Clinical trial NCT06014476: Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness
Official title: Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Distress
Anxiety Depression
Burden, Caregiver
Disorders of Consciousness
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 256
Sex: ALL
Minimum age (years): 17
Maximum age (years): 81
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Caregivers of patients with DoC and other diseases

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.

Eligibility criteria: 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

Primary outcomes:
measure: The prevalence of anxiety in caregivers of patients with disorders of consciousness.
timeFrame: Within 1 days
measure: The prevalence and severity degree of depression in caregivers of patients with disorders of consciousness.
timeFrame: Within 1 days
measure: The prevalence and severity degree of burden in caregivers of patients with disorders of consciousness.
timeFrame: Within 1 days
measure: The predictors of anxiety in caregivers of patients with disorders of consciousness.
timeFrame: Within 1 days
measure: The predictors of depression in caregivers of patients with disorders of consciousness.
timeFrame: Within 1 days
measure: The predictors of burden in caregivers of patients with disorders of consciousness.
timeFrame: Within 1 days
Secondary outcomes:
measure: The diagnoses of patients with disorders of consciousness (DoC)
timeFrame: Within 10 days
measure: The relationship between patient diagnoses and caregivers' anxiety
timeFrame: Within 1 days
measure: The relationship between patient diagnoses and caregivers' depression
timeFrame: Within 1 days
measure: The relationship between patient diagnoses and caregivers' burden
timeFrame: Within 1 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
state: Zhejiang
Study officials:
affiliation: Hangzhou Normal University
name: Hao YA Wang
role: STUDY_CHAIR
References: