Effects of CBT-Based Intervention Among Patients With Liver Cancer

The Nethersole School of Nursing

Status: Not yet enrolling

Conditions: CBT; Depression; Anxiety; Liver Cancer

Treatments: Behavioral: Cognitive behavioural therapy-based intervention; Behavioral: Educational group

Study type: Interventional

Funder types: Other

Identifiers

NCT05942560

CREC2022.328

Details and patient eligibility

About

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.

Full description

In the present research project, the investigators have developed a Cognitive Behavioral Therapy (CBT)-based intervention protocol to investigate the impact of this intervention on depression, anxiety, quality of life, immune function, and overall survival in patients diagnosed with liver cancer. Additionally, this research protocol aims to examine the hypothesized mechanisms underlying the effects of the CBT-based intervention on quality of life and immune function. Specifically, we will investigate: 1) whether the effect of the CBT-based intervention on quality of life is mediated by improvements in anxiety and depression, and 2) whether the effect of the CBT-based intervention on immune function is mediated by improvements in anxiety and depression among patients with liver cancer.

A total of 160 participants will be recruited and randomly assigned to either the CBT-based intervention group or an educational group receiving non-psychological interventions. Assessments will be conducted at baseline (pre-treatment) and at 3, 6, and 12 months after the intervention period. Survival data will be collected throughout the follow-up period until the patients' end-of-life.

By examining the effects of the CBT-based intervention on multiple outcomes and exploring the potential mediating mechanisms, this research project aims to contribute to a comprehensive understanding of the intervention's effectiveness and its impact on the well-being of liver cancer patients.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Cognitive behavioural therapy-based(CBT-based) intervention group

Experimental group

Description:

A specifically designed CBT-based intervention consisting of 8 weekly sessions will be conducted in a group format.

Treatment:

Behavioral: Cognitive behavioural therapy-based intervention

Control group

Active Comparator group

Description:

Participants will receive eight health education sessions simultaneously with the CBT-based intervention group.

Treatment:

Behavioral: Educational group