To hear about similar clinical trials, please enter your email below
Trial Title:
Effects of CBT-Based Intervention Among Patients With Liver Cancer
NCT ID:
NCT05942560
Condition:
Depression
Anxiety
Liver Cancer
CBT
Conditions: Official terms:
Liver Neoplasms
Depression
Depressive Disorder
Anxiety Disorders
Conditions: Keywords:
cognitive behavioural therapy
depression
anxiety
immune
quality of life
survival
liver cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The study will be a parallel, multicenter, randomized controlled trial.
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
We will ensure that the assessors are unaware of the treatment assignments or
intervention details for each participant. We will use anonymized coded data that does
not reveal the group allocation during the outcome assessment. The data will be presented
in a standardized format that prevents any identification of treatment groups.
Intervention:
Intervention type:
Behavioral
Intervention name:
Cognitive behavioural therapy-based intervention
Description:
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.
Arm group label:
Cognitive behavioural therapy-based(CBT-based) intervention group
Intervention type:
Behavioral
Intervention name:
Educational group
Description:
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.
Arm group label:
Control group
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhuhai People's Hospital
Address:
City:
Zhuhai
Zip:
519000
Country:
China
Start date:
December 30, 2023
Completion date:
June 30, 2029
Lead sponsor:
Agency:
The Nethersole School of Nursing
Agency class:
Other
Collaborator:
Agency:
ZhuHai Hospital
Agency class:
Other
Source:
The Nethersole School of Nursing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05942560
