies were developed in the west and hence are likely to be underpinned by western values. It is therefore believed that CBT might need modification before it can be used in the non-western cultures because it involves exploration and attempts to modify automatic thoughts and core beliefs (Padesky et al, 1995). A systematic literature search found few studies of cognitive therapy from the non western world. However, the research so far indicates towards effectiveness of this therapy (Sumathipala, 2008, Araya et al, 2003, Wong et al, 2008 & Rahman et al, 2009). We have adapted CBT for depression in Pakistan (Naeem et al, 2009) and a pilot study to evaluate the effectiveness of CBT has shown it to be effective (Naeem et al, 2011).

The focus of the mental health services in Pakistan seem to be in the secondary care. Psychiatric services are available in major cities and patients come to see professionals from around the country. As such it seems only logical that we try to assess the effectiveness of CBT in secondary care. However, given the deficits in resources both human and financial, as well as based on the experience of our team, it will make more sense if we evaluate brief interventions. In this trial we would like to test the applicability of a brief culturally adapted CBT for patients with depression who attend secondary care in Pakistan.

Methodology Objective To assess effectiveness of brief Culturally Sensitive CBT (CS-CBT) for depression against care as usual.

Study design and duration This study is a Randomized Control Trial (RCT) which aims to assess effectiveness of brief Culturally Sensitive CBT (CS-CBT) against care as usual for depression. Study participants will be randomly assigned to two groups the intervention group will receive brief CBT developed and adapted for use in Pakistan using a series of qualitative studies (Naeem et.al 2009).

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, Investigator)

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

入选标准

  • All those who fulfil the diagnostic criteria of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (based on interviews using SCAN Urdu version),
  • Are between the ages of 19-60,
  • Score 8 or more on HADS, Depression Subscale, and
  • Who live within traveling distance of the psychiatry department will be approached

排除标准

  • Excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence)
  • Significant cognitive impairment (for example learning disability or dementia) and
  • Active psychosis

结局指标

主要结局

Hospital Anxiety and depression Rating Scale- Depression subscale

时间窗: Participants will be assessed at baseline and then end of therapy at 12 weeks

Measurement of depression

次要结局

  • Hospital Anxiety and Depression Scale, Anxiety subscale(Participants will be assessed at baseline and then end of therapy at 12 weeks)
  • Bradford Somatic Inventory(Participants will be assessed at baseline and then end of therapy at 12 weeks)
  • Brief disability questionnaire(Participants will be assessed at baseline and then end of therapy at 12 weeks)

研究者

发起方
Pakistan Association of Cognitive Therapists
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fraooq Naeem

President, Pakistan Association of Cognitive Therapists

Pakistan Association of Cognitive Therapists

研究点 (1)

Loading locations...

相似试验

Brief Culturally Adapted Cognitive Behaviour Therapy... | 临床试验