Health TrialsbyHealthPanel

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

ConditionsDepressionAnxietyCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPakistan Association of Cognitive Therapists

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥ 18 years)

Clinical diagnosis of cancer

Experiencing moderate to severe psychological distress (HADS score ≥ 8)

Able to read and write the Urdu language

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Culturally adapted guided self-help CBT manual 'Khushi or Khatoon (KoK)'Experimental treatment 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
8 weeks
2

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

Time frame
8 weeks
3

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.

Time frame
8 weeks

Secondary outcomes

1

Quality of life of cancer patients

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.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pakistan Association of Cognitive Therapists

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: