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

NCT ID: NCT07236164

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-28
• Study Completion Date: 2026-02-27

Brief Summary

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.

Detailed 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.

Conditions

Depression; Anxiety; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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 as Usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pakistan Association of Cognitive Therapists

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farooq Naeem

Role: PRINCIPAL_INVESTIGATOR

Professional Association of Cognitive Therapy

Locations

Pakistan Association of Cognitive Therapists

Lahore, , Pakistan

Countries

Pakistan

Central Contacts

Laiba Qayyum

Role: CONTACT

laiba90012@gmail.com

+923021474287

Farooq Naeem

Role: CONTACT

farooqnaeem7@gmail.com

+16137706890

Other Identifiers

RCTCANCER2025

Identifier Type: -

Identifier Source: org_study_id