Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness

Psychological Distress Clinical Trial

Official title:

Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06014476
• Other study ID #: Hangzhou Normal University
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: August 2023
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 predictors to caregivers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 81 Years

Eligibility

Inclusion Criteria:

• (1) Family caregivers without neurological, mental health, or learning disability history.

(2) Family caregiver with consciousness and capability of independently completing questionnaires.

Exclusion criteria:

1. Caregivers unwilling to participate

2. Not the dominant caregivers

Related Conditions & MeSH terms

• Anxiety Depression
• Caregiver Burden
• Consciousness Disorders
• Disorders of Consciousness
• Psychological Distress

Intervention

Other:
• questionnaires
Sent questionnaires to caregivers and used CRS-R to assess patients with DoC

Locations

Country	Name	City	State
China	International Vegetative State and Consciousness Science Institute, Hangzhou Normal University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 1 days
Primary	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.	Within 1 days
Primary	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.	Within 1 days
Primary	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.	Within 1 days
Primary	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.	Within 1 days
Primary	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.	Within 1 days
Secondary	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.	Within 10 days
Secondary	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.	Within 1 days
Secondary	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.	Within 1 days
Secondary	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.	Within 1 days