DepressionNCT05942560
Effects of CBT-Based Intervention Among Patients With Liver Cancer
A study testing Cognitive behavioural therapy-based intervention and Educational group in people with Depression and Anxiety, run by The Nethersole School of Nursing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Liver Cancer
- What is being tested?
- Cognitive behavioural therapy-based intervention and Educational group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2023to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (aged ≥18);
- Diagnosed with liver cancer based on pathological findings or imaging findings in the medical record;
- 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).
Who cannot join
- 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
- Patients with active immunological diseases, such as autoimmune diseases, and inflammatory diseases.
- Patients accepting hormone therapy or taking long-term antibiotic drugs.
- Patients who lack the basic ability of understanding and expression and are incompetent in giving consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Cognitive Behavioral Therapy-Based Intervention on Depression, Anxiety, Quality of Life, Immune Indicators, and Survival Among Patients With Liver Cancer
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.
Read the 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.
- Conditions
- Depression, Anxiety, Liver Cancer, CBT
- Being tested
- Cognitive behavioural therapy-based intervention, Educational group
- Keywords
- cognitive behavioural therapy, depression, anxiety, immune, quality of life, survival, liver cancer
- Medical subject headings
- Depression, Anxiety Disorders, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapy-based interventionBehavioural
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 groupBehavioural
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 group | Role | What they receive |
|---|---|---|
| Cognitive behavioural therapy-based(CBT-based) intervention group | Experimental | A specifically designed CBT-based intervention consisting of 8 weekly sessions will be conducted in a group format. Receives: Behavioral: Cognitive behavioural therapy-based intervention |
| Control group | Active comparator | Participants will receive eight health education sessions simultaneously with the CBT-based intervention group. Receives: Behavioral: Educational group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms at 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.
Measured: T0(Baseline)
Change in depression symptoms at 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.
Measured: T1(3 months)
Change in depression symptoms at 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.
Measured: T2(6 months)
Change in depression symptoms at 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.
Measured: T3(12 months)
Anxiety symptoms at 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.
Measured: T0(Baseline)
Change in anxiety symptoms at 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.
Measured: T1(3 months)
Change in anxiety symptoms at 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.
Measured: T2(6 months)
Change in anxiety symptoms at 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.
Measured: T3(12 months)
Secondary outcomes (24)
Quality of life score (The EORTC QLQ-C30) at baseline
The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results.
Scores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Measured: T0(Baseline)
Change in Quality of life score (The EORTC QLQ-C30) at 3 months
The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results.
Scores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Measured: T1(3 months)
Change in Quality of life score (The EORTC QLQ-C30) at 6 months
The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results.
Scores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Measured: T2(6 months)
Change in Quality of life score (The EORTC QLQ-C30) at 12 months
The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results.
Scores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Measured: T3(12 months)
Quality of life score (The EORTC QLQ-HCC18) at baseline
The Hepatocellular Carcinoma Module of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Scores range from 0 to 100. A higher score represents a high level of symptomatology or problems.
Measured: T0(Baseline)
Change in Quality of life score (The EORTC QLQ-HCC18) at 3 months
The Hepatocellular Carcinoma Module of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Scores range from 0 to 100. A higher score represents a high level of symptomatology or problems.
Measured: T1(3 months)
Change in Quality of life score (The EORTC QLQ-HCC18) at 6 months
The Hepatocellular Carcinoma Module of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Scores range from 0 to 100. A higher score represents a high level of symptomatology or problems.
Measured: T2(6 months)
Change in Quality of life score (The EORTC QLQ-HCC18) at 12 months
The Hepatocellular Carcinoma Module of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Scores range from 0 to 100. A higher score represents a high level of symptomatology or problems.
Measured: T3(12 months)
Immune variables 1 at baseline
Total lymphocyte count. Collected from daily medical records.
Measured: T0(Baseline)
Change in Immune variables 1 at 3 months
Total lymphocyte count. Collected from daily medical records.
Measured: T1(3 months)
Change in Immune variables 1 at 6 months
Total lymphocyte count. Collected from daily medical records.
Measured: T2(6 months)
Immune variables 2 at baseline
Level of IFN-γ. Collected from blood sample.
Measured: T0(Baseline)
Change in Immune variables 2 at 3 months
Level of IFN-γ. Collected from blood sample.
Measured: T1(3 months)
Change in Immune variables 2 at 6 months
Level of IFN-γ. Collected from blood sample.
Measured: T2(6 months)
Immune variables 3 at baseline
IL-2. Collected from blood sample.
Measured: T0(Baseline)
Change in Immune variables 3 at 3 months
IL-2. Collected from blood sample.
Measured: T1(3 months)
Change in Immune variables 3 at 6 months
IL-2. Collected from blood sample.
Measured: T2(6 months)
Immune variables 4 at baseline
IL-4. Collected from blood sample.
