Psychological DistressNCT06014476
Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness
An observational study of Psychological Distress and Anxiety Depression, run by Hangzhou Normal University at 1 site in China.
Trial summary
Caregivers of patients with disorders of consciousness are highly prone to developing mental health issues. The aim of this study is to investigate the psychological symptoms and care burden of caregivers of patients with disorders of consciousness (DoC), and to examine which characteristics of patients were burden… Read more about this study
- Who is it for?
- Ages 17 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Anxiety Depression, Burden, Caregiver
- What is being tested?
- questionnaires
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 to 81 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Caregivers of patients with DoC and other diseases
Who may be able to join
- (1) Family caregivers without neurological, mental health, or learning disability history.
- Family caregiver with consciousness and capability of independently completing questionnaires.
Who cannot join
- Caregivers unwilling to participate
- Not the dominant caregivers
Trial locations and contacts
1 site in 1 country.
China1 site
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
Hangzhou, Zhejiang
About this study
Caregivers of patients with disorders of consciousness are highly prone to developing mental health issues. The aim of this study is to investigate the psychological symptoms and care burden of caregivers of patients with disorders of consciousness (DoC), and to examine which characteristics of patients were burden predictors to caregivers.
Read the detailed description
This is a multi-center cross-sectional study in China, from August 2021 to October 2022. Patients were assessed by Coma Recovery Scale-Revised (CRS-R), and caregivers' anxiety, depression, and burden were assessed by State-Trait Anxiety Inventory Form Y (STAI), Beck Depression Inventory-II (BDI- II), and Zarit Caregiver Burden scale (ZBI). The comparison with patients' age and caregivers' age-matched subjects who were randomly selected and without DoC; intra-group comparison of caregivers for DoC was conducted. Descriptive statistics were used to illustrate the socio-demographics. One-sample t-test, independent sample t-test, one-way ANOVA, Mann-Whitney U test, and Kruskal-Wallis test were executed to detect the difference between groups due to the distribution of each variable.
- Being tested
- questionnaires
- Medical subject headings
- Caregiver Burden, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Also called Coma Recovery Scale-Revised (CRS-R)
Sent questionnaires to caregivers and used CRS-R to assess patients with DoC
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Caregivers of patients with disorders of consciousness, including Coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Consciousness State (MCS). And caregivers of patients emerge from the minimally conscious state (EMCS) Receives: Other: questionnaires | |
| Control group | caregivers of patients with other disease Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of anxiety in caregivers of patients with disorders of consciousness.
We use the State-Trait Anxiety Inventory Form Y (STAI-Y) to assess the prevalence and severity degree of anxiety for caregivers of patients with disorders of consciousness (DoC)
STAI was a self-rating scale, consisting of 40 items and divided into two subscales: 1) state anxiety (S-AI) scale includes questions 1-20, state anxiety shows the transitory unpleasant. 2) trait anxiety (T-AI) scale includes questions 21-40, trait anxiety tends to the personality trait. The cumulative score values of state anxiety and trait anxiety scales were calculated respectively, the minimum to maximum value was from 20 to 80, the higher scores mean a worse outcome.
Measured: Within 1 days
The prevalence and severity degree of depression in caregivers of patients with disorders of consciousness.
We use the Beck Depression Inventory-II (BDI-II) to assess the prevalence and severity degree of depression for caregivers of patients with disorders of consciousness (DoC)
BDI total score: 0-13 as no depression, 14-19 as mild depression, 20-28 as medium depression, and 29-63 as severe depression.
Measured: Within 1 days
The prevalence and severity degree of burden in caregivers of patients with disorders of consciousness.
We use the Zarit Caregiver Burden Scale (ZBI) to assess the prevalence and severity degree of burden for caregivers of patients with disorders of consciousness (DoC)
ZBI total score: 0-20 indicates no burden, 21-40 mild burden, 41-60 moderate burden, and 61-88 severe burden.
Measured: Within 1 days
The predictors of anxiety in caregivers of patients with disorders of consciousness.
We choose a series of questionnaires to figure out: what are the characteristics of patients and caregivers were caregivers' anxiety predictors?
The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information) and the State-Trait Anxiety Inventory Form Y (STAI-Y).
We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' anxiety.
Measured: Within 1 days
The predictors of depression in caregivers of patients with disorders of consciousness.
We choose a series of questionnaires to figure out:
(1) What are the characteristics of patients and caregivers were caregivers' depression predictors?
The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information), and the Beck Depression Inventory-II (BDI-II).
We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' depression.
Measured: Within 1 days
The predictors of burden in caregivers of patients with disorders of consciousness.
We choose a series of questionnaires to figure out:
(1) What are the characteristics of patients and caregivers were caregivers' burden predictors?
The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information), and the Zarit Caregiver Burden Scale (ZBI).
We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' burden.
Measured: Within 1 days
Secondary outcomes (4)
The diagnoses of patients with disorders of consciousness (DoC)
The DoC patients were evaluated 3-5 times Coma Recovery Scale-Revised (CRS-R) within 10 days after questionnaire distribution to determine their current state of consciousness.
Measured: Within 10 days
The relationship between patient diagnoses and caregivers' anxiety
We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' anxiety (assessed by the State-Trait Anxiety Inventory Form Y (STAI-Y) )
We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' anxiety.
Measured: Within 1 days
The relationship between patient diagnoses and caregivers' depression
We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' depression (assessed by the Beck Depression Inventory-II (BDI-II) )
We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' depression.
