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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07236164
Enrollment
108
Registered
2025-11-19
Start date
2025-12-28
Completion date
2026-02-27
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Cancer, Depression

Keywords

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

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.

Interventions

BEHAVIORALCulturally 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.

Sponsors

Pakistan Association of Cognitive Therapists
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Preliminary efficacy of Guided self-help CBT manual 'Khushi or Khatoon' in treating depression and anxiety in cancer patients8 weeksBy 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.
Feasibility of the Guided Self-Help CBT manual 'Khushi or Khatoon' for depressed and anxious cancer patients8 weeksBy using indicators like recruitment success, dropout rates, and completion rates recorded in numbers during study
Acceptability of the Guided Self-Help CBT manual 'Khushi or Khatoon' in depressed and anxious cancer patients8 weeksAssessed 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

MeasureTime frameDescription
Quality of life of cancer patients8 weeksBy 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.

Countries

Pakistan

Contacts

Primary ContactLaiba Qayyum
laiba90012@gmail.com+923021474287
Backup ContactFarooq Naeem
farooqnaeem7@gmail.com+16137706890

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026