Measured: T0(Baseline)
Change in Immune variables 4 at 3 months
IL-4. Collected from blood sample.
Measured: T1(3 months)
Change in Immune variables 4 at 6 months
IL-4. Collected from blood sample.
Measured: T2(6 months)
Immune variables 5 at baseline
IL-6. Collected from blood sample.
Measured: T0(Baseline)
Change in Immune variables 5 at 3 months
IL-6. Collected from blood sample.
Measured: T1(3 months)
Change in Immune variables 5 at 6 months
IL-6. Collected from blood sample.
Measured: T2(6 months)
Overall survival
Survival status form follow-up
Measured: T3 (12 months) and later till the end of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start30 Dec 2023 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a parallel, multicenter, randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Nethersole School of Nursing
- Sponsor type
- University, hospital or other
- Collaborators
- ZhuHai Hospital
- Responsible party
- Principal investigator, Hua Yin, The Nethersole School of Nursing
- Investigators
- Hua Yin, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942560
- Sponsor's protocol ID
- CREC2022.328
- Status last verified
- Nov 2023
- First submitted
- 25 Jun 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Behavioral Therapy-Based Intervention on Depression, Anxiety, Quality of Life, Immune Indicators, and Survival Among Patients With Liver Cancer
- ClinicalTrials.gov ID
- NCT05942560
- Acronym / sponsor ID
- CREC2022.328
- Conditions
- Depression, Anxiety, Liver Cancer, CBT
- Keywords
- cognitive behavioural therapy, depression, anxiety, immune, quality of life, survival, liver cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Nethersole School of NursingUniversity, hospital or other
- Collaborators
- ZhuHai Hospital
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be a parallel, multicenter, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioural therapy-based(CBT-based) intervention group | Experimental | Behavioral: Cognitive behavioural therapy-based interventionA specifically designed CBT-based intervention consisting of 8 weekly sessions will be conducted in a group format. |
| Control group | Active comparator | Behavioral: Educational groupParticipants will receive eight health education sessions simultaneously with the CBT-based intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (aged ≥18);
- Diagnosed with liver cancer based on pathological findings or imaging findings in the medical record;
- 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).
Key exclusion criteria (4 listed)
- 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
- Patients with active immunological diseases, such as autoimmune diseases, and inflammatory diseases.
- Patients accepting hormone therapy or taking long-term antibiotic drugs.
- Patients who lack the basic ability of understanding and expression and are incompetent in giving consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural therapy-based interventionA 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. | Behavioural | Cognitive behavioural therapy-based(CBT-based) intervention group |
| Educational groupThe 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. | Behavioural | Control group |
Primary outcome
Depression symptoms at baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
24 secondary outcomes
Quality of life score (The EORTC QLQ-C30) at baseline
Time frame: T0(Baseline)
Change in Quality of life score (The EORTC QLQ-C30) at 3 months
Time frame: T1(3 months)
Change in Quality of life score (The EORTC QLQ-C30) at 6 months
Time frame: T2(6 months)
Change in Quality of life score (The EORTC QLQ-C30) at 12 months
Time frame: T3(12 months)
Quality of life score (The EORTC QLQ-HCC18) at baseline
Time frame: T0(Baseline)
Change in Quality of life score (The EORTC QLQ-HCC18) at 3 months
Time frame: T1(3 months)
Change in Quality of life score (The EORTC QLQ-HCC18) at 6 months
Time frame: T2(6 months)
Change in Quality of life score (The EORTC QLQ-HCC18) at 12 months
Time frame: T3(12 months)
Immune variables 1 at baseline
Time frame: T0(Baseline)
Change in Immune variables 1 at 3 months
Time frame: T1(3 months)
Change in Immune variables 1 at 6 months
Time frame: T2(6 months)
Immune variables 2 at baseline
Time frame: T0(Baseline)
Change in Immune variables 2 at 3 months
Time frame: T1(3 months)
Change in Immune variables 2 at 6 months
Time frame: T2(6 months)
Immune variables 3 at baseline
Time frame: T0(Baseline)
Change in Immune variables 3 at 3 months
Time frame: T1(3 months)
Change in Immune variables 3 at 6 months
Time frame: T2(6 months)
Immune variables 4 at baseline
Time frame: T0(Baseline)
Change in Immune variables 4 at 3 months
Time frame: T1(3 months)
Change in Immune variables 4 at 6 months
Time frame: T2(6 months)
Immune variables 5 at baseline
Time frame: T0(Baseline)
Change in Immune variables 5 at 3 months
Time frame: T1(3 months)
Change in Immune variables 5 at 6 months
Time frame: T2(6 months)
Overall survival
Time frame: T3 (12 months) and later till the end of life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hua Yin principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy-based intervention and Educational group in people with Depression and Anxiety, run by The Nethersole School of Nursing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hua Yin (+8613823013393, huayin0408@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms at baseline (time frame: T0(Baseline)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.