Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07236164

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Association of Cognitive Therapists

Lahore, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Preliminary efficacy of Guided self-help CBT manual 'Khushi or Khatoon' in treating depression and anxiety in cancer patients

    Time frame: 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.

  2. Feasibility of the Guided Self-Help CBT manual 'Khushi or Khatoon' for depressed and anxious cancer patients

    Time frame: 8 weeks

    By using indicators like recruitment success, dropout rates, and completion rates recorded in numbers during study

  3. Acceptability of the Guided Self-Help CBT manual 'Khushi or Khatoon' in depressed and anxious cancer patients

    Time frame: 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.

Secondary outcomes

  1. Quality of life of cancer patients

    Time frame: 8 weeks

    By comparing pre- and post-therapy scores on the World Health Organization Disability Assessment Schedule. The average score on the scale ranges from 0-4. Low score indicates less decline in functioning. Thus, decreased post-assessment scale score is the desired outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Farooq Naeem

CONTACT

[email protected]

+16137706890

Laiba Qayyum

CONTACT

[email protected]

+923021474287

Sponsors and collaborators

Lead sponsor

Pakistan Association of Cognitive Therapists

Other

Registry information

Official study title

Effectiveness of the Guided Self-Help CBT Manual 'Khushi or Khatoon (KoK)' in Cancer Patients: A Randomised Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.