Measured: Within 1 days
The relationship between patient diagnoses and caregivers' burden
We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' depression (assessed by the Zarit Caregiver Burden Scale (ZBI) )
We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' burden.
Measured: Within 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Aug 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies 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
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haibo Di, Hangzhou Normal University
- Investigators
- Hao YA Wang, Study chair, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014476
- Sponsor's protocol ID
- Hangzhou Normal University
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- 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 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT06014476
- Acronym / sponsor ID
- Hangzhou Normal University
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 28 Aug 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.
Caregivers of patients with disorders of consciousness are highly prone to developing mental health issues. The aim of this study is to investigate the psychological symptoms and care burden of caregivers of patients with disorders of consciousness (DoC), and to examine which characteristics of patients were burden predictors to caregivers.
Detailed description
This is a multi-center cross-sectional study in China, from August 2021 to October 2022. Patients were assessed by Coma Recovery Scale-Revised (CRS-R), and caregivers' anxiety, depression, and burden were assessed by State-Trait Anxiety Inventory Form Y (STAI), Beck Depression Inventory-II (BDI- II), and Zarit Caregiver Burden scale (ZBI). The comparison with patients' age and caregivers' age-matched subjects who were randomly selected and without DoC; intra-group comparison of caregivers for DoC was conducted. Descriptive statistics were used to illustrate the socio-demographics. One-sample t-test, independent sample t-test, one-way ANOVA, Mann-Whitney U test, and Kruskal-Wallis test were executed to detect the difference between groups due to the distribution of each variable.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Other: questionnairesCaregivers of patients with disorders of consciousness, including Coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Consciousness State (MCS). And caregivers of patients emerge from the minimally conscious state (EMCS) |
| Control group | – | Other: questionnairescaregivers of patients with other disease |
Who may qualify
- Ages
- 17 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Caregivers of patients with DoC and other diseases
Key inclusion criteria (2 listed)
- (1) Family caregivers without neurological, mental health, or learning disability history.
- Family caregiver with consciousness and capability of independently completing questionnaires.
Key exclusion criteria (2 listed)
- Caregivers unwilling to participate
- Not the dominant caregivers
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 |
|---|---|---|
| questionnairesAlso: Coma Recovery Scale-Revised (CRS-R)Sent questionnaires to caregivers and used CRS-R to assess patients with DoC | Other | Control group, Experimental Group |
Primary outcome
The prevalence of anxiety in caregivers of patients with disorders of consciousness.
Time frame: Within 1 days
We use the State-Trait Anxiety Inventory Form Y (STAI-Y) to assess the prevalence and severity degree of anxiety for caregivers of patients with disorders of consciousness (DoC) STAI was a self-rating scale, consisting of 40 items and divided into two subscales: 1) state anxiety (S-AI) scale includes questions 1-20, state anxiety shows the transitory unpleasant. 2) trait anxiety (T-AI) scale includes questions 21-40, trait anxiety tends to the personality trait. The cumulative score values of state anxiety and trait anxiety scales were calculated respectively, the minimum to maximum value was from 20 to 80, the higher scores mean a worse outcome.
The prevalence and severity degree of depression in caregivers of patients with disorders of consciousness.
Time frame: Within 1 days
We use the Beck Depression Inventory-II (BDI-II) to assess the prevalence and severity degree of depression for caregivers of patients with disorders of consciousness (DoC) BDI total score: 0-13 as no depression, 14-19 as mild depression, 20-28 as medium depression, and 29-63 as severe depression.
The prevalence and severity degree of burden in caregivers of patients with disorders of consciousness.
Time frame: Within 1 days
We use the Zarit Caregiver Burden Scale (ZBI) to assess the prevalence and severity degree of burden for caregivers of patients with disorders of consciousness (DoC) ZBI total score: 0-20 indicates no burden, 21-40 mild burden, 41-60 moderate burden, and 61-88 severe burden.
The predictors of anxiety in caregivers of patients with disorders of consciousness.
Time frame: Within 1 days
We choose a series of questionnaires to figure out: what are the characteristics of patients and caregivers were caregivers' anxiety predictors? The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information) and the State-Trait Anxiety Inventory Form Y (STAI-Y). We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' anxiety.
The predictors of depression in caregivers of patients with disorders of consciousness.
Time frame: Within 1 days
We choose a series of questionnaires to figure out: (1) What are the characteristics of patients and caregivers were caregivers' depression predictors? The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information), and the Beck Depression Inventory-II (BDI-II). We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' depression.
The predictors of burden in caregivers of patients with disorders of consciousness.
Time frame: Within 1 days
We choose a series of questionnaires to figure out: (1) What are the characteristics of patients and caregivers were caregivers' burden predictors? The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information), and the Zarit Caregiver Burden Scale (ZBI). We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' burden.
4 secondary outcomes
The diagnoses of patients with disorders of consciousness (DoC)
Time frame: Within 10 days
The relationship between patient diagnoses and caregivers' anxiety
Time frame: Within 1 days
The relationship between patient diagnoses and caregivers' depression
Time frame: Within 1 days
The relationship between patient diagnoses and caregivers' burden
Time frame: Within 1 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hao YA Wang study chair
Hangzhou Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Distress and Anxiety Depression, run by Hangzhou Normal University 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 28 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of anxiety in caregivers of patients with disorders of consciousness. (time frame: Within 1 days). The study lists 6 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 28 Aug 2023.