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

November 22, 2025 updated by: Pakistan Association of Cognitive Therapists

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
No Intervention: Treatment as Usual
Receive usual care, which may include standard support provided by the oncology team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks
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.
8 weeks
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Association of Cognitive Therapists

Investigators

  • Principal Investigator: Farooq Naeem, Professional Association of Cognitive Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 28, 2025

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

February 27, 2026

Study Registration Dates

First Submitted

September 25, 2025

First Submitted That Met QC Criteria

November 15, 2025

First Posted (Estimated)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 22, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCTCANCER2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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