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

NCT07236164 | Not Yet Recruiting

• 1 other identifier: RCTCANCER2025
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Cancer

Keywords

Depression; Anxiety; Guided self-help; Cancer; CBT

Outcome Measures

Primary Outcomes (3)

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

  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

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

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

  8 weeks

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

  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 Outcomes (1)

• Quality of life of cancer patients

  8 weeks

Study Arms (2)

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

EXPERIMENTAL

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)'

Treatment as Usual

NO INTERVENTION

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

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Association of Cognitive Therapists: lead

Study Sites (1)

Pakistan Association of Cognitive Therapists

Lahore, Pakistan

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Farooq Naeem

  Professional Association of Cognitive Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laiba Qayyum

CONTACT

+923021474287; laiba90012@gmail.com

Farooq Naeem

CONTACT

+16137706890; farooqnaeem7@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a randomized controlled trial with two parallel groups: an intervention group receiving the CBT self-help manual and a control group receiving usual care.

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: November 19, 2025
• Study Start: December 28, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 27, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)