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

Completed

• Conditions: Psychological Distress; Disorders of Consciousness; Anxiety Depression; Burden, Caregiver
• Interventions: Other: questionnaires

• Registration Number: NCT06014476
• Lead Sponsor: Hangzhou Normal University

Brief 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.

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 Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-08
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-23
• Last Update Submitted: 2023-08-23
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Group	questionnaires	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)
Control group	questionnaires	caregivers of patients with other disease

Primary Outcome Measures

Name	Time	Method
The prevalence of anxiety in caregivers of patients with disorders of consciousness.	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 burden in caregivers of patients with disorders of consciousness.	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 depression in caregivers of patients with disorders of consciousness.	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.	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.
The predictors of anxiety in caregivers of patients with disorders of consciousness.	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 prevalence and severity degree of depression in caregivers of patients with disorders of consciousness.	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.

Secondary Outcome Measures

Name	Time	Method
The relationship between patient diagnoses and caregivers' burden	Within 1 days	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.
The diagnoses of patients with disorders of consciousness (DoC)	Within 10 days	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.
The relationship between patient diagnoses and caregivers' anxiety	Within 1 days	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.
The relationship between patient diagnoses and caregivers' depression	Within 1 days	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.

Trial Locations

Locations (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University; 🇨🇳 Hangzhou, Zhejiang, China