Effectiveness of a Guided Self-Help CBT Manual 'KOK' in Cancer Patients

Pakistan Association of Cognitive Therapists

Status: Not yet enrolling

Conditions: Cancer; Depression; Anxiety

Treatments: Behavioral: Culturally adapted guided self-help CBT manual 'Khushi or Khatoon (KoK)'

Study type: Interventional

Funder types: Other

Identifiers

NCT07236164

RCTCANCER2025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

108 participants in 2 patient groups

Culturally adapted guided self-help CBT manual 'Khushi or Khatoon (KoK)'

Experimental group

Description:

Participants will receive the culturally adapted Guided self-help CBT manual 'Khushi or Khatoon (KoK)'. The manual includes eight modules on managing anxiety and depression. The modules focus on cognitive restructuring, problem solving, behavioural activation, conflict management, interpersonal relationships, mental health and well-being, and self-care. Each module is delivered over one week. The intervention uses culturally appropriate stories, drawings, and examples from local folklore and religious contexts to describe the concepts of CBT.

Treatment:

Behavioral: Culturally adapted guided self-help CBT manual 'Khushi or Khatoon (KoK)'

Treatment as Usual

No Intervention group

Description:

Receive usual care, which may include standard support provided by the oncology team.