Effectiveness of the Guided Self-Help CBT Manual 'Khushi or Khatoon (KoK)' in Cancer Patients: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Preliminary efficacy of Guided self-help CBT manual 'Khushi or Khatoon' in treating depression and anxiety in cancer patients
研究概览
简要总结
This study aimed to assess the feasibility, acceptability, and preliminary efficacy of the Guided self-help CBT intervention 'Khushi or Khatoon' to treat anxiety and depression, and enhance quality of life and satisfaction with treatment in cancer patients.
详细描述
Cancer diagnosis and treatment are profoundly distressing experiences that can lead to significant psychological challenges, including depression, anxiety, and fear of recurrence. These psychological issues not only affect the quality of life of cancer patients but can also interfere with their physical health, treatment adherence, and overall recovery.
Cognitive Behavioural Therapy (CBT) is an evidence-based psychological intervention that has been widely recognised for its effectiveness in managing anxiety and depression in various patient populations, including cancer patients. CBT focuses on identifying and changing negative thought patterns and behaviours that contribute to emotional distress. However, access to skilled therapists may be limited, especially in resource-constrained settings, or for patients who are unable to attend in-person sessions due to their condition or logistical issues.
Various CBT-based self-help programs are effective in the West (Cuijpers, 1997; Gould and Clum, 1993; Marrs, 1995; Scogin et al., 1990). However, CBT requires a person to be literate, especially for guided self-help or self-help. Pakistan has a literacy rate (ability to read or write) of 58%. An estimated 67% of children study up to primary level (years 1-5), and an estimated 43% have achieved secondary education (up to year 12). These are mostly people from low socio-economic backgrounds who are less likely to suffer from mental health problems such as depression and anxiety.
A Guided self-help CBT manual, based on the core principles of CBT, could provide an accessible, cost-effective way to support cancer patients in managing their psychological distress. This study aims to evaluate the effectiveness of such a self-help manual in reducing symptoms of anxiety, depression, and overall psychological distress among cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Adults (≥ 18 years)
- •Clinical diagnosis of cancer
- •Experiencing moderate to severe psychological distress (HADS score ≥ 8)
- •Able to read and write the Urdu language
- •Willing to participate and provide informed consent
排除标准
- •Severe psychiatric conditions requiring immediate intervention/hospitalisation
- •Cognitive impairments preventing understanding of the manual/therapy
- •Visual impairments that may prevent the reading of the manual
- •Already been receiving any psychological therapy
结局指标
主要结局
Preliminary efficacy of Guided self-help CBT manual 'Khushi or Khatoon' in treating depression and anxiety in cancer patients
时间窗: 8 weeks
By comparing pre- and post-therapy depression and anxiety scores using the Hospital Anxiety and Depression Scale. The scale has a score range of 0-21 with a cut off of 8, higher scores indicate clinically significant depression/anxiety. A low post-treatment score on the Hospital Anxiety and Depression Scale is the desired outcome.
Feasibility of the Guided Self-Help CBT manual 'Khushi or Khatoon' for depressed and anxious cancer patients
时间窗: 8 weeks
By using indicators like recruitment success, dropout rates, and completion rates recorded in numbers during study
Acceptability of the Guided Self-Help CBT manual 'Khushi or Khatoon' in depressed and anxious cancer patients
时间窗: 8 weeks
Assessed through patients' satisfaction using the Verona satisfaction scale. An average score on the scale ranges from 1-5. High score on the scale indicates more satisfaction with the treatment and thus is the desired outcome.
Preliminary efficacy of Guided self-help CBT manual 'Khushi or Khatoon' in treating depression and anxiety in cancer patients
时间窗: 8 weeks
By comparing pre- and post-therapy depression and anxiety scores using the Hospital Anxiety and Depression Scale. The scale has a score range of 0-21 with a cut off of 8, higher scores indicate clinically significant depression/anxiety. A low post-treatment score on the Hospital Anxiety and Depression Scale is the desired outcome.
Feasibility of the Guided Self-Help CBT manual 'Khushi or Khatoon' for depressed and anxious cancer patients
时间窗: 8 weeks
By using indicators like recruitment success, dropout rates, and completion rates recorded in numbers during study
Acceptability of the Guided Self-Help CBT manual 'Khushi or Khatoon' in depressed and anxious cancer patients
时间窗: 8 weeks
Assessed through patients' satisfaction using the Verona satisfaction scale. An average score on the scale ranges from 1-5. High score on the scale indicates more satisfaction with the treatment and thus is the desired outcome.
次要结局
- Quality of life of cancer patients(8 weeks)
- Quality of life of cancer patients(8 weeks)