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Clinical Trials in China / NCT05942560
Starting soon Not applicable

Effects of CBT-Based Intervention Among Patients With Liver Cancer

NCT05942560 · tracked via the Priya Life Science China tracker
Sponsor
The Nethersole School of Nursing
Phase
Not applicable
Started
2023-12-30
Last updated
2023-11-22

Condition(s) studied

DepressionAnxietyLiver CancerCBT

Investigational drug(s) / intervention(s)

Cognitive behavioural therapy-based interventionEducational group

Cognitive behavioural therapy-based intervention: A specifically designed CBT-based intervention consisting of 8 weekly sessions with group format. Each group will be comprised of 4-10 participants, and each session will last 1.5 hours. The content of the weekly sessions will be based on Beck's cognitive theory and the cognitive therapy in groups guidelines. The framework of every session will follow a pre-determined structure.

Educational group: The educational sessions are consisting of 8 weekly sessions with a group format. These sessions will focus on cancer-related information and care knowledge which will be delivered in daily routine care.

Study summary

This study investigates the effects of a CBT- based intervention on depression, anxiety, immune function, quality of life, and overall survival. It also explores if the effects of the intervention on immune function and quality of life are mediated through the improvements in depression and anxiety among patients with liver cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adults (aged ≥18); 2. Diagnosed with liver cancer based on pathological findings or imaging findings in the medical record; 3. The severity level of depression and anxiety: Depression \> 7 using HAD-D, or Anxiety \> 7 using HAD-A (Hospital Anxiety and Depression Scale, HADS; HAD-D, Hospital Depression Scale; HAD-A, Hospital Anxiety Scale). Exclusion Criteria: 1. Patients who are taking part in another psychological intervention clinical trial or consented to receive another psychotherapy, suffered from aphasia and other communication difficulties will be excluded from the study 2. Patients with active immunological diseases, such as autoimmune diseases, and inflammatory diseases. 3. Patients accepting hormone therapy or taking long-term antibiotic drugs. 4. Patients who lack the basic ability of understanding and expression and are incompetent in giving consent.

Primary outcome measure(s)

  • Depression symptoms at baseline — T0(Baseline)
    Participants' depression score with the depression subscale of the Hospital depression and Depression Scale (HADS). The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.
  • Change in depression symptoms at 3 months — T1(3 months)
    Change in participants' depression score with the HADS depression subscale from baseline to 3 months. The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.
  • Change in depression symptoms at 6 months — T2(6 months)
    Change in participants' depression score with the HADS depression subscale from baseline to 6 months. The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.
  • Change in depression symptoms at 12 months — T3(12 months)
    Change in participants' depression score with the HADS depression subscale from baseline to 12 months. The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.
  • Anxiety symptoms at baseline — T0(Baseline)
    Participants' anxiety score with the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
  • Change in anxiety symptoms at 3 months — T1(3 months)
    Change in participants' anxiety score with the HADS anxiety subscale from baseline to 3 months. The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
  • Change in anxiety symptoms at 6 months — T2(6 months)
    Change in participants' anxiety score with the HADS anxiety subscale from baseline to 6 months. The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
  • Change in anxiety symptoms at 12 months — T3(12 months)
    Change in participants' anxiety score with the HADS anxiety subscale from baseline to 12 months. The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.

Trial sites (1)

FacilityCityRegionStatus
Zhuhai People's Hospital Zhuhai Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05942560 on ClinicalTrials.gov ↗ ← All trials